WorldWideScience

Sample records for arthritis clinical trials

  1. Prospective Clinical Trial for Septic Arthritis

    DEFF Research Database (Denmark)

    Schmal, Hagen; Bernstein, Anke; Feucht, Matthias J

    2016-01-01

    Background. Intra-articular infections can rapidly lead to osteoarthritic degradation. The aim of this clinical biomarker analysis was to investigate the influence of inflammation on cartilage destruction and metabolism. Methods. Patients with acute joint infections were enrolled in a prospective...

  2. Clinical trials of new drugs for the treatment of rheumatoid arthritis: focus on early disease

    NARCIS (Netherlands)

    Smolen, Josef S.; Collaud Basset, Sabine; Boers, Maarten; Breedveld, Ferdinand; Edwards, Christopher J.; Kvien, Tore K.; Miossec, Pierre; Sokka-Isler, Tuulikki; van Vollenhoven, Ronald F.; Abadie, Eric C.; Bruyère, Olivier; Cooper, Cyrus; Mäkinen, Heidi; Thomas, Thierry; Tugwell, Peter; Reginster, Jean-Yves

    2016-01-01

    The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases convened a task force of experts in rheumatoid arthritis (RA) and clinical trial methodology to comment on the new draft 'Guideline on clinical investigation of medicinal products for

  3. Optimal use of MRI in clinical trials, clinical care and clinical registries of patients with rheumatoid arthritis

    DEFF Research Database (Denmark)

    Østergaard, Mikkel; Møller-Bisgaard, Signe

    2014-01-01

    the benefits of including MRI in treat-to-target strategies. The benefits of incorporating MRI into clinical registries are not yet known, but may include improved knowledge about the real-life advantages of MRI, as well as opportunities to develop better clinical and laboratory composite measures to monitor......Magnetic resonance imaging (MRI) clearly is more sensitive than clinical examination and conventional radiography (x-ray) for detection of inflammation (synovitis, bone marrow oedema (osteitis) and tenosynovitis) and damage (bone erosion and cartilage loss/joint space narrowing) in patients...... with rheumatoid arthritis (RA). The question is when and how MRI should be used. The present article reviews our knowledge about, and provides suggestions for, the use of MRI in clinical trials, clinical care and clinical registries. In clinical trials, the OMERACT RA MRI scoring system (RAMRIS) is a thoroughly...

  4. Formative research in clinical trial development: attitudes of patients with arthritis in enhancing prevention trials

    Science.gov (United States)

    Taylor, Holly A; Sugarman, Jeremy; Pisetsky, David S; Bathon, Joan

    2007-01-01

    In preparation for randomised controlled trials (RCTs) of disease‐modifying antirheumatic drugs in patients with early inflammatory arthritis (EIA), formative research was conducted to enhance the design of such trials. The objectives of this research were to (1) determine patients' educational needs as they relate to the necessary elements of informed consent; and (2) assess patients' interest in enrolling in a hypothetical prevention trial. In‐depth interviews were conducted with nine patients. Seven patients were women and all but one white. The mean age was 48 years. During the 4‐month enrolment period, only three patients with EIA were identified; six patients with longer duration of symptoms were also interviewed. Most patients were able to express the primary aim of a hypothetical prevention trial presented. Factors cited by patients favouring enrolment were potential for direct medical benefit and knowledge that they would be withdrawn from the trial if they developed symptoms. Factors cited by patients against enrolment were the inclusion of a placebo and general uncertainty regarding treatment required by the RCT design. Pending larger‐scale empirical projects to explore patients' attitudes about prevention trials, small‐scale formative research in advance of such trials ought to be conducted. PMID:16984939

  5. Effects of aerobic exercise on hematologic indices of women with rheumatoid arthritis: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Yaser Jafari Shapoorabadi

    2016-01-01

    Full Text Available Background: To investigate the effects of moderate aerobic exercise on the hemoglobin, hematocrit, and red blood cell (RBC mass of women with rheumatoid arthritis (RA. Materials and Methods: This randomized clinical trial was conducted at the Specialized Clinic of Physical Medicine and Rehabilitation, Al-Zahra Hospital of Isfahan, during a 4-month period in 2014. We included patients with RA who did not have any malignancy and hematologic disorder. Two groups - one group receiving aerobic therapy along with medical therapy (N = 16 and the other group receiving medical therapy alone (N = 17 both for a period of 8 weeks. The levels of RBC mass, Hb, and HCT were measured before and after the intervention. The changes in these parameters were compared between the two study groups. Results: There was no significant difference between the two study groups regarding the baseline characteristics. The aerobic exercise resulted in increased RBC mass (P < 0.001, Hb (P < 0.001, and HCT (P < 0.001. However, those who received medical therapy alone did not experience any significant changes in these parameters. We found that the RBC mass (P = 0.581, Hb (P = 0.882, and HCT (P = 0.471 were comparable between the two study groups after 8 weeks of intervention. Conclusion: Although the aerobic exercise results in increased Hb, HCT, and RBC mass in patients with RA, the increase was not significant when compared to that in controls. Thus, the increase in the HB, HCT, and RBC could not be attributable to aerobic exercise.

  6. International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials.

    Science.gov (United States)

    Orbai, Ana-Maria; de Wit, Maarten; Mease, Philip; Shea, Judy A; Gossec, Laure; Leung, Ying Ying; Tillett, William; Elmamoun, Musaab; Callis Duffin, Kristina; Campbell, Willemina; Christensen, Robin; Coates, Laura; Dures, Emma; Eder, Lihi; FitzGerald, Oliver; Gladman, Dafna; Goel, Niti; Grieb, Suzanne Dolwick; Hewlett, Sarah; Hoejgaard, Pil; Kalyoncu, Umut; Lindsay, Chris; McHugh, Neil; Shea, Bev; Steinkoenig, Ingrid; Strand, Vibeke; Ogdie, Alexis

    2017-04-01

    To identify a core set of domains (outcomes) to be measured in psoriatic arthritis (PsA) clinical trials that represent both patients' and physicians' priorities. We conducted (1) a systematic literature review (SLR) of domains assessed in PsA; (2) international focus groups to identify domains important to people with PsA; (3) two international surveys with patients and physicians to prioritise domains; (4) an international face-to-face meeting with patients and physicians using the nominal group technique method to agree on the most important domains; and (5) presentation and votes at the Outcome Measures in Rheumatology (OMERACT) conference in May 2016. All phases were performed in collaboration with patient research partners. We identified 39 unique domains through the SLR (24 domains) and international focus groups (34 domains). 50 patients and 75 physicians rated domain importance. During the March 2016 consensus meeting, 12 patients and 12 physicians agreed on 10 candidate domains. Then, 49 patients and 71 physicians rated these domains' importance. Five were important to >70% of both groups: musculoskeletal disease activity, skin disease activity, structural damage, pain and physical function. Fatigue and participation were important to >70% of patients. Patient global and systemic inflammation were important to >70% of physicians. The updated PsA core domain set endorsed by 90% of OMERACT 2016 participants includes musculoskeletal disease activity, skin disease activity, pain, patient global, physical function, health-related quality of life, fatigue and systemic inflammation. The updated PsA core domain set incorporates patients' and physicians' priorities and evolving PsA research. Next steps include identifying outcome measures that adequately assess these domains. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  7. Clinical Trials

    Medline Plus

    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore ...

  8. Effects of cold mist shower on patients with inflammatory arthritis: a crossover controlled clinical trial.

    Science.gov (United States)

    Hinkka, H; Väättänen, S; Ala-Peijari, S; Nummi, T

    2017-05-01

    To evaluate the safety and effects of a new home treatment method, a whole-body cold mist treatment, on patients with chronic inflammatory arthritis. Whole-body cold mist shower therapy was given to 121 voluntary patients with chronic inflammatory arthritis in this crossover study during 1-week rehabilitation periods. Pain and sleep quality were assessed by a 10-cm visual analogue scale (VAS). Mental status was assessed by the Depression Scale (DEPS). Body temperature, blood pressure, heart rate, use of occasional pain and sleep medication, and possible side-effects were recorded. The differences in pain (VAS) between treatment and control periods were significant (2.0 vs. 2.4, p = 0.006, paired t-test) in the last measurement, when assessing the pain of the past week as a whole. A trend could be seen of an increasing difference towards the end of the week. The treatment effect was statistically significant [likelihood ratio test (LRT), p < 0.0001] after controlling for period and sequence effects. There was an indication of better sleep quality (VAS) during the treatment period (2.3 vs. 2.7, p = 0.058 paired t-test) when assessing the past week as a whole. The mean DEPS scores showed no difference between the treatment periods (5.5 vs. 5.0, p = 0.1874 paired t-test, at start, and 4.5 vs. 4.1 p = 0.29 paired t-test, at the end). No significant side-effects were recorded. The new whole-body cold treatment method may offer a safe option for self-treatment of pain at home but further study is needed to determine the clinical significance of the effect after longer use.

  9. Selecting magnetic resonance imaging (MRI) outcome measures for juvenile idiopathic arthritis (JIA) clinical trials: first report of the MRI in JIA special interest group.

    Science.gov (United States)

    Hemke, Robert; Doria, Andrea S; Tzaribachev, Nikolay; Maas, Mario; van der Heijde, Désirée M F M; van Rossum, Marion A J

    2014-02-01

    Recent advances in magnetic resonance imaging (MRI) techniques have substantially improved the evaluation of joint pathologies in juvenile idiopathic arthritis (JIA). Because of the current availability of highly effective antirheumatic therapies and the unique and useful features of MRI, there is a growing need for an accurate and reproducible MRI assessment scoring system for JIA, such as the rheumatoid arthritis MRI Scoring (RAMRIS) for patients with rheumatoid arthritis (RA). To effectively evaluate the efficacy of treatment in clinical research trials, we need to develop and validate scoring methods to accurately measure joint outcomes, standardize imaging protocols for data acquisition and interpretation, and create imaging atlases to differentiate physiologic and pathologic joint findings in childhood and adolescence. Such a standardized, validated, JIA-MRI scoring method could be used as an outcome measure in clinical trials.

  10. Transaminase Levels and Hepatic Events During Tocilizumab Treatment: Pooled Analysis of Long-Term Clinical Trial Safety Data in Rheumatoid Arthritis

    NARCIS (Netherlands)

    Genovese, Mark C.; Kremer, Joel M.; van Vollenhoven, Ronald F.; Alten, Rieke; Scali, Juan Jose; Kelman, Ariella; Dimonaco, Sophie; Brockwell, Laura

    2017-01-01

    To investigate liver enzyme abnormalities and hepatic adverse events (AEs) during long-term tocilizumab treatment for rheumatoid arthritis in clinical trials. Data were pooled from patients who received intravenous tocilizumab (4, 8, or 10 mg/kg with or without disease-modifying antirheumatic drugs

  11. Clinical Trials

    Medline Plus

    Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... purpose is to ensure that clinical trials are ethical and that the participants' rights are protected. The ...

  13. Protocol for a randomised controlled trial for Reducing Arthritis Fatigue by clinical Teams (RAFT) using cognitive-behavioural approaches.

    Science.gov (United States)

    Hewlett, S; Ambler, N; Almeida, C; Blair, P S; Choy, E; Dures, E; Hammond, A; Hollingworth, W; Kirwan, J; Plummer, Z; Rooke, C; Thorn, J; Tomkinson, K; Pollock, J

    2015-08-06

    Rheumatoid arthritis (RA) fatigue is distressing, leading to unmanageable physical and cognitive exhaustion impacting on health, leisure and work. Group cognitive-behavioural (CB) therapy delivered by a clinical psychologist demonstrated large improvements in fatigue impact. However, few rheumatology teams include a clinical psychologist, therefore, this study aims to examine whether conventional rheumatology teams can reproduce similar results, potentially widening intervention availability. This is a multicentre, randomised, controlled trial of a group CB intervention for RA fatigue self-management, delivered by local rheumatology clinical teams. 7 centres will each recruit 4 consecutive cohorts of 10-16 patients with RA (fatigue severity ≥ 6/10). After consenting, patients will have baseline assessments, then usual care (fatigue self-management booklet, discussed for 5-6 min), then be randomised into control (no action) or intervention arms. The intervention, Reducing Arthritis Fatigue by clinical Teams (RAFT) will be cofacilitated by two local rheumatology clinicians (eg, nurse/occupational therapist), who will have had brief training in CB approaches, a RAFT manual and materials, and delivered an observed practice course. Groups of 5-8 patients will attend 6 × 2 h sessions (weeks 1-6) and a 1 hr consolidation session (week 14) addressing different self-management topics and behaviours. The primary outcome is fatigue impact (26 weeks); secondary outcomes are fatigue severity, coping and multidimensional impact, quality of life, clinical and mood status (to week 104). Statistical and health economic analyses will follow a predetermined plan to establish whether the intervention is clinically and cost-effective. Effects of teaching CB skills to clinicians will be evaluated qualitatively. Approval was given by an NHS Research Ethics Committee, and participants will provide written informed consent. The copyrighted RAFT package will be freely available. Findings

  14. American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials

    Science.gov (United States)

    Felson, David T.; Smolen, Josef S.; Wells, George; Zhang, Bin; van Tuyl, Lilian H. D.; Funovits, Julia; Aletaha, Daniel; Allaart, Renée; Bathon, Joan; Bombardieri, Stefano; Brooks, Peter; Brown, Andrew; Matucci-Cerinic, Marco; Choi, Hyon; Combe, Bernard; de Wit, Maarten; Dougados, Maxime; Emery, Paul; Furst, Dan; Gomez-Reino, Juan; Hawker , Gillian; Keystone, Edward; Khanna, Dinesh; Kirwan, John; Kvien, Tore; Landewé, Robert; Listing, Joachim; Michaud, Kaleb; Mola, Emilio Martin; Montie, Pam; Pincus, Ted; Richards, Pam; Siegel, Jeff; Simon, Lee; Sokka, Tuulikki; Strand, Vibeke; Tugwell, Peter; Tyndall, Alan; van der Heijde, Desirée; Verstappen, Suzan; White, Barbara; Wolfe, Fred; Zink, Angela; Boers, Maarten

    2010-01-01

    Background With remission in rheumatoid arthritis (RA) an increasingly attainable goal, there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome in clinical trials. Methods A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism and the Outcome Measures in Rheumatology Initiative (OMERACT) met to guide the process and review prespecified analyses from clinical trials of patients with RA. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures to define remission including at least joint counts and an acute phase reactant. Members were surveyed to select the level of each core set measure consistent with remission. Candidate definitions of remission were tested including those that constituted a number of individual measures in remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient reported outcomes and the ability of candidate measures to predict later good x-ray and functional outcomes. Results Survey results for the definition of remission pointed to indexes at published thresholds and to a count of core set measures with each measure scored as 1 or less (e.g. tender and swollen joint counts, CRP and global assessments on 0-10 scale). Analyses suggested the need to include a patient reported measure. Examination of 2 year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good x-ray and functional outcomes, although DAS28 based measures of remission did not predict good radiographic outcomes as well as did the other candidate definitions. Given these and other considerations, we propose that a patient be defined as in remission based on one of two definitions : 1: When their scores on the

  15. Clinical Trials

    Medline Plus

    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore whether ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... study results. Clinical Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These ... provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient ...

  4. Effects of Probiotic Supplementation on Oxidative Stress Indices in Women with Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial.

    Science.gov (United States)

    Vaghef-Mehrabany, Elnaz; Homayouni-Rad, Aziz; Alipour, Beitullah; Sharif, Sakineh-Khatoun; Vaghef-Mehrabany, Leila; Alipour-Ajiry, Serour

    2016-01-01

    Rheumatoid arthritis (RA) is an autoimmune inflammatory disease that causes great pain and disability and increasing oxidative stress in patients. The objective of the present study was to evaluate the effects of probiotics-live microorganisms with many health benefits, including antioxidant properties-on oxidative stress indices of patients with RA. This study is a secondary analysis from a previously published study Methods: In a randomized double-blind placebo-controlled clinical trial, 46 patients with RA were assigned to one of two groups; patients in the probiotic group received a daily capsule containing 10(8) colony forming units (CFUs) of Lactobacillus casei 01 (L. casei 01), while those in the placebo group took identical capsules containing maltodextrin, for 8 weeks. In the baseline and at the end of the study, anxiety, physical activity levels, and dietary intakes were assessed. Anthropometric parameters, serum malondialdehyde (MDA), total antioxidant capacity (TAC), erythrocyte superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase (CAT) activities were measured. There was no significant difference between the two groups for demographic characteristics, anthropometric parameters, physical activity, anxiety levels, or dietary intakes, throughout the course of the study. No significant within- and between-group differences were observed for MDA, TAC, or CAT. SOD activity decreased only in the probiotic group and GPx activity decreased in both study groups (p 0.05). No significant effect of L. casei 01 supplementation was observed on the oxidative status of patients with RA, compared to placebo.

  5. Efficacy of Turmeric Extracts and Curcumin for Alleviating the Symptoms of Joint Arthritis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

    Science.gov (United States)

    Daily, James W; Yang, Mini; Park, Sunmin

    2016-08-01

    Although turmeric and its curcumin-enriched extracts have been used for treating arthritis, no systematic review and meta-analysis of randomized clinical trials (RCTs) have been conducted to evaluate the strength of the research. We systemically evaluated all RCTs of turmeric extracts and curcumin for treating arthritis symptoms to elucidate the efficacy of curcuma for alleviating the symptoms of arthritis. Literature searches were conducted using 12 electronic databases, including PubMed, Embase, Cochrane Library, Korean databases, Chinese medical databases, and Indian scientific database. Search terms used were "turmeric," "curcuma," "curcumin," "arthritis," and "osteoarthritis." A pain visual analogue score (PVAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were used for the major outcomes of arthritis. Initial searches yielded 29 articles, of which 8 met specific selection criteria. Three among the included RCTs reported reduction of PVAS (mean difference: -2.04 [-2.85, -1.24]) with turmeric/curcumin in comparison with placebo (P turmeric/curcumin treatment (mean difference: -15.36 [-26.9, -3.77]; P = .009). Furthermore, there was no significant mean difference in PVAS between turmeric/curcumin and pain medicine in meta-analysis of five studies. Eight RCTs included in the review exhibited low to moderate risk of bias. There was no publication bias in the meta-analysis. In conclusion, these RCTs provide scientific evidence that supports the efficacy of turmeric extract (about 1000 mg/day of curcumin) in the treatment of arthritis. However, the total number of RCTs included in the analysis, the total sample size, and the methodological quality of the primary studies were not sufficient to draw definitive conclusions. Thus, more rigorous and larger studies are needed to confirm the therapeutic efficacy of turmeric for arthritis.

  6. Clinical Trials

    Medline Plus

    Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people who ... for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information about ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ... All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical ...

  11. Clinical Trials

    Medline Plus

    Full Text Available ... list of NHLBI-sponsored clinical trials. NIH Clinical Research Studies Search for studies conducted within other Institutes at the NIH, including trials performed on our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

  12. Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis.

    Science.gov (United States)

    Kay, Jonathan; Fleischmann, Roy; Keystone, Edward; Hsia, Elizabeth C; Hsu, Benjamin; Zhou, Yiying; Goldstein, Neil; Braun, Jürgen

    2016-12-01

    Assess 5-year golimumab (GOL) safety in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Subcutaneous (SC) GOL (50 mg or 100 mg every 4 weeks) was evaluated in phase 3 trials of patients with active RA, PsA, and AS. Safety data through Year 5 were pooled across 3 RA trials [1 each evaluating methotrexate (MTX)-naive, MTX-experienced, and antitumor necrosis factor (TNF)-experienced patients], 1 PsA trial, and 1 AS trial. Data summarized was derived from both placebo-controlled (through weeks 24-52) and uncontrolled study periods. For adverse events (AE) of special interest [serious infections (SI), opportunistic infections (OI), deaths, malignancies, demyelination, tuberculosis (TB)], incidence per 100 patient-years (pt-yrs) was determined. Across all trials, 639 patients received placebo and 2228 received SC GOL 50 mg only (n = 671), 50 mg and 100 mg (n = 765), or 100 mg only (n = 792). Safety followup extended for averages of 28.5 and 203.2 weeks for placebo and GOL, respectively. Respective placebo and GOL AE incidence/100 pt-yrs (95% CI) through Year 5 were 4.86 (2.83-7.78) and 3.29 (2.92-3.69) for SI, 0.00 (0.00-0.86) and 0.23 (0.14-0.35) for TB, 0.00 (0.00-0.86) and 0.22 (0.13-0.34) for OI, 0.00 (0.00-0.86) and 0.10 (0.05-0.20) for lymphoma, 0.00 (0.00-0.86) and 0.08 (0.03-0.17) for demyelination, and 0.29 (0.01-1.59) and 0.41 (0.29-0.57) for death. TB, OI, lymphoma, and demyelination incidence appeared to be higher among patients receiving GOL 100 mg only. SC GOL safety through Year 5 remained consistent with previously reported Year 3 findings and with other TNF antagonists. Numerically higher incidences of TB, OI, lymphoma, and demyelination were observed with 100 mg versus 50 mg. Clinicaltrials.gov identifiers: NCT00264537 (GO-BEFORE), NCT00264550 (GO-FORWARD), NCT00299546 (GO-AFTER), NCT00265096 (GO-REVEAL), and NCT00265083 (GO-RAISE).

  13. Clinical Trials

    Medline Plus

    Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... trial participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating in clinical trials at the NIH. The NHLBI conducts a large number of ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... Blood Institute (NHLBI) sponsored a trial of two different combinations of asthma treatments. The trial found that ... ways, taking part in a clinical trial is different from having regular care from your own doctor. ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... to the strategies and treatments that work best. How Clinical Trials Work If you take part in ... a protocol (PRO-to-kol). This plan explains how the trial will work. The trial is led ...

  18. THE RESULTS OF A PHASE III COMPARATIVE CLINICAL TRIAL OF RITUXIMAB (ACELLBIA® AND MABTHERA® IN RHEUMATOID ARTHRITIS (THE BIORA STUDY

    Directory of Open Access Journals (Sweden)

    E. L. Nasonov

    2016-01-01

    Full Text Available The article considers the results of an international multicenter randomized clinical trial of the efficacy and safety of the brand-name drug rituximab (MabThera, a monoclonal antibody against CD20 antigen of B cells, and its biosimi-lar drug (Acellbia® (the BIORA study in patients with rheumatoid arthritis (RA refractory to therapy with tumor necrosis factor-а inhibitors.Objective: to provide evidence for the therapeutic equivalence of Acellbia® and MabThera® and also to assess their interchangeability.Subjects and methods. The trial enrolled adult patients with active seropositive RA, who were randomized into two groups (1:1: 1 the patients who received Acellbia® 1000 mg intravenously on days 1 and 15; 2 those who had MabThera® in a similar way. When RA activity persisted at 24 weeks, there was re-randomization (1:1 with a partial overlap: Group 1 patients were randomized into group AA (the drug of the second therapy cycle was Acellbia® or Group AM (that was MabThera®, the similar methodology was followed in Group 2 (Groups MM and MA. Throughout the study, the patients received methotrexate at a stable dose of 7.5—25 mg/week and folic acid at a dose of 5 mg/week. The follow-up lasted 48 weeks.Results and discussion. 24 weeks after treatment initiation, the ACR20 response was observed in 84.1% of the patients in the Acellbia® group (95% CI, 74.75—90.50 and in 87% in the MabThera® group (95% CI, 77.71—92.79%; p = 0.773, which suggests that the drugs are therapeutically equivalent. In the second phase of the study, the efficiency of therapy remained high; there were no differences in Groups AA/MM, AA/AM and MM/MA. In both phases, the safety profile of the drugs was comparable; the immunogenicity of treatment remained low. The findings suggest that the brand-name MabThera® and its biosimilar drug Acellbia® are equivalent. Switching from the biosimilar drug to the brand-name one and vice versa has no negative impact on treatment

  19. Clinical Trials

    Medline Plus

    Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials. An IRB is an independent committee created by the institution that sponsors a clinical trial. ... have not only shaped medical practice around the world, but have improved the health of millions of ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines who is ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... are doctors, statisticians, and community members. The IRB's purpose is to ensure that clinical trials are ethical ... enrolling in a clinical trial: What is the purpose of the study? Who is sponsoring the study, ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines who is ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... best data available for health care decisionmaking. The purpose of clinical trials is research, so the studies ... Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... providers don't always cover all patient care costs for clinical trials. If you're thinking about ... clinical trial, find out ahead of time about costs and coverage. You should learn about the risks ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for ... other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results ...

  11. Clinical Trials

    Medline Plus

    Full Text Available ... whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about ... other National Institutes of Health (NIH) Institutes and Centers sponsor clinical trials. Many other groups, companies, and ...

  12. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... are needed focusing on children's health with the goal to develop treatments, drugs, and devices specific to ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... are research studies that explore whether a medical strategy, treatment, or device is safe and effective for ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient ... that does the study uses the same protocol. Key information in a protocol includes how many patients ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, ... and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... team also may ask you to do other tasks. For example, you may have to keep a ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ... in a clinical trial, find out ahead of time about costs and coverage. You should learn about ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... care providers might be part of your treatment team. They will monitor your health closely. You may ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... for health-related questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health of millions of ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of ...

  7. Efficacy of Turmeric Extracts and Curcumin for Alleviating the Symptoms of Joint Arthritis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

    Science.gov (United States)

    Daily, James W.; Yang, Mini

    2016-01-01

    Abstract Although turmeric and its curcumin-enriched extracts have been used for treating arthritis, no systematic review and meta-analysis of randomized clinical trials (RCTs) have been conducted to evaluate the strength of the research. We systemically evaluated all RCTs of turmeric extracts and curcumin for treating arthritis symptoms to elucidate the efficacy of curcuma for alleviating the symptoms of arthritis. Literature searches were conducted using 12 electronic databases, including PubMed, Embase, Cochrane Library, Korean databases, Chinese medical databases, and Indian scientific database. Search terms used were “turmeric,” “curcuma,” “curcumin,” “arthritis,” and “osteoarthritis.” A pain visual analogue score (PVAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were used for the major outcomes of arthritis. Initial searches yielded 29 articles, of which 8 met specific selection criteria. Three among the included RCTs reported reduction of PVAS (mean difference: −2.04 [−2.85, −1.24]) with turmeric/curcumin in comparison with placebo (P < .00001), whereas meta-analysis of four studies showed a decrease of WOMAC with turmeric/curcumin treatment (mean difference: −15.36 [−26.9, −3.77]; P = .009). Furthermore, there was no significant mean difference in PVAS between turmeric/curcumin and pain medicine in meta-analysis of five studies. Eight RCTs included in the review exhibited low to moderate risk of bias. There was no publication bias in the meta-analysis. In conclusion, these RCTs provide scientific evidence that supports the efficacy of turmeric extract (about 1000 mg/day of curcumin) in the treatment of arthritis. However, the total number of RCTs included in the analysis, the total sample size, and the methodological quality of the primary studies were not sufficient to draw definitive conclusions. Thus, more rigorous and larger studies are needed to confirm the therapeutic efficacy

  8. Clinical Trials

    Medline Plus

    Full Text Available ... proven to work and you're in the group getting it, you might be among the first to benefit. If you're in a clinical trial and ... health closely. In late-phase clinical trials, possible benefits or ... trials have large groups of similar patients taking the same treatment the ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating ...

  11. Clinical Trials

    Medline Plus

    Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... medical centers, and hospitals. ClinicalTrials.gov View a database of clinical studies (past and present) funded or ...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... or strategies work best for certain illnesses or groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, ... be identified earlier than they would be in general medical practice. This is because late-phase trials ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, Lung, and ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... help produce reliable study results. Clinical trials are one of the final stages of a long and ... trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of lowering ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... In the past, clinical trial participants often were White men. Researchers assumed that trial results were valid ... in different ethnic groups sometimes respond differently than White men to the same medical approach. As a ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored ... risks. Other examples of clinical trials that test principles or strategies include studies that explore whether surgery ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants & ... or groups to help sponsor some trials. All types of clinical trials contribute to medical knowledge and ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... trial's results apply. These criteria also are a safety measure. They ensure a trial excludes any people for whom the protocol has known risks that outweigh any possible ... groups of people for safety and side effects. Phase II clinical trials look ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking ... people will need to travel or stay in hospitals to take part in clinical trials. For example, ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and ... drugs, and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... rights that help protect them. Scientific Oversight Institutional Review Board Institutional review boards (IRBs) help provide scientific ... ClinicalTrials.gov View a database of clinical studies (past and present) funded or sponsored by the NIH ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... and how often they will get them; what type of data will be collected during the clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical ...

  11. Clinical Trials

    Medline Plus

    Full Text Available ... of research. Sometimes, when no accepted standard treatment exists for a condition, people in one group may ... medical centers, and hospitals. ClinicalTrials.gov View a database of clinical studies (past and present) funded or ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ... more about the new approach's risks and benefits. A clinical trial ...

  13. Measurement error in the assessment of radiographic progression in rheumatoid arthritis (RA) clinical trials: the smallest detectable change (SDC) revisited.

    Science.gov (United States)

    Navarro-Compán, V; van der Heijde, D; Ahmad, Harris A; Miller, Colin G; Wolterbeek, R; Landewé, R

    2014-06-01

    To evaluate if the mean smallest detectable change (SDC) of multiple time intervals using the Bland & Altman (B&A) levels of agreement (LoA) method is an appropriate surrogate for the generalisability analysis method for estimating the overall SDC of radiological progression in rheumatoid arthritis (RA) trials. Secondly, to compare the SDC based on 95% LoA with the SDC based on 80% LoA, and to investigate the association between SDC and baseline damage and progression. Fifteen datasets from randomised controlled trials in RA were scored by 13 experienced readers as pairs according to the modified Sharp/van der Heijde method. The SDC using the 95% and 80% LoA and the generalisability methods was calculated. 21 295 radiographic time points from 7643 patients were included. The mean (range) SDC for the LoA and the generalisability methods was 3.1 (2.3-4.3) and 3.2 (2.3-4.6) units, respectively. The mean ± SD difference between the two methods was -0.13 ± 0.28. The mean SDC including all intervals (n=31) was 3.0 ± 0.7 for 95% LoA and 2.0 ± 0.4 for 80% LoA. No relationship was observed between baseline damage and the SDC, whereas the SDC increased with increasing radiological progression. The mean of the interval SDCs obtained by the simple LoA method is a valid surrogate for the SDC obtained by complex generalisability methods. The SDC depends on the level of radiographic progression rather than on the level of absolute damage. In addition, the use of an SDC based on 80% rather than on 95% LoA is proposed.

  14. Testing of the preliminary OMERACT validation criteria for a biomarker to be regarded as reflecting structural damage endpoints in rheumatoid arthritis clinical trials: the example of C-reactive protein

    NARCIS (Netherlands)

    Keeling, Stephanie O.; Landewe, Robert; van der Heijde, Desiree; Bathon, Joan; Boers, Maarten; Garnero, Patrick; Geusens, Piet; El-Gabalawy, Hani; Inman, Robert D.; Kraus, Virginia B.; Kvien, Tore K.; Mease, Philip J.; Ostergaard, Mikkel; Ritchlin, Chris; Syversen, Silje W.; Maksymowych, Walter P.

    2007-01-01

    A list of 14 criteria for guiding the validation of a soluble biomarker as reflecting structural damage endpoints in rheumatoid arthritis (RA) clinical trials was drafted by an international working group after a Delphi consensus exercise. C-reactive protein (CRP), a soluble biomarker extensively

  15. Clinical Trials

    Medline Plus

    Full Text Available ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists of a group of research and study topic experts. The NIH also requires DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... phase II clinical trials. The risk of side effects might be even greater for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health care providers don't always ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... how these studies should be done. Patient Rights Informed Consent Informed consent is the process of giving clinical trial participants ... part and during the course of the trial. Informed consent includes details about the treatments and tests you ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... health closely. In late-phase clinical trials, possible benefits or risks of a treatment can be identified earlier than they would be in general medical practice. This is because late-phase trials have large groups of similar patients taking the same treatment ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... involve animal testing. This shows how the approach affects a living body and whether it's harmful. However, ... or other factors not related to the protocol affect the trial's results. Comparison Groups In most clinical ...

  20. Clinical Trials

    Science.gov (United States)

    ... of Personal Stories Peers Celebrating Art Peers Celebrating Music Be Vocal Support Locator DBSA In-Person Support ... by participating in a clinical trial is to science first and to the patient second. More About ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... issues arise. Participation and Eligibility Each clinical trial defines who is eligible to take part in the ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... symptoms. It also was increasingly being used for prevention of heart disease.) The study found that HT ... enroll healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... small groups of people for safety and side effects. Phase II clinical trials look at how well ... confirm how well treatments work, further examine side effects, and compare new treatments with other available treatments. ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for new medicines ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... treatment is or how well it works. Children (aged 18 and younger) get special protection as research ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling the clinical trial participants which treatment they're getting. Masking, or "blinding," helps avoid bias. For this reason, ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists ... part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...

  11. Clinical Trials

    Medline Plus

    Full Text Available ... as gene therapy) or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial for safety problems or differences in results among different groups. The DSMB also reviews research results ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... as gene therapy or new biological treatments. Health insurance and health care providers don't always cover ... oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... seems promising, the next step may involve animal testing. This shows how the approach affects a living ... FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews ...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... combination of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... IRB is an independent committee created by the institution that sponsors a clinical trial. IRB members are ... provide guidance and oversight to the IRBs, develop educational programs and materials, and offer advice on research- ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... work best for certain illnesses or groups of people. Clinical trials produce the best data available for ... or animals doesn't always work well in people. Thus, research in humans is needed. For safety ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... records can quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines ... and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... sponsor clinical trials that test the safety of products, such as medicines, and how well they work. ... placebo (plah-SE-bo). This is an inactive product that looks like the test product. You'll ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and ... in clinical trials at the NIH. The NHLBI conducts a large number of research studies at the ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... medical centers and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain access to new ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... care providers might be part of your treatment team. They will monitor your health closely. You may ... taking part in a clinical trial. Your treatment team also may ask you to do other tasks. ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines who is ... Learn More Connect With Us Contact Us Directly Policies Privacy Policy Freedom of Information Act (FOIA) Accessibility ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... patients to find out whether a new approach causes any harm. In later phases of clinical trials, ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... issues arise. Participation and Eligibility Each clinical trial defines who is eligible to take part in the ... and Usage No FEAR Act Grants and Funding Customer Service/Center for Health Information Email Alerts Jobs ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... how you feel. Some people will need to travel or stay in hospitals to take part in ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit ... public health. We offer a variety of funding mechanisms tailored to planning and conducting clinical trials at ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ... how you feel. Some people will need to travel or stay in hospitals to take part in ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... patients to find out whether a new approach causes any harm. In later phases of clinical trials, ... device improves patient outcomes; offers no benefit; or causes unexpected harm All of these results are important ...

  11. Clinical Trials

    Medline Plus

    Full Text Available ... and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, ...

  12. Clinical Trials

    Medline Plus

    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... results. Clinical trials are one of the final stages of a long and careful research process. The ... a patient's age and gender, the type and stage of disease, and whether the patient has had ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... study explored whether the benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials that test principles or strategies include studies that explore whether ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?" ... in Bethesda, Maryland. The physicians, nurses, scientists and staff of the NHLBI encourage you to explore NIH ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... look at the best age and frequency for doing screening tests, such as mammography; and compare two ... available treatments. Steps To Avoid Bias The researchers doing clinical trials take steps to avoid bias. "Bias" ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... has had certain treatments or has other health problems. Eligibility criteria ensure that new approaches are tested ... review data from a clinical trial for safety problems or differences in results among different groups. The ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... research process. The process often begins in a laboratory (lab), where scientists first develop and test new ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... studies. View funding information for clinical trials optimization . Building 31 31 Center Drive Bethesda, MD 20892 Learn ... and Usage No FEAR Act Grants and Funding Building 31 31 Center Drive Bethesda, MD 20892 Learn ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... the shortest time possible. Clinical trials, like the two described above, help improve and advance medical care. ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... patients. The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI ... had to accept medicines and treatments based on what is known to work in adults. To improve clinical care of children, ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... Wide Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  8. A randomized, double-blind, multicenter, controlled clinical trial of chicken type II collagen in patients with rheumatoid arthritis.

    Science.gov (United States)

    Zhang, Ling-Ling; Wei, Wei; Xiao, Feng; Xu, Jian-Hua; Bao, Chun-De; Ni, Li-Qing; Li, Xing-Fu

    2008-07-15

    To assess the efficacy and safety of chicken type II collagen (CCII) in rheumatoid arthritis (RA) compared with methotrexate (MTX). We conducted a prospective, 24-week, followup, multicenter, double-blind, controlled study of CCII (0.1 mg/day) versus MTX (10 mg/week) in patients with active RA. Clinical assessments were performed at screening and at 12, 18, and 24 weeks of treatment. A total of 236 RA patients were included; 211 patients (89.4%) completed the 24-week followup. In both groups there was a decrease in pain, morning stiffness, tender joint count, swollen joint count, Health Assessment Questionnaire score, and investigator and patient assessment of function; all differences were statistically significant. In the MTX group, erythrocyte sedimentation rate and C-reactive protein level decreased. Rheumatoid factor did not change in either group. At 24 weeks, 68.57% of patients in the CCII group and 83.02% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR20), and 40.95% and 57.54%, respectively, met the ACR50 criteria. The ACR20 and ACR50 response rates in the CCII group were lower than those in the MTX group, and this difference was statistically significant (P < 0.05). Gastrointestinal symptoms were common in both groups. There were fewer and milder side effects in the CCII group than the MTX group. The difference in incidence of adverse events between the 2 groups was statistically significant (P < 0.05). CCII is effective in the treatment of RA. CCII is well tolerated, and the incidence of adverse events of CCII is lower than that of MTX.

  9. Prospective Clinical Trial for Septic Arthritis: Cartilage Degradation and Inflammation Are Associated with Upregulation of Cartilage Metabolites

    Directory of Open Access Journals (Sweden)

    Hagen Schmal

    2016-01-01

    Full Text Available Background. Intra-articular infections can rapidly lead to osteoarthritic degradation. The aim of this clinical biomarker analysis was to investigate the influence of inflammation on cartilage destruction and metabolism. Methods. Patients with acute joint infections were enrolled in a prospective clinical trial and the cytokine composition of effusions (n=76 was analyzed. Characteristics of epidemiology and disease severity were correlated with levels of cytokines with known roles in cartilage turnover and degradation. Results. Higher synovial IL-1β concentrations were associated with clinical parameters indicating a higher disease severity (p<0.03 excluding the incidence of sepsis. Additionally, intra-articular IL-1β levels correlated with inflammatory serum parameters as leucocyte counts (LC and C-reactive protein concentrations (p<0.05 but not with age or comorbidity. Both higher LC and synovial IL-1β levels were associated with increased intra-articular collagen type II cleavage products (C2C indicating cartilage degradation. Joints with preinfectious lesions had higher C2C levels. Intra-articular inflammation led to increased concentrations of typical cartilage metabolites as bFGF, BMP-2, and BMP-7. Infections with Staphylococcus species induced higher IL-1β expression but less cartilage destruction than other bacteria. Conclusion. Articular infections have bacteria-specific implications on cartilage metabolism. Collagen type II cleavage products reliably mark destruction, which is associated with upregulation of typical cartilage turnover cytokines. This trial is registered with DRKS00003536, MISSinG.

  10. Measurement error in the assessment of radiographic progression in rheumatoid arthritis (RA) clinical trials: the smallest detectable change (SDC) revisited

    NARCIS (Netherlands)

    Navarro-Compán, V.; van der Heijde, D.; Ahmad, Harris A.; Miller, Colin G.; Wolterbeek, R.; Landewé, R.

    2014-01-01

    To evaluate if the mean smallest detectable change (SDC) of multiple time intervals using the Bland & Altman (B&A) levels of agreement (LoA) method is an appropriate surrogate for the generalisability analysis method for estimating the overall SDC of radiological progression in rheumatoid arthritis

  11. Clinical Trials

    Medline Plus

    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... Studies Women’s Health All Science A-Z Grants & Training Grants and Training Home Policies and Guidelines Funding ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... examples of clinical trials that test principles or strategies include studies that explore whether surgery or other medical treatments ... board consists of a group of research and study topic experts. The NIH also ... alternative strategies for diagnosis or treatment. In addition, the NIH ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials that have not only shaped medical practice around the world, but have improved the health of millions of people suffering from heart, lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... moderate persistent asthma. The results provided important treatment information for doctors and patients. The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... treatments produce better results for certain illnesses or groups of people; look at the best age and frequency for doing screening tests, such as mammography; and compare two or more screening tests to see which test ... Some companies and groups sponsor clinical trials that test the safety of ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain access to new treatments before they're widely available. If a new treatment is proven to work and you're in the group getting it, ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... safe a treatment is or how well it works. Children (aged 18 and younger) get special protection as research subjects. Almost always, parents must give legal consent for their child to take part in a clinical trial. When ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... educational programs and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board ... of a group of research and study topic experts. The NIH also requires ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ... Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants & Training Grants and Training Home Policies and Guidelines Funding ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... people and is safe and which treatments or strategies work best for certain illnesses or groups of people. Some clinical trials show a positive ... available. If a new treatment is proven to work and you're in the group getting ... get the new strategy being tested, you may receive the current standard ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... protect patients and help produce reliable study results. Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for new medicines and devices before any testing on humans is done. They check to make sure that ...

  4. A randomised trial of differentiated prednisolone treatment in active rheumatoid arthritis. Clinical benefits and skeletal side effects

    DEFF Research Database (Denmark)

    Hansen, M; Podenphant, J; Florescu, A

    1999-01-01

    OBJECTIVES: To study benefits and skeletal side effects of carefully monitored prednisolone treatment in patients with active rheumatoid arthritis. METHODS: One hundred and two patients with active rheumatoid arthritis were randomly allocated to treatment with disease modifying anti......, radiograph of the hands (Larsen score), and bone mineral density (BMD) of the lumbar spine, distal forearm and hand. At one year 26 patients had withdrawn from the investigation leaving 76 patients for evaluation. RESULTS: The results showed that disease activity in the prednisolone treated group was reduced......-inflammatory drug (DMARD) alone or DMARD and prednisolone in a one year follow up study. Prednisolone was given in a dose regimen adapted to the disease activity of the individual patient. The mean dose was 6 mg and the mean cumulated dose was 2160 mg. Patients were followed up with disease activity parameters...

  5. Effects of probiotic supplementation on lipid profile of women with rheumatoid arthritis: A randomized placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Elnaz Vaghef-Mehrabany

    2017-03-01

    lipids of RA women. Methods: In the present parallel randomized double-blind placebo-controlled clinical trial, 60 RA patients were recruited and divided into 2 groups. They received either a daily capsule containing 108 CFU of L. casei 01, or identical capsules containing maltodextrin, for 8 weeks. Anthropometric parameters, dietary intake and physical activity were assessed at 2 ends of the study. Serum levels of total cholesterol (TC, high-density lipoprotein-cholesterol (HDL-C, low-density lipoprotein-cholesterol (LDL-C and triglyceride (TG were measured. Independent-samples t test and analysis of covariance (ANCOVA test, and paired t test were used to test between- and within-group differences, respectively. Results: There were no significant between- or within-group differences for demographic and anthropometric parameters, physical activity and dietary intakes, throughout the study. No statistically significant within-group changes were observed for serum lipids in either group; between-group differences were also insignificant by the end of study period (TC: -0.18 [-0.65, 0.29], P = 0.801, HDL-C: -1.66 [-19.28, 15.59], P = 0.663, LDL-C: -2.73 [-19.17, 13.73], P = 0.666, TG: 0.12 [-19.76, 20.00], P = 0.900. Conclusion: Lactobacillus casei 01 could not improve serum lipids in RA patients. Further studies using probiotic foods and different probiotic strains are suggested.

  6. The Effects of Written Emotional Disclosure and Coping Skills Training in Rheumatoid Arthritis: A Randomized Clinical Trial

    Science.gov (United States)

    Lumley, Mark A.; Keefe, Francis J.; Mosley-Williams, Angelia; Rice, John R.; McKee, Daphne; Waters, Sandra J.; Partridge, R. Ty; Carty, Jennifer N.; Coltri, Ainoa M.; Kalaj, Anita; Cohen, Jay L.; Neely, Lynn C.; Pahssen, Jennifer K.; Connelly, Mark A.; Bouaziz, Yelena B.; Riordan, Paul A.

    2014-01-01

    Objective Two psychological interventions for rheumatoid arthritis (RA) are cognitive-behavioral coping skills training (CST) and written emotional disclosure (WED). These approaches have developed independently, and their combination may be more effective than either one alone. Furthermore, most studies of each intervention have methodological limitations, and each needs further testing. Method We randomized 264 adults with RA in a 2 × 2 factorial design to one of two writing conditions (WED vs. control writing) followed by one of two training conditions (CST vs. arthritis education control training). Patient-reported pain and functioning, blinded evaluations of disease activity and walking speed, and an inflammatory marker (C-reactive protein) were assessed at baseline and 1-, 4-, and 12-month follow-ups. Results Completion of each intervention was high (> 90% of patients), and attrition was low (10.2% at 12-month follow-up). Hierarchical linear modeling of treatment effects over the follow-up period, and ANCOVAs at each assessment point, found no interactions between writing and training; however, both interventions had main effects on outcomes, with small effect sizes. Compared to control training, CST decreased pain and psychological symptoms through 12 months. The effects of WED were mixed: compared with control writing, WED reduced disease activity and physical disability at 1 month only, but WED had more pain than control writing on one of two measures at 4 and 12 months. Conclusions The combination of WED and CST does not improve outcomes, perhaps because each intervention has unique effects at different time points. CST improves health status in RA and is recommended for patients, whereas WED has limited benefits and needs strengthening or better targeting to appropriate patients. PMID:24865870

  7. The effects of written emotional disclosure and coping skills training in rheumatoid arthritis: a randomized clinical trial.

    Science.gov (United States)

    Lumley, Mark A; Keefe, Francis J; Mosley-Williams, Angelia; Rice, John R; McKee, Daphne; Waters, Sandra J; Partridge, R Ty; Carty, Jennifer N; Coltri, Ainoa M; Kalaj, Anita; Cohen, Jay L; Neely, Lynn C; Pahssen, Jennifer K; Connelly, Mark A; Bouaziz, Yelena B; Riordan, Paul A

    2014-08-01

    Two psychological interventions for rheumatoid arthritis (RA) are cognitive-behavioral coping skills training (CST) and written emotional disclosure (WED). These approaches have developed independently, and their combination may be more effective than either one alone. Furthermore, most studies of each intervention have methodological limitations, and each needs further testing. We randomized 264 adults with RA in a 2 × 2 factorial design to 1 of 2 writing conditions (WED vs. control writing) followed by 1 of 2 training conditions (CST vs. arthritis education control training). Patient-reported pain and functioning, blinded evaluations of disease activity and walking speed, and an inflammatory marker (C-reactive protein) were assessed at baseline and 1-, 4-, and 12-month follow-ups. Completion of each intervention was high (>90% of patients), and attrition was low (10.2% at 12-month follow-up). Hierarchical linear modeling of treatment effects over the follow-up period, and analyses of covariance at each assessment point, revealed no interactions between writing and training; however, both interventions had main effects on outcomes, with small effect sizes. Compared with control training, CST decreased pain and psychological symptoms through 12 months. The effects of WED were mixed: Compared with control writing, WED reduced disease activity and physical disability at 1 month only, but WED had more pain than control writing on 1 of 2 measures at 4 and 12 months. The combination of WED and CST does not improve outcomes, perhaps because each intervention has unique effects at different time points. CST improves health status in RA and is recommended for patients, whereas WED has limited benefits and needs strengthening or better targeting to appropriate patients. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  8. Textbook of clinical trials

    National Research Council Canada - National Science Library

    Day, Simon; Machin, David; Green, Sylvan B

    2006-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 The Development of Clinical Trials Simon...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

  11. Synovial tissue sublining CD68 expression is a biomarker of therapeutic response in rheumatoid arthritis clinical trials: consistency across centers.

    LENUS (Irish Health Repository)

    Bresnihan, Barry

    2012-02-01

    OBJECTIVE: To determine whether the correlation between the mean change in disease activity and the mean change in synovial sublining (sl) CD68 expression could be demonstrated across different academic centers. METHODS: Synovial biopsies obtained at arthroscopy from patients with rheumatoid arthritis before and 160 days after rituximab therapy were selected and coded. Paired sections were processed independently at Amsterdam Medical Center (AMC) and at St. Vincent\\'s University Hospital (SVUH), Dublin. Digital image analysis (DIA) was employed at both centers to quantify sublining CD68 expression. RESULTS: After analysis of CD68sl expression at centers in 2 different countries, high levels of intracenter and intercenter agreement were observed. For the pooled sections stained at AMC, the correlation between 2 investigators was R = 0.942, p = 0.000, and for sections stained at SVUH, R = 0.899, p = 0.001. Similarly, the intracenter correlations for DeltaCD68sl expression after treatment were R = 0.998, p = 0.000, for sections stained at AMC and R = 0.880, p = 0.000, for sections stained at SVUH. The intercenter correlation for the pooled scores of sections stained at AMC was R = 0.85, p = 0.000, and for the sections stained at SVUH, R = 0.62, p = 0.001. The consistent correlation between DeltaDAS (Disease Activity Score) and DeltaCD68sl expression across different studies (Pearson correlation = 0.895, p < 0.001) was confirmed. The standardized response mean values for DeltaCD68sl, calculated from analyses at both AMC and SVUH, were consistently 0.5 or greater, indicating a moderate to high potential to detect change. CONCLUSION: The correlation between mean DeltaDAS and mean DeltaCD68sl expression was confirmed across 2 centers. Examination of serial biopsy samples can be used reliably to screen for interesting biological effects at the site of inflammation at an early stage of drug development.

  12. A multicenter, double-blind, randomized, controlled phase III clinical trial of chicken type II collagen in rheumatoid arthritis.

    Science.gov (United States)

    Wei, Wei; Zhang, Ling-Ling; Xu, Jian-Hua; Xiao, Feng; Bao, Chun-De; Ni, Li-Qing; Li, Xing-Fu; Wu, Yu-Qing; Sun, Ling-Yun; Zhang, Rong-Hua; Sun, Bao-Liang; Xu, Sheng-Qian; Liu, Shang; Zhang, Wei; Shen, Jie; Liu, Hua-Xiang; Wang, Ren-Cheng

    2009-01-01

    Chicken type II collagen (CCII) is a protein extracted from the cartilage of chicken breast and exhibits intriguing possibilities for the treatment of autoimmune diseases by inducing oral tolerance. A 24-week, double-blind, double-dummy, randomized, methotrexate (MTX)-controlled study was conducted to evaluate the efficacy and safety of CCII in the treatment of rheumatoid arthritis (RA). Five hundred three RA patients were included in the study. Patients received either 0.1 mg daily of CCII (n = 326) or 10 mg once a week of MTX (n = 177) for 24 weeks. Each patient was evaluated for pain, morning stiffness, tender joint count, swollen joint count, health assessment questionnaire (HAQ), assessments by investigator and patient, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) by using the standard tools at baseline (week 0) and at weeks 12 and 24. Additionally, rheumatoid factor (RF) was evaluated at weeks 0 and 24. Measurement of a battery of biochemical parameters in serum, hematological parameters, and urine analysis was performed to evaluate the safety of CCII. Four hundred fifty-four patients (94.43%) completed the 24-week follow-up. In both groups, there were decreases in pain, morning stiffness, tender joint count, swollen joint count, HAQ, and assessments by investigator and patient, and all differences were statistically significant. In the MTX group, ESR and CRP decreased. RF did not change in either group. At 24 weeks, 41.55% of patients in the CCII group and 57.86% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR-20) and 16.89% and 30.82%, respectively, met the ACR 50% improvement criteria (ACR-50). Both response rates for ACR-20 and ACR-50 in the CCII group were lower than those of the MTX group, and this difference was statistically significant (P < 0.05). The DAS28 (disease activity score using 28 joint counts) values of the two treatment groups were calculated, and there was a statistically

  13. Clinical trials in rheumatoid arthritis: methodological suggestions for assessing radiographs arising from the GRISAR Study. Gruppo Reumatologi Italiani Studio Artrite Reumatoide.

    Science.gov (United States)

    Ferrara, R; Priolo, F; Cammisa, M; Bacarini, L; Cerase, A; Pasero, G; Ferraccioli, G F; Alberighi, O D; Antonellini, A; Marubini, E

    1997-10-01

    The three x ray assessors of the GRISAR study (blinded to treatment) gave consensual erosion and damage scores to the baseline and 12 month radiographs of 284 rheumatoid arthritis (RA) patients using three different methods: single readings (blinded as to patient and chronological sequence of the x rays), paired readings (blinded as to sequence), and chronologically ordered paired readings. The aim was to evaluate which of these reading procedures is the most appropriate for clinical trials. The progression of the scores obtained using each procedure was compared by means of descriptive statistics, principal components analysis, and intra-patient correlation coefficients of pairs of methods. Bootstrap estimates of the variance of the difference in the means of two equally sized random samples were calculated to evaluate the power of the statistical analysis performed to assess the possible treatment effect for both paired and chronological reading methods. (a) The standard deviations of the paired and chronological readings were similar, but that of the single readings was higher. (b) The knowledge that two x rays were of the same patient accounted for a sizeable proportion of the between method variability. (c) Agreement was satisfactory between the paired and chronological methods for both scores but, between them and the single readings, it was modest for erosions and poor for damage. (d) The bootstrap estimate of the variance of the difference was smaller for the paired than the chronological method, possibly giving it greater power to test treatment effect. These results suggested that paired readings were the most suitable for evaluating the progression of joint damage in the GRISAR study.

  14. Clinical Trials

    Medline Plus

    Full Text Available ... doing screening tests, such as mammography; and compare two or more screening tests to see which test ... and Blood Institute (NHLBI) sponsored a trial of two different combinations of asthma treatments. The trial found ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... sponsored a trial of two different combinations of asthma treatments. The trial found that one of the ... much better than the other for moderate persistent asthma. The results provided important treatment information for doctors ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...

  19. Marine Oil Supplements for Arthritis Pain: A Systematic Review and Meta-Analysis of Randomized Trials

    Directory of Open Access Journals (Sweden)

    Ninna K. Senftleber

    2017-01-01

    Full Text Available Arthritis patients often take fish oil supplements to alleviate symptoms, but limited evidence exists regarding their efficacy. The objective was to evaluate whether marine oil supplements reduce pain and/or improve other clinical outcomes in patients with arthritis. Six databases were searched systematically (24 February 2015. We included randomized trials of oral supplements of all marine oils compared with a control in arthritis patients. The internal validity was assessed using the Cochrane Risk of Bias tool and heterogeneity was explored using restricted maximum of likelihood (REML-based meta-regression analysis. Grading of Recommendations Assessment, Development and Evaluation (GRADE was used to rate the overall quality of the evidence. Forty-two trials were included; 30 trials reported complete data on pain. The standardized mean difference (SMD suggested a favorable effect (−0.24; 95% confidence interval, CI, −0.42 to −0.07; heterogeneity, I2 = 63%. A significant effect was found in patients with rheumatoid arthritis (22 trials; −0.21; 95% CI, −0.42 to −0.004 and other or mixed diagnoses (3 trials; −0.63; 95% CI, −1.20 to −0.06, but not in osteoarthritis patients (5 trials; −0.17; 95% CI, −0.57–0.24. The evidence for using marine oil to alleviate pain in arthritis patients was overall of low quality, but of moderate quality in rheumatoid arthritis patients.

  20. Clinical Trials

    Medline Plus

    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept ... and Clinical Studies Learn about the importance of children in clinical studies and get answers to common questions. ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... NIH also requires DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs for some earlier phase trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the ... part in the study? How might this trial affect my daily life? Will I have to be ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... long and careful research process. The process often begins in a laboratory (lab), where scientists first develop ... IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... are ethical and that the participants' rights are protected. The IRB reviews the trial's protocol before the ... may know about studies going on in your area. You can visit the following website to learn ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in ... trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... as gene therapy or new biological treatments. Health insurance and health care providers don't always cover ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug ... life? Will I have to be in the hospital? How long will the trial last? Who will ...

  11. Clinical Trials

    Medline Plus

    Full Text Available ... or groups of people; look at the best age and frequency for doing screening tests, such as ... trial. They include factors such as a patient's age and gender, the type and stage of disease, ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A- ... assumed that trial results were valid for other populations as well. Researchers now realize that women and ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT was already in common use for the treatment of menopausal symptoms. It also ...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... Form Search the NHLBI, use the drop down list to select: the entire site, the Health Topics ... specific trials you're interested in. For a list of questions to ask your doctor and the ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... a laboratory (lab), where scientists first develop and test new ideas. If an approach seems promising, the ... Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... trials optimization . Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Get ... and Funding Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Connect ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... get special protection as research subjects. Almost always, parents must give legal consent for their child to ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... Masking, or "blinding," helps avoid bias. For this reason, researchers also may not be told which treatments ... from a study at any time, for any reason. Also, during the trial, you have the right ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these ... trials are a key research tool for advancing medical knowledge and patient care. ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... IRBs, develop educational programs and materials, and offer advice on research-related issues. Data Safety Monitoring Board ...

  2. Efficacy and safety of Tofacitinib in patients with active rheumatoid arthritis resistant to conventional therapy: Preliminary results of an open-label clinical trial

    Directory of Open Access Journals (Sweden)

    E. L. Luchikhina

    2016-01-01

    Full Text Available Despite the advances in the therapy of rheumatoid arthritis (RA, which are associated with the use of biological anti-rheumatic drugs, the problemof effective treatment of RA is not still solved. Inclusion of new methods in treatment strategies, in particular the so-called «small molecules», i.e. synthetic compounds acting on intracellular signaling pathways, such as Tofacitinib (TOFA approved for use in rheumatologic practice, is very important.Objective: to evaluate the efficacy and safety of therapy with TOFA in combination with synthetic disease-modifying anti-rheumatic drugs (s-DMARDs, primarily methotrexate (MTX in in patients with active RA in real clinical practice.Subjects and methods. This ongoing open-label trial is a part of the scientific program «Russian Investigation of Methotrexate and Biologics in Early Active Inflammatory Arthritis» (REMARCA that explores the possibility of adapting the «treat-to-target» strategy in real prac-tice in Russia. The study included RA patients with moderate to high disease activity despite treatment with MTX or other DMARDs. A total of 41 patients with RA were included (8 males, 33 females; mean age 52.6±14.2 years, disease duration 47.2±49.7 months, 82.9% RF+ and 80.5% anti-CCP+,DAS28-ESR 5.45±0.95, SDAI 30.2±12.2. All the patients had previously received s-DMARDs; 12 (29.3% patients also had biological DMARDs (1 to 4 biologics. Oral TOFA 5 mg in combination with MTX or leflunomide was administered twice daily to 40 and 1 patients, respectively, with the possibility of increasing the dose up to 10 mg BID. To date, 37 and 12 patients received TOFA for 3 and 6 months, respectively.Results. TOFA was used as a second-line drug (after s-DMARDs failure in 29 (70.7%, as a third line drug (after s-DMARDs and biologics failure in 12 (29.3% patients. The dose was escalated to 10 mg BID in 13 (31.2% patients, on the average, 11.2±1.7 weeks after treatment initiation. TOFA was not

  3. Testing of the preliminary OMERACT validation criteria for a biomarker to be regarded as reflecting structural damage endpoints in rheumatoid arthritis clinical trials: the example of C-reactive protein

    DEFF Research Database (Denmark)

    Keeling, Stephanie O; Landewe, Robert; van der Heijde, Desiree

    2007-01-01

    OBJECTIVE: A list of 14 criteria for guiding the validation of a soluble biomarker as reflecting structural damage endpoints in rheumatoid arthritis (RA) clinical trials was drafted by an international working group after a Delphi consensus exercise. C-reactive protein (CRP), a soluble biomarker...... in a special interest soluble biomarker group at OMERACT 8. Participants at OMERACT 8 were asked to rate the strength of evidence and the strength of the recommendation in support of each individual criterion on a 0-10 numerical rating scale. Working group members not present at OMERACT voted by a Web...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... go to the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept medicines and treatments based on what is known to work in adults. To improve ...

  5. Clinical and metabolic response to probiotic supplementation in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Zamani, Batol; Golkar, Hamid R; Farshbaf, Shima; Emadi-Baygi, Modjtaba; Tajabadi-Ebrahimi, Maryam; Jafari, Parvaneh; Akhavan, Reyhaneh; Taghizadeh, Mohsen; Memarzadeh, Mohammad R; Asemi, Zatollah

    2016-09-01

    This study was performed to determine the effects of probiotic supplementation on clinical and metabolic status of patients with rheumatoid arthritis (RA). Sixty patients with RA aged 25-70 years were assigned into two groups to receive either probiotic capsules (n = 30) or placebo (n = 30) in this randomized, double-blind, placebo-controlled trial. The patients in the probiotic group received a daily capsule that contained three viable and freeze-dried strains: Lactobacillus acidophilus (2 × 10(9) colony-forming units [CFU]/g), Lactobacillus casei (2 × 10(9) CFU/g) and Bifidobacterium bifidum (2 × 10(9) CFU/g) for 8 weeks. The placebo group took capsules filled with cellulose for the same time period. Fasting blood samples were taken at the beginning and the end of the study to quantify related markers. After 8 weeks of intervention, compared with the placebo, probiotic supplementation resulted in improved Disease Activity Score of 28 joints (DAS-28) (-0.3 ± 0.4 vs. -0.1 ± 0.4, P = 0.01). In addition, a significant decrease in serum insulin levels (-2.0 ± 4.3 vs. +0.5 ± 4.9 μIU/mL, P = 0.03), homeostatic model assessment-B cell function (HOMA-B) (-7.5 ± 18.0 vs. +4.3 ± 25.0, P = 0.03) and serum high-sensitivity C-reactive protein (hs-CRP) concentrations (-6.66 ± 2.56 vs. +3.07 ± 5.53 mg/L, P probiotics compared with the placebo. Subjects who received probiotic capsules experienced borderline statistically significant improvement in total- (P = 0.09) and low-density lipoprotein-cholesterol levels (P = 0.07) compared with the placebo. Overall, the results of this study indicated that taking probiotic supplements for 8 weeks among patients with RA had beneficial effects on DAS-28, insulin levels, HOMA-B and hs-CRP levels. © 2016 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

  6. Clinical Trials

    Medline Plus

    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... go to the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about ... Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... taking the same treatment the same way. These patients are closely watched by Data and Safety Monitoring Boards. Even if you don't directly ... risk procedures (such as gene therapy) or vulnerable patients (such as ... trial for safety problems or differences in results among different groups. ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... include factors such as a patient's age and gender, the type and stage of disease, ... helps ensure that any differences observed during a trial are due to the ...

  11. Clinical Trials

    Science.gov (United States)

    ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... include factors such as a patient's age and gender, the type and stage of disease, ... helps ensure that any differences observed during a trial are due to the ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... preexisting differences between the patients. Usually, a computer program makes the group assignments. Masking The term "masking" ... Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical ...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... have not only shaped medical practice around the world, but have improved the health of millions of ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... The NHLBI conducts a large number of research studies at the NIH Clinical Center, America's research hospital, located on the NIH campus in Bethesda, Maryland. The physicians, nurses, scientists and staff of the NHLBI encourage you to ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... and useful results, which in turn will improve public health. We offer a variety of funding mechanisms tailored to planning and conducting clinical ... Privacy Policy Freedom of Information Act (FOIA) Accessibility ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... approach seems promising, the next step may involve animal testing. This shows how the approach affects a living ... approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical ...

  18. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    OpenAIRE

    Turner, Deborah E; Helliwell, Philip S; Woodburn, James

    2007-01-01

    Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Method...

  19. Relationship between disease activity and patient-reported outcomes in rheumatoid arthritis: Post hoc analyses of overall and Japanese results from two phase 3 clinical trials.

    Science.gov (United States)

    Ishiguro, Naoki; Dougados, Maxime; Cai, Zhihong; Zhu, Baojin; Ishida, Masato; Sato, Masayo; Gaich, Carol; Quebe, Amanda; Stoykov, Ivaylo; Tanaka, Yoshiya

    2018-02-02

    To examine patient-reported outcomes (PROs) in patients with different rheumatoid arthritis (RA) disease activity levels and identify residual symptoms. Post hoc analyses of overall and Japanese data from two randomized controlled trials including RA patients with previous inadequate responses to methotrexate (NCT01710358) or no/minimal previous disease-modifying antirheumatic drug treatment (NCT01711359) (sponsor: Eli Lilly and Company). Week 24 assessments were disease activity (Simplified Disease Activity Index, Disease Activity Score/Disease Activity Score 28 joints-erythrocyte sedimentation rate) and PROs (pain visual analog scale [VAS], morning joint stiffness [MJS], Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue, and Medical Outcomes Study Short Form 36 Health Survey Physical and Mental Component Scores). Patients achieving remission/low disease activity (LDA) at Week 24 had larger/significant improvements from baseline in pain, MJS, disability, fatigue, and physical and emotional quality of life versus patients with high/moderate disease activity. Some patients achieving remission and LDA, reported residual pain (pain VAS >10 mm): 20.8-39.3% and 48.7-70.0% (overall study populations), 16.0-34.5% and 47.1-62.0% (Japanese patients). Residual MJS and fatigue were also reported. Remission/LDA were associated with improvements in PROs in overall and Japanese patient populations; however, some patients achieving remission had residual symptoms, including pain.

  20. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  1. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    "Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...

  2. THE EFFICACY AND SAFETY OF RITUXIMAB BIOSIMILAR (ACELLBIA® IN RHEUMATOID ARTHRITIS AS THE FIRST BIOLOGICAL AGENT: RESULTS OF PHASE III (ALTERRA CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    E. L. Nasonov

    2017-01-01

    Full Text Available The Russian biotechnological company «BIOCAD» has designed a chimeric monoclonal antibody against CD20 (BCD-020, Acellbia® that is a biosimilar of rituximab (RTM; MabThera®, F. Hoffmann-La Roche Ltd., Switzerland. In recent years, there has been evidence that RTM can be used at lower doses than those given in the standard recommendations and instructions for the use of this drug. This serves as the basis for the BCD-020-4/ALTERRA (ALTErnative Rituximab regimen in Rheumatoid Arthritis trial, the objective of which was to investigate the efficiency and safety of using Acellbia® (at a dose of 600 mg twice at a 2-week interval as the first biological agent (BA for methotrexate (MTX-resistant active rheumatoid arthritis (RA. The investigation enrolled 159 patients aged 18 to 80 years with active RA. After 24 weeks 65.7 and 29.4% of patients achieved 20% improvement by the American College of Rheumatology (ACR criteria in the Acellbia® + MTX and placebo (PL + MTX groups, respectively (p<0.0001. The differences in the ACR20 response rate in the two groups were 36.3% (95% CI, 19.27–53.28%. There were significant differences between the groups in the ACR50 response rates: 28.4% and 5.9% (p=0.001 and in the ACR70 ones: 12.8% and only 2.0%, respectively (p=0.036. Analysis of all recorded adverse events (AE frequency showed no significant differences between the patients in the study and control groups and demonstrates its equivalence with that of RTM (MabThera®; all the AE were expectable. It is noted that antibodies to RTM with binding and neutralizing activities had no impact on the efficiency and safety of therapy.

  3. Effects of Nigella sativa oil extract on inflammatory cytokine response and oxidative stress status in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Hadi, Vahid; Kheirouri, Sorayya; Alizadeh, Mohammad; Khabbazi, Alireza; Hosseini, Hossein

    2016-01-01

    Nigella sativa is a medicinal plant that has long been used in traditional medicine for treating various conditions. Numerous animal studies provided evidences that the seed may elicit a broad anti-inflammatory/anti-oxidant activity. The aim of the present clinical trial was to evaluate anti-inflammatory and antioxidant properties of Nigella sativa oil in patients with rheumatoid arthritis (RA). Forty-two patients with RA were assigned into two groups in this randomized, double blind, placebo-controlled clinical trial. Subjects in intervention group received two capsules, 500 mg each, of Nigella sativa oil, each day for 8 weeks. The other group consumed two capsules as placebo per day for the same period of time. Serum TNF-α, IL-10, and whole blood levels of oxidative stress parameters were measured at baseline and end of the trial. The serum level of IL-10 was increased in the Nigella sativa group (pNigella sativa led to significant reduction of serum MDA and NO compared with baseline (p0.05). This study indicates that Nigella sativa could improve inflammation and reduce oxidative stress in patients with RA. It is suggested that Nigella sativa may be a beneficial adjunct therapy in this population of patients.

  4. Clinical evaluation of joint scintigraphy in rheumatoid arthritis

    International Nuclear Information System (INIS)

    Shimabukuro, Kunisada; Sakata, Hiromichi; Shirono, Kazuo; Nakajo, Masataka; Shinohara, Shinji

    1983-01-01

    Pertechnetate (sup(99m)TcO 4 - ) joint scintigraphy was performed on 45 patients with rheumatoid arthritis, 3 with nonspecific arthritis and 6 normal subjects. 1) The sites of radioisotopic accumulation were generally in agreement with those of clinical involvement in rheumatoid arthritis. 2) By analysis of build-up curves in the wrist joint, tracer was found to be concentrated more rapidly in rheumatoid arthritis (T 1/2 = 0.67 min.) than in nonspecific arthritis (T 1/2 = 2.66 min.) 3) The degree of radioisotopic accumulation correlated well with the value of CRP and erythrocyte sedimentation rate. It could be cosidered that pertechnetate joint scintigraphy is useful for clinical evaluation of rheumatoid arthritis. (author)

  5. Clinical and immunologic effects of fractionated total lymphoid irradiation in refractory rheumatoid arthritis

    International Nuclear Information System (INIS)

    Trentham, D.E.; Belli, J.A.; Anderson, R.J.; Buckley, J.A.; Goetzl, E.J.; David, J.R.; Austen, K.F.

    1981-01-01

    Ten patients with refractory rheumatoid arthritis were given 3000 rad of fractionated total lymphoid irradiation in an uncontrolled therapeutic trial. Total lymphoid irradiation was associated with objective evidence of considerable clinical improvement in eight patients and with reduced blood lymphocyte counts in all 10. On completion of irradiation, there was an abrogation of lymphocyte reactivity in vitro in the patients with clinical responses, but abnormal antibody activities characteristic of rheumatoid arthritis and normal components of humoral immunity were not suppressed. Partial recrudescence of arthritis occurred shortly before a year after the completion of irradiation and was paralleled by a restitution of lymphocyte concentrations and responsiveness to mitogens to levels similar to those observed before irradiation. These data provide further evidence of T-cell involvement in the pathogenesis of rheumatoid arthritis and demonstrate that total lymphoid irradiation can induce temporary relief, but they do not ascertain whether the natural history of this disease was altered

  6. Clinical and immunologic effects of fractionated total lymphoid irradiation in refractory rheumatoid arthritis

    International Nuclear Information System (INIS)

    Trentham, D.E.; Belli, J.A.; Anderson, R.J.; Buckley, J.A.; Goetzl, E.J.; David, J.R.; Austen, K.F.

    1981-01-01

    Ten patients with refractory rheumatoid arthritis were given 3000 rad of fractionated total lymphoid irradiation in an uncontrolled therapeutic trial. Total lymphoid irradiation was associated with objective evidence of considerable clinical improvement in eight patients and with reduced blood lymphocyte counts in all 10. On completion of irradiation, there was an abrogation of lymphocyte reactivity in vitro in the patients with clinical responses, but abnormal antibody activities characteristic of rheumatoid arthritis and normal components of humoral immunity were not suppressed. Partial recrudescence of arthritis occurred shortly after a year after the completion of irradiation and was paralleled by a restitution of lymphocyte concentrations and responsiveness to mitogens to levels similar to those observed before irradiation. These data provide further evidence of T-cell involvement in the pathogenesis of rheumatoid arthritis and demonstrate that total lymphoid irradiation can induce temporary relief, but they do not ascertain whether the natural history of this disease was altered

  7. Synovial tissue rank ligand expression and radiographic progression in rheumatoid arthritis: observations from a proof-of-concept randomized clinical trial of cytokine blockade.

    LENUS (Irish Health Repository)

    Rooney, Terence

    2012-02-01

    The objective of the study was to evaluate synovial tissue receptor activator of nuclear factor-kappabeta ligand (RANKL) and osteoprotegerin (OPG) as biomarkers of disease activity, progressive joint damage, and therapeutic response, during cytokine blockade in rheumatoid arthritis (RA). Patients with active RA entered a randomized open-label 12-month study of anakinra 100 mg\\/day, administered as monotherapy or in combination with pegsunercept 800 mug\\/kg twice weekly. Arthroscopic synovial tissue biopsies were obtained at baseline, at 4 weeks and at the final time point. Following immunohistochemical staining, RANKL and OPG expression was quantified using digital image analysis. Radiographic damage was evaluated using the van der Heijde modification of the Sharp scoring system. Twenty-two patients were randomized. Baseline expression of RANKL, but not OPG, correlated significantly with baseline CRP levels (r = 0.61, P < 0.01). While a significant reduction in OPG expression following treatment was observed in clinical responders at the final time point (P < 0.05 vs. baseline), RANKL levels did not change, and the RANKL:OPG ratio remained unaltered, even at the highest levels of clinical response. When potential predictors of radiographic outcome were evaluated, baseline RANKL expression correlated with erosive progression at 1 year (r = 0.71, P < 0.01). Distinct, though related, pathophysiologic processes mediate joint inflammation and destruction in RA. Elevated synovial tissue RANKL expression is associated with progressive joint erosion, and may be independent of the clinical response to targeted therapy. The potential therapeutic importance of modulating RANKL in RA is highlighted, if radiographic arrest is to be achieved.

  8. The effects of arthritis gloves on people with Rheumatoid Arthritis or Inflammatory Arthritis with hand pain: a study protocol for a multi-centre randomised controlled trial (the A-GLOVES trial).

    Science.gov (United States)

    Prior, Yeliz; Sutton, Chris; Cotterill, Sarah; Adams, Jo; Camacho, Elizabeth; Arafin, Nazina; Firth, Jill; O'Neill, Terence; Hough, Yvonne; Jones, Wendy; Hammond, Alison

    2017-05-30

    Arthritis gloves are regularly provided as part of the management of people with rheumatoid arthritis (RA) and undifferentiated (early) inflammatory arthritis (IA). Usually made of nylon and elastane (i.e. Lycra®), these arthritis gloves apply pressure with the aims of relieving hand pain, stiffness and improving hand function. However, a systematic review identified little evidence supporting their use. We therefore designed a trial to compare the effectiveness of the commonest type of arthritis glove provided in the United Kingdom (Isotoner gloves) (intervention) with placebo (control) gloves (i.e. larger arthritis gloves providing similar warmth to the intervention gloves but minimal pressure only) in people with these conditions. Participants aged 18 years and over with RA or IA and persistent hand pain will be recruited from National Health Service Trusts in the United Kingdom. Following consent, participants will complete a questionnaire booklet, then be randomly allocated to receive intervention or placebo arthritis gloves. Within three weeks, they will be fitted with the allocated gloves by clinical specialist rheumatology occupational therapists. Twelve weeks (i.e. the primary endpoint) after completing the baseline questionnaire, participants will complete a second questionnaire, including the same measures plus additional questions to explore adherence, benefits and problems with glove-wear. A sub-sample of participants from each group will be interviewed at the end of their participation to explore their views of the gloves received. The clinical effectiveness and cost-effectiveness of the intervention, compared to placebo gloves, will be evaluated over 12 weeks. The primary outcome measure is hand pain during activity. Qualitative interviews will be thematically analysed. This study will evaluate the commonest type of arthritis glove (Isotoner) provided in the NHS (i.e. the intervention) compared to a placebo glove. The results will help

  9. A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

    Directory of Open Access Journals (Sweden)

    Sternlieb Beth

    2011-01-01

    Full Text Available Abstract Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823

  10. The lungs in rheumatoid arthritis - a clinical, radiographic and ...

    African Journals Online (AJOL)

    The lungs in rheumatoid arthritis - a clinical, radiographic and pulmonary function study. Stephen C. Morrison, Girish M. Mody, Sally R. Benatar, Orlando L Meyers. Abstract. Objective. To detennine the prevalence and spectrum of pulmonary abnormalities in patients with rheumatoid arthritis (RA) in a developing country.

  11. Managing clinical trials

    Directory of Open Access Journals (Sweden)

    Kenyon Sara

    2010-07-01

    Full Text Available Abstract Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.

  12. PSORIATIC ARTHRITIS: CLASSIFICATION, CLINICAL PRESENTATION, DIAGNOSIS, TREATMENT

    Directory of Open Access Journals (Sweden)

    T. V. Korotaeva

    2014-01-01

    Full Text Available The lecture gives basic information about psoriatic arthritis (PsA, a chronic inflammatory disease of the joints, spine, and enthesises from a group of spondyloarthritis. It describes the epidemiology of the disease and considers current ideas on its pathogenesis and factors influencing the development of PsA in psoriatic patients. The classification and clinical forms of PsA are presented. The major clinical manifestations of the disease are indicated to include peripheral arthritis, enthesitis, dactylitis, and spondylitis. The diagnosis of the disease is noted to be established on the basis of its detected typical clinical and radiological signs, by applying the CASPAR criteria. A dermatologist, rheumatologist, and general practitioner screen PsA, by actively detecting complaints, characteristic clinical and radiological signs of damage to the joints, and/or spine, and/or enthesises and by using screening questionnaires. There are data that patients with PsA are observed to be at higher risk for a number of diseases type 2 diabetes mellitus hypertension, coronary heart disease, obesity, metabolic syndrome, inflammatory bowel diseases, etc. The aim of current pharmacotherapy for PsA is to achieve remission or minimal activity of clinical manifestations of the disease, to delay or prevent its X-ray progression, to increase survival, to improve quality of life in patients, and to reduce the risk of comorbidities. The paper considers groups of medicines used to treat the disease, among other issues, information about biological agents (BA registered in the Russian Federation for the treatment of PsA. Most patients are mentioned to show a good response to this therapy option just 3–6 months after treatment initiation; however, some of them develop primary inefficiency. In this case, switching one BA to another is recommended. Some patients using a BA develop secondary treatment inefficiency, which is firstly due to the appearance of

  13. Clinical characteristics and outcomes in polyarticular septic arthritis.

    Science.gov (United States)

    Lieber, Sarah B; Fowler, Mary Louise; Zhu, Clara; Moore, Andrew; Shmerling, Robert H; Paz, Ziv

    2017-09-14

    Septic polyarthritis is rarer than septic monoarthritis, but associated with higher mortality. Septic polyarthritis may be difficult to distinguish clinically from noninfectious inflammatory arthritis. We describe one of the largest samples of septic polyarthritis with the aim of distinguishing septic monoarthritis from polyarthritis. We conducted a retrospective study of adults admitted to tertiary care with septic monoarthritis and polyarthritis. Baseline characteristics, microbial profiles, joint involvement, length of stay, and 60-day readmission rates were determined. We identified 464 and 42 cases of septic monoarthritis and polyarthritis, respectively, including 7 cases of septic polyarthritis with comorbid rheumatoid arthritis. Compared to those with septic monoarthritis, patients with septic polyarthritis were more likely to have rheumatoid arthritis (Pseptic arthritis (Pseptic polyarthritis with/without underlying rheumatoid arthritis were similar in terms of presenting features and outcomes, except for more frequent immunosuppressive therapy in rheumatoid arthritis (Pseptic arthritis, patients with septic polyarthritis were more likely to have systemic infection at presentation than those with septic monoarthritis. Despite this difference, patients with septic monoarthritis and polyarthritis tended to have similar outcomes. While rheumatoid arthritis was observed more frequently among patients with septic polyarthritis, those with/without underlying rheumatoid arthritis had similar presenting features and outcomes. Copyright © 2017 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

  14. CLINICAL HETEROGENEITY OF EARLY PSORIATIC ARTHRITIS

    Directory of Open Access Journals (Sweden)

    V. V. Badokin

    2016-01-01

    Full Text Available Objective: to reveal the characteristic symptoms and syndromes of early-stage psoriatic arthritis (ePsA, which are pivotal to its early diagnosis.Patients and methods. Fifty-one patients with a PsA duration of less than 2 years (mean 12 months were examined. The diagnosis of PsA was established on the basis of the conventional CASPAR criteria and the Russian criteria developed by the expert method. The conventional current criteria, including the number of tender and swollen joints, DAS28, values of acute-phase indicators, were used to detect inflammatory activity. Skin syndrome was evaluated using the Psoriasis Area and Severity Index (PASI. X-ray study of the hands, distal and proximal feet, pelvis, and other involved joints and MRI of the distal hands/feet were performed. The Maastricht Ankylosing Spondylitis Enthesitis Score (MASES and reduced GUESS were used to assess enthesopathy.Results. The types of articular syndrome in ePsA were identified in accordance of the duration of the disease. The authors determined the characteristic features of arthritis, spondylitis, enthesitis, and dactylitis, their diagnostic value and associations with other manifestations in the first 2 years of PsA. There was a relationship of dermatitis and psoriatic onychopathy to the clinical picture of articular syndrome.Conclusion. ePsA is characterized by marked heterogeneity of articular syndrome with predominantly mono/oligoarthritic and polyarthritic articular syndrome. The significant signs are enthesitis and dactylitis, which serve as risk factors for the unfavorable course of the disease. 

  15. Cost-Effectiveness of Intensive Exercise Therapy Directly Following Hospital Discharge in Patient With Arthritis: Results of a Randomized Controlled Clinical Trial

    NARCIS (Netherlands)

    Bulthuis, Y.; Mohammad, Sabrina; Braakman-Jansen, Louise Marie Antoinette; Drossaers-Bakker, K.W.; van de Laar, Mart A F J

    2008-01-01

    Objective: To estimate the cost-utility and cost-effectiveness of a 3-week intensive exercise training (IET) program directly following hospital discharge in patients with rheumatic diseases. - Methods: Patients with arthritis who were admitted to the hospital because of a disease activity flare or

  16. Clinical trials of homoeopathy.

    Science.gov (United States)

    Kleijnen, J; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

  17. [Evaluation of a clinical pathway for septic arthritis].

    Science.gov (United States)

    Merino Muñoz, R; Martín Vega, A; García Caballero, J; García-Consuegra Molina, J

    2007-07-01

    Clinical pathways are tools that coordinate clinical work, reducing interclinican variability and improving patient care and management. The use of clinical pathways in septic arthritis is appropriate, as this disease has a predictable course and there is considerable variation in its management. The aim of this study was to evaluate a septic arthritis clinical pathway 2 years after its introduction and to describe the characteristics of the patients included. Clinical pathway documents: pathway matrix sheet, variance form, parent information sheet, satisfaction survey and evaluation indicators sheet. Thirty-five patients were included, seven with a definitive diagnosis of septic arthritis and 28 with probable septic arthritis. No differences were found between the two groups, with good outcomes in both. Laboratory analyses were performed at admission in all patients, at discharge in 51 %, and at the end of treatment in 97 %. The indicators that best met the standard were clinical pathway coverage, performance of arthrocentesis/arthrotomy, and satisfaction with dealings with staff and the information received. The indicators furthest from the standard were admission shorter than 7 days (77 % vs > 95 %) and obtaining articular fluid prior to antibiotic therapy (76 % vs > 90 %). The clinical pathway is useful for standardizing the process of septic arthritis diagnosis and treatment. With adequate clinical support, application of this pathway allows decisions to be made on hospital discharge following the clinical criteria of improvement without worsening prognosis. Our immediate challenges are to reduce inpatient stay and to obtain synovial fluid before starting antibiotic therapy.

  18. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...... both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials...... and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety...

  19. Arthritis

    Science.gov (United States)

    ... common type of arthritis. It's often related to aging or to an injury. Autoimmune arthritis happens when your body's immune system attacks healthy cells in your body by mistake. Rheumatoid arthritis is ...

  20. Glenohumeral arthritis after Latarjet procedure: Progression and it's clinical significance.

    Science.gov (United States)

    Kee, Young Moon; Kim, Hwan Jin; Kim, Jung Youn; Rhee, Yong Girl

    2017-09-01

    The risk factors of glenohumeral arthritis after the Latarjet procedure remain relatively unexplored. The purposes of this study are to evaluate the clinical significance of glenohumeral arthritis after the Latarjet procedure, and to investigate risk factors associated with arthritis progression. We evaluated 110 patients (110 shoulders) who underwent the Latarjet procedure for recurrent anterior shoulder instability. Patients had a mean age of 23.8 years (range, 14-52 years) at the time of the operation, and the mean duration of follow-up was 31 months (range, 24-111 months). At the last follow-up, the mean Visual Analog Scale (VAS), Rowe and University of California at Los Angeles (UCLA) scores significantly improved from 3.1, 36.5 and 23.6 points preoperatively to 1.6, 87.6 and 32.6 points (all P Latarjet procedure was in 20 shoulders (18.2%). At the final, overall prevalence of arthritis was 23.6% (26 shoulders). The non-arthritis group showed significantly better functional outcomes (VAS score: 0.9, Rowe Score: 89.3, UCLA score: 33.5) than the arthritis group (2.1, 84.9, 29.2; all P Latarjet procedure yielded satisfactory functional outcomes with low recurrent rate at mid-term follow-up. Development or progression of arthritis was observed in 18.2% of patients, postoperatively. Glenohumeral arthritis after the Latarjet procedure had an adverse effect on clinical outcome. Generalized laxity and lateral overhang should be considered as risk factors of progression to glenohumeral arthritis after the Latarjet procedure. Copyright © 2017 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.

  1. Evaluation of the Disease Activity Score in Twenty-Eight Joints-Based Flare Definitions in Rheumatoid Arthritis: Data From a Three-Year Clinical Trial.

    OpenAIRE

    Dougados, Maxime; Huizinga, Tom W J; Choy, Ernest H; Bingham, Clifton O; Aassi, Maher; Bernasconi, Corrado Angelo

    2015-01-01

    OBJECTIVE To assess the flare rate using published criteria (Disease Activity Score in 28 joints [DAS28-2] increase between visits of >1.2 or >0.6 if current DAS28 ≥3.2) in patients receiving constant treatment, and to compare published flare criteria to criteria used by study investigators after biologic treatment discontinuation in the ACT-RAY study. METHODS Patients with rheumatoid arthritis (n = 553) were randomized to add tocilizumab to ongoing methotrexate, or switch to toci...

  2. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  3. Clinical Trial Basics

    Science.gov (United States)

    ... participating in was reviewed by an IRB. Further reading For more information about research protections, see: Office ... information and decide whether the results have medical importance. Results from clinical trials are often published in ...

  4. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  5. A commentary on TREAT: The trial of early aggressive drug therapy in juvenile idiopathic arthritis

    Directory of Open Access Journals (Sweden)

    Baildam Eileen

    2012-06-01

    Full Text Available Abstract Polyarticular juvenile idiopathic arthritis (JIA is a category of JIA where multiple joints are affected by chronic inflammation, and where serious and lasting damage to joints is the expected natural history in untreated disease. There is evidence of response to disease-modifying antirheumatic and biologic drugs, but little evidence of permanent remission from any of the existing therapeutic trials. The TREAT trial by Wallace et al., recently published in Arthritis and Rheumatism, used a collaborative multicenter approach to studying early aggressive treatment of polyarticular JIA in an attempt to achieve full clinical inactive disease after 6 months of treatment. The study's main finding that the earlier in the disease course that treatment is started, the better the chance of disease control, has provided evidence that there is a 'window of opportunity' for treating JIA as there is in adult rheumatoid arthritis (RA. The study provides both a platform and an impetus for concentrating future treatment trials on early rather than established disease and investigating a standard of starting treatment within 10 to 12 weeks.

  6. Effect of intermittent aerobic exercise on sleep quality and sleep disturbances in patients with rheumatoid arthritis - design of a randomized controlled trial.

    Science.gov (United States)

    Løppenthin, Katrine; Esbensen, Bente Appel; Jennum, Poul; Østergaard, Mikkel; Christensen, Jesper Frank; Thomsen, Tanja; Bech, Julie Schjerbech; Midtgaard, Julie

    2014-02-21

    Poor sleep is prevalent in patients with systemic inflammatory disorders, including rheumatoid arthritis, and, in addition to fatigue, pain, depression and inflammation, is associated with an increased risk of co-morbidity and all-cause mortality. Whereas non-pharmacological interventions in patients with rheumatoid arthritis have been shown to reduce pain and fatigue, no randomized controlled trials have examined the effect of non-pharmacological interventions on improvement of sleep in patients with rheumatoid arthritis. The aim of this trial was to evaluate the efficacy of an intermittent aerobic exercise intervention on sleep, assessed both objectively and subjectively in patients with rheumatoid arthritis. A randomized controlled trial including 44 patients with rheumatoid arthritis randomly assigned to an exercise training intervention or to a control group. The intervention consists of 18 session intermittent aerobic exercise training on a bicycle ergometer three times a week. Patients are evaluated according to objective changes in sleep as measured by polysomnography (primary outcome). Secondary outcomes include changes in subjective sleep quality and sleep disturbances, fatigue, pain, depressive symptoms, physical function, health-related quality of life and cardiorespiratory fitness. This trial will provide evidence of the effect of intermittent aerobic exercise on the improvement of sleep in patients with rheumatoid arthritis, which is considered important in promotion of health and well-being. As such, the trial meets a currently unmet need for the provision of non-pharmacological treatment initiatives of poor sleep in patients with rheumatoid arthritis. ClinicalTrials.gov Identifier: NCT01966835.

  7. Psoriatic arthritis: An assessment of clinical, biochemical and ...

    African Journals Online (AJOL)

    Although psoriatic arthritis (PsA) is a well-documented clinical entity,[1] epidemiological, clinical and radiological studies of. South African (SA) patients are scarce. There are, in fact, no published data regarding the prevalence and incidence of PsA in the SA population. In 1973, Moll and Wright[1] defined PsA as an.

  8. Clinical value of MRI on wrists with arthritis

    International Nuclear Information System (INIS)

    Ma Qiang; Ma Daqing; He Wen; Le Erhu; Ma Xinfa; Wang Jun; Zuo Zhaoyong

    2006-01-01

    Objective: To study the appearances of various kinds of arthritis on MRI, and to assess and evaluate the role of MRI on diagnosing various kinds of arthritis. Methods: One hundred and fifty-one patients with medical history of wrist pain entered the study. T 1 -weighted spin echo, STIR (short time inversion recovery) of both wrists, gadolinium contrast material-enhanced sequences of dominant wrists were examined in the coronal planes. MRl, plain wrist radiographs, clinical data including swollen joint and patient global assessment (AIMS), and laboratory, examinations including ESR, RF, APF, and AKA were obtained at the same time. Functional disability was assessed using the Health Assessment Questionnaire Disability Score (HAQ). According to 1987 American Rheumatism Association (ARA) revised criteria, in 151 patients, 80 patients were diagnosed as rheumatoid arthritis, 29 patients as undifferentiated spondyloarthropathy, 20 patients as seronegative spondyloarthropathy, and 22 as other kinds of connective tissue diseases. Results: All 80 patients diagnosed with rheumatoid arthritis had bilateral pannus. Among 29 patients diagnosed with undifferentiated spondyloanthropathy, 3 cases had bilateral pannus, 24 had lateral pannus. Among 20 patients diagnosed with seronegative spondyloanthropathy, 4 cases had bilateral pannus, 15 had lateral pannus. Among 22 patients diagnosed with other kinds of connective tissue disease, 21 had lateral pannus. Bilateral pannus on bilateral wrists occured in 87 patients. There were not significant difference in the unilateral pannus among patients with various arthritis (χ 2 =6.157; P>0.05). But there were significant difference in the bilateral pannus among patients with various arthritis (χ 2 =126.882, P 2 =94.192, P 2 =70.354, P 2 =96.174, P<0.001). Conclusion: MRI can show the pathologic changes of wrists with various kinds of arthritis. MRI plays an important role in the differential diagnosis of various kinds of arthritis

  9. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct......, and reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After...... and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials...

  10. Clinical and Biochemical Characteristics of Children with Juvenile Idiopathic Arthritis

    International Nuclear Information System (INIS)

    Ahmed, S.; Ali, S. R.; Ishaque, S.

    2014-01-01

    Objective: To determine the clinical and biochemical characteristics of children with Juvenile Idiopathic Arthritis (JIA) at a tertiary care centre in Karachi, Pakistan. Study Design: A descriptive study. Place and Duration of Study: Paediatric Rheumatology Clinic of The Aga Khan University Hospital (AKUH), Karachi, from January 2008 to December 2011. Methodology: Clinical and laboratory profile and outcome of children less than 15 years of age attending the Paediatric Rheumatology Clinic of the Aga Khan University, Karachi with the diagnosis of Juvenile Idiopathic Arthritis according to International League against Rheumatism were studied. These children were classified into different types of JIA; their clinical and laboratory characteristics, response to therapy and outcome was evaluated. Results: Sixty eight patients satisfying the criteria of International League against Rheumatism (ILAR) for Juvenile Idiopathic Arthritis were enrolled during the study period of four consecutive years, their age ranged from 9 months to 15 years. Mean age at onset was 6.45 +- 4.03 years while mean age at diagnosis was 7.60 +- 3.93 years. Polyarticular was the most predominant subtype with 37 (54%) patients, out of these, 9 (24%) were rheumatoid factor positive. An almost equal gender predisposition was observed. Fever and arthritis were the most common presenting symptoms, with only 2 patients presenting with uveitis. Conclusion: The clinico-biochemical characteristics of JIA at the study centre showed a pattern distinct with early onset of disease, high frequency of polyarticular type and a higher rheumatoid factor (QRA) and ANA positivity in girls. (author)

  11. Arthritis

    Science.gov (United States)

    ... prevent joint damage. If you have a family history of arthritis, tell your provider, even if you do not have joint pain. Avoiding ... in hip Rheumatoid arthritis Knee joint replacement - series Hip joint ...

  12. Antigens from Leishmania amastigotes inducing clinical remission of psoriatic arthritis.

    Science.gov (United States)

    O'Daly, J A; Gleason, J; Lezama, R; Rodriguez, P J; Silva, E; Indriago, N R

    2011-08-01

    A first generation vaccine (AS100-1) was manufactured with protein from four cultured Leishmania species, which proved to be effective in the treatment of psoriasis. A single blind trial on 3,132 psoriasis patients revealed 508 (16.2%) subjects with psoriatic arthritis (PsA) that received AS100-1 antigens. The study group was distributed according to percent psoriasis area and severity index (PASI) reduction from PASI 10 to PASI 100. All groups decreased in arthritis score (AS), tender joints counts and nail changes after treatment; the highest decreased in the PASI 100 group. Relapses of psoriasis and PsA had PASI and AS lower than initial values before treatment. Clinical remissions were at lower doses and less time, after the second course of treatment. Peripheral blood mononuclear cells (PBMC) lymphocyte subsets (LS) varied with PASI range (1-10, 11-20 and 21-72). Pre-treatment, absolute values of gated LS: CD4+, CD8+HLA-, CD8+HLA+, CD8+CD3-, CD8+CD3+ decreased in PBMC as PASI increased, suggesting migration from the blood to the skin. In contrary to the previous finding, the following LS: CD8+CD4-, CD3+CD8-, HLA+CD8-, CD19, CD8+CD4+ and membrane surface immunoglobulin IgA+, IgD+, IgM+, IgE+, and IgG+ increased in PBMC as PASI increased suggesting activation and proliferation by unknown antigens creating a homeostatic cycle between skin/joints and peripheral blood. After nine doses of AS100-1, the following LS: CD8+CD3+, CD8+HLA+, CD3+CD8-, CD4+CD8-, CD8+HLA-, HLA+CD8-, CD8+CD3-, CD19+, CD8+CD4-, CD8+CD4+, IgA+, IgD+, IgM+, IgE+, and IgG+ decreased significantly as compared with values before treatment. The LS decreased stops the vicious cycle between skin/joints and blood explaining clinical remission of lesions.

  13. Rheumatoid arthritis: Clinical, SPECT and MRI investigations

    International Nuclear Information System (INIS)

    Ascoli, G.; Cinti, P.; Nonni, M.; Rossi, B.

    2002-01-01

    Aim: To demonstrate psychometric test and neuroimaging technic capacity in subclinical conditions of cerebral affection in patients with rheumatoid arthritis; to demonstrate agreement between topographic cerebral site and morphological signs in neuroimaging study; to evaluate agreement between cognitive deficits and rheumatoid severity. Material and Method: We have enrolled 20 patients, 17 pts. (85%) showed low score evocative for executive function limitation; 6 pts. (33%) showed attention anomaly, movement organization and verbal fluency. SPECT acquisition shows frontal lobe uptake in 95% (19/20 pts.) extended to parietal lobs in 42% (8/19pts.); 1 pt. Shows normal uptake and very high score. RMN study shows a specific sign of leukoencephalopaty in 35% (7/20pts.) and liquoral spaces increased in 25% (5/20 pts.). Conclusions: Frequent cognitive functions alteration during rheumatoid arthritis; very high topographic agreement between cognitive deficits and cerebral perfusion uptake showed by SPECT study; significant correlation between severity index and disease activity and cognitive deterioration; necessity of further longitudinal study for greater number of patient; pathogenetic disconnect mechanism cortical-subcortical by vasculitic reason or deafferentation jointed to negative interaction between motor limit and cognitive deficit

  14. Ethics of clinical trials.

    Science.gov (United States)

    Palter, S F

    1996-05-01

    The modern clinical trial is a form of human experimentation. There is a long history of disregard for individual rights of the patient in this context, and special attention must be paid to ethical guidelines for these studies. Clinical trials differ in basic ways from clinical practice. Foremost is the introduction of outside interests, beyond those of the patient's health, into the doctor-patient therapeutic alliance. Steps must be taken to protect the interests of the patient when such outside influence exists. Kantian moral theory and the Hippocratic oath dictate that the physician must respect the individual patient's rights and hold such interests paramount. These principles are the basis for informed consent. Randomization of patients is justified when a condition of equipoise exists. The changing nature of health care delivery in the United States introduces new outside interests into the doctor-patient relationship.

  15. Randomised clinical trial

    DEFF Research Database (Denmark)

    Meineche-Schmidt, V.; Christensen, E.; Bytzer, P.

    2011-01-01

    Background: Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. Aim: To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. Methods: Eight hundred and five uninvestigated, primary care patients with upper GI....... Conclusions In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968)....

  16. Features of Onset and Clinical Course of Reactive Arthritis in Children

    Directory of Open Access Journals (Sweden)

    I.S. Lebets

    2013-09-01

    Results. Reactive arthritis of chlamydial etiology is characterized by lesion of large and medium-sized joints of the lower limbs, which is often accompanied by short-term morning stiffness and rapid onset of transient hypomyatrophy. Reiter’s disease may develop rarely. Mycoplasma-induced reactive arthritis is characterized by debut with arthritis of knee, ankle, wrist and small joints of the hand, the development of bursitis and hypomyatrophy. Feature of Ureaplasma arthritis is the formation of bursitis in the heel and tendinitis. Reactive arthritis associated with elevated titers to antistreptolysin O differs with polymorphism of articular syndrome manifestations and, to some extent, of similarity with juvenile rheumatoid arthritis. Unspecified reactive arthritis has a number of the general features with others reactive arthritis and it is characterized by rather benign clinical course, long preservation of joints function and low laboratory activity. Relapse rate of reactive arthritis increases with an increase of duration of illness.

  17. MR imaging assessment of clinical problems in rheumatoid arthritis

    International Nuclear Information System (INIS)

    Narvaez, Jose A.; Roca, Yolanda; Aguilera, Carlos; Narvaez, Javier

    2002-01-01

    Although MR imaging has been increasingly recognized as a useful tool in the diagnosis of early rheumatoid arthritis (RA) and in the assessment of disease activity, these applications have not yet been usually included in the routine management of this condition. Our goal is to review the current role of MRI in the everyday clinical management of patients with RA. The usefulness of MRI in the evaluation of articular and para-articular changes in specific locations, mainly the craniocervical region and the temporomandibular joint, are reviewed. Clinical problems derived from local extra-articular involvement, such as tenosynovitis, ''rice-bodies'' bursitis, and Baker's cyst rupture, are also described. Finally, we also review the value of MRI in evaluation of some complications of RA such as tendinous rupture, osteonecrosis, stress fracture, and septic arthritis/osteomyelitis. (orig.)

  18. MR imaging assessment of clinical problems in rheumatoid arthritis

    Energy Technology Data Exchange (ETDEWEB)

    Narvaez, Jose A.; Roca, Yolanda; Aguilera, Carlos [Department of CT and MR Imaging, Hospital Duran i Reynals, Universitaria de Bellvitge, Barcelona (Spain); Narvaez, Javier [Department of Medicine, Delfos Medical Center, Barcelona (Spain)

    2002-07-01

    Although MR imaging has been increasingly recognized as a useful tool in the diagnosis of early rheumatoid arthritis (RA) and in the assessment of disease activity, these applications have not yet been usually included in the routine management of this condition. Our goal is to review the current role of MRI in the everyday clinical management of patients with RA. The usefulness of MRI in the evaluation of articular and para-articular changes in specific locations, mainly the craniocervical region and the temporomandibular joint, are reviewed. Clinical problems derived from local extra-articular involvement, such as tenosynovitis, ''rice-bodies'' bursitis, and Baker's cyst rupture, are also described. Finally, we also review the value of MRI in evaluation of some complications of RA such as tendinous rupture, osteonecrosis, stress fracture, and septic arthritis/osteomyelitis. (orig.)

  19. The clinical role of nuclear medicine in rheumatoid arthritis patients

    Energy Technology Data Exchange (ETDEWEB)

    Vos, K. (Leiden Univ. Medical Center (Netherlands). Dept. of Rheumatology); Van der Linden, E. (Leiden Univ. Medical Center (Netherlands). Dept. of Radiology); Pauwels, E.K.J. (Leiden Univ. Medical Center (Netherlands). Dept. of Radiology Leiden Univ. Medical Center (Netherlands). Division of Nuclear Medicine)

    1999-03-01

    In patients with rheumatoid arthritis (RA) synovitis activity is the dominant clinical variable that determines the therapeutic approach. At present, the amount of painful and swollen joint assessed by physical examination, is generally used to measure the degree of synovitis activity is not available. The availability of an objective and reproducible method to evaluate synovitis activity in RA would be of great value in patient management and in examination of therapeutic effects. An advantage of the use of radiopharmaceuticals in detection of arthritis activity, compared with other imaging techniques, is the possibility to depict all joints in a single image. Furthermore the technique may image joints which are difficult to assess clinically or radiographically and may also detect joint inflammation in an early phase. In this overview different scintigraphic techniques are compared with each other and with other diagnostic imaging modalities.

  20. Arthritis

    Science.gov (United States)

    ... Psoriatic Arthritis can occur in people who have psoriasis (scaly red and white skin patches). It affects ... Cómo vivir con artritis: Información básica de salud para usted y su familia Rheumatoid Arthritis: Handout on ...

  1. Rheumatoid disease without arthritis; clinical case of pulmonary fibrosis, rheumatoid nodulosis and positive rheumatoid factor without arthritis

    International Nuclear Information System (INIS)

    Ochoa Franco, Julian Andres; Canas Davila, Carlos Alberto

    2003-01-01

    We reported a case of a patient suffering pulmonary fibrosis rapidly progressive and a positive rheumatoid factor test with the presence of HLA DR11 y HLADR17, without arthritis, We discuss how rare is this clinical appearance, and remark the concept that rheumatoid arthritis is a systemic disease, with a wide clinical presentation, that some authors with a right criteria have called rheumatoid disease

  2. Clinical trials in India.

    Science.gov (United States)

    Maiti, Rituparna; M, Raghavendra

    2007-07-01

    The concept of outsourcing for the development and global studies on new drugs has become widely accepted in the pharmaceutical industry due to its cost and uncertainty. India is going to be the most preferred location for contract pharma research and development due to its huge treatment naïve population, human resources, technical skills, adoption/amendment/implementation of rules/laws by regulatory authorities, and changing economic environment. But still 'miles to go' to fulfill the pre-requisites to ensure India's success. In spite of all the pitfalls, the country is ambitious and optimist to attract multinational pharmaceutical companies to conduct their clinical trials in India.

  3. Effect of intermittent aerobic exercise on sleep quality and sleep disturbances in patients with rheumatoid arthritis – design of a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Poor sleep is prevalent in patients with systemic inflammatory disorders, including rheumatoid arthritis, and, in addition to fatigue, pain, depression and inflammation, is associated with an increased risk of co-morbidity and all-cause mortality. Whereas non-pharmacological interventions in patients with rheumatoid arthritis have been shown to reduce pain and fatigue, no randomized controlled trials have examined the effect of non-pharmacological interventions on improvement of sleep in patients with rheumatoid arthritis. The aim of this trial was to evaluate the efficacy of an intermittent aerobic exercise intervention on sleep, assessed both objectively and subjectively in patients with rheumatoid arthritis. Methods/design A randomized controlled trial including 44 patients with rheumatoid arthritis randomly assigned to an exercise training intervention or to a control group. The intervention consists of 18 session intermittent aerobic exercise training on a bicycle ergometer three times a week. Patients are evaluated according to objective changes in sleep as measured by polysomnography (primary outcome). Secondary outcomes include changes in subjective sleep quality and sleep disturbances, fatigue, pain, depressive symptoms, physical function, health-related quality of life and cardiorespiratory fitness. Discussion This trial will provide evidence of the effect of intermittent aerobic exercise on the improvement of sleep in patients with rheumatoid arthritis, which is considered important in promotion of health and well-being. As such, the trial meets a currently unmet need for the provision of non-pharmacological treatment initiatives of poor sleep in patients with rheumatoid arthritis. Trial registration ClinicalTrials.gov Identifier: NCT01966835 PMID:24559487

  4. Patellofemoral pain, instability, and arthritis. Clinical presentation, imaging, and treatment

    Energy Technology Data Exchange (ETDEWEB)

    Zaffagnini, Stefano [Laboratorio di Biomeccanica, Bologna (Italy). Istituti Ortopedici Rizzoli; Dejour, David [Lyon-Ortho-Clinic (France). Knee Surgery Orthopaedic Dept.; Arendt, Elizabeth A. (eds.) [Minnesota Univ., Minneapolis, MN (United States). Dept. of Orthopaedics

    2010-07-01

    Despite numerous studies, a lack of consensus still exists over many aspects of patellofemoral pain, instability, and arthritis. This book adopts an evidence-based approach to assess each of these topics in depth. The book reviews general features of clinical examination and global evaluation techniques including the use of different imaging methods, e.g. x-rays, CT, MRI, stress x-rays, and bone scan. Various conservative and surgical treatment approaches for each of the three presentations - pain, instability, and arthritis - are then explained and assessed. Postoperative management and options in the event of failed surgery are also evaluated. Throughout, careful attention is paid to the literature in an attempt to establish the level of evidence for the efficacy of each imaging and treatment method. It is hoped that this book will serve as an informative guide for the practitioner when confronted with disorders of the patellofemoral joint. (orig.)

  5. Ankle tenosynovitis in rheumatoid arthritis: clinical and ultrasonographic evaluation

    Directory of Open Access Journals (Sweden)

    Ana Luiza Naves Pereira

    2016-11-01

    Full Text Available Objective: To investigate ankle tenosynovitis in rheumatoid arthritis patients, regarding its presence, the kind of tendon involved and the concordance between clinical and ultrasound findings. Methods: Twenty patients with rheumatoid arthritis and pain or swollen ankle joint were evaluated. Tendon involvement was evaluated with ultrasound imaging. The Health Assessment Questionnaire (HAQ was performed for disability evaluation. Age, sex, disease duration, and vocational activity levels were also obtained. The statistical analysis included Fisher’s exact test. The significance level was 0.05. Results: Tenosynovitis was found in 13 of 20 (65.0% patients in 19 joints, in which 6 were bilaterally (46.1% and unilateral in 7 (53.8%. Tibialis posterior tenosynovitis was seen in nine (45.0% patients, Achilles tenosynovitis in seven (35.0%, tibialis anterior tenosynovitis in three (15.0%, and peroneal tenosynovitis in three (15.0% patients. We found concordance between symptomatic ankle and ultrasonographic findings in 92.3% of the patients with tenosynovitis. Association between severe HAQ with tendon involvement was not found (p>0.05. Disease duration was not associated with tenosynovitis. Patients were predominantly older, female, with mean age around 50.8 years. The long disease duration of patients presented a mean of 11.4 years and, most of them, with no vocational activity (65.0%. Conclusions: The results indicate that ankle tenosynovitis is very common in rheumatoid arthritis patients, both unilateral and bilateral. Tibialis posterior was the most common tendon involvement found. Finally, we found concordance between the clinical and ultrasound findings in almost all rheumatoid arthritis patients with ankle tenosynovitis.

  6. [Clinical trials in nursing journals].

    Science.gov (United States)

    Di Giulio, Paola; Campagna, Sara; Dimonte, Valerio

    2014-01-01

    Clinical trials are pivotal for the development of nursing knowledge. To describe the clinical trials published in nursing journals in the last two years and propose some general reflections on nursing research. A search with the key-word trial was done on PubMed (2009-2013) on Cancer Nursing, European Journal of Oncology Nursing, International Journal of Nursing Studies, Journal of Advanced Nursing, Journal of Clinical Nursing and Nursing Research. Of 228 trials identified, 104 (45.8%) were published in the last 2 years. Nurses from Asian countries published the larger number of trials. Educational and supportive interventions were the most studied (61/104 trials), followed by clinical interventions (33/104). Samples were limited and most trials are monocentric. A growing number of trials is published, on issues relevant for the nursing profession, however larger samples and multicentric studies would be necessary.

  7. Protocol for the Foot in Juvenile Idiopathic Arthritis trial (FiJIA: a randomised controlled trial of an integrated foot care programme for foot problems in JIA

    Directory of Open Access Journals (Sweden)

    Hendry Gordon J

    2009-06-01

    Full Text Available Abstract Background Foot and ankle problems are a common but relatively neglected manifestation of juvenile idiopathic arthritis. Studies of medical and non-medical interventions have shown that clinical outcome measures can be improved. However existing data has been drawn from small non-randomised clinical studies of single interventions that appear to under-represent the adult population suffering from juvenile idiopathic arthritis. To date, no evidence of combined therapies or integrated care for juvenile idiopathic arthritis patients with foot and ankle problems exists. Methods/design An exploratory phase II non-pharmacological randomised controlled trial where patients including young children, adolescents and adults with juvenile idiopathic arthritis and associated foot/ankle problems will be randomised to receive integrated podiatric care via a new foot care programme, or to receive standard podiatry care. Sixty patients (30 in each arm including children, adolescents and adults diagnosed with juvenile idiopathic arthritis who satisfy the inclusion and exclusion criteria will be recruited from 2 outpatient centres of paediatric and adult rheumatology respectively. Participants will be randomised by process of minimisation using the Minim software package. The primary outcome measure is the foot related impairment measured by the Juvenile Arthritis Disability Index questionnaire's impairment domain at 6 and 12 months, with secondary outcomes including disease activity score, foot deformity score, active/limited foot joint counts, spatio-temporal and plantar-pressure gait parameters, health related quality of life and semi-quantitative ultrasonography score for inflammatory foot lesions. The new foot care programme will comprise rapid assessment and investigation, targeted treatment, with detailed outcome assessment and follow-up at minimum intervals of 3 months. Data will be collected at baseline, 6 months and 12 months from baseline

  8. Clinical manifestations, treatment outcomes, and risk factors for sternoclavicular septic arthritis.

    Science.gov (United States)

    Rodchuae, Muchima; Ruangpin, Chonlada; Katchamart, Wanruchada

    2017-05-01

    Septic arthritis of the sternoclavicular joint (SCJ) is an atypical and rarely seen clinical condition. The prognosis for patients with SCJ septic arthritis is often poor. The objective of this study was to compare clinical characteristics between SCJ and non-sternoclavicular joint (NSCJ) septic arthritis and to identify independent risk factors for SCJ septic arthritis. A total of 450 adult patients diagnosed with septic arthritis during the January 2002 to December 2013 study period were included in this retrospective cohort study. Patient characteristics, clinical manifestations, and treatment outcomes were examined. Univariate and multivariate analysis was performed to identify potential risk factors for SCJ septic arthritis. Thirty-three (7.3%) of 450 patients had SCJ septic arthritis and the remaining 417 patients had NSCJ. Oligoarthritis or polyarthritis were seen more often in SCJ patients than in NSCJ patients (55 vs. 19%; p septic arthritis. SCJ septic arthritis is an uncommon septic arthritis that frequently presents with local and systemic complications. Factors found to be significantly associated with SCJ septic arthritis were extra-articular infection and immunocompromised host. A high index of suspicion in high-risk patients is the key to achieving improved outcomes.

  9. Clinical registry for rheumatoid arthritis; a preliminary analysis

    International Nuclear Information System (INIS)

    Fakhr, A.; Hakim, F.; Zaidi, S.K.; Sharif, A.

    2017-01-01

    To establish a clinical registry for Rheumatoid Arthritis and delineate the most common symptoms that rheumatoid arthritis (RA) patients experience in our set up. Study Design: Cross sectional study. Place and Duration of Study: Study was carried out at Military Hospital (MH) Rawalpindi at Rheumatology Department during the period of Jan 2013 to Jun 2015. Material and Methods: A clinical registry for Rheumatoid Arthritis was developed as per criteria jointly developed by American College of Rheumatology (ACR) along with European League against Rheumatism (EULAR) (2010). Fifty-eight patients were registered after their informed consent and approval by Military Hospital (MH) Rawalpindi ethical committee. Age, gender and relevant clinical parameters of RA patients were recorded on case report forms and stored for analysis in the RA registry in Excel 2010. The figures were reported in frequencies and percentages. Results: Multiple joint pains (48.28%), fever (24.14%), morning stiffness of joints (22.41%) were the most common symptoms in RA patients. Other clinical manifestations included painful bilateral swollen joints (13.79%), pain in different parts of the body (10.34%), Raynaud's phenomenon (10.34%), malaise (8.62%), swollen body parts (8.62%), ulcers (8.62%), fatigue (6.90%), nodules on skin/elbow/interphalangeal joints (6.90%), deformities of fingers/ hand (3.45%), redness of eyes (3.45%), body rash (3.45%), inability to walk (3.45%), cervical lymphadenopathy (1.72%), stiffness of spine (1.72%) and myalgias (1.72%). Conclusion: It is concluded that multiple joint pains, fever and morning stiffness of joints are the most common symptoms of RA patients. (author)

  10. Differences between participants and nonparticipants in an exercise trial for adults with rheumatoid arthritis.

    NARCIS (Netherlands)

    Jong, Z. de; Munneke, M.; Jansen, L.M.; Ronday, K.; Schaardenburg, D.J. van; Brand, R.; Ende, C.H.M. van den; Vliet Vlieland, T.P.M.; Zuijderduin, W.M.; Hazes, J.M.

    2004-01-01

    OBJECTIVE: To investigate the generalizability of the results of a randomized controlled trial on the effectiveness of long-term, high-intensity exercises in the rheumatoid arthritis patients in training (RAPIT) trial by comparing the characteristics of the participants with the nonparticipants.

  11. Clinical trials of homoeopathy

    NARCIS (Netherlands)

    Kleijnen, J.; Knipschild, P.; ter Riet, G.

    1991-01-01

    OBJECTIVE: To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN: Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using

  12. Algorithm development for corticosteroid management in systemic juvenile idiopathic arthritis trial using consensus methodology

    Directory of Open Access Journals (Sweden)

    Ilowite Norman T

    2012-08-01

    Full Text Available Abstract Background The management of background corticosteroid therapy in rheumatology clinical trials poses a major challenge. We describe the consensus methodology used to design an algorithm to standardize changes in corticosteroid dosing during the Randomized Placebo Phase Study of Rilonacept in Systemic Juvenile Idiopathic Arthritis Trial (RAPPORT. Methods The 20 RAPPORT site principal investigators (PIs and 4 topic specialists constituted an expert panel that participated in the consensus process. The panel used a modified Delphi Method consisting of an on-line questionnaire, followed by a one day face-to-face consensus conference. Consensus was defined as ≥ 75% agreement. For items deemed essential but when consensus on critical values was not achieved, simple majority vote drove the final decision. Results The panel identified criteria for initiating or increasing corticosteroids. These included the presence or development of anemia, myocarditis, pericarditis, pleuritis, peritonitis, and either complete or incomplete macrophage activation syndrome (MAS. The panel also identified criteria for tapering corticosteroids which included absence of fever for ≥ 3 days in the previous week, absence of poor physical functioning, and seven laboratory criteria. A tapering schedule was also defined. Conclusion The expert panel established consensus regarding corticosteroid management and an algorithm for steroid dosing that was well accepted and used by RAPPORT investigators. Developed specifically for the RAPPORT trial, further study of the algorithm is needed before recommendation for more general clinical use.

  13. Clinical characteristics, treatment and outcome of children with Lyme arthritis in Nova Scotia.

    Science.gov (United States)

    Glaude, Pier Diane; Huber, Adam M; Mailman, Timothy; Ramsey, Suzanne; Lang, Bianca; Stringer, Elizabeth

    2015-10-01

    Lyme disease is an emerging problem in Nova Scotia. Lyme arthritis is a late manifestation of Lyme disease. To describe the demographic characteristics, referral patterns and clinical course of children diagnosed with Lyme arthritis in a tertiary care pediatric rheumatology clinic in Nova Scotia. In the present retrospective chart review, subjects diagnosed with Lyme arthritis between 2006 and 2013 were identified through the clinic database. Demographic variables, referral patterns, clinical presentation and information regarding treatment course and outcome were collected. Seventeen patients were identified; 76% presented in 2012 and 2013. In 37.5% of cases, the referring physician suspected Lyme disease. Most patients presented with one or more painful and/or swollen joints; 94% had knee involvement. Only three of 17 patients had a history of erythema migrans and four of 17 recalled a tick bite. Five patients had a history of neurological manifestations consistent with Lyme disease, although, none had a diagnosis made at the time. Arthritis usually resolved after treatment with standard antibiotics; however, at last follow-up, two patients had antibiotic refractory Lyme arthritis, with one having joint damage despite aggressive arthritis treatment. A significant increase in cases of Lyme arthritis has recently been recognized in a pediatric rheumatology clinic in Nova Scotia. A history of a tick bite or erythema migrans were not sensitive markers of Lyme arthritis, and this diagnosis was often not considered by the referring physician. Educational initiatives should be undertaken to increase local awareness of this treatable cause of arthritis in children.

  14. Exploratory analyses of the association of MRI with clinical, laboratory and radiographic findings in patients with rheumatoid arthritis

    DEFF Research Database (Denmark)

    Emery, Paul; van der Heijde, Désirée; Østergaard, Mikkel

    2011-01-01

    Evaluate relationships between MRI and clinical/laboratory/radiographic findings in rheumatoid arthritis (RA).......Evaluate relationships between MRI and clinical/laboratory/radiographic findings in rheumatoid arthritis (RA)....

  15. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...

  16. [Septic arthritis in children with normal initial C-reactive protein: clinical and biological features].

    Science.gov (United States)

    Basmaci, R; Ilharreborde, B; Bonacorsi, S; Kahil, M; Mallet, C; Aupiais, C; Doit, C; Dugué, S; Lorrot, M

    2014-11-01

    Septic arthritis has to be suspected in children with joint effusion and fever so as to perform joint aspiration, which will confirm the diagnosis by bacteriological methods, and to perform surgical treatment by joint lavage. Since development of current molecular methods, such as real-time PCR, Kingella kingae has become the first microbial agent of osteoarticular infections in young children, whereas Staphylococcus aureus is second. C-reactive protein (CRP) is an aid used to diagnose septic arthritis, but its elevation could be moderate. In a previous study, conducted at our hospital, 10% of children hospitalized for S. aureus or K. kingae septic arthritis had a CRP levelseptic arthritis could be made by other parameters, we analyzed the clinical and biologic features of these patients and compared them to those of children hospitalized for septic arthritis with initial CRP ≥10 mg/L. Among the 89 children with septic arthritis, 10% (n=9) had initial CRPseptic arthritis had no fever, CRP elevation, or fibrinogen elevation. In the CRP-negative group, three of four children with S. aureus arthritis and one of five with K. kingae arthritis had a high CRP level (34, 40, 61, and 13 mg/L, respectively) 3 days after surgery and antibiotic treatment. One child with K. kingae septic arthritis and initial CRParthritis. In the S. aureus arthritis group, none of the children with initial CRP10 mg/L during septic arthritis in children, it could be negative in up to 20% of patients in different studies. However, a mild inflammatory syndrome or even a CRPseptic arthritis. Therefore, a first episode of monoarthritis in children has to be considered as septic arthritis and treatment should not be delayed. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  17. Clinical characteristics and outcomes of community-acquired methicillin-resistant Staphylococcus aureus septic arthritis

    Directory of Open Access Journals (Sweden)

    Sian Yik Lim

    2017-01-01

    Full Text Available Objective: We investigated the clinical characteristics, treatment patterns and outcomes of community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA septic arthritis. Methods: This was a retrospective chart review of CA-MRSA septic arthritis in a tertiary care hospital from 2000-2013. We compared CA-MRSA septic arthritis cases with HA-MRSA septic arthritis cases to identify important differences between the two groups. Results: We identified 11 cases of CA-MRSA septic arthritis and 34 cases of hospital-acquired methicillin-resistant SA (HA-MRSA septic arthritis. Community-acquired methicillin-resistant Staphylococcus aureus caused 25% of the MRSA septic arthritis cases. Community-acquired methicillin-resistant Staphylococcus aureus septic arthritis occurred in younger patients with fewer comorbidities or risk factors. There was no difference in initial presentation between CA-MRSA and HA-MRSA. Community-acquired methicillin-resistant Staphylococcus aureus patients were less likely to be treated with appropriate antibiotics initially. Community-acquired methicillin-resistant Staphylococcus aureus septic arthritis was associated with increased morbidity with a high percentage of patients developing poor joint outcomes or osteomyelitis complications.  Community-acquired methicillin-resistant Staphylococcus aureus septic arthritis was also associated with increased utilization of health care resources due to long hospital stays, high readmissions rates, and increased requirements for rehabilitation facility placement and home health support. There was no difference in mortality, poor joint outcome, readmissions, and osteomyelitis complications between CA-MRSA septic arthritis and HA-MRSA septic arthritis. Conclusions: Community-acquired methicillin-resistant Staphylococcus aureus septic arthritis is associated with increased morbidity and health care resource utilization. Increased awareness into CA-MRSA as a cause of septic

  18. Social media in clinical trials.

    Science.gov (United States)

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.

  19. Controlled trial of synovectomy of knee and metacarpophalangeal joints in rheumatoid arthritis.

    Science.gov (United States)

    1975-10-01

    In a multicentre study patients with rheumatoid arthritis judged by prevailing criteria to be suitable for synovectomy of the knee or metacarpophalangeal (MCP) joints were randomly allocated to one of two groups. One group had the operation, the other was observed without operation from a notional corresponding date. 3 years later the outcome of synovectomy was compared with that of observation without synovectomy. Synovectomy of the knee was followed by significantly less pain and tenderness, smaller effusions, and smaller and less frequent erosions and geodes. By contrast, MCP joints were no better clinically or radiographically than those treated conservatively. The results have been compared with those of two other controlled trials, one concerned with the knee and MCP joints, the other only with MCP joints. In the present trial results were more favourable in the knee but comparable in the MCP joints with those reported in the first of these two trials but less favourable in the MCP joints than those observed in the second.

  20. Designing clinical trials for amblyopia

    Science.gov (United States)

    Holmes, Jonathan M.

    2015-01-01

    Randomized clinical trial (RCT) study design leads to one of the highest levels of evidence, and is a preferred study design over cohort studies, because randomization reduces bias and maximizes the chance that even unknown confounding factors will be balanced between treatment groups. Recent randomized clinical trials and observational studies in amblyopia can be taken together to formulate an evidence-based approach to amblyopia treatment, which is presented in this review. When designing future clinical studies of amblyopia treatment, issues such as regression to the mean, sample size and trial duration must be considered, since each may impact study results and conclusions. PMID:25752747

  1. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For each...... relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies...

  2. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998...

  3. Insurance Coverage and Clinical Trials

    Science.gov (United States)

    Most health insurance plans are required to cover routine patient care costs in clinical trials under certain conditions. Learn about the conditions that insurance plans take into account and how to work with your insurance company.

  4. Types of Treatment: Clinical Trials

    Science.gov (United States)

    ... Careers at LLS Language English Spanish Canadian English French Canadian I am a Patient looking for Disease/ ... other treatments you've used. Your doctor may speak to you about participating in a clinical trial. ...

  5. Rose hip herbal remedy in patients with rheumatoid arthritis - a randomised controlled trial.

    Science.gov (United States)

    Willich, S N; Rossnagel, K; Roll, S; Wagner, A; Mune, O; Erlendson, J; Kharazmi, A; Sörensen, H; Winther, K

    2010-02-01

    To investigate if standardised powder made from rose-hip (Rosa canina) can reduce the symptom score in patients with rheumatoid arthritis. In a double-blind placebo-controlled trial, patients with rheumatoid arthritis (RA) according to ARA/ACR criteria were randomised to treatment with capsulated rose-hip powder 5g daily or matching placebo for 6 months at two outpatient clinics in Berlin and Copenhagen. Primary outcome variable was Health Assessment Questionnaire (HAQ) at 6 months, secondary outcome included DAS-28, physician's global evaluation of disease activity, RAQoL, SF-12 and concomitant pain medication. In a total of 89 patients (90% female, mean age 56.6+11.3 years, mean disease duration 12.8+9.6 years) HAQ-DI in the rose-hip group improved by 0.105+/-0.346, whereas in the placebo group it worsened by 0.039+/-0.253 (p adjusted=0.032). In the HAQ Patient Pain Scale no significant differences were observed between both groups. In the HAQ Patient Global Scale a trend was seen favouring rose-hip (p=0.078). The DAS-28 score yielded improvement in the rose-hip group of 0.89+/-1.32 and in the placebo group of 0.34+/-1.27 (p=0.056) indicating moderate clinical relevance. The Physicians Global Scale demonstrated more improvement in the rose-hip compared to the placebo group (p=0.012). RAQoL and SF-12 physical score improved significantly in the rose-hip group compared to placebo, whereas SF-12 mental score remained unchanged. Intake of pain medication was not different between the groups. Per-protocol analysis confirmed these results. The results indicate that patients with RA may benefit from additional treatment with rose hip powder. Copyright 2009 Elsevier GmbH. All rights reserved.

  6. Native Joint Septic Arthritis: Epidemiology, Clinical Features, and Microbiological Causes in a New Zealand Population.

    Science.gov (United States)

    Kennedy, Nicholas; Chambers, Steven T; Nolan, Imogen; Gallagher, Kate; Werno, Anja; Browne, Melanie; Stamp, Lisa K

    2015-12-01

    To determine the epidemiology, clinical features, and microbiology of adult native joint septic arthritis in Canterbury, New Zealand, over a 5-year period in individuals with and without an underlying rheumatic disorder. Patients with native joint septic arthritis were identified retrospectively and classified by Newman's criteria. The clinical characteristics were described and comparisons made between those with and without underlying rheumatic disease. Two hundred forty-eight cases of native joint septic arthritis (mean age 60, range 16-97 yrs) were identified with an overall incidence rate of 12.0/100,000/year (95% CI 10.6-13.6). Yearly incidence increased with age to a maximum of 73.4/100,000 in those > 90 years of age. Septic arthritis was iatrogenic in 16.9% of cases while 27% had an underlying inflammatory arthritis including gout (14.9%), calcium pyrophosphate disease (8.5%), and rheumatoid arthritis (4%). Few patients were taking immunosuppressant therapy, with just 1 taking a biological agent. Staphylococcus aureus was the most commonly identified organism. Those with underlying inflammatory arthritis were significantly older (73.6 yrs vs 55.6 yrs; p septic polyarthritis (16.4% vs 4.4%; p = 0.002). The 30-day mortality was 2%, increasing to 6% at 90 days. The incidence of septic arthritis in Canterbury, New Zealand, is higher than in previous studies. Crystal arthropathy commonly coexisted with infection although autoimmune arthritis and immunosuppression was less of a factor than anticipated.

  7. Birth Control in Clinical Trials

    Science.gov (United States)

    Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.

    2015-01-01

    The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398

  8. The Effects of Aromatherapy Massage and Reflexology on Pain and Fatigue in Patients with Rheumatoid Arthritis: A Randomized Controlled Trial.

    Science.gov (United States)

    Gok Metin, Zehra; Ozdemir, Leyla

    2016-04-01

    Nonpharmacologic interventions for symptom management in patients with rheumatoid arthritis are underinvestigated. Limited data suggest that aromatherapy massage and reflexology may help to reduce pain and fatigue in patients with rheumatoid arthritis. The aim of this study was to examine and compare the effects of aromatherapy massage and reflexology on pain and fatigue in patients with rheumatoid arthritis. The study sample was randomly assigned to either an aromatherapy massage (n = 17), reflexology (n = 17) or the control group (n = 17). Aromatherapy massage was applied to both knees of subjects in the first intervention group for 30 minutes. Reflexology was administered to both feet of subjects in the second intervention group for 40 minutes during weekly home visits. Control group subjects received no intervention. Fifty-one subjects with rheumatoid arthritis were recruited from a university hospital rheumatology clinic in Turkey between July 2014 and January 2015 for this randomized controlled trial. Data were collected by personal information form, DAS28 index, Visual Analog Scale and Fatigue Severity Scale. Pain and fatigue scores were measured at baseline and within an hour after each intervention for 6 weeks. Pain and fatigue scores significantly decreased in the aromatherapy massage and reflexology groups compared with the control group (p aromatherapy massage (week 1 vs week 2 for pain, week 1 vs week 4 for fatigue) (p Aromatherapy massage and reflexology are simple and effective nonpharmacologic nursing interventions that can be used to help manage pain and fatigue in patients with rheumatoid arthritis. Copyright © 2016 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  9. Clinical Trials in Surgery

    African Journals Online (AJOL)

    The history of experimental studies is as old as humanity itself. One of the earliest references to a trial in the bible is in ... there are lesser reports for surgical procedures. (8). Challenges faced when designing surgical RCTs .... after modified radical mastectomy. Ann Afr Surg. 2014;11(2):5-8. 12. Ogunrombi A, Onakpoya U, ...

  10. Clinical Aspects of Pregnancy-induced Amelioration of Rheumatoid Arthritis: PARA-study

    NARCIS (Netherlands)

    Y.A. de Man (Yael)

    2009-01-01

    textabstractIn this PhD thesis, embedded in the PARA (Pregnancy-induced Amelioration of Rheumatoid Arthritis) study, several clinical aspects of the spontaneously occurring pregnancy-induced improvement of rheumatoid arthritis (RA) are addressed. An overview is given of inflammatory rheumatic

  11. Rheumatoid Arthritis Educational Video Series

    Medline Plus

    Full Text Available ... Arthritis Managing Chronic Pain and Depression in Arthritis Nutrition & Rheumatoid Arthritis Arthritis and Health-related Quality of ... Rheumatology Arthritis Center Lupus Center Lyme Disease Clinical Research Center Myositis Center Scleroderma Center Sjogren’s Syndrome Center ...

  12. Contrast-enhanced MRI of the knee in children unaffected by clinical arthritis compared to clinically active juvenile idiopathic arthritis patients

    Energy Technology Data Exchange (ETDEWEB)

    Nusman, Charlotte M.; Hemke, Robert [University of Amsterdam, Department of Radiology, Academic Medical Center, Amsterdam (Netherlands); University of Amsterdam, Department of Pediatric Hematology, Immunology, Rheumatology and Infectious Disease, Emma Children' s Hospital AMC, Amsterdam (Netherlands); Benninga, Marc A.; Kindermann, Angelika [University of Amsterdam, Department of Pediatric Gastroenterology, Emma Children' s Hospital AMC, Amsterdam (Netherlands); Schonenberg-Meinema, Dieneke; Berg, J.M. van den; Kuijpers, Taco W. [University of Amsterdam, Department of Pediatric Hematology, Immunology, Rheumatology and Infectious Disease, Emma Children' s Hospital AMC, Amsterdam (Netherlands); Rossum, Marion A.J. van [University of Amsterdam, Department of Pediatric Hematology, Immunology, Rheumatology and Infectious Disease, Emma Children' s Hospital AMC, Amsterdam (Netherlands); Reade, Department of Pediatric Rheumatology, Amsterdam (Netherlands); Maas, Mario [University of Amsterdam, Department of Radiology, Academic Medical Center, Amsterdam (Netherlands)

    2016-04-15

    To evaluate enhancing synovial thickness upon contrast-enhanced magnetic resonance imaging (MRI) of the knee in children unaffected by clinical arthritis compared with clinically active juvenile idiopathic arthritis (JIA) patients. A secondary objective was optimization of the scoring method based on maximizing differences on MRI between these groups. Twenty-five children without history of joint complaints nor any clinical signs of joint inflammation were age/sex-matched with 25 clinically active JIA patients with arthritis of at least one knee. Two trained radiologists, blinded for clinical status, independently evaluated location and extent of enhancing synovial thickness with the validated Juvenile Arthritis MRI Scoring system (JAMRIS) on contrast-enhanced axial fat-saturated T1-weighted MRI of the knee. Enhancing synovium (≥2 mm) was present in 13 (52 %) unaffected children. Using the total JAMRIS score for synovial thickening, no significant difference was found between unaffected children and active JIA patients (p = 0.091). Additional weighting of synovial thickening at the JIA-specific locations enabled more sensitive discrimination (p = 0.011). Mild synovial thickening is commonly present in the knee of children unaffected by clinical arthritis. The infrapatellar and cruciate ligament synovial involvement were specific for JIA, which - in a revised JAMRIS - increases the ability to discriminate between JIA and unaffected children. (orig.)

  13. A Novel Mobile App and Population Management System to Manage Rheumatoid Arthritis Flares: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Wang, Penny; Luo, Dee; Lu, Fengxin; Elias, Josephine S; Landman, Adam B; Michaud, Kaleb D; Lee, Yvonne C

    2018-04-11

    Rheumatoid arthritis flares have a profound effect on patients, causing pain and disability. However, flares often occur between regularly scheduled health care provider visits and are, therefore, difficult to monitor and manage. We sought to develop a mobile phone app combined with a population management system to help track RA flares between visits. The objective of this study is to implement the mobile app plus the population management system to monitor rheumatoid arthritis disease activity between scheduled health care provider visits over a period of 6 months. This is a randomized controlled trial that lasts for 6 months for each participant. We aim to recruit 190 patients, randomized 50:50 to the intervention group versus the control group. The intervention group will be assigned the mobile app and be prompted to answer daily questionnaires sent to their mobile devices. Both groups will be assigned a population manager, who will communicate with the participants via telephone at 6 weeks and 18 weeks. The population manager will also communicate with the participants in the intervention group if their responses indicate a sustained increase in rheumatoid arthritis disease activity. To assess patient satisfaction, the primary outcomes will be scores on the Treatment Satisfaction Questionnaire for Medication as well as the Perceived Efficacy in Patient-Physician Interactions questionnaire at 6 months. To determine the effect of the mobile app on rheumatoid arthritis disease activity, the primary outcome will be the Clinical Disease Activity Index at 6 months. The trial started in November 2016, and an estimated 2.5 years will be necessary to complete the study. Study results are expected to be published by the end of 2019. The completion of this study will provide important data regarding the following: (1) the assessment of validated outcome measures to assess rheumatoid arthritis disease activity with a mobile app between routinely scheduled health care

  14. Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial

    Science.gov (United States)

    2010-01-01

    Background Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications. Methods Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR) criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), and laboratory tests for erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Results Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052) and statistically significant improvement in Pain Scale (P = .046) vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study. Conclusions Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results. Trial registration ACTRN12609000435280 PMID:20067641

  15. Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Eichas Katy

    2010-01-01

    Full Text Available Abstract Background Lactic acid-producing bacteria (LAB probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA in combination with pharmacological anti-arthritic medications. Methods Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI, and laboratory tests for erythrocyte sedimentation rate (ESR and C-reactive protein (CRP. Results Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052 and statistically significant improvement in Pain Scale (P = .046 vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study. Conclusions Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results. Trial registration ACTRN12609000435280

  16. Cryotherapy decreases synovial Doppler activity and pain in knee arthritis: A randomized-controlled trial.

    Science.gov (United States)

    Guillot, Xavier; Tordi, Nicolas; Prati, Clément; Verhoeven, Frank; Pazart, Lionel; Wendling, Daniel

    2017-07-01

    To measure and compare the effects of 2 local cryotherapy techniques on synovial power Doppler activity (primary outcome) and pain in non-septic knee arthritis without any concurrent treatment. 30 patients were randomized (ice: 30min, n=15 or cold CO 2 : 2min, n=15 both applied twice at 8h interval). Contralateral non-treated arthritic knees were used as paired controls (n=11 and n=10 respectively). The PDUS semi-quantitative score (0-3) and pain visual analogic scale were evaluated before/after each cold application, 2min, 2h, 24h after the first application. PDUS scores were checked in double-blind by 2 ultrasonographists. The inter-class effect size of local cryotherapy on the power Doppler score remained significant the day after treatment in local cryotherapy-treated compared to contralateral non-treated knees (Global difference: -1 [95% confidence interval: -1.23; -0.77]; ice: -0.73 [-1.06; -0.4]; CO 2 : -0.7 [-1.18; -0.22]). Both techniques significantly and to the same extent reduced the power Doppler score and pain visual analogic scale at all evaluation times and globally throughout the 24 hour-study period. No dropout nor adverse event was reported. In multivariate analysis, the Power Doppler score decrease was associated with pain decrease, while pain decrease was associated with the female sex and ice technique. Local ice and cold CO 2 applied twice equally reduced synovial Power Doppler activity and pain over 24h in knee arthritis. These effects remained significant the day after treatment. ClinicalTrials.gov identifier: NCT02573298. Copyright © 2016 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

  17. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... the Media Room Public Affairs News Releases Speeches Videos Publications National Observances Veterans Day Memorial Day Celebrating America's Freedoms Special Events Adaptive Sports Program Creative Arts Festival Golden Age Games Summer Sports Clinic Training - Exposure - Experience (TEE) Tournament ...

  18. Short-term effect of ultrasound-guided low-molecular-weight hyaluronic acid injection on clinical outcomes and imaging changes in patients with rheumatoid arthritis of the ankle and foot joints. A randomized controlled pilot trial.

    Science.gov (United States)

    Wang, Chien-Chih; Lee, Si-Huei; Lin, Hsiao-Yi; Liu, Fu-Wei; Chiou, Hong-Jen; Chan, Rai-Chi; Chou, Chen-Liang

    2017-11-01

    To determine whether hyaluronic acid (HA) injection into rheumatoid arthritis ankles and feet can achieve improvement in foot function and reduce synovial hyper-vascularization. Forty-four patients with RA having unilateral or bilateral painful ankle and foot involvement (N = 75) were studied. All the patients were randomized to receive HA (N = 40) or lidocaine (LI) (N = 35) injection at 2-week intervals; Clinical assessments were performed using a visual analog scale (VAS) and foot function index (FFI total ) including subscales of pain (FFI pain) before injection at baseline, 4 weeks (first evaluation) and 12 weeks (secondary evaluation). Imaging evaluation based on color Doppler ultrasound (CDUS) and synovitis scores was performed simultaneously. HA injection improved the VAS score (p = .009), FFI pain (p = .041), and FFI total (p = .032) considerably more than LI injections did at the first evaluation. The CDUS values at first evaluation (p = .005) and secondary evaluation (p injections reduced the CDUS values of more than half of the joints (54%, p = .042) while the control group exhibited no change (20%, p = .56). However, HA injection did not reduce the CDUS values more than LI injection did. Regarding the evaluation of synovial hypertrophy, no significant difference was observed between or within the groups in the synovitis scores. HA injection improved short-term foot function and pain reduction. HA injection may have a modest effect in reducing synovial hyper-vascularization. Further large-scale study is warranted to confirm this result.

  19. Clinical trials. A pending subject.

    Science.gov (United States)

    Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

    2017-07-31

    Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  20. Insights into methotrexate in rheumatoid arthritis: a clinical review ...

    African Journals Online (AJOL)

    Objective: To review the efficacy and safety profile of methotrexate in rheumatoid arthritis. Data source: Published original research work and reviews were searched in English related to efficacy and safety profile of methotrexate in rheumatoid arthritis. Study design: Only articles that emphasis on efficacy and safety profile of ...

  1. Generalization and extrapolation of treatment effects from clinical studies in rheumatoid arthritis

    NARCIS (Netherlands)

    Nair, S.C.; Kievit, W.; Janse, R.W.; Bijlsma, J.W.J.; Fransen, J.; Lafeber, F.P.J.G.; Welsing, P.M.J.

    2014-01-01

    OBJECTIVE: Pragmatic clinical trials have been proposed as a solution for nongeneralizability of randomized clinical trial (RCT) results. We investigated whether treatment effects of pragmatic clinical trials are indeed generalizable to clinical practice and how efficacy estimates from published

  2. From clinical expert to guide: experiences from coaching people with rheumatoid arthritis to increased physical activity.

    Science.gov (United States)

    Nessen, Thomas; Opava, Christina H; Martin, Cathrin; Demmelmaier, Ingrid

    2014-05-01

    Physical activity levels in people with rheumatoid arthritis are lower than what are recommended for a healthful lifestyle. To support physical activity, health care professionals may use behavioral change techniques based on a biopsychosocial perspective. Investigating the implementation process may be relevant for understanding how these techniques translate to practice. The study objective was to explore the experiences of physical therapists using behavioral change techniques to coach people with rheumatoid arthritis to health-enhancing physical activity in a 2-year trial, the Physical Activity in Rheumatoid Arthritis 2010 study. This was an exploratory study with qualitative content analysis. Semistructured interviews were conducted with all 12 physical therapists in the study. They were asked about their experiences with an educational program and with their delivery of a health-enhancing physical activity intervention. Codes, subcategories, categories, and an overarching theme were derived from the transcribed interviews by use of qualitative content analysis. The overarching theme (from clinical expert to guide) was based on 3 main categories: challenges in the coaching role, growing into the coaching role, and coach education and support. Early in the process, the physical therapists encountered challenges that needed to be addressed for a smoother transition into their coaching role. Assisted by education and support, they gradually adopted practices that facilitated their use of behavioral change techniques and promoted growth into the role of coach. Adapting to a new role is a challenging process for health care professionals; it requires relevant education and support. The experiences identified in the present study may inform future educational programs targeting the skills of health care professionals in promoting various health-related behaviors.

  3. Clinical course and outcome of early rheumatoid arthritis.

    Science.gov (United States)

    Papadopoulos, I A; Katsimbri, P; Katsaraki, A; Temekonidis, T; Georgiadis, A; Drosos, A A

    2001-07-01

    We studied whether patients with seropositivity in early rheumatoid arthritis (RA) comprise a different clinical group than those with seronegativity. Four hundred seventeen patients with early RA according to the American College of Rheumatology criteria (disease duration less than 1 year) were retrospectively studied by analysis of demographic, clinical, laboratory, radiological, and therapeutic disease characteristics from the time of diagnosis until the end of the study period (1981 1999) using a data base. There were 248 seropositive patients and 169 seronegative patients with RA. No statistically significant differences were seen between the two groups before commencement of the study period in relation to age of disease onset, male:female ratio, and disease duration. However, seropositive patients showed longer medical follow-up. In addition, at disease onset, seropositive RA patients presented more frequently with symmetrical polyarthritis and small joint involvement than seronegative patients. The seropositive group also had more tender and swollen joints, weaker grip strength, and higher erythrocyte sedimentation and C-reactive protein rates during the follow-up period. In contrast, the seronegative group had less severe radiological findings and greater functional ability at the end of the study. In Greek patients with early RA, rheumatoid factor seems to be a predictor of more severe disease activity.

  4. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    Directory of Open Access Journals (Sweden)

    Helliwell Philip S

    2007-11-01

    Full Text Available Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Methods Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF and activity limitation/participation restriction (LFISAP subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS, Health Assessment Questionnaire (HAQ score and walking speed (m/s were also recorded. Results Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores, there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF but not activity/participation (LFISAP or function (walking speed over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits and 3 self-withdrew (lost to follow-up. Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3, foot orthoses (n = 9, footwear referral to the orthotist (n = 5, and ultrasound

  5. Maintenance of Clinical and Radiographic Benefit With Intravenous Golimumab Therapy in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy: Week-112 Efficacy and Safety Results of the Open-Label Long-Term Extension of a Phase III, Double-Blind, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Bingham, Clifton O; Mendelsohn, Alan M; Kim, Lilianne; Xu, Zhenhua; Leu, Jocelyn; Han, Chenglong; Lo, Kim Hung; Westhovens, Rene; Weinblatt, Michael E

    2015-12-01

    To evaluate the safety, efficacy, pharmacokinetics, immunogenicity, and radiographic progression through 2 years of treatment with intravenous (IV) golimumab plus methotrexate (MTX) in an open-label extension of a phase III trial of patients with active rheumatoid arthritis (RA) despite MTX therapy. In the phase III, double-blind, randomized, placebo-controlled GO-FURTHER trial, 592 patients with active RA were randomized (2:1) to intravenous golimumab 2 mg/kg plus MTX (Group 1) or placebo plus MTX (Group 2) at weeks 0 and 4, then every 8 weeks thereafter; placebo patients crossed over to golimumab at week 16 (early escape) or week 24 (crossover). The final golimumab infusion was at week 100. Assessments included American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) response criteria, 28-joint count disease activity score using the C-reactive protein level (DAS28-CRP), physical function and quality of life measures, and changes in the modified Sharp/van der Heijde scores (SHS). Safety was monitored through week 112. In total, 486 patients (82.1%) continued treatment through week 100, and 68.1%, 43.8%, and 23.5% had an ACR20/50/70 response, respectively, at week 100. Clinical response and improvements in physical function and quality of life were generally maintained from week 24 through 2 years. Mean change from baseline to week 100 in SHS score was 0.74 in Group 1 and 2.10 in Group 2 (P = 0.005); progression from week 52 to week 100 was clinically insignificant in both groups. A total of 481 patients completed the safety followup through week 112; 79.1% had an adverse event, and 18.2% had a serious adverse event. Clinical response to IV golimumab plus MTX was maintained through week 100. Radiographic progression following golimumab treatment was clinically insignificant between week 52 and week 100. No unexpected adverse events occurred through week 112, and the safety profile was consistent with anti-tumor necrosis factor therapy. © 2015 The

  6. Clinical trial insurance in Serbia

    Directory of Open Access Journals (Sweden)

    Žagar Zlatko A.

    2015-01-01

    Full Text Available Prior the commencement of the clinical trial in Serbia the Sponsor is obliged to provide the insurance policy covering the patient's bodily injury and damaged health caused by the clinical trial. According to provisions of Serbian Insurance law insurance polices have to be issued by the insurance companies established in Serbia. Every insurance policy not issued by the insurance company established in Serbia shall be deemed as null and void. The only expectance, is when the foreign clinical trial liability policy is stipulated that the insurance contract acknowledges the jurisdiction of Serbian domestic courts and other Serbian authorities to decide on damage claims (that never happened in Serbian practice. The Sponsor will fulfill this obligation stipulated in Serbian law when provides the Clinical Trial Liability policy issued by the Serbian insurance company. Nowadays, few of Serbian insurance companies are issuing such polices. Under the clinical trial liability insurance cover the insured's are: Sponsor, Medical Centers in Serbia performing or controlling the clinical trial, Principal Investigators and their assistant staff performing or controlling the clinical trial. The beneficiaries of the insurance cover are patients and/or members of their families - inheritresses. The insurance company will indemnify the beneficiary mentioned in the policy when the insured event occurred i.e. when occurred bodily injury, psychic disease and alienation, psychic damages, illnesses and deaths caused by the clinical trial. The amount of indemnity by the insurance company to the beneficiaries is limited by the amount of sum insured per occurrence and/or by the total amount of the sum insured for the total period of the insurance cover. According to case-law in Serbia the total sum insured between EUR 500.000 and EUR 1.000.000 is considered as sufficient so far to indemnify the patients in case of the insured event. If an insurance event occurs the

  7. The clinical and radiological evaluation of pyogenic arthritis

    International Nuclear Information System (INIS)

    Cho, Young Jun; Kim, Kyung Joo; Yoo, Jung Keun; Kim, Young Chul; Hur, Don

    1984-01-01

    Pyogenic arthritis remain a difficult problem, despite the availability of a wide range of powerful modern antibiotics. Early and correct diagnosis is imperative to assure the prompt initiation of an effective therapeutic regimen and the prevent of late sequela. Careful clinical, laboratory and roentgenological analysis are fundamental to early and precise diagnosis. Therefore, plain roentgenogram should not be overlooked. A radiological and clinical observation was made in 51 cases of pyogenic arthritis admitted to Chosun University Hospital during the period from January 1976 to December 1983 and following results were obtained. 1. Among the 51 cases, 36 cases (70.6%) were male and 15 cases (29.4%) were females. The most prevalent age was 5 to 9 (27.6%). 2. Symptom duration less than 5 days was in 21 cases (41.2%) and more than 31 days was in 6 cases (11.7%). 3. The most common symptom on admission was pain around the involved joint and others are limitation of motion, swelling, tenderness, fever, local heating and erythema. 4. The underlying causes were composed of unknown in 21 cases (41.2%), trauma in 18 cases (35.3%), infections focus in 8 cases (15.7%) and iatrogenic reason 4 cases (7.8%). 5. The most commonly affected joint was hip joint (45.1%). The other affected sites in order of frequency were knee, ankle, shoulder, S-I and elbow joint. In infants and children, hip and knee joint are commonly affected: in adults, knee joint is most is most commonly affected. 6. In laboratory findings, the number of W.B.C and E.S.R were increased in 56.9%. Symptom duration more than 31 days in 5 cases were increased E.S.R only. Causative microorganism was isolated in 31 cases: the most common microorganism was Staphylococcus aureus in 22 cases. Others are B-hemolytics Stretoocccus, Enterobacteriaceae species and Pseudomonas aeruginosa. 7. In 26 cases (50.9%) of the patients, roentgenographic findings was negative. The most common radiological findings was soft tissue

  8. Clinical and immunogenetic characterization in psoriatic arthritis patients.

    Science.gov (United States)

    Schneeberger, Emilce Edith; Citera, Gustavo; Rodríguez Gil, Gustavo; Granel, Amelia; Arturi, Alfredo; Rosemffet, Gabriel Marcos; Maldonado Cocco, José Antonio; Berman, Alberto; Spindler, Alberto; Morales, Victor Hugo

    2015-08-01

    In psoriatic arthritis (PsA), genetic factors play a substantial role in disease susceptibility as well as in its expression. This study aims to determine the distribution of class I and class II HLA antigens in PsA patients and secondly to analyze the influence of genetic factors in the clinical expression of the disease. Consecutive PsA patients (CASPAR criteria) with less than 1 year of disease duration were included. Sociodemographic and clinical data were recorded. Blood samples were obtained, DNA was extracted by polymerase chain reaction (PCR), and class I (A, B, and C) and class II (DR) HLA antigens were determined by oligotyping. A control group of 100 nonrelated healthy controls from the general population served as control. p values were corrected (pc) according to the number of alleles tested. A total of 73 patients were included, 37 were females (50.7 %) with a median disease duration of 72 months (interquartile range (IQR) 24-149). Thirty-three patients (45.2 %) had a family history of psoriasis. When analyzing all the class I and class II HLA antigens, a significantly higher frequency of B38 (odds ratio (OR) 2.95, p = 0.03) and Cw6 (OR 2.78, p = 0.009) was found in PsA patients compared to the control group. On the contrary, the HLA-A11 (OR 0.14, p = 0.04) and B7 (OR 0.31, p = 0.03) were significantly more frequent among healthy controls. Furthermore, B18 was significantly more frequent in patients with early arthritis onset (less than 40 years): seven patients (22.6 %) with early onset compared to two patients (4.8 %) with late onset (p = 0.03). No association between HLA-B27 and spondylitis or HLA-DR4 with polyarticular involvement was observed. The HLA-B38 and Cw6 alleles are associated with a greater PsA susceptibility in Argentine population.

  9. INFLUENCE OF PHYSIOTHERAPY ON CLINICAL AND IMMUNOLOGICAL PARAMETERS IN CHILDREN WITH JUVENILE RHEUMATOID ARTHRITIS

    Directory of Open Access Journals (Sweden)

    T.L. Nastausheva

    2008-12-01

    Full Text Available Clinical and immunological status has been evaluated in 85 children with juvenile rheumatoid arthritis (RA before and after physiotherapeutic procedures: electrophoresis with dimexid and magnetotherapy. The control group of 31 children did not follow physiotherapeutic procedures. The following results were fixed: clinical indices and immunological status of children with juvenile rheumatoid arthritis have been changed in a larger degree in case of magnetotherapy.

  10. Remission induction by Raising the dose of Remicade in RA (RRRR study: Rationale and study protocol for a randomized controlled trial comparing for sustained clinical remission after discontinuation of infliximab in patients with rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    Koji Oba

    2017-12-01

    Full Text Available Infliximab, an inhibitor of TNF-α, is one of the most widely used biological disease-modifying antirheumatic drugs. Recent studies indicated that baseline serum TNF-α could be considered as a key indicator for optimal dosing of infliximab for RA treatment to achieve the clinical response and its sustained remission. The Remission induction by Raising the dose of Remicade in RA (RRRR study is an open-label, parallel group, multicenter randomized controlled trial to compare the proportions of clinical remission based on the simplified disease activity index (SDAI after 1 year of treatment and its sustained remission rate after another 1 year between the investigational treatment strategy (for which the dose of infliximab was chosen based on the baseline serum TNF and the standard strategy of 3 mg/kg per 8 weeks of infliximab administration in infliximab-naïve patients with RA showing an inadequate response to MTX. The primary endpoint is the proportion of patients who kept discontinuation of infliximab 1 year after discontinued infliximab at the time of 54 weeks after the first administration of infliximab. The secondary endpoints are the proportion of clinical remission based on SDAI and changes in SDAI from baseline at each time point, other clinical parameters, quality of life measures and adverse events. Target sample size of randomized patients is 400 patients in total. The main results of the RRRR study are expected to be published at the end of 2017.

  11. Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial.

    Science.gov (United States)

    Mandel, David R; Eichas, Katy; Holmes, Judith

    2010-01-12

    Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications. Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR) criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), and laboratory tests for erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052) and statistically significant improvement in Pain Scale (P = .046) vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study. Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results. ACTRN12609000435280.

  12. Experimental arthritis induced by a clinical Mycoplasma fermentans isolate

    Directory of Open Access Journals (Sweden)

    Giono Silvia

    2002-06-01

    Full Text Available Abstract Background Mycoplasma fermentans has been associated with rheumatoid arthritis. Recently, it was detected in the joints and blood of patients with rheumatoid arthritis, but it is not clear yet how the bacteria enter the body and reach the joints. The purpose of this study was to determine the ability of M. fermentans to induce experimental arthritis in rabbits following inoculation of the bacteria in the trachea and knee joints. Methods P-140 and PG-18 strains were each injected in the knee joints of 14 rabbits in order to evaluate and compare their arthritogenicity. P-140 was also injected in the trachea of 14 rabbits in order to test the ability of the bacteria to reach the joints and induce arthritis. Results M. fermentans produced an acute arthritis in rabbits. Joint swelling appeared first in rabbits injected with P-140, which caused a more severe arthritis than PG-18. Both strains were able to migrate to the uninoculated knee joints and they were detected viable in the joints all along the duration of the experiment. Changes in the synovial tissue were more severe by the end of the experiment and characterized by the infiltration of neutrophils and substitution of adipose tissue by connective tissue. Rabbits intracheally injected with P-140 showed induced arthritis and the bacteria could be isolated from lungs, blood, heart, kidney, spleen, brain and joints. Conclusion M. fermentans induced arthritis regardless of the inoculation route. These findings may help explain why mycoplasmas are commonly isolated from the joints of rheumatic patients.

  13. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial.

    Science.gov (United States)

    Turner, Deborah E; Helliwell, Philip S; Woodburn, James

    2007-11-06

    Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems) were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF) and activity limitation/participation restriction (LFISAP) subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS), Health Assessment Questionnaire (HAQ) score and walking speed (m/s) were also recorded. Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores), there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF) but not activity/participation (LFISAP) or function (walking speed) over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits) and 3 self-withdrew (lost to follow-up). Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3), foot orthoses (n = 9), footwear referral to the orthotist (n = 5), and ultrasound guided intra-articular steroid injection

  14. Population issues in clinical trials.

    Science.gov (United States)

    Mosenifar, Zab

    2007-05-01

    Inclusion of underrepresented groups in clinical trials is important for several reasons. Age, sex, race, genetic factors, concomitant use of other medications, and comorbid conditions all may play pivotal roles in response to a drug or intervention. Despite the legislation for broader inclusion of underrepresented groups in clinical trials (via the National Institutes of Health [NIH] Revitalization Act of 1993), underrepresentation of particular populations, particularly minorities, continues to be a problem. Studies of predictors of clinical trial enrollment suggest that most people participate in clinical research to find relief from a disease, not for financial remuneration. Yet, men and whites are more likely to enroll in studies and some data indicate that certain patient populations are preferentially (albeit sometimes inadvertently) chosen for study enrollment. This tendency toward inclusion stems from human nature-the natural tendency for an investigator to relate to a particular investigative topic due to a special connection based on a cultural, socioeconomic, age, ethnicity, or gender level. This article reviews the most common population issues for clinical studies: age, gender, race, socioeconomic status, comorbidities, and disease severity, with examples of each from published studies. Recommendations are also offered to overcome these barriers.

  15. Pediatric Obstructive Uropathy: Clinical Trials

    International Nuclear Information System (INIS)

    Chan, C. M. C.; Scheinman, J. I.; Roth, K. S.

    2005-01-01

    As the powerful tools of molecular biology continue to delineate new concepts of pathogenesis of diseases, new molecular-level therapeutic modalities are certain to emerge. In order to design and execute clinical trials to evaluate outcomes of these new treatment modalities, we will soon need a new supply of investigators with training and experience in clinical research. The slowly-progressive nature of chronic pediatric kidney disease often results in diagnosis being made at a time remote from initial result, and the inherently slow rate of progression makes changes difficult to measure. Thus, development of molecular markers for both diagnosis and rate of progression will be critical to studies of new therapeutic modalities. We will review general aspects of clinical trials and will use current and past studies as examples to illustrate specific points, especially as these apply to chronic kidney disease associated with obstructive uropathy in children. (author)

  16. Concepts of pathogenesis in psoriatic arthritis: genotype determines clinical phenotype.

    LENUS (Irish Health Repository)

    FitzGerald, Oliver

    2015-05-07

    This review focuses on the genetic features of psoriatic arthritis (PsA) and their relationship to phenotypic heterogeneity in the disease, and addresses three questions: what do the recent studies on human leukocyte antigen (HLA) tell us about the genetic relationship between cutaneous psoriasis (PsO) and PsA - that is, is PsO a unitary phenotype; is PsA a genetically heterogeneous or homogeneous entity; and do the genetic factors implicated in determining susceptibility to PsA predict clinical phenotype? We first discuss the results from comparing the HLA typing of two PsO cohorts: one cohort providing the dermatologic perspective, consisting of patients with PsO without evidence of arthritic disease; and the second cohort providing the rheumatologic perspective, consisting of patients with PsA. We show that these two cohorts differ considerably in their predominant HLA alleles, indicating the heterogeneity of the overall PsO phenotype. Moreover, the genotype of patients in the PsA cohort was shown to be heterogeneous with significant elevations in the frequency of haplotypes containing HLA-B*08, HLA-C*06:02, HLA-B*27, HLA-B*38 and HLA-B*39. Because different genetic susceptibility genes imply different disease mechanisms, and possibly different clinical courses and therapeutic responses, we then review the evidence for a phenotypic difference among patients with PsA who have inherited different HLA alleles. We provide evidence that different alleles and, more importantly, different haplotypes implicated in determining PsA susceptibility are associated with different phenotypic characteristics that appear to be subphenotypes. The implication of these findings for the overall pathophysiologic mechanisms involved in PsA is discussed with specific reference to their bearing on the discussion of whether PsA is conceptualised as an autoimmune process or one that is based on entheseal responses.

  17. Total glucosides of paeony for rheumatoid arthritis: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Luo, Jing; Jin, Di-Er; Yang, Guo-Yan; Zhang, Ying-Ze; Wang, Jian-Ming; Kong, Wei-Ping; Tao, Qing-Wen

    2017-10-01

    Total glucosides of paeony (TGP) is commonly used to treat rheumatoid arthritis (RA) in China. However, clinical practice hasn't been well informed by evidence from appropriately conducted systematic reviews. This PRISMA-compliant systematic review aims at examining the effectiveness and safety of TGP for RA. Randomized controlled trials (RCTs) comparing TGP with placebo, no treatment, or disease-modifying antirheumatic drugs (DMARDs) for patients with RA were retrieved by searching seven databases. Primary outcomes included disease improvement and disease remission. Secondary outcomes included adverse effects, pain, health-related quality of life, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Data extraction and analyses were conducted according to the Cochrane standards. We assessed risk of bias for each included studies and quality of evidence on pre-specified outcomes. Eight studies enrolling 1209 patients with active RA were included in this systematic review. On the basis of traditional DMARD(s), TGP might be beneficial for patients with RA in improvement of American College of Rheumatology (ACR) 20 response rate, ACR 50 response rate, ACR70 response rate, and in reduction of adverse effects, compared with no treatment. The overall methodological quality of included studies and the quality of evidence for each outcome were limited. Current trials suggested potential benefits of TGP for RA on the basis of traditional DMARD(s). Therefore, TGP may be a good choice for RA as an adjuvant therapy. However, considering the limited methodological quality and strength of evidence, high-quality RCTs are warranted to support the use of TGP for RA. Copyright © 2017. Published by Elsevier Ltd.

  18. CLINICAL CASE OF TOCILIZUMAB THERAPY IN A PATIENT WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS

    Directory of Open Access Journals (Sweden)

    E. I. Alexeeva

    2013-01-01

    Full Text Available The article presents a case of successful application of a monoclonal antibodies drug to interleukin 6 receptors (tocilizumab at severe systemic juvenile idiopathic arthritis with the development of secondary hemophagocytic syndrome. Tocilizumab treatment secured a decrease in clinical and laboratory parameters of the disease activity, life quality improvement, systemic juvenile idiopathic arthritis and hemophagocytic syndrome remission and allowed avoiding the per os prescription of glucocorticoids.

  19. Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Erhayiem, Bara; Pavitt, Sue; Baxter, Paul; Andrews, Jacqueline; Greenwood, John P; Buch, Maya H; Plein, Sven

    2014-11-08

    The incidence of cardiovascular disease (CVD) in rheumatoid arthritis (RA) is increased compared to the general population. Immune dysregulation and systemic inflammation are thought to be associated with this increased risk. Early diagnosis with immediate treatment and tight control of RA forms a central treatment paradigm. It remains unclear, however, whether using tumor necrosis factor inhibitors (TNFi) to achieve remission confer additional beneficial effects over standard therapy, especially on the development of CVD. Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA) is a prospective cardiovascular imaging study that bolts onto an existing single-centre, randomized controlled trial, VEDERA (Very Early versus Delayed Etanercept in Rheumatoid Arthritis). VEDERA will recruit 120 patients with early, treatment-naïve RA, randomized to TNFi therapy etanercept (ETN) combined with methotrexate (MTX), or therapy with MTX with or without additional synthetic disease modifying anti-rheumatic drugs with escalation to ETN following a 'treat-to-target' regimen. VEDERA patients will be recruited into CADERA and undergo cardiac magnetic resonance (CMR) assessment with; cine imaging, rest/stress adenosine perfusion, tissue-tagging, aortic distensibility, T1 mapping and late gadolinium imaging. Primary objectives are to detect the prevalence and change of cardiovascular abnormalities by CMR between TNFi and standard therapy over a 12-month period. All patients will enter an inflammatory arthritis registry for long-term follow-up. CADERA is a multi-parametric study describing cardiovascular abnormalities in early, treatment-naïve RA patients, with assessment of changes at one year between early biological therapy and conventional therapy. This trial was registered with Current Controlled Trials (registration number: ISRCTN50167738) on 8 November 2013.

  20. Gatekeepers for pragmatic clinical trials.

    Science.gov (United States)

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

  1. Comfrey root: from tradition to modern clinical trials.

    Science.gov (United States)

    Staiger, Christiane

    2013-02-01

    Comfrey (Symphytum officinale L.) has been used over many centuries as a medicinal plant. In particular, the use of the root has a longstanding tradition. Today, several randomised controlled trials have demonstrated the efficacy and safety. Comfrey root extract has been used for the topical treatment of painful muscle and joint complaints. It is clinically proven to relieve pain, inflammation and swelling of muscles and joints in the case of degenerative arthritis, acute myalgia in the back, sprains, contusions and strains after sports injuries and accidents, also in children aged 3 years and older. This paper provides information on clinical trials, non-interventional studies and further literature published on comfrey root till date.

  2. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    ... AIDS Drugs Clinical Trials Apps skip to content HIV Overview Home Understanding HIV/AIDS Fact Sheets HIV/ ... 4 p.m. ET) Send us an email HIV/AIDS Clinical Trials Last Reviewed: August 25, 2017 ...

  3. Clinical trials in neurology: design, conduct, analysis

    National Research Council Canada - National Science Library

    Ravina, Bernard

    2012-01-01

    .... Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases...

  4. Clinical Trials: Key to Medical Progress

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: Key to Medical Progress Past Issues / Summer 2008 ... this page please turn Javascript on. Photo iStock Clinical trials are research studies that test how well new ...

  5. Overlap between systemic sclerosis and rheumatoid arthritis: a distinct clinical entity?

    Directory of Open Access Journals (Sweden)

    Alex Magno Coelho Horimoto

    Full Text Available ABSTRACT Introduction: Systemic sclerosis (SSc is an autoimmune disease of the connective tissue characterized by the triad of vascular injury, autoimmunity (cellular and humoral and tissue fibrosis. It is estimated that musculoskeletal pain is a common complaint of patients with SSc, ranging from 40 to 80%, and mainly in patients with early diffuse disease. Arthritis, clinically observed, may be a feature seen in the presentation of SSc, often leading to early diagnostic errors with rheumatoid arthritis (RA. In the course of the disease, arthritis is observed in 24–97% of patients with SSc. Objectives: To correlate the occurrence or nonoccurrence of arthritis in patients with SSc of the Midwest region of Brazil with possible distinct clinical and laboratory manifestations observed in three groups of patients. To report the frequency of true association between systemic sclerosis and rheumatoid arthritis in patients with clinically and radiologically observed synovitis. Methods: Sixty-one SSc patients were subsequently assessed every 3 months within 1 year, in order to clinically observe the occurrence of synovitis and its patterns of progression. Patients were divided into 3 groups: 41 patients with SSc without arthritis, 16 SSc patients with arthritis and 4 patients with overlap of SSc and RA. All patients underwent a radiological examination of the hands at the end of the study. Results: Among all patients evaluated, we found a female predominance (98.7%, mean age of 50.94 years, white color (49.2%, limited form of the disease (47.6%, time of diagnosis between 5 and 10 years (47.6% and duration of the disease of 8.30 years. Among all patients, 14 (22.9% had positive rheumatoid factor (RF, while among those with positive RF, only 10 patients had arthritis during one-year follow-up. The antibody anticitrulline (anti-CCP test was performed in 24 patients, being positive in 4 of them (16.7%, with positivity being observed only in patients with

  6. Overlap between systemic sclerosis and rheumatoid arthritis: a distinct clinical entity?

    Science.gov (United States)

    Horimoto, Alex Magno Coelho; da Costa, Izaias Pereira

    2016-01-01

    Systemic sclerosis (SSc) is an autoimmune disease of the connective tissue characterized by the triad of vascular injury, autoimmunity (cellular and humoral) and tissue fibrosis. It is estimated that musculoskeletal pain is a common complaint of patients with SSc, ranging from 40 to 80%, and mainly in patients with early diffuse disease. Arthritis, clinically observed, may be a feature seen in the presentation of SSc, often leading to early diagnostic errors with rheumatoid arthritis (RA). In the course of the disease, arthritis is observed in 24-97% of patients with SSc. To correlate the occurrence or nonoccurrence of arthritis in patients with SSc of the Midwest region of Brazil with possible distinct clinical and laboratory manifestations observed in three groups of patients. To report the frequency of true association between systemic sclerosis and rheumatoid arthritis in patients with clinically and radiologically observed synovitis. Sixty-one SSc patients were subsequently assessed every 3 months within 1 year, in order to clinically observe the occurrence of synovitis and its patterns of progression. Patients were divided into 3 groups: 41 patients with SSc without arthritis, 16 SSc patients with arthritis and 4 patients with overlap of SSc and RA. All patients underwent a radiological examination of the hands at the end of the study. Among all patients evaluated, we found a female predominance (98.7%), mean age of 50.94 years, white color (49.2%), limited form of the disease (47.6%), time of diagnosis between 5 and 10 years (47.6%) and duration of the disease of 8.30 years. Among all patients, 14 (22.9%) had positive rheumatoid factor (RF), while among those with positive RF, only 10 patients had arthritis during one-year follow-up. The antibody anticitrulline (anti-CCP) test was performed in 24 patients, being positive in 4 of them (16.7%), with positivity being observed only in patients with SSc/RA overlap. Comparing the clinical manifestations among the

  7. [Overlap between systemic sclerosis and rheumatoid arthritis: a distinct clinical entity?

    Science.gov (United States)

    Horimoto, Alex Magno Coelho; Costa, Izaias Pereira da

    2015-03-04

    Systemic sclerosis (SSc) is an autoimmune disease of the connective tissue characterized by the triad of vascular injury, autoimmunity (cellular and humoral) and tissue fibrosis. It is estimated that musculoskeletal pain is a common complaint of patients with SSc, ranging from 40 to 80%, and mainly in patients with early diffuse disease. Arthritis, clinically observed, may be a feature seen in the presentation of SSc, often leading to early diagnostic errors with rheumatoid arthritis (RA). In the course of the disease, arthritis is observed in 24 to 97% of patients with SSc. To correlate the occurrence or nonoccurrence of arthritis in patients with SSc of the Midwest region of Brazil with possible distinct clinical and laboratory manifestations observed in three groups of patients. To report the frequency of true association between systemic sclerosis and rheumatoid arthritis in patients with clinically and radiologically observed synovitis. Sixty-one SSc patients were subsequently assessed every 3 months within 1 year, in order to clinically observe the occurrence of synovitis and its patterns of progression. Patients were divided into 3 groups: 41 patients with SSc without arthritis, 16 SSc patients with arthritis and 4 patients with overlap of SSc and RA. All patients underwent a radiological examination of the hands at the end of the study. Among all patients evaluated, we found a female predominance (98.7%), mean age of 50.94 years, white color (49.2%), limited form of the disease (47.6%), time of diagnosis between 5 to 10 years (47.6%) and duration of the disease of 8.30 years. Among all patients, 14 (22.9%) had positive rheumatoid factor (RF), while among those with positive RF, only 10 patients had arthritis during one-year follow-up. The antibody anticitrulline (anti-CCP) test was performed in 24 patients, being positive in 4 of them (16.7%), with positivity being observed only in patients with SSc/RA overlap. Comparing the clinical manifestations among

  8. Glucocorticoid Effect on Radiographic Progression in Placebo Arms of Rheumatoid Arthritis Biologics Trials.

    Science.gov (United States)

    Boers, Maarten; Aletaha, Daniel; Mela, Christopher M; Baker, Daniel G; Smolen, Josef S

    2016-06-01

    To assess the effect of glucocorticoids (GC) on damage progression in placebo-biologic arms of rheumatoid arthritis (RA) biologics trials. Posthoc metaanalysis of 2 infliximab (IFX) trials (established and early RA) and 1 tocilizumab (TCZ) trial (established RA). The proportion of patients receiving GC was 38%-64%, baseline damage was 11-82 Sharp/van der Heijde points, and progression in the placebo groups was 0.5-4.8 points in 6 months. In the pooled IFX studies, GC cotreatment reduced 6-month progression by 2.6 points (95% CI 0.6-4.5). In the TCZ study (progression rate 0.5 Genant points), no such difference was seen. GC cotreatment may affect results in RA trials.

  9. Psoriatic – Arthritis among Psoriasis Patients Attending Skin Clinics ...

    African Journals Online (AJOL)

    Background: Psoriasis is an autoimmune inflammatory disease which primarily affects the skin but joints may also be targeted. Psoriatic arthritis is a destructive inflammatory arthropathy and ensethopathy which is considered to be rare in sub Saharan Africa. Left untreated the condition is permanently disabling. There are ...

  10. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010

    NARCIS (Netherlands)

    Califf, R.M.; Zarin, D.A.; Kramer, J.M.; Sherman, R.E.; Aberle, L.H.; Tasneem, A.

    2012-01-01

    CONTEXT: Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable a comprehensive evaluation of the national trials

  11. Survival, comorbidities and joint damage 11 years after the COBRA combination therapy trial in early rheumatoid arthritis

    NARCIS (Netherlands)

    van Tuyl, Lilian H. D.; Boers, Maarten; Lems, Willem F.; Landewé, Robert B.; Han, Huub; van der Linden, S.; van de Laar, Mart; Westhovens, Rene; van Denderen, J. Christiaan; Westedt, Marie-Louise; Peeters, André J.; Jacobs, Piet; Huizinga, Tom W. J.; van de Brink, Hans; Dijkmans, Ben A. C.; Voskuyl, Alexandre E.

    2010-01-01

    COBRA (for 'COmbinatie therapie Bij Rheumatoide Artritis') combination therapy is effective for the treatment of rheumatoid arthritis (RA), but long-term safety is unknown. This study evaluates survival, comorbidities and joint damage in the original COBRA trial cohort. In the COBRA trial, 155

  12. Hyperthermia-related clinical trials on cancer treatment within the ClinicalTrials.gov registry

    NARCIS (Netherlands)

    Cihoric, Nikola; Tsikkinis, Alexandros; van Rhoon, Gerard; Crezee, Hans; Aebersold, Daniel M.; Bodis, Stephan; Beck, Marcus; Nadobny, Jacek; Budach, Volker; Wust, Peter; Ghadjar, Pirus

    2015-01-01

    Hyperthermia has been shown to improve the effectiveness of chemotherapy and radiotherapy in the treatment of cancer. This paper summarises all recent clinical trials registered in the ClinicalTrials.gov registry. The records of 175,538 clinical trials registered at ClinicalTrials.gov were

  13. Accrual to Cancer Clinical Trials

    LENUS (Irish Health Repository)

    Kelly, C

    2016-07-01

    Accrual to cancer clinical trials (CCT) is imperative to safeguard continued improvement in cancer outcomes. A retrospective chart review was performed of patients (n=140) starting a new anti-cancer agent in a north Dublin cancer centre. This review was performed over a four-month period, beginning in November 2015. Only 29% (n=41) had a CCT option. The overall accrual rate to CCT was 5% (n=7), which is comparable to internationally reported figures. The main reasons for failure to recruit to CCT included the lack of a CCT option for cancer type (n=30, 23%), stage (n=25, 19%), and line of treatment (n=23, 17%). Over the last decade, the rate of accrual to CCTs has in fact doubled and the number of trials open to recruitment has tripled. Ongoing governmental and philanthropic support is necessary to continue this trend to further expand CCT patient options with a target accrual rate of 10%.

  14. Assessment of enthesitis in patients with psoriatic arthritis using clinical examination and ultrasound

    DEFF Research Database (Denmark)

    Kristensen, Salome; Christensen, Jeppe Hagstrup; Schmidt, Erik Berg

    2016-01-01

    BACKGROUND: Enthesitis is a major feature of psoriatic arthritis. However, clinical assessment of enthesitis is known to lack accuracy and have poor interobserver reliability. OBJECTIVE: To determine effect of training on clinical assessment of enthesitis and to compare ultrasonography with clini...

  15. Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity.

    Science.gov (United States)

    Pope, Janet; Bingham, Clifton O; Fleischmann, Roy M; Dougados, Maxime; Massarotti, Elena M; Wollenhaupt, Jürgen; Duncan, Benjamin; Coteur, Geoffroy; Weinblatt, Michael E

    2015-11-27

    The effect of certolizumab pegol (CZP) on patient-reported outcomes (PROs) was investigated in 1063 patients with rheumatoid arthritis (RA) from the REALISTIC trial (double-blind, placebo-controlled to week 12, open-label to week 28; randomized 4:1 [CZP:placebo]). Correlations between PROs and RA signs and symptoms, and the relative efficacy of these measures, were examined. Adults with RA and an inadequate response to at least one disease-modifying antirheumatic drug were enrolled. PROs assessed included physical function (using the Health Assessment Questionnaire-Disability Index), pain, fatigue, sleep disturbance, Patient Global Assessment of Disease Activity (PtGA), Routine Assessment of Patient Index Data 3 (RAPID3), and Rheumatoid Arthritis Disease Activity Index (RADAI). Early significant and clinically meaningful improvements in all PROs were observed to week 12 with CZP vs. placebo and were maintained to the end of the trial (week 28). At week 12, up to one-third more CZP patients showed improvements compared with placebo that were greater than or equal to the minimal clinically important difference (MCID) in fatigue, sleep problems, pain, PtGA, RADAI, and RAPID3. The changes in PROs were correlated with clinical measures of disease activity, including the Disease Activity Score in 28 joints using C-reactive protein as well as tender and swollen joint counts. Rapid improvements in PROs were seen in patients with RA treated with CZP. The magnitude of improvement exceeded the MCID in multiple domains and demonstrated that CZP improves aspects of health-related quality of life that are meaningful to patients and superior to placebo. PROs provide information complementary to clinical outcomes in assessment of treatment benefits. ClinicalTrials.gov identifier: NCT00717236 . Registered on 15 July 2008.

  16. The motherhood choices decision aid for women with rheumatoid arthritis increases knowledge and reduces decisional conflict: a randomized controlled trial.

    Science.gov (United States)

    Meade, T; Dowswell, E; Manolios, N; Sharpe, L

    2015-09-22

    For many women with Rheumatoid Arthritis (RA) motherhood decisions are complicated by their condition and complex pharmacological treatments. Decisions about having children or expanding their family require relevant knowledge and consultation with their family and physician as conception and pregnancy has to be managed within the RA context. Relevant information is not readily available to women with RA. Therefore a randomized controlled study was conducted to evaluate the effectiveness of a new motherhood decision aid (DA) developed specifically for women with RA. One hundred and forty-four women were randomly allocated to either an intervention or control group. All women completed a battery of questionnaires at pre-intervention, including, the Pregnancy in Rheumatoid Arthritis Questionnaire (PiRAQ), the Decisional Conflict Scale (DCS), the Hospital Anxiety and Depression Scale (HADS), and the Arthritis Self-Efficacy Scale (ASES), and provided basic demographic information. Women in the DA group were sent an electronic version of the DA, and completed the battery of questionnaires for a second time post-intervention. Women who received the DA had a 13 % increase in relevant knowledge (PiRAQ) scores and a 15 % decrease in scores on the decisional conflict (DCS), compared to the control group (1 %, 2 % respectively). No adverse psychological effects were detected as evident in unchanged levels of depression and anxiety symptoms. The findings of this study suggest that this DA may be an effective tool in assisting women with RA when contemplating having children or more children. Australian New Zealand Clinical Trials Registry, http://www.anzctr.org.au/ , ACTRN12615000523505.

  17. Juvenil idiopatisk arthritis

    DEFF Research Database (Denmark)

    Herlin, Troels

    2002-01-01

    The new classification of juvenile idiopathic arthritis (JIA) is described in this review. Clinical characteristics divide JIA in to subtypes: systemic, oligoarticular (persistent and extended type), RF-positive and--negative polyarticular, enthesitis-related arthritis and psoriatic arthritis...

  18. Clinical trials and gender medicine.

    Science.gov (United States)

    Cassese, Mariarita; Zuber, Veronica

    2011-01-01

    Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22%) which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa) which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  19. Clinical trials and gender medicine

    Directory of Open Access Journals (Sweden)

    Mariarita Cassese

    2011-01-01

    Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  20. EULAR recommendations for the use of imaging of the joints in the clinical management of rheumatoid arthritis

    DEFF Research Database (Denmark)

    Colebatch, Alexandra N; Edwards, Christopher John; Østergaard, Mikkel

    2013-01-01

    To develop evidence-based recommendations on the use of imaging of the joints in the clinical management of rheumatoid arthritis (RA).......To develop evidence-based recommendations on the use of imaging of the joints in the clinical management of rheumatoid arthritis (RA)....

  1. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...

  2. Predictors of poor response to methotrexate in polyarticular-course juvenile idiopathic arthritis: analysis of the PRINTO methotrexate trial

    NARCIS (Netherlands)

    Vilca, Iris; Munitis, Pablo Garcia; Pistorio, Angela; Ravelli, Angelo; Buoncompagni, Antonella; Bica, Blanca; Campos, Lucia; Häfner, Renate; Hofer, Michael; Ozen, Seza; Huemer, Christian; Bae, Sang Cheol; Sztajnbok, Flavio; Arguedas, Olga; Foeldvari, Ivan; Huppertz, Hans Iko; Gamir, Maria Luz; Magnusson, Bo; Dressler, Frank; Uziel, Yosef; van Rossum, Marion A. J.; Hollingworth, Peter; Cawkwell, Gail; Martini, Alberto; Ruperto, Nicolino

    2010-01-01

    Objectives To determine whether baseline demographic, clinical, articular and laboratory variables predict methotrexate (MTX) poor response in polyarticular-course juvenile idiopathic arthritis. Methods Patients newly treated for 6 months with MTX enrolled in the Paediatric Rheumatology

  3. Bayesian adaptive methods for clinical trials

    CERN Document Server

    Berry, Scott M; Muller, Peter

    2010-01-01

    Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adaptive Methods for Clinical Trials explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. The book first summarizes the current state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative. It then gives an overview of basic Bayesian methodological and computational tools needed for Bayesian clinical trials. With a focus on Bayesian designs that achieve good power and Type I error, the next chapters present Bayesian tools useful in early (Phase I) and middle (Phase II) clinical trials as well as two recent Bayesian adaptive Phase II studies: the BATTLE and ISP...

  4. Contraceptive development and clinical trials.

    Science.gov (United States)

    Fraser, I S

    1986-02-01

    This article provides an overview of the contraceptive development process, with particular emphasis on the importance of clinical trials. Development of a new contraceptive drug begins with chemical synthesis of a large number of substances that may have antifertility effects. Before human trials are considered, drugs must undergo a complex process of animal toxicology testing. Such studies assess acute, subacute, and chronic toxicity. Once a drug has passed the initial screening process, human testing must follow a logical sequence of clinical trials: phase I, pharmacology testing; phase II, initial assessment of efficacy, safety, acceptability, and ease of use; phase III, acurate assessment of efficacy, side effects, and reasons for discontinuation under controlled conditions; and phase IV, evaluation of effectiveness under field conditions. When these have been satisfactorily completed, a detailed marketing application must be submitted to the drug regulatory agency in each country. The process of assessment of the application often takes as long as 2 years. Once marketing approval has been received, there is still a need for postmarketing surveillance of the performance of the new contraceptive method. In many cases, a careful program of training is required. Among the research and recording strategies for postmarketing surveillance are voluntary recording of possible adverse reactions, longterm prospective cohort studies, retrospective case-control studies, and registered release. As controls on the safety and performance of new contraceptive methods are being tightened, the time scale and costs of development are increasing. The time from the 1st synthesis of a drug to marketing approval often takes 13-14 years and costs US$25-50 million. Since the patent life of a new substance is limited to 17 years in most countries, pharmaceutical companies have little time to recoup development costs, which has caused fewer new methods to be developed.

  5. NIH Clinical Research Trials and You

    Science.gov (United States)

    ... Info Lines Health Services Locator HealthCare.gov NIH Clinical Research Trials and You Talking to Your Doctor Science ... Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation and Guidance More » Quick Links ...

  6. European perspective on the management of rheumatoid arthritis: clinical utility of tofacitinib

    Directory of Open Access Journals (Sweden)

    Kawalec P

    2017-12-01

    Full Text Available Paweł Kawalec,1 Katarzyna Śladowska,2 Iwona Malinowska-Lipień,3 Tomasz Brzostek,3 Maria Kózka4 1Drug Management Department, Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, 2Department of Experimental Hematology, Institute of Zoology and Biomedical Research, Faculty of Biology and Earth Sciences, Jagiellonian University, Krakow, Poland; 3Department of Internal and Community Nursing, Institute of Nursing and Midwifery, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland; 4Department of Clinical Nursing, Institute of Nursing and Midwifery, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland Abstract: Xeljanz® (tofacitinib is an oral small-molecule inhibitor that reversibly inhibits Janus-activated kinase (JAK-dependent cytokine signaling, thus reducing inflammation. As a result of these mechanisms, effects on the immune system such as a moderate decrease in the total lymphocyte count, a dose-dependent decrease in natural killer (NK cell count, and an increase in B-cell count have been observed. Therefore, tofacitinib provides an innovative approach to modulating the immune and inflammatory responses in patients with rheumatoid arthritis (RA, which is especially important in individuals who do not respond to tumor necrosis factor inhibitors or show a loss of response over time. The aim of this article was to review studies on the pharmacology, mode of action, pharmacokinetics, efficacy, and safety of tofacitinib in patients with RA. Tofacitinib has been shown to reduce symptoms of RA and improve the quality of life in the analyzed groups of patients. Moreover, it showed high efficacy and an acceptable safety profile in Phase III randomized clinical trials on RA and was the first JAK inhibitor approved by the US Food and Drug Administration (FDA and European Medicines Agency (EMA in the RA therapy, thus providing a useful alternative

  7. Obesity and rates of clinical remission and low MRI inflammation in rheumatoid arthritis.

    Science.gov (United States)

    George, Michael D; Østergaard, Mikkel; Conaghan, Philip G; Emery, Paul; Baker, Daniel G; Baker, Joshua F

    2017-10-01

    Obesity has been proposed as a risk factor for refractory rheumatoid arthritis (RA). We evaluated the impact of obesity on achieving clinical and imaging definitions of low disease activity. This study evaluated 470 patients with RA from GO-BEFORE and GO-FORWARD randomised clinical trials. Included patients had blinded clinical disease activity measures and MRI at baseline, 24 and 52 weeks. Synovitis, osteitis and total inflammation scores were determined using the RA MRI scoring system. Multivariable logistic regression analyses compared odds of achieving Disease Activity Score using 28 joints and C-reactive protein (DAS28-CRP) remission, low component measures, or low MRI inflammation measures at 24 weeks in patients with obesity versus no obesity. At 24 weeks, patients with obesity were significantly less likely to achieve DAS28(CRP) remission (OR 0.47; 95% CI 0.24 to 0.92, p=0.03). In contrast, patients with obesity had similar odds of achieving low synovitis (OR 0.94; 95% CI 0.51 to 1.72, p=0.84) and inflammation scores (OR 1.16; 95% CI 0.61 to 2.22, p=0.64) and greater odds of achieving low osteitis scores (OR 2.06; 95% CI 1.10 to 3.84, p=0.02) versus normal weight patients. Patients with RA and obesity have lower rates of DAS28 remission but similar rates of low MRI activity compared with patients without obesity, suggesting that obesity and its associated comorbidities can bias clinical disease activity measures. NCT00361335 and NCT00264550; Post-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. A Clinical Study Evaluating the Effects of Fluvastatin on Serum Osteoprotegerin Levels in Rheumatoid Arthritis Patients.

    Science.gov (United States)

    Hegazy, Sahar Kamal; El-Ghany El-Sayed, Salwa El-Morsy Abd; El-Hefnawy, Marwa El-Saeed

    2016-10-01

    Osteoprotegerin (OPG), a member of the tumor necrosis factor receptor family, has been identified as a critical regulator of bone resorption. Considering the possible role of OPG in rheumatoid arthritis (RA) and in the osteoclastogenesis suppression effects of statins, the present study aims to investigate the effects of fluvastatin on serum levels OPG and disease activity score (DAS) in patients with RA. Forty patients with RA were randomized in a placebo-controlled trial to receive 40 mg fluvastatin or placebo as an adjunct to existing disease-modifying antirheumatic drug (DMARD) therapy (methotrexate, leflunomide, hydroxychloroquine). Patients were followed up over 12 weeks. OPG and disease activity variables were measured at baseline and after 12 weeks of treatment. After 12 weeks, the OPG level was significantly increased in the fluvastatin group compared to the placebo group. DAS-28 was significantly decreased in the fluvastatin group compared to the placebo group. C-reactive protein (CRP), morning stiffness, swollen joint count (SJC), and tender joint count (TJC) were significantly decreased in the fluvastatin group compared to the placebo group; however, erythrocyte sedimentation rate (ESR), modified health assessment questionnaire (MHAQ), and visual analogue screen (VAS) were not changed significantly. In conclusion, fluvastatin administration could increase the OPG levels and improve disease activity variables in patients with RA. Therefore, fluvastatin may serve a potential benefit in the treatment of RA patients. © 2016, The American College of Clinical Pharmacology.

  9. Psoriatic arthritis

    International Nuclear Information System (INIS)

    Espinoza, L.R.

    1985-01-01

    In the past 10 years, a number of well-controlled surveys of psoriatic patients selective for the presence of arthritis have been conducted. A Canadian group reported that of 100 patients admitted to the hospital for treatment of psoriasis, 32 had clinical or radiologic evidence of psoriatic arthritis, and 17 had both types of evidence. Eighty patients with radiologic evidence of spinal or sacroiliac involvement were asymptomatic, and seven had clinical evidence of peripheral arthritis but without radiologic evidence. The authors concluded that psoriatic arthritis is a common event in patients with severe psoriasis and that it is associated with more extensive skin disease than is found in patients without arthritis. The information gathered from these epidemiologic studies coupled with clinical, radiologic, and serologic characteristics have provided the basis for the current belief that psoriatic arthritis is indeed a distinct entity

  10. Current HIV clinical trial design issues

    NARCIS (Netherlands)

    Lange, J. M.

    1995-01-01

    Aids-free time and survival time of people with HIV infection has gradually increased since the first clinical trial of zidovudine(AZT) in 1987. This change in pattern of disease course has, however, made it difficult for current clinical trials to rely on "hard" clinical end points, such as

  11. [Profile of clinical trials enrolling Brazilian children].

    Science.gov (United States)

    Vieira, Jean Mendes de Lucena; Lima, Elisangela da Costa; Land, Marcelo Gerardin Poirot; Ventura, Miriam; Coelho, Helena Lutescia Luna

    2017-06-12

    This study aimed to characterize the clinical trials with medicines enrolling Brazilian children and adolescents, registered in the databases of Clinical Trials and the Brazilian Clinical Trials Network (ReBEC) from 1994 to 2014. Only 462 clinical trials enrolled Brazilian children and adolescents. There was an increase in registrations beginning in 2003, with an important drop in 2011. Among these trials, 35.5% were hosted in Brazil. The international clinical trials were mostly conducted by North American companies. In both cases, multinational industry was the principal source of funding. The clinical trials were predominantly phase III with injectable and solid oral pharmaceutical forms of antiviral drugs. Domestic clinical trials showed wider variation in the pharmaceutical forms and higher percentage of liquid formulations, when compared to the international trials. In addition to heavy external dependence for conducting clinical trials, the study emphasized the challenge for pediatric care in Brazil, which presents epidemiological peculiarities in an environment prone to the use of unlicensed medicines for children.

  12. Obesity and rates of clinical remission and low MRI inflammation in rheumatoid arthritis

    DEFF Research Database (Denmark)

    George, Michael D.; Østergaard, Mikkel; Conaghan, Philip G.

    2017-01-01

    Objectives O besity has been proposed as a risk factor for refractory rheumatoid arthritis (RA). We evaluated the impact of obesity on achieving clinical and imaging definitions of low disease activity. Methods T his study evaluated 470 patients with RA from GO-BEFORE and GO-FORWARD randomised cl...

  13. Clinical trials in dentistry in India: Analysis from trial registry

    Science.gov (United States)

    Gowri, S.; Kannan, Sridharan

    2017-01-01

    Introduction: Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. Methodology: All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword “dental.” Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. Results: The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients

  14. [Clinical observation of traumatic ankle arthritis with orthopedics lotion on 60 cases].

    Science.gov (United States)

    Zhang, Hui; Yu, Jie

    2014-02-01

    Observing the clinical curative effect of orthopedics lotion to treat traumatic ankle arthritis, the outpatient department of orthopedics in Guang'anmen Hospital collected 60 cases who were diagnosed as traumatic ankle arthritis. The cases who already met the inclusion criteria, were randomly divided into the treatment group (30 cases) and control group (30 cases). Thirty patients in treatment group were received fumigation treatment with orthopedics lotion; 30 patients in control group were treated by intra-articular injection of sodium hyaluronate. After 5 weeks treatment, the effects on the both groups would be observed and analysed. Baird-Jackson scoring system was used to assess the overall curative effect. Visual analogue scales (VAS) was used to assess analgesic effect. BJ scores of pre-treatment and post-treatment in both the treatment group and the control group were compared, P orthopedics lotion is a effective way to treat traumatic ankle arthritis, and it has significant effect on analgesic.

  15. Opioid detoxification : from controlled clinical trial to clinical practice

    NARCIS (Netherlands)

    Dijkstra, Boukje A G; De Jong, Cor A J; Wensing, Michel; Krabbe, Paul F M; van der Staak, Cees P F

    2010-01-01

    Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

  16. International Clinical Trial Day and clinical trials in Ethiopia and Africa.

    Science.gov (United States)

    Fekadu, Abebaw; Teferra, Solomon; Hailu, Asrat; Gebre-Mariam, Tsige; Addissie, Adamu; Deressa, Wakgari; Yimer, Getnet; Reja, Ahmed

    2014-12-19

    Low income countries like Ethiopia are underrepresented in clinical research. As a major public commitment to clinical research, Ethiopia celebrated the International Clinical Trial Day (ICTD) for the first time on 20 May 2014 under the auspices of Addis Ababa University. The motto for the day was 'Clinical Trials for Excellence in Patient Care'. The celebration offered an opportunity to inform academic staff, researchers, students and the leadership about clinical trials being conducted and to discuss the future of clinical trials in the country. Although clear challenges to the conduct of trials abound, clinical trials registered from Ethiopia in trial registration databases is increasing. Cross-country collaborations, international funding support, motivation of academic staff to conduct clinical trials and the commitment and engagement of the leadership in research are all improving. The overall impact of clinical trials is also encouraging. For example, some of the trials conducted in Ethiopia have informed treatment guidelines. However, administrative capacity, research infrastructure as well as financial support remain weak. There is a need for enhanced university-industry linkage and translation of research findings into locally relevant evidence. Ethiopia, as well as the whole of Africa, has an unparalleled opportunity to lead the way in clinical trials, given its prospect of development and the need to have locally relevant evidence for its growing population. In this commentary we reflect on the celebration of ICTD, the status and opportunities for conducting clinical trials and the way forward for facilitating clinical trials in Ethiopia and Africa.

  17. Clinical responsiveness of self-report functional assessment measures for children with juvenile idiopathic arthritis undergoing intraarticular corticosteroid injections.

    Science.gov (United States)

    Brown, G Ted; Wright, F Virginia; Lang, Bianca A; Birdi, Nina; Oen, Kim; Stephens, Derek; McComas, Joan; Feldman, Brian M

    2005-12-15

    The Childhood Health Assessment Questionnaire (CHAQ), Juvenile Arthritis Functional Assessment Report (JAFAR), and Juvenile Arthritis Functional Status Index (JASI) are widely used functional measures for juvenile idiopathic arthritis (JIA) that differ in content, format, and completion time. We compared the responsiveness and child-parent agreement of the JAFAR, CHAQ, and JASI in a prospective, multicenter study. Children and adolescents from 5 rheumatology centers were enrolled. Subjects were about to undergo therapy (intraarticular corticosteroid injections [IAS] and methotrexate or hip surgery (MTX/hip]) expected to produce a functional improvement. All subjects were studied before the intervention and at 6 weeks and 6 months posttreatment. At each study visit, the 3 measures were administered in randomized, balanced order to both parents and children. A total of 92 subjects (mean age 12.8 years) were enrolled in the study, 74 of which were in the IAS group. The responsiveness of all 3 measures was moderate to strong. The standardized response mean at 6 weeks for the IAS group on the JAFAR, CHAQ, and JASI was 0.41 (95% confidence interval [95% CI] 0.18, 0.64), 0.70 (95% CI 0.47, 0.93), and 0.36 (95% CI 0.13, 0.59), respectively. The CHAQ was somewhat more responsive to change at 6 weeks (IAS group: relative efficiency 0.34 [JAFAR], 0.27 [JASI]), but less responsive at 6 months (MTX/hip group: relative efficiency 5.1 [JAFAR], 3.9 [JASI]). All 3 questionnaires showed acceptable parent-child agreement, and overall, there were few differences between the 3 questionnaires. The functional outcome measures currently used for JIA are all adequately responsive for use in trials or in the clinic setting. The choice of which measure to use should therefore be based on the time available for completion, the intended clinical/research use, and the depth of content required.

  18. The quality of registration of clinical trials.

    Directory of Open Access Journals (Sweden)

    Roderik F Viergever

    Full Text Available BACKGROUND: Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials. METHODS AND FINDINGS: A 5% sample of records of clinical trials that were registered between 17 June 2008 and 17 June 2009 was taken from the International Clinical Trials Registry Platform (ICTRP database and assessed for the presence of contact information, the presence of intervention specifics in drug trials and the quality of primary and secondary outcome reporting. 731 records were included. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in 94.4% of records from non-industry funded trials and 53.7% of records from industry funded trials. Either an email address or a phone number was present in 76.5% of non-industry funded trial records and in 56.5% of industry funded trial records. Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration. Of 3643 reported outcomes, 34.9% were specific measures with a meaningful time frame. CONCLUSIONS: Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records.

  19. Data monitoring committees for pragmatic clinical trials.

    Science.gov (United States)

    Ellenberg, Susan S; Culbertson, Richard; Gillen, Daniel L; Goodman, Steven; Schrandt, Suzanne; Zirkle, Maryan

    2015-10-01

    In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical

  20. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  1. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were...... discussed by a group of trialists. This review focuses on the arguments for conducting posttrial database studies and presents examples of studies in which posttrial knowledge generation has been substantial. Possible strategies to ensure successful trial database or biobank generation are discussed...

  2. Clinical uses of melatonin: evaluation of human trials.

    Science.gov (United States)

    Sánchez-Barceló, E J; Mediavilla, M D; Tan, D X; Reiter, R J

    2010-01-01

    During the last 20 years, numerous clinical trials have examined the therapeutic usefulness of melatonin in different fields of medicine. The objective of this article is to review, in depth, the science regarding clinical trials performed to date. The efficacy of melatonin has been assessed as a treatment of ocular diseases, blood diseases, gastrointestinal tract diseases, cardiovascular diseases, diabetes, rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, infectious diseases, neurological diseases, sleep disturbances, aging and depression. Melatonin has been also used as a complementary treatment in anaesthesia, hemodialysis, in vitro fertilization and neonatal care. The conclusion of the current review is that the use of melatonin as an adjuvant therapy seems to be well funded for macular degeneration, glaucoma, protection of the gastric mucosa, irritable bowel syndrome, arterial hypertension, diabetes, side effects of chemotherapy and radiation in cancer patients or hemodialysis in patients with renal insufficiency and, especially, for sleep disorders of circadian etiology (jet lag, delayed sleep phase syndrome, sleep deterioration associated with aging, etc.) as well as in those related with neurological degenerative diseases (Alzheimer, etc.,) or Smith-Magenis syndrome. The utility of melatonin in anesthetic procedures has been also confirmed. More clinical studies are required to clarify whether, as the preliminary data suggest, melatonin is useful for treatment of fibromyalgia, chronic fatigue syndrome, infectious diseases, neoplasias or neonatal care. Preliminary data regarding the utility of melatonin in the treatment of ulcerative colitis, Crohn's disease, rheumatoid arthritis are either ambiguous or negative. Although in a few cases melatonin seems to aggravate some conditions, the vast majority of studies document the very low toxicity of melatonin over a wide range of doses.

  3. One Year Effects of a Workplace Integrated Care Intervention for Workers with Rheumatoid Arthritis: Results of a Randomized Controlled Trial

    NARCIS (Netherlands)

    Vilsteren, M. van; Boot, C.R.L.; Twisk, J.W.R.; Steenbeek, R.; Voskuyl, A.E.; Schaardenburg, D. van; Anema, J.R.

    2017-01-01

    Purpose To evaluate the effectiveness of a workplace integrated care intervention on at-work productivity loss in workers with rheumatoid arthritis (RA) compared to usual care. Methods In this randomized controlled trial, 150 workers with RA were randomized into either the intervention or control

  4. Construction of ethics in clinical research: clinical trials registration

    Directory of Open Access Journals (Sweden)

    C. A. Caramori

    2007-01-01

    Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

  5. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Silverstein, F E; Graham, D Y; Senior, J R; Davies, H W; Struthers, B J; Bittman, R M; Geis, G S

    1995-08-15

    To investigate whether concurrent administration of misoprostol reduces the occurrence of serious upper gastrointestinal complications, such as perforation, gastric outlet obstruction, or bleeding, in patients with rheumatoid arthritis who are receiving nonsteroidal anti-inflammatory drugs (NSAIDs). 6-month randomized, double-blind, placebo-controlled trial. 664 clinical practices of family medicine, internal medicine, or rheumatology in the United States and Canada. 8843 men and women (mean age, 68 years) receiving continuous therapy with any of 10 specified NSAIDs for control of symptoms of rheumatoid arthritis. Patients were enrolled between July 1991 and August 1993. Patients were randomly assigned to receive 200 micrograms of misoprostol or placebo four times a day. Development of serious upper gastrointestinal complications detected by clinical symptoms or findings (not by scheduled endoscopy). Serious upper gastrointestinal complications were reduced by 40% (odds ratio, 0.598 [95% CI, 0.364 to 0.982; P = 0.049]) among patients receiving misoprostol (25 of 4404 patients) compared with those receiving placebo (42 of 4439 patients). During the first month, more patients receiving misoprostol (20%) than placebo (15%) withdrew from the study, primarily because of diarrhea and related problems (P rheumatoid arthritis, misoprostol reduced serious NSAID-induced upper gastrointestinal complications by 40% compared with placebo.

  6. The Danish nationwide clinical register for patients with rheumatoid arthritis: DANBIO

    Directory of Open Access Journals (Sweden)

    Ibfelt EH

    2016-10-01

    Full Text Available Else Helene Ibfelt,1 Dorte Vendelbo Jensen,2,3 Merete Lund Hetland2,4 1Registry Support Centre (East, Epidemiology and Biostatistics, Research Centre for Prevention and Health, Rigshospitalet, Glostrup University Hospital, 2DANBIO Registry and Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Glostrup, 3Department of Rheumatology, Herlev and Gentofte University Hospital, Hellerup, 4Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark Introduction: DANBIO is a research register and a data source for rheumatologic diseases (rheumatoid arthritis [RA], axial spondyloarthritis, and psoriatic arthritis for monitoring clinical quality at the national, regional, and hospital levels. Study population: The register includes patients with rheumatologic diseases who are treated at a hospital or a private rheumatologic clinic. Registration is mandatory for all patients with RA regardless of treatment and also for patients with other diagnoses if treated with biological disease-modifying antirheumatic drugs. Since 2006, the registration has been done electronically, including patient-reported outcome measures registered electronically by the patients with the use of touch screens. Main variables: Core variables such as diagnosis, year of diagnosis, age, and sex are registered at the beginning. Data entered at later visits included the following: patient-reported outcomes for disease activity, pain, fatigue, functional status, and physician-reported objective measures of disease activity, treatment, C-reactive protein, and, when indicated, imaging. For subgroups of patients, the variables such as quality of life, sociodemographic factors, lifestyle, and comorbidity are also registered. Descriptive data: The DANBIO cohort comprised ~26,000 patients with RA, 3,200 patients with axial spondyloarthritis, and 6

  7. Methodology series module 4: Clinical trials

    Directory of Open Access Journals (Sweden)

    Maninder Singh Setia

    2016-01-01

    Full Text Available In a clinical trial, study participants are (usually divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care. We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1 parallel study design, (2 cross-over design, (3 factorial design, and (4 withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials. Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  8. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial.

    NARCIS (Netherlands)

    Farkouh, M.E.; Kirshner, H.; Harrington, R.A.; Ruland, S.; Verheugt, F.W.A.; Schnitzer, T.J.; Burmester, G.R.; Mysler, E.; Hochberg, M.C.; Doherty, M.; Ehrsam, E.; Gitton, X.; Krammer, G.; Mellein, B.; Gimona, A.; Matchaba, P.; Hawkey, C.J.; Chesebro, J.H.

    2004-01-01

    BACKGROUND: The potential for cyclo-oxygenase 2 (COX2)-selective inhibitors to increase the risk for myocardial infarction is controversial. The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) aimed to assess gastrointestinal and cardiovascular safety of the COX2 inhibitor

  9. Rheumatoid arthritis.

    Science.gov (United States)

    Vikingsson, Arnor; Graziano, Frank M

    1993-12-01

    Preview Once considered relatively benign, rheumatoid arthritis is now recognized as a disabling systemic disease that causes substantial morbidity and mortality. Early, aggressive therapy may be critical for altering the course of disease. Drs Vikings-son and Graziano describe the causes and clinical course of rheumatoid arthritis and discuss diagnostic considerations and prognostic indicators that support optimum management.

  10. Is a long-term high-intensity exercise program effective and safe in patients with rheumatoid arthritis? Results of a randomized controlled trial.

    NARCIS (Netherlands)

    Jong, Z. de; Munneke, M.; Zwinderman, A.H.; Kroon, H.M.; Jansen, A.; Ronday, K.H.; Schaardenburg, D. van; Dijkmans, B.A.C.; Ende, C.H.M. van den; Breedveld, F.C.; Vliet Vlieland, T.P.M.; Hazes, J.M.W.

    2003-01-01

    OBJECTIVE: There are insufficient data on the effects of long-term intensive exercise in patients with rheumatoid arthritis (RA). We undertook this randomized, controlled, multicenter trial to compare the effectiveness and safety of a 2-year intensive exercise program (Rheumatoid Arthritis Patients

  11. How well are the ASAS/OMERACT Core Outcome Sets for Ankylosing Spondylitis implemented in randomized clinical trials? A systematic literature review

    NARCIS (Netherlands)

    Bautista-Molano, Wilson; Navarro-Compán, Victoria; Landewé, Robert B. M.; Boers, Maarten; Kirkham, Jamie J.; van der Heijde, Désirée

    2014-01-01

    This study aims to investigate how well the Assessment of SpondyloArthritis international Society (ASAS)/Outcome Measures in Rheumatology Clinical Trials (OMERACT) core set and response criteria for ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing

  12. Clinical and microbiological findings of septic arthritis caused by Haemophilus parainfluenzae.

    Science.gov (United States)

    Cobo, F; Jiménez, G; Rodríguez-Granger, J; Sampedro, A; Aliaga-Martínez, L; Navarro-Marí, J M

    2017-12-01

    To report a case of septic arthritis due to H. parainfluenzae and to review the clinical and microbiological characteristics of published case patients. Data was collected on age, sex, infection localization, underlying risk factors, symptom onset-diagnosis interval, analytical findings, microbiological diagnosis, treatment, outcome, and follow-up of the present patient (presenting with septic arthritis of the pubic symphysis due to H. parainfluenzae) and those identified in a literature analysis. Data of 18 patients, including 17 reported case patients, was collected. Mean age at presentation was 51±9 years. Underlying diseases for septic arthritis were recorded in 11 patients. The infection site was the knee in eight patients, hip and/or acromioclavicular joint in five. Pain was observed in 15 patients and fever in 10; the mean symptom onset-diagnosis interval was 9.4 days. Diagnosis was obtained from synovial fluid aspirate in 12 patients and from blood cultures in four. Susceptibility of H. parainfluenzae strains was reported in 12 cases. Eight patients were treated with cephalosporins and 10 with penicillins. A favorable outcome was observed in 13 patients. Septic arthritis caused by H. parainfluenzae is a rare entity that requires a high level of suspicion before application of laboratory methods for rapid diagnosis and treatment. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  13. Ankylosing spondylitis and psoriatic arthritis: clinical and economic consequences of the use of etanercept

    Directory of Open Access Journals (Sweden)

    Viola Sacchi

    2010-06-01

    Full Text Available Spondyloarthritis (SpA is the name for a family of inflammatory rheumatic disease that can affect the spine and joints, ligaments and tendons. Spondyloarthritis disease include ankylosing spondylitis, reactive arthritis, psoriatic arthritis, the spondylitis associated with the inflammatory bowel diseases and the undifferentiated spondyloarthritis. The most common treatments prescribed for spondyloarthritis are nonsteroidal anti-inflammatory drugs (NSAIDs given in combination with disease-modifying antirheumatic drugs (DMARDs. Due to a recently suggested role of the tumour necrosis factor (TNFa in the pathogenesis of SpA, new therapies specifically blocking TNFa have been investigated. Anti-TNF medications currently available on the Italian market are etanercept, infliximab and adalimumab. The aim of the present work was to furnish a clinical and pharmaco-economical profile of etanercept in treatment of psoriatic arthritis and ankylosing spondylitis based on a review of the published literature. Economical evaluations performed in several countries indicate that total treatment costs are lower with etanercept and adalimumab as compared to infliximab, mainly because of differences in the route of administration. Etanercept appears to be cost effective for the treatment of psoriatic arthritis and ankylosing spondylitis especially considering improved health related quality of life and lower medical costs due to superior efficacy of treatment.

  14. Agreement of clinical examination and ultrasound methods for detection of joints involvements in rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    Hadi Karimzadeh

    2017-01-01

    Full Text Available Background: Rheumatoid arthritis is a chronic autoimmune disease characterized by synovial tissue inflammation and destruction of articular components which if not controlled properly, can cause disability in patients. For this reason, evaluation of disease activity and its control is very important. In recent years using sonography is promising for the evaluation of disease activity. This study aimed to compare “clinical examination” and “ultrasonography” methods in the detection of disease activity in patients with rheumatoid arthritis. Materials and Methods: This cross-sectional study was conducted during 2015 in Al-Zahra Hospital of Isfahan. Based on the American College of Rheumatology 2010 criteria, ninety patients with rheumatoid arthritis who diagnosed by rheumatologist entered into the study. All patients, collaborator by radiologists were subjected to sonography of specific joints structures using two methods, i.e., high-resolution ultrasonography and power Doppler. Results: A total of 2520 joints from ninety patients were examined by physical examination and ultrasonography that 244 joints (9.7% in physical examination and 348 joints (13.4% in ultrasonography were involved and the difference between the two groups was statistically significant (P < 0.001. Conclusion: Probably, ultrasonography can diagnose joint involvement better than physical examination in patients with Rheumatoid arthritis.

  15. Agreement of clinical examination and ultrasound methods for detection of joints involvements in rheumatoid arthritis.

    Science.gov (United States)

    Karimzadeh, Hadi; Rafiei, Ramin; Sayedbonakdar, Zahra; Karami, Mehdi

    2017-01-01

    Rheumatoid arthritis is a chronic autoimmune disease characterized by synovial tissue inflammation and destruction of articular components which if not controlled properly, can cause disability in patients. For this reason, evaluation of disease activity and its control is very important. In recent years using sonography is promising for the evaluation of disease activity. This study aimed to compare "clinical examination" and "ultrasonography" methods in the detection of disease activity in patients with rheumatoid arthritis. This cross-sectional study was conducted during 2015 in Al-Zahra Hospital of Isfahan. Based on the American College of Rheumatology 2010 criteria, ninety patients with rheumatoid arthritis who diagnosed by rheumatologist entered into the study. All patients, collaborator by radiologists were subjected to sonography of specific joints structures using two methods, i.e., high-resolution ultrasonography and power Doppler. A total of 2520 joints from ninety patients were examined by physical examination and ultrasonography that 244 joints (9.7%) in physical examination and 348 joints (13.4%) in ultrasonography were involved and the difference between the two groups was statistically significant ( P < 0.001). Probably, ultrasonography can diagnose joint involvement better than physical examination in patients with Rheumatoid arthritis.

  16. Psoriatic arthritis: An assessment of clinical, biochemical and ...

    African Journals Online (AJOL)

    , epidemiological, clinical and radiological studies of South African (SA) patients are scarce. Objectives. To assess clinical, biochemical and radiological features in a single-centre SA cohort. Methods. We conducted a prospective assessment ...

  17. A comparison of ultrasound and clinical examination in the detection of flexor tenosynovitis in early arthritis

    Directory of Open Access Journals (Sweden)

    Abouqal Redouane

    2011-05-01

    Full Text Available Abstract Background Tenosynovitis is widely accepted to be common in rheumatoid arthritis (RA and postulated to be the first manifestation of RA, but its true prevalence in early disease and in particular the hand has not been firmly established. The aims of this study were first to investigate the frequency and distribution of finger flexor tenosynovitis using ultrasound in early arthritis, second to compare clinical examination with ultrasound (US using the latter as the gold standard. Methods 33 consecutive patients who had who were initially diagnosed with polyarthritis and suspected of polyarthritis and clinical suspicion of inflammatory arthritis of the hands and wrists were assessed during consecutive, routine presentations to the rheumatology outpatient clinic. We scanned a total of 165 finger tendons and subsequent comparisons were made using clinical examination. Results Flexor tenosynovitis was found in 17 patients (51.5% on ultrasound compared with 16 (48.4% of all patients on clinical examination. Most commonly damaged joint involved on US was the second finger followed by the third, fifth, and fourth. Both modalities demonstrated more pathology on the second and third metacarpophalangeal (MCP compared with the fourth and fifth MCP. A joint-by-joint comparison of US and clinical examination demonstrated that although the sensitivity, specificities and positive predictive values of clinical examination were relatively high, negative predictive value of clinical examination was low (0.23. Conclusions Our study suggest that clinical examination can be a valuable tool for detecting flexor disease in view of its high specificity and positive predictive values, but a negative clinical examination does not exclude inflammation and an US should be considered. Further work is recommended to standardize definitions and image acquisition for peritendinous inflammation for ultrasound.

  18. Kinetics of gene expression and bone remodelling in the clinical phase of collagen induced arthritis

    DEFF Research Database (Denmark)

    Denninger, Katja Caroline Marie; Litman, Thomas; Marstrand, Troels

    2015-01-01

    Introduction: Pathological bone changes differ considerably between inflammatory arthritic diseases and most studies have focused on bone erosion. Collagen-induced arthritis (CIA) is a model for rheumatoid arthritis, which, in addition to bone erosion, demonstrates bone formation at the time...... of clinical manifestations. The objective of this study was to use this model to characterise the histological and molecular changes in bone remodelling, and relate these to the clinical disease development. Methods: A histological and gene expression profiling time-course study on bone remodelling in CIA......), and secreted phosphoprotein 1 (Spp1). Pregnancy-associated protein A (Pappa) and periostin (Postn), differentially expressed in the early disease phase, are proposed to participate in bone formation, and we suggest that they play a role in early bone formation in the CIA model. Comparison to human genome...

  19. Impact of tumour necrosis factor inhibitor treatment on radiographic progression in rheumatoid arthritis patients in clinical practice

    DEFF Research Database (Denmark)

    Ørnbjerg, Lykke Midtbøll; Østergaard, Mikkel; Bøyesen, Pernille

    2013-01-01

    To compare radiographic progression during treatment with disease-modifying antirheumatic drugs (DMARD) and subsequent treatment with tumour necrosis factor α inhibitors (TNF-I) in rheumatoid arthritis (RA) patients in clinical practice.......To compare radiographic progression during treatment with disease-modifying antirheumatic drugs (DMARD) and subsequent treatment with tumour necrosis factor α inhibitors (TNF-I) in rheumatoid arthritis (RA) patients in clinical practice....

  20. Globalization of Alzheimer's disease clinical trials

    Science.gov (United States)

    2011-01-01

    Alzheimer's disease (AD) therapies are increasingly being tested in global clinical trials. A search of ClincalTrials.gov revealed that of 269 currently active trials, 28% are currently being conducted in the United States; the majority of trials and the majority of trial sites are ex-US. The US has the largest number of trial sites of any single country; cumulatively, nearly half of all sites are outside the US. The US conducts more trials in all phases of drug development but has a greater proportion of phase 3 trials. The increasing importance of global participants in clinical trials emphasizes the importance of considering the ethnic and international factors that may influence trial outcome. The International Conference on Harmonization guidelines divide ethnic factors that may affect drug development into intrinsic and extrinsic influences. These include language, cultural factors, educational levels, the general level of health and standard of care, as well as nutrition and diet. Ethnic influences on pharmacokinetics are known for some metabolic pathways. The biology of AD may also differ among the world's populations. The frequency of the apolipoprotein e4 allele, a major risk factor for AD, differs internationally. Genetic variations might also affect inflammatory, excitotoxic, and oxidative components of AD. Diagnostic standards and experience vary from country to country. Levels of practitioner training and experience, diagnostic approaches to AD, and attitudes regarding aging and AD may differ. Experience and sophistication with regard to clinical trial conduct also vary within and between countries. Experience with conducting the necessary examinations, as well as the linguistic and cultural validity of instrument translations, may affect trial outcomes. Operational and regulatory aspects of clinical trials vary and provide important barriers to seamless conduct of multiregional clinical trials. Collection and testing of biological samples, continuous

  1. Globalization of Alzheimer's disease clinical trials.

    Science.gov (United States)

    Cummings, Jeffrey; Reynders, Robert; Zhong, Kate

    2011-08-17

    Alzheimer's disease (AD) therapies are increasingly being tested in global clinical trials. A search of ClincalTrials.gov revealed that of 269 currently active trials, 28% are currently being conducted in the United States; the majority of trials and the majority of trial sites are ex-US. The US has the largest number of trial sites of any single country; cumulatively, nearly half of all sites are outside the US. The US conducts more trials in all phases of drug development but has a greater proportion of phase 3 trials. The increasing importance of global participants in clinical trials emphasizes the importance of considering the ethnic and international factors that may influence trial outcome. The International Conference on Harmonization guidelines divide ethnic factors that may affect drug development into intrinsic and extrinsic influences. These include language, cultural factors, educational levels, the general level of health and standard of care, as well as nutrition and diet. Ethnic influences on pharmacokinetics are known for some metabolic pathways. The biology of AD may also differ among the world's populations. The frequency of the apolipoprotein e4 allele, a major risk factor for AD, differs internationally. Genetic variations might also affect inflammatory, excitotoxic, and oxidative components of AD. Diagnostic standards and experience vary from country to country. Levels of practitioner training and experience, diagnostic approaches to AD, and attitudes regarding aging and AD may differ. Experience and sophistication with regard to clinical trial conduct also vary within and between countries. Experience with conducting the necessary examinations, as well as the linguistic and cultural validity of instrument translations, may affect trial outcomes. Operational and regulatory aspects of clinical trials vary and provide important barriers to seamless conduct of multiregional clinical trials. Collection and testing of biological samples, continuous

  2. Marketing and clinical trials: a case study.

    Science.gov (United States)

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-11-20

    Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  3. Clinical significance of dynamic magnetic resonance imaging in the evaluation of wrist joint in Rheumatoid arthritis

    International Nuclear Information System (INIS)

    Shim, Yong Woon; Suh, Jin Suck; Lee, Soo Kon; Lee, Ji Soo; Cho, Jae Hyun

    1996-01-01

    To assess the role of contrast-enhanced dynamic Magnetic Resonance Imaging in evaluation disease activity of rheumatoid arthritis. Forty-seven wrist joints with rheumatoid arthritis were examined prospectively. Coronal images of the wrist were obtained using fat-suppression Fast multi-planar spoiled gradient recalled (FMPSPGR) acquisition in the steady state ; TR/TE 102/6.4 msec, flip angle = 60, 4 slices per sequence, FOV = 8 cm, matrix 256 X 192 at 1.5 Tesla. Scans were carried out once before and five to eight times after an intravenous Gd-DPTA injection, at 30-second-intervals. The enhancement of synovium were measured, the enhancement ratio was calculated(postcontrast SNR/precontrast SNR) and time-enhancement ratio curves were plotted. Patients were divided into three groups according to the ratio of initial to peak enhancement : less than 30% ; 30-80% more than 80%. Differences among the three groups were statistically tested using clinical indices and laboratory data as variable. Comparing one group with another, there were no significant differences in clinical indices and laboratory data except for the parameter of grip strength. Enhancement pattern measured in a single wrist joint was not comparable to a clinical index in predicting disease activity in rheumatoid arthritis

  4. Cancer Clinical Trials at the National Institutes of Health Clinical Center

    Science.gov (United States)

    ... Questions to Ask about Your Treatment Research Cancer Clinical Trials at the National Institutes of Health Clinical Center ... they are eligible for a clinical trial . NCI Clinical Trials at the NIH Clinical Center Cancer research at ...

  5. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  6. Critical concepts in adaptive clinical trials

    Directory of Open Access Journals (Sweden)

    Park JJH

    2018-03-01

    Full Text Available Jay JH Park,1 Kristian Thorlund,2,3 Edward J Mills2,3 1Department of Medicine, University of British Columbia, Vancouver, BC, Canada; 2Department of Health Research Methods, Evidence, and Impact (HEI, McMaster University, Hamilton, ON, Canada; 3The Bill and Melinda Gates Foundation, Seattle, WA, USA Abstract: Adaptive clinical trials are an innovative trial design aimed at reducing resources, decreasing time to completion and number of patients exposed to inferior interventions, and improving the likelihood of detecting treatment effects. The last decade has seen an increasing use of adaptive designs, particularly in drug development. They frequently differ importantly from conventional clinical trials as they allow modifications to key trial design components during the trial, as data is being collected, using preplanned decision rules. Adaptive designs have increased likelihood of complexity and also potential bias, so it is important to understand the common types of adaptive designs. Many clinicians and investigators may be unfamiliar with the design considerations for adaptive designs. Given their complexities, adaptive trials require an understanding of design features and sources of bias. Herein, we introduce some common adaptive design elements and biases and specifically address response adaptive randomization, sample size reassessment, Bayesian methods for adaptive trials, seamless trials, and adaptive enrichment using real examples. Keywords: adaptive designs, response adaptive randomization, sample size reassessment, Bayesian adaptive trials, seamless trials, adaptive enrichment

  7. Exploring Data Quality Management within Clinical Trials.

    Science.gov (United States)

    Houston, Lauren; Probst, Yasmine; Yu, Ping; Martin, Allison

    2018-01-01

    Clinical trials are an important research method for improving medical knowledge and patient care. Multiple international and national guidelines stipulate the need for data quality and assurance. Many strategies and interventions are developed to reduce error in trials, including standard operating procedures, personnel training, data monitoring, and design of case report forms. However, guidelines are nonspecific in the nature and extent of necessary methods.  This article gathers information about current data quality tools and procedures used within Australian clinical trial sites, with the aim to develop standard data quality monitoring procedures to ensure data integrity.  Relevant information about data quality management methods and procedures, error levels, data monitoring, staff training, and development were collected. Staff members from 142 clinical trials listed on the National Health and Medical Research Council (NHMRC) clinical trials Web site were invited to complete a short self-reported semiquantitative anonymous online survey.  Twenty (14%) clinical trials completed the survey. Results from the survey indicate that procedures to ensure data quality varies among clinical trial sites. Centralized monitoring (65%) was the most common procedure to ensure high-quality data. Ten (50%) trials reported having a data management plan in place and two sites utilized an error acceptance level to minimize discrepancy, set at data variables checked (10-100%), the frequency of visits (once-a-month to annually), and types of variables (100%, critical data or critical and noncritical data audits) for data monitoring varied among respondents. The average time spent on staff training per person was 11.58 hours over a 12-month period and the type of training was diverse.  Clinical trial sites are implementing ad hoc methods pragmatically to ensure data quality. Findings highlight the necessity for further research into "standard practice" focusing on

  8. Prevalence and clinical patterns of psoriatic arthritis in Indian patients with psoriasis

    Directory of Open Access Journals (Sweden)

    Ramesh Kumar

    2014-01-01

    Full Text Available Background: The prevalence and clinical patterns of psoriatic arthritis (PsA varies in different parts of the world and there is little clinical and epidemiological data from the Indian subcontinent. Aims: Our study was designed to evaluate the prevalence and clinical patterns of PsA in Indian patients. Methods: This was a non-interventional, cross-sectional study, in which 1149 consecutive psoriasis patients seen over 1 year were screened for PsA according to classification of psoriatic arthritis (CASPAR criteria. Demographic and disease parameters were recorded including Psoriasis Area and Severity Index (PASI, Nail Psoriasis Severity Index (NAPSI, and number of swollen and tender joints. Results: Among 1149 patients with psoriasis, 100 (8.7% patients had PsA, of which 83% were newly diagnosed. The most common pattern was symmetrical polyarthritis (58%, followed by spondyloarthropathy 49%, asymmetric oligoarthritis (21%, isolated spondyloarthropathy (5%, predominant distal interphalangeal arthritis (3%, and arthritis mutilans (1%. Enthesitis and dactylitis were present in 67% and 26% of cases, respectively. The mean number of swollen and tender joints were 3.63 ± 3.59 (range, 0-22 and 7.76 ± 6.03 (range, 1-26, respectively. Nail changes were present in 87% of the cases. The median PASI and NAPSI of the subjects with PsA was 3.6 and 20, respectively. There was no significant correlation of number of swollen/tender joints with PASI or NAPSI. Conclusion: There is a relatively low prevalence of PsA among Indian psoriasis patients presenting to dermatologists. No correlation was found between the severity of skin and nail involvement and articular disease.

  9. Clinical trial data analysis using R

    National Research Council Canada - National Science Library

    Chen, Ding-Geng; Peace, Karl E

    2011-01-01

    .... Case studies demonstrate how to select the appropriate clinical trial data. The authors introduce the corresponding biostatistical analysis methods, followed by the step-by-step data analysis using R...

  10. Overcoming Age Limits in Cancer Clinical Trials

    Science.gov (United States)

    Adolescents, young adults, and the elderly lag far behind other age groups when it comes to enrolling in clinical trials. Their participation is critical to advancing effective therapies for these age groups.

  11. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  12. Physical function continues to improve when clinical remission is sustained in rheumatoid arthritis patients.

    Science.gov (United States)

    Radner, Helga; Alasti, Farideh; Smolen, Josef S; Aletaha, Daniel

    2015-08-11

    To investigate the course of functional status assessed by health assessment questionnaire (HAQ) in rheumatoid arthritis (RA) patients with sustained clinical remission (REM). In recent RA clinical trials, we identified patients with subsequent visits of ≥24 weeks in clinical REM according to the disease activity score using 28-joint counts including C-reactive protein (DAS28) (≤2.6), or simplified disease activity index (SDAI) (≤3.3). Area under the curve (AUC) and mean HAQ scores throughout the time in sustained REM were compared using t test, analyses of variance (ANOVA) and adjusted general linear modeling (GLM) with repeated measures. In Cox regression analyses, the time to regain full physical function was modeled. Sensitivity analyses were performed in patients of sustained SDAI low disease activity (LDA; SDAI ≤11). A total of 610 out of 4364 patients achieved sustained DAS28 REM (14%) and 252 SDAI REM (5.8%). ANOVA testing for linear trend showed significant decrease of mean HAQ from week 0 (start of REM) to week 24, regardless of REM criteria used. AUC of HAQ throughout 24 weeks of REM was higher in DAS28 compared to SDAI REM (p ≤0.01). GLM adjusting for covariates showed significant decrease of monthly HAQ scores from week 0 to 24 (DAS28: 0.276, 0.243, 0.229, 0.222, 0.219, 0.209 to 0.199; p = 0.0001; SDAI: 0.147, 0.142, 0.149, 0.129, 0.123, 0.117 to 0.114; p = 0.029). Similarly, a decrease of HAQ over time was found in patients of sustained SDAI LDA. In DAS28 REM, the chance of regaining full physical function was higher for female (hazard ratio HR [95% confidence interval]: 1.41 [1.13-1.76]) and early RA patients (disease duration ≤2 years: HR 1.29 [1.01-1.65]); in SDAI REM no significant differences were found. Physical function continues to improve if the target of REM or LDA is sustained. The stringency of the remission criteria determines achievement of the best possible functional improvement.

  13. Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov.

    Science.gov (United States)

    Riley, Isaretta L; Boulware, L Ebony; Sun, Jie-Lena; Chiswell, Karen; Que, Loretta G; Kraft, Monica; Todd, Jamie L; Palmer, Scott M; Anderson, Monique L

    2018-02-01

    Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1 year of trial completion or termination. We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013. We estimated the cumulative percentage of applicable clinical trials reporting results by pulmonary disease category. Multivariable Cox regression modeling identified characteristics independently associated with results reporting. Results Of 1450 pulmonary highly likely applicable clinical trials, 380 (26%) examined respiratory neoplasms, 238 (16%) asthma, 175 (12%) chronic obstructive pulmonary disease, and 657 (45%) other respiratory diseases. Most (75%) were pharmaceutical highly likely applicable clinical trials and 71% were industry-funded. Approximately 15% of highly likely applicable clinical trials reported results within 1 year of trial completion, while 55% reported results over the 5-year study period. Earlier phase highly likely applicable clinical trials were less likely to report results compared to phase 4 highly likely applicable clinical trials (phases 1/2 and 2 (adjusted hazard ratio 0.41 (95% confidence interval: 0.31-0.54)), phases 2/3 and 3 (adjusted hazard ratio 0.55 (95% confidence interval: 0.42-0.72)) and phase not applicable (adjusted hazard ratio 0.43 (95% confidence interval: 0.29-0.63)). Pulmonary highly likely applicable clinical trials without Food and Drug Administration oversight were less likely to report results compared with those with oversight (adjusted hazard ratio 0.65 (95% confidence interval: 0

  14. The clinical significance of Epitrochlear lymphadenopathy on elbow radiographs in rheumatoid arthritis

    International Nuclear Information System (INIS)

    Kwon, Bae Ju; Joo, Kyung Bin; Lee, Hak Soo; Song, Ho Taek; Park, Dong Woo; Lee, Seung Ro; Hahm, Chang Kok

    2000-01-01

    To evaluate the radiographic findings of epitrochlear lymphadenopathy with regard to the distribution and severity of the disease and clinal parameters in patients with rheumatoid arthritis. Forty six patients with rheumatoid arthritis in whom epitrochlear oval-shaped densities were seen on radiographs were involved in this study. There were 14 cases of unilateral epitrochlear lymphadenopathy in which bilateral arthritic evidence was revealed by radiographs (mixed group), and 32 of bilateral lymphadenopathy in which there was arthritic evidence (positive group). Twenty-three patients in whom lymphadenopathy was not seen on radiographs of the elbow and who were diagnosed as suffering from rheumatoid arthritis functioned as controls (negative group).For scoring the degree of arthritis using the simplified scoring method proposed by Kaye et al., joints were divided into six groups, as follows: Joint 1, elbow; Joint 2, wrist; Joint 3, radial (1st and 2nd) PIP and MCP; Joint 4, ulnar (3rd, 4th, 5th) PIP and MCP; Joint 5, Joints 1 + 2+ 3 + 4; Joint 6, Joints 1 + 4. For each joint, scores were compared with those on the contralateral side in the mixed group. Differences in clinical parameters ( disease duration, rheumatoid factor, ESR, and CRP), and scores for each joint in each arm were statistically compared between be positive and negative group. The number, mean diameter, and maximal diameter of epitrochlear lymph nodes were calculated and correlated with clinical parameters and scores for each joint. To evaluate the incidence of epitrochlear lymphadenopathy without radiographic evidence of arthritis in 46 patients (78 arms) with lymphadenopathy, the frequency of cases in which the score for the joint was zero was assessed. In the mixed group, the mean score for Joint 6 of the arm with epitrochlear lymphadenopathy was significantly higher than that for the contralateral side in the mixed group (p=3D0.022). Only CRP was significantly higher in the positive group than

  15. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates......Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  16. Developments in statistical evaluation of clinical trials

    CERN Document Server

    Oud, Johan; Ghidey, Wendimagegn

    2014-01-01

    This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

  17. A report on clinical application of 99Tc-MDP treatment in patients with juvenile rheumatoid arthritis

    International Nuclear Information System (INIS)

    Chen Huilin; Chen Wanqian; Xie Mei; Liang Jun

    2003-01-01

    Objective: To asses clinical application of the Yunke therapy and observe the early curative effect in juvenile rheumatoid arthritis. Methods: 9 patients of juvenile rheumatoid arthritis were enrolled. The age ranged 4.5-16 years old with medical history ranged 3-12 months. All patients had been treated using Yunke therapy. A high dose of 100 mg or 200 mg was given by intravenous infusion in alternative day for 2 to 3 times during the first course of treatment. Then a small dose of 5 mg alternate day was given by intravenous injection for 10-15 times during the second course and the treatment phase continue for 2-3 courses. Results: Significance curative effect was observed in all cases. Conclusion: Early clinical effect of the Yunke therapy was obvious in juvenile rheumatoid arthritis. It was necessary that a specific dose be used for juvenile rheumatoid arthritis

  18. Inclusion of Minority Patients in Breast Cancer Clinical Trials: The Role of the Clinical Trial Environment

    National Research Council Canada - National Science Library

    Kaplan, Celia P

    2007-01-01

    .... While inroads to increasing minority inclusion in breast cancer clinical trials have been made, recent reports continue to demonstrate lower enrollment among African Americans, Asian Americans...

  19. [The clinical picture of rheumatoid arthritis--the complex of three independent mechanisms].

    Science.gov (United States)

    Fassbender, Hans Georg; Meyer-Scholten, Carola; Zorn, Kati

    2009-01-01

    The assumption of inflamation as the only cause of the complex clinical picture of rheumatoid atrhritis does not correspond to facts. We have found and proven the existence of three seemingly unconnected mechanisms, and only their combination can account for the general clinical picture of rheumatoid arthritis. They are: 1. immunologic synovitis, responsible for pain, swelling and stiffnes; 2. oncological process ("tumorlike proliferation"), responsible for the destruction of joints; 3. Primary necrotizing process, responsible for the (sometimes lethal) destructions in the heart and blood vessels.

  20. The Effect of Triptolide in Rheumatoid Arthritis: From Basic Research towards Clinical Translation

    Directory of Open Access Journals (Sweden)

    Danping Fan

    2018-01-01

    Full Text Available Triptolide (TP, a major extract of the herb Tripterygium wilfordii Hook F (TWHF, has been shown to exert potent pharmacological effects, especially an immunosuppressive effect in the treatment of rheumatoid arthritis (RA. However, its multiorgan toxicity prevents it from being widely used in clinical practice. Recently, several attempts are being performed to reduce TP toxicity. In this review, recent progress in the use of TP for RA, including its pharmacological effects and toxicity, is summarized. Meanwhile, strategies relying on chemical structural modifications, innovative delivery systems, and drug combinations to alleviate the disadvantages of TP are also reviewed. Furthermore, we also discuss the challenges and perspectives in their clinical translation.

  1. Strengthening and stretching for rheumatoid arthritis of the hand (SARAH: design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343

    Directory of Open Access Journals (Sweden)

    Adams Jo

    2012-11-01

    Full Text Available Abstract Background Rheumatoid Arthritis (RA commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA. Methods/design 480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel. Discussion This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care. Trial registration Current Controlled Trials ISRCTN89936343

  2. Septic Arthritis of the Elbow in Children: Clinical Presentation and Microbiological Profile.

    Science.gov (United States)

    Nduaguba, Afamefuna M; Flynn, John M; Sankar, Wudbhav N

    2016-01-01

    Septic arthritis of the elbow in children is a rare but important musculoskeletal infection, and there is little published data to guide treating clinicians. The purpose of this study was to describe the clinical presentation and diagnostic findings, associated pathology, and microbiological profile of septic arthritis of the elbow in a pediatric population. We retrospectively analyzed a consecutive series of children who had an elbow arthrocentesis for presumed septic arthritis and whose joint aspirates were positive for microbial growth. Data collected included demographics, presenting signs and symptoms, imaging, and laboratory data, including culture results. Twelve children underwent diagnostic arthrocentesis of the elbow joint for septic arthritis at an average age of 6 years and 9 months (range, 2 mo to 13 y and 7 mo). Every child had pain, localized erythema and edema, and restricted range of motion; 10/12 were febrile. Mean duration of symptoms prior to joint tap was 4 days (range, 1 to 14 d). Concurrent osteomyelitis was found in 7 patients, as confirmed with magnetic resonance imaging (MRI): 5 at initial presentation and 2 after readmission for persistent symptoms. Causative pathogens were MSSA (7), MRSA (2), Group G streptococcus (1), Pseuodomonas aureginosa (1), and Streptococcus pneumonia (1). ESR was >40 mm/h in 8/11 patients, CRP was >2 mg/dL in all patients, and synovial WBC count was >50,000 cells/mm in 8/9 patients. One patient developed fulminant sepsis during hospitalization and 2 children were readmitted within 30 days of discharge for unrecognized osteomyelitis and/or recurrence of septic arthritis of the elbow. In 12 children studied with septic arthritis, S. aureus was the most common pathogen. Diagnosis is often delayed, and in most cases inflammatory markers were elevated (ESR>40 mm/h, CRP>2 mg/dL). Concomitant osteomyelitis is quite common, and therefore magnetic resonance imaging should be considered as part of the diagnostic work

  3. An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

    Science.gov (United States)

    Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

    2013-11-01

    To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

  4. Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov.

    Science.gov (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Minniti, Giuseppe; Lagerwaard, Frank J; Herrlinger, Ulrich; Mathier, Etienne; Soldatovic, Ivan; Jeremic, Branislav; Ghadjar, Pirus; Elicin, Olgun; Lössl, Kristina; Aebersold, Daniel M; Belka, Claus; Herrmann, Evelyn; Niyazi, Maximilian

    2017-01-03

    The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed.

  5. Public information about clinical trials and research.

    Science.gov (United States)

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

    2003-01-01

    Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.

  6. Massage Therapy for Pain and Function in Patients With Arthritis: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Nelson, Nicole L; Churilla, James R

    2017-09-01

    Massage therapy is gaining interest as a therapeutic approach to managing osteoarthritis and rheumatoid arthritis symptoms. To date, there have been no systematic reviews investigating the effects of massage therapy on these conditions. Systematic review was used. The primary aim of this review was to critically appraise and synthesize the current evidence regarding the effects of massage therapy as a stand-alone treatment on pain and functional outcomes among those with osteoarthritis or rheumatoid arthritis. Relevant randomized controlled trials were searched using the electronic databases Google Scholar, MEDLINE, and PEDro. The PEDro scale was used to assess risk of bias, and the quality of evidence was assessed with the GRADE approach. This review found seven randomized controlled trials representing 352 participants who satisfied the inclusion criteria. Risk of bias ranged from four to seven. Our results found low- to moderate-quality evidence that massage therapy is superior to nonactive therapies in reducing pain and improving certain functional outcomes. It is unclear whether massage therapy is more effective than other forms of treatment. There is a need for large, methodologically rigorous randomized controlled trials investigating the effectiveness of massage therapy as an intervention for individuals with arthritis.

  7. ORIGINAL ARTICLES Pharmacologically active: clinical trials and ...

    African Journals Online (AJOL)

    2008-01-22

    Jan 22, 2008 ... There is no reliable published value of pharmaceutical industry expenditure on clinical trials. The Pharmaceutical. Manufacturers Association, on the basis of a survey of its ... To determine the scale of current pharmaceutical R&D and clinical .... African market, a relatively drug-naïve population, and a high.

  8. Ottawa Panel Evidence-Based Clinical Practice Guidelines for Patient Education in the Management of Rheumatoid Arthritis (RA)

    Science.gov (United States)

    Brosseau, Lucie; Wells, George A.; Tugwell, Peter; Egan, Mary; Dubouloz, Claire-Jehanne; Welch, Vivian A.; Trafford, Laura; Sredic, Danjiel; Pohran, Kathryn; Smoljanic, Jovana; Vukosavljevic, Ivan; De Angelis, Gino; Loew, Laurianne; McEwan, Jessica; Bell, Mary; Finestone, Hillel M.; Lineker, Sydney; King, Judy; Jelly, Wilma; Casimiro, Lynn; Haines-Wangda, Angela; Russell-Doreleyers, Marion; Laferriere, Lucie; Lambert, Kim

    2012-01-01

    Background and purpose: The objective of this article is to create guidelines for education interventions in the management of patients ([greater than] 18 years old) with rheumatoid arthritis (RA). Methods: The Ottawa Methods Group identified and synthesized evidence from comparative controlled trials using Cochrane Collaboration methods. The…

  9. Clinical significance of changes of plasma prethrombotic state markers levels in patients with rheumatoid arthritis

    International Nuclear Information System (INIS)

    Chen Yonghua; Qian Haigen; Gao Li; Tang Jie

    2010-01-01

    Objective: To study the clinical significance of changes of plasma prethrombotic state markers levels in patients with rheumatoid arthritis. Methods: The plasma concentrations of TAT, FPA, PC, vWF, P-selectin, TpP and D-D were detected with ELISA in 84 patients with rheumatoid arthritis and 70 controls. Hand and wrist X-ray pictures were taken in all the 84 patients for staging of the disease with ARA 1987 revised criteria. Results: The plasma levels of TpP, TAT, vWF, FPA, P-Selectin and D-D were significantly higher in the patients than those in controls (P<0.05, respectively), but the plasma levels of PC were significantly lower (P<0.01). Changes of levels between successive stages were significantly (P<0.05) with the exception of the change between stage III and stage IV. Except PC, the levels of all the markers were significantly higher in patients with active disease (n=46) than those in patients with inactive disease (n=38) (P<0.05). Conclusion: There was risk for development of thrombotic events in patients with rheumatoid arthritis and prophylactic treatment might be desirable. (authors)

  10. Impact of sonography in gouty arthritis: Comparison with conventional radiography, clinical examination, and laboratory findings

    International Nuclear Information System (INIS)

    Schueller-Weidekamm, Claudia; Schueller, Gerd; Aringer, Martin; Weber, Michael; Kainberger, Franz

    2007-01-01

    Objective: To explore the typical sonographic features of gray-scale and Power Doppler of acute and chronic gouty arthritis in conjunction with radiographic, clinical, and laboratory findings. Materials and methods: All hand, finger, and toe joints of 19 patients with acute and chronic gout were examined with gray-scale and Power Doppler sonography. The number and size of bone changes detected with sonography was compared to radiographic findings. Vascularization of the synovial tissue was scored on Power Doppler (grades 0-3), and was compared with clinical appearance, including swelling, tenderness, and redness (grades 0-3). Results: In acute gout, mild to moderate echogenic periarticular nodules with sonotransmission and hypervascularization of the edematous surrounding soft tissue were found. In chronic gout, tophaceous nodules completely blocked transmission of US wave, leading to strong reflexion and dorsal shadowing in a minority of cases. No significant difference in the detection of large bone changes (>2 mm) was found between sonography and radiography. However, gray-scale sonography was significantly more sensitive in the detection of small bone changes (p < 0.001). Power Doppler scores were statistically significantly higher than clinical examination scores (p < 0.001). Discussion: Sonography is superior to radiographs in evaluating small bone changes. The inflammatory process in joints can be better detected with Power Doppler sonography than with clinical examination. Typical sonographic appearance of acute and in particular of chronic gout might provide clues on gouty arthritis that adds to the information available from conventional radiography, clinical, and laboratory findings

  11. Hepatitis C-associated arthritis.

    Science.gov (United States)

    Buskila, D

    2000-07-01

    Rheumatologic complications of hepatitis C virus (HCV) infection are common and include mixed cryoglobulinemia, vasculitis, sicca symptoms, myalgia, arthritis, and fibromyalgia. The prevalence of cryoglobulinemia in Sweden and Germany is much lower compared with data from southern Europe. Viral, genetic, or environmental factors may be responsible for such a difference in prevalence. There is no single clinical picture of arthritis in patients with HCV infection. There is a well-defined picture of arthritis associated with the presence of mixed cryoglobulinemia that consists of an intermittent mono- or oligoarticular, nondestructive arthritis affecting large and medium-size joints. Involvement of salivary and lacrimal glands is common in HCV-infected subjects, but HCV antigens are not detected in affected glands. HCV-infected subjects express a high prevalence of a variety of autoantibodies, usually in low titers. The clinical significance of most of these autoantibodies is not clear. The prevalence and titer of these autoantibodies are unaffected by interferon-alpha therapy. Several studies have attempted to assess whether HCV infection may be involved in the etiopathogenesis of rheumatic and autoimmune diseases. The results of most of these studies do not support the idea that HCV infection may play a pathogenic role in the development of systemic lupus erythematosus, antiphospholipid syndrome, or leukocytoclastic vasculitis. Experience treating patients with HCV-associated arthritis is limited and treatment remains controversial. No major therapeutic trials in HCV-associated arthritis were reported in the past 2 years.

  12. Involving South Asian patients in clinical trials.

    Science.gov (United States)

    Hussain-Gambles, M; Leese, B; Atkin, K; Brown, J; Mason, S; Tovey, P

    2004-10-01

    To investigate how South Asian patients conceptualise the notion of clinical trials and to identify key processes that impact on trial participation and the extent to which communication difficulties, perceptions of risk and attitudes to authority influence these decisions. Also to identify whether 'South Asian' patients are homogeneous in these issues, and which factors differ between different South Asian subgroups and finally how professionals regard the involvement of South Asian patients and their views on strategies to increase participation. A review of the literature on minority ethnic participation in clinical trials was followed by three qualitative interview studies. Interviews were taped and transcribed (and translated if required) and subjected to framework analysis. Face-to-face interviews were conducted with 25 health professionals; 60 South Asian lay people who had not taken part in a trial and 15 South Asian trial participants. Motivations for trial participation were identified as follows: to help society, to improve own health or that of family and friends, out of obligation to the doctor and to increase scientific knowledge. Deterrents were concerns about drug side-effects, busy lifestyles, language, previous bad experiences, mistrust and feelings of not belonging to British society. There was no evidence of antipathy amongst South Asians to the concept of clinical trials and, overall, the younger respondents were more knowledgeable than the older ones. Problems are more likely to be associated with service delivery. Lack of being approached was a common response. Lay-reported factors that might affect South Asian participation in clinical trials include age, language, social class, feeling of not belonging/mistrust, culture and religion. Awareness of clinical trials varied between each group. There are more similarities than differences in attitudes towards clinical trial participation between the South Asian and the general population

  13. The Danish nationwide clinical register for patients with rheumatoid arthritis: DANBIO.

    Science.gov (United States)

    Ibfelt, Else Helene; Jensen, Dorte Vendelbo; Hetland, Merete Lund

    2016-01-01

    DANBIO is a research register and a data source for rheumatologic diseases (rheumatoid arthritis [RA], axial spondyloarthritis, and psoriatic arthritis) for monitoring clinical quality at the national, regional, and hospital levels. The register includes patients with rheumatologic diseases who are treated at a hospital or a private rheumatologic clinic. Registration is mandatory for all patients with RA regardless of treatment and also for patients with other diagnoses if treated with biological disease-modifying antirheumatic drugs. Since 2006, the registration has been done electronically, including patient-reported outcome measures registered electronically by the patients with the use of touch screens. Core variables such as diagnosis, year of diagnosis, age, and sex are registered at the beginning. Data entered at later visits included the following: patient-reported outcomes for disease activity, pain, fatigue, functional status, and physician-reported objective measures of disease activity, treatment, C-reactive protein, and, when indicated, imaging. For subgroups of patients, the variables such as quality of life, sociodemographic factors, lifestyle, and comorbidity are also registered. The DANBIO cohort comprised ∼26,000 patients with RA, 3,200 patients with axial spondyloarthritis, and 6,200 patients with psoriatic arthritis in 2015. DANBIO has high nationwide coverage and completeness on key data variables. More than 60 original papers as well as annual reports of clinical quality (since 2005) have been published. DANBIO is a powerful register for research in rheumatologic diseases and furthermore serves as a Clinical Quality Register with the aim of monitoring treatment quality in patients with RA in Denmark.

  14. Quality of clinical trials: A moving target

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2011-01-01

    Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

  15. Aspergillus arthritis: analysis of clinical manifestations, diagnosis, and treatment of 31 reported cases.

    Science.gov (United States)

    Gamaletsou, Maria N; Rammaert, Blandine; Bueno, Marimelle A; Sipsas, Nikolaos V; Moriyama, Brad; Kontoyiannis, Dimitrios P; Roilides, Emmanuel; Zeller, Valerie; Taj-Aldeen, Saad J; Henry, Michael; Petraitis, Vidmantas; Denning, David W; Lortholary, Olivier; Walsh, Thomas J

    2017-04-01

    Aspergillus arthritis is a debilitating form of invasive aspergillosis. Little is known about its epidemiology, clinical manifestations, laboratory features, treatment, and prognosis. Cases of Aspergillus arthritis were reviewed in the English literature from 1967 through 2015 for variables of arthritis with Aspergillus spp. recovered from joint and/or adjacent bone, underlying conditions, symptoms, signs, inflammatory biomarkers, diagnostic imaging, management, and outcome. Among 31 evaluable cases, 87% were males and 13% pediatric. Median age was 50 y (range 1-83 y). Seventeen (55%) patients were immunosuppressed with such conditions as hematological malignancies (26%), corticosteroids (39%), and/or transplantation (26%). Approximately one-half (52%) of patients had hematogenous seeding of the joint, and more than 80% had de novo infection with no prior antifungal therapy. Oligoarticular infection (2-3 joints) occurred in 45% and contiguous osteomyelitis was present in 61%. Clinical manifestations included pain (87%), edema (26%), and limited function (23%), with knees (35%), intervertebral discs (26%), and hips (16%) being most commonly infected. Aspergillus fumigatus constituted 77% of cases followed by Aspergillus flavus in 13%, Aspergillus niger in 3%, and not specified in 7%. Median ESR was 90 mm/hr and median CRP was 3.6 mg/dl. Median synovial fluid WBC was 17,200/μL (7,300-128,000) with 72% PMNs (range 61-92). Osteolysis occurred in 35%, and soft-tissue extension 47%. Nineteen patients (61%) were managed with combined medical and surgical therapy, 10 (32%) with medical therapy only, and 2 (6%) surgery only. Amphotericin B and itraconazole were the most frequently used agents with median duration of therapy of 219 days (range 30-545). Surgical interventions included debridement in 61%, drainage 19%, and amputation 6%. Complete or partial response was achieved in 71% and relapse occurred in 16%. Medical therapy was reinstituted with successful outcome in

  16. Relationship Between Work Productivity and Clinical Characteristics in Rheumatoid Arthritis.

    Science.gov (United States)

    Salazar-Mejía, Carlos Eduardo; Galarza-Delgado, Dionicio Ángel; Colunga-Pedraza, Iris Jazmín; Azpiri-López, José Ramón; Wah-Suárez, Martín; Wimer-Castillo, Blanca Otilia; Salazar-Sepúlveda, Laura Leticia

    2018-03-01

    This study assesses the relationship between the ability to perform productive activities and the clinical characteristics of RA, such as disease activity, quality of life, functional capacity, workload, pharmacotherapy, and comorbidities. A cross-sectional, observational and descriptive study was conducted. Patients aged 18-75years with a diagnosis of RA according to ACR/EULAR 2010 criteria who attended regularly to the Rheumatology service in the period between January and March 2017 were included. The questionnaires, WPAI-AR, HAQ-DI and RAQoL, were applied. RA disease activity was measured by DAS28-PCR. Correlations were made between the clinical data obtained and work productivity and activity impairment measured by WPAI-AR. Two hundred four patients with a diagnosis of RA were included, of whom 92.6% were women. Mean age was 54.46±9.3years. Regarding the percentage of impairment of daily life activities, we found a significant difference between employed and unemployed patients (P≤.002). A positive correlation was found between RA activity measured by DAS28-PCR, quality of life, and functional ability with the percentages of absenteeism, presenteeism, overall productivity loss, and impairment of daily life activities. A correlation between RA disease activity, functional capacity, quality of life, and working impairment was found. The strongest association was established with the degree of functional capacity. Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  17. Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT

    NARCIS (Netherlands)

    Frewer, L.J.; Coles, D.G.; Lans, van der I.A.; Schroeder, D.; Champion, K.; Apperley, J.F.

    2011-01-01

    The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial

  18. Improvement in latent variable indirect response joint modeling of a continuous and a categorical clinical endpoint in rheumatoid arthritis.

    Science.gov (United States)

    Hu, Chuanpu; Zhou, Honghui

    2016-02-01

    Improving the quality of exposure-response modeling is important in clinical drug development. The general joint modeling of multiple endpoints is made possible in part by recent progress on the latent variable indirect response (IDR) modeling for ordered categorical endpoints. This manuscript aims to investigate, when modeling a continuous and a categorical clinical endpoint, the level of improvement achievable by joint modeling in the latent variable IDR modeling framework through the sharing of model parameters for the individual endpoints, guided by the appropriate representation of drug and placebo mechanism. This was illustrated with data from two phase III clinical trials of intravenously administered mAb X for the treatment of rheumatoid arthritis, with the 28-joint disease activity score (DAS28) and 20, 50, and 70% improvement in the American College of Rheumatology (ACR20, ACR50, and ACR70) disease severity criteria were used as efficacy endpoints. The joint modeling framework led to a parsimonious final model with reasonable performance, evaluated by visual predictive check. The results showed that, compared with the more common approach of separately modeling the endpoints, it is possible for the joint model to be more parsimonious and yet better describe the individual endpoints. In particular, the joint model may better describe one endpoint through subject-specific random effects that would not have been estimable from data of this endpoint alone.

  19. Altruism among participants in cancer clinical trials.

    Science.gov (United States)

    Truong, Tony H; Weeks, Jane C; Cook, E Francis; Joffe, Steven

    2011-10-01

    Patients' motivations for participation in cancer clinical trials are incompletely understood. Even less is known about the factors that influence participants' motivations for enrolling in trials. We studied the reasons why adult patients and parents of pediatric patients agree to participate in cancer trials. We focused on the role of altruism across all phases of trial. We surveyed adult patients and parents of pediatric patients participating in phase I, II, or III cancer clinical trials. We asked respondents why they agreed to enroll, and examined correlates of altruistic motivation using univariate and multivariate analyses. Among 205 adults and 48 parents of children participating in cancer trials, 47% reported that altruistic motivations were 'very important' to their decisions to enroll. In multivariate analysis with phase III trial participants as the reference group, phase I trial participants least often identified altruism as a 'very important' motivation for enrolling (phase I OR 0.4, 95% CI (confidence interval) 0.2-0.8; phase II OR 0.9, 95% CI 0.5-1.5, overall P = 0.017). Thirty-three respondents (13%) reported being motivated primarily by altruism. In multivariate analysis, participants with poor prognoses-defined as an expected 5-year disease-free survival of ≤ 10%-reported altruism as their primary motivation less often than those with better prognoses (OR 0.2, 95% CI 0.1-0.5, P = 0.001). Altruistic motivations did not differ between adult patients and parents of pediatric participants. The data are derived from related academic medical centers in one city, and the study sample reflects limited sociodemographic diversity, thereby limiting generalizability to other settings. Although cancer trial participants commonly report that altruism contributed to their decision to enroll, it is rarely their primary motivation for study participation. Participants in early phase trials and those with poor prognoses are least often motivated by altruism.

  20. Clinical effectiveness and safety of leflunomide in inflammatory arthritis: a report from the RAPPORT database with supporting patient survey.

    Science.gov (United States)

    Schultz, Morgan; Keeling, Stephanie O; Katz, Steven J; Maksymowych, Walter P; Eurich, Dean T; Hall, Jill J

    2017-07-01

    Leflunomide is indicated for the treatment of adults with rheumatoid arthritis, yet is underutilized. Given the cost of biologic therapy, understanding real-life effectiveness, safety, and sustainability of leflunomide, particularly in patients who have failed methotrexate, would be of value. The primary objective was to assess the proportion of patients achieving clinically meaningful benefit following an adequate trial of leflunomide. A retrospective analysis of a cohort supplemented with patient self-reported data using a standardized questionnaire. Data were analyzed using descriptive statistics, with a database multivariate logistic regression analysis to determine predictors of leflunomide response. Of the cohort available (N = 2591), 1671 patients with confirmed leflunomide use were included in the retrospective analysis, of whom 249 were incident users. Low disease activity (DAS-28 reported by 29% of incident users and after 1 year, 45% remained on leflunomide. Achievement of "minimal or no joint symptoms" was reported by 34% in the 661 analyzable survey responses (39% response rate). AE were reported by 55%, with nuisance (hair loss, nausea, stomach pain) AE and diarrhea being most common. Leflunomide was discontinued by 67% of responders within 1 year. An important proportion of patients, the majority of whom had previously failed methotrexate, achieved disease response with leflunomide with a low risk of serious adverse effects, suggesting that a trial of leflunomide may be a reasonable and cost-effective strategy prior to biologic therapy.

  1. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial.

    LENUS (Irish Health Repository)

    French, Helen P

    2009-01-01

    Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy.

  2. Clinical trial networks in orthopaedic surgery.

    Science.gov (United States)

    Rangan, A; Jefferson, L; Baker, P; Cook, L

    2014-05-01

    The aim of this study was to review the role of clinical trial networks in orthopaedic surgery. A total of two electronic databases (MEDLINE and EMBASE) were searched from inception to September 2013 with no language restrictions. Articles related to randomised controlled trials (RCTs), research networks and orthopaedic research, were identified and reviewed. The usefulness of trainee-led research collaborations is reported and our knowledge of current clinical trial infrastructure further supplements the review. Searching yielded 818 titles and abstracts, of which 12 were suitable for this review. Results are summarised and presented narratively under the following headings: 1) identifying clinically relevant research questions; 2) education and training; 3) conduct of multicentre RCTs and 4) dissemination and adoption of trial results. This review confirms growing international awareness of the important role research networks play in supporting trials in orthopaedic surgery. Multidisciplinary collaboration and adequate investment in trial infrastructure are crucial for successful delivery of RCTs. Cite this article: Bone Joint Res 2014;3:169-74. ©2014 The British Editorial Society of Bone & Joint Surgery.

  3. Randomised controlled trial examining the effect of exercise in people with rheumatoid arthritis taking anti-TNFα therapy medication

    Directory of Open Access Journals (Sweden)

    Veale Douglas J

    2011-01-01

    Full Text Available Abstract Background Substantial progress has been made in the medical management of rheumatoid arthritis (RA over the past decade with the introduction of biologic therapies, including anti-tumour necrosis factor alpha (anti-TNFα therapy medications. However, individuals with RA taking anti-TNFα medication continue to experience physical, psychological and functional consequences, which could potentially benefit from rehabilitation. There is evidence that therapeutic exercise should be included as an intervention for people with RA, but to date there is little evidence of the benefits of therapeutic exercise for people with RA on anti-TNFα therapy medication. A protocol for a multicentre randomised controlled three-armed study which aims to examine the effect of dynamic group exercise therapy on land or in water for people with RA taking anti-TNFα therapy medication is described. Methods/Design Six hundred and eighteen individuals with RA, on anti-TNFα therapy medication, will be randomised into one of 3 groups: a land-based exercise group; a water-based exercise group or a control group. The land and water-based groups will exercise for one hour, twice a week for eight weeks. The control group will receive no intervention and will be asked not to alter their exercise habits for the duration of the study. The primary outcome measure, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI which measures functional ability, and secondary measures of pain, fatigue and quality of life, will be assessed at baseline, eight and 24 weeks by an independent assessor unaware of group allocation. Changes in outcome from 0 to 8 weeks and 0 to 24 weeks in the 'land-based exercise group versus control group' and the 'water-based exercise group versus control group' will be examined. Analysis will be conducted on an intention to treat basis. Discussion This trial will evaluate the effectiveness of group exercise therapy on land or in water

  4. Disease-mongering through clinical trials.

    Science.gov (United States)

    González-Moreno, María; Saborido, Cristian; Teira, David

    2015-06-01

    Our goal in this paper is to articulate a precise concept of at least a certain kind of disease-mongering, showing how pharmaceutical marketing can commercially exploit certain diseases when their best definition is given through the success of a treatment in a clinical trial. We distinguish two types of disease-mongering according to the way they exploit the definition of the trial population for marketing purposes. We argue that behind these two forms of disease-mongering there are two well-known problems in the statistical methodology of clinical trials (the reference class problem and the distinction between statistical and clinical significance). Overcoming them is far from simple. Copyright © 2015 Elsevier Ltd. All rights reserved.

  5. Marine oil supplements for arthritis pain

    DEFF Research Database (Denmark)

    Senftleber, Ninna K.; Nielsen, Sabrina M.; Andersen, Jens Rikardt

    2017-01-01

    Arthritis patients often take fish oil supplements to alleviate symptoms, but limited evidence exists regarding their efficacy. The objective was to evaluate whether marine oil supplements reduce pain and/or improve other clinical outcomes in patients with arthritis. Six databases were searched......-regression analysis. Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to rate the overall quality of the evidence. Forty-two trials were included; 30 trials reported complete data on pain. The standardized mean difference (SMD) suggested a favorable effect (-0.24; 95% confidence.......57–0.24). The evidence for using marine oil to alleviate pain in arthritis patients was overall of low quality, but of moderate quality in rheumatoid arthritis patients....

  6. Bruton's tyrosine kinase inhibitor BMS-986142 in experimental models of rheumatoid arthritis enhances efficacy of agents representing clinical standard-of-care.

    Directory of Open Access Journals (Sweden)

    Kathleen M Gillooly

    Full Text Available Bruton's tyrosine kinase (BTK regulates critical signal transduction pathways involved in the pathobiology of rheumatoid arthritis (RA and other autoimmune disorders. BMS-986142 is a potent and highly selective reversible small molecule inhibitor of BTK currently being investigated in clinical trials for the treatment of both RA and primary Sjögren's syndrome. In the present report, we detail the in vitro and in vivo pharmacology of BMS-986142 and show this agent provides potent and selective inhibition of BTK (IC50 = 0.5 nM, blocks antigen receptor-dependent signaling and functional endpoints (cytokine production, co-stimulatory molecule expression, and proliferation in human B cells (IC50 ≤ 5 nM, inhibits Fcγ receptor-dependent cytokine production from peripheral blood mononuclear cells, and blocks RANK-L-induced osteoclastogenesis. Through the benefits of impacting these important drivers of autoimmunity, BMS-986142 demonstrated robust efficacy in murine models of rheumatoid arthritis (RA, including collagen-induced arthritis (CIA and collagen antibody-induced arthritis (CAIA. In both models, robust efficacy was observed without continuous, complete inhibition of BTK. When a suboptimal dose of BMS-986142 was combined with other agents representing the current standard of care for RA (e.g., methotrexate, the TNFα antagonist etanercept, or the murine form of CTLA4-Ig in the CIA model, improved efficacy compared to either agent alone was observed. The results suggest BMS-986142 represents a potential therapeutic for clinical investigation in RA, as monotherapy or co-administered with agents with complementary mechanisms of action.

  7. Effects of Amerindian Genetic Ancestry on Clinical Variables and Therapy in Patients with Rheumatoid Arthritis.

    Science.gov (United States)

    Sánchez, Elena; García de la Torre, Ignacio; Sacnún, Mónica; Goñi, Mario; Berbotto, Guillermo; Paira, Sergio; Musuruana, Jorge Luis; Graf, César; Alvarellos, Alejandro; Messina, Osvaldo D; Babini, Alejandra; Strusberg, Ingrid; Marcos, Juan Carlos; Scherbarth, Hugo; Spindler, Alberto; Quinteros, Ana; Toloza, Sergio; Moreno, José Luis C; Catoggio, Luis J; Tate, Guillermo; Eimon, Alicia; Citera, Gustavo; Pellet, Antonio Catalán; Nasswetter, Gustavo; Cardiel, Mario H; Miranda, Pedro; Ballesteros, Francisco; Esquivel-Valerio, Jorge A; Maradiaga-Ceceña, Marco A; Acevedo-Vásquez, Eduardo M; García, Conrado García; Tusié-Luna, Teresa; Pons-Estel, Bernardo A; Alarcón-Riquelme, Marta E

    2017-12-01

    To define whether Amerindian genetic ancestry correlates with clinical and therapeutic variables in admixed individuals with rheumatoid arthritis (RA) from Latin America. Patients with RA (n = 1347) and healthy controls (n = 1012) from Argentina, Mexico, Chile, and Peru were included. Samples were genotyped for the Immunochip v1 using the Illumina platform. Clinical data were obtained through interviews or the clinical history. Percentage of Amerindian ancestry was comparable between cases and controls. Morning stiffness (p ancestry after Bonferroni correction. Higher Amerindian ancestry correlated only with weight loss (p Bonferroni ancestry correlated with higher doses of azathioprine (p ancestry protects against most major clinical criteria of RA, but regarding the association of RF with increased European ancestry, age, sex, and smoking are modifiers. Ancestry also correlates with the therapeutic profiles.

  8. Industry funded clinical trials: bias and quality.

    Science.gov (United States)

    Del Parigi, Angelo

    2012-01-01

    The quality of the clinical data supporting the development and ultimately the approval for medical use of new drugs is often challenged. Many share the perception that the business goals of the pharmaceutical industry overrule the best scientific efforts to accrue critical knowledge on a new molecule, in order to inform investment of resources, regulatory approvals and appropriate use by patients. Despite this common belief, few scientists have attempted to assess objectively the quality of industry funded (IF) clinical trials by measuring it and comparing it with non-industry funded (NIF) clinical trials in a data-driven fashion. Overall, the average quality of IF clinical research has been reported to be higher than the quality of NIF clinical research.

  9. Randomization in substance abuse clinical trials.

    Science.gov (United States)

    Hedden, Sarra L; Woolson, Robert F; Malcolm, Robert J

    2006-02-06

    A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA)-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn randomization schemes and other highly adaptive designs. In many

  10. Catch-up growth during tocilizumab therapy for systemic juvenile idiopathic arthritis: results from a phase III trial.

    Science.gov (United States)

    De Benedetti, Fabrizio; Brunner, Hermine; Ruperto, Nicolino; Schneider, Rayfel; Xavier, Ricardo; Allen, Roger; Brown, Diane E; Chaitow, Jeffrey; Pardeo, Manuela; Espada, Graciela; Gerloni, Valeria; Myones, Barry L; Frane, James W; Wang, Jianmei; Lipman, Terri H; Bharucha, Kamal N; Martini, Alberto; Lovell, Daniel

    2015-03-01

    To investigate the impact of tocilizumab treatment on growth and growth-related laboratory parameters in patients with systemic juvenile idiopathic arthritis (JIA) enrolled in a phase III clinical trial. Patients with systemic JIA ages 2-17 years (n = 112) received tocilizumab in a 12-week, randomized, placebo-controlled period and a long-term open-label extension. Height velocity and standard deviation (SD) score; levels of insulin-like growth factor 1 (IGF-1), osteocalcin (OC), and C-telopeptide of type I collagen (CTX-I); and Juvenile Arthritis Disease Activity Score in 71 joints (JADAS-71) were measured in a post hoc analysis of 83 patients who never received growth hormone and did not reach Tanner stage 5 by the end of the first year of treatment. Patients had stunted growth at baseline (mean height SD score -2.2). During tocilizumab treatment, males (73%) and females (83%) experienced above-normal mean height velocities of 6.6 cm/year (P < 0.0001 versus World Health Organization norms). Mean height SD score increases during year 1 (0.29) and year 2 (0.31) were significant (both P < 0.0001). The mean SD score for IGF-1 levels increased significantly (-0.2 for year 1 and -0.1 for year 2 versus -1.0 at baseline; both P < 0.0001). Mean OC and CTX-I levels (both P < 0.0001) and the OC:CTX-I ratio (P = 0.014) significantly increased from baseline to year 2. In multiple regression analysis, first-year height velocity had a significant inverse relationship to JADAS-71 at year 1, age, mean glucocorticoid dosage during the year, and height SD score at baseline. Our findings indicate that during treatment with tocilizumab, patients with systemic JIA experience significant catch-up growth, normalization of IGF-1 levels, and bone balance improvement favoring bone formation. Copyright © 2015 by the American College of Rheumatology.

  11. Clinical trials in male hormonal contraception.

    Science.gov (United States)

    Nieschlag, Eberhard

    2010-11-01

    Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depot-medroxyprogesterone acetate. The first randomized, placebo-controlled clinical trial performed by the pharmaceutical industry demonstrated the effectiveness of a combination of testosterone undecanoate and etonogestrel in suppressing spermatogenesis in volunteers. Copyright © 2010 Elsevier Inc. All rights reserved.

  12. Prevalence Of Lung Involvement Due To Rheumatoid Arthritis Based On Clinical, Radiographic And Pulmonary Functions Test

    Directory of Open Access Journals (Sweden)

    Sedighi N

    2004-07-01

    Full Text Available Background: Pulmonary involvement is a common and serious complication of rheumatoid arthritis. This cross sectional study sought to determine the prevalence of pulmonary disease in patients with rheumatoid arthritis on the basis of history, physical examination, chest X-ray and PFT. Materials and Methods: 103 patients (81 Women, 22 Men fulfilling the ACR (American College of Rheumatology criteria for RA (Rheumatoid arthritis were consecutively included in a cross sectional study. Detailed medical (including respiratory symptoms and the disease activity symptoms and drug and occupational histories and smoking were obtained. All patients underwent a complete pulmonary and rheumatologic examination and conventional chest radiography. All patients underwent PFT that comprised spirometry and body plethysmography. Results for PFTs were expressed as percentage of predicted values for each individual adjusted for age, sex, and height. Results: On the basis of history: Their mean age was 43.3 ± 2.6 years (range: 17-74 and the mean duration of the disease was 69.3 ± 15.6 months. Rheumatoid factor was positive in% 61.2. No patients were 0.5Pack/Year smoker in whole life. Prevalence of pulmonary involvement based on radiographic and pulmonary function test detected in 41 patients (39/7%. The most frequent respiratory clinical finding was dyspnea (33%, (NYHA grade I in 17.5% and NYHA grade II in 15.5%, Cough (with or without sputum in 13.6 %, Crackle was the most sign in pulmonary examination (5.8%. Chest X-ray was abnormal in 13.3 % that the most common finding in this study was reticulonodular pattern in 20 patients (19.4 %, and pleural effusion detected in 7 patients (6.7%. PFT was abnormal in 30 patients (29.1 %. A significant decrease of FEF 25%-75% below 1.64 SD. Small airway involvements was the most abnormal finding of PFT. No relation between rheumatoid arthritis disease activity (ESR>30, Morning stiffness>30', Anemia, thrombocytosis with

  13. Rhizomes of Eremostachys laciniata: Isolation and Structure Elucidation of Chemical Constituents and a Clinical Trial on Inflammatory Diseases

    Directory of Open Access Journals (Sweden)

    Abbas Delazar

    2013-08-01

    Full Text Available Purpose: The purpose of this study was the isolation and structure elucidation of chemical compounds from the rhizomes of Eremostachys laciniata (L Bunge (EL, an Iranian traditional medicinal herb with a thick root and pale purple or white flowers as well as the clinical studies on the therapeutic efficacy and safety of topical application of the EL extract in the management of some inflammatory conditions, e.g., arthritis, rheumatoid arthritis and septic arthritis (Riter’s syndrome. Methods: The structures of the isolated compounds were elucidated unequivocally on the basis of one and two dimensional NMR, UV and HR-FABMS spectroscopic data analyses. A single-blinded randomized clinical trial was carried out with the extract of the rhizomes of E. laciniata (EL to determine the efficacy and safety of the traditional uses of EL compared to that of piroxicam in treatment of inflammatory diseases, e.g., osteoarthritis, rheumatoid arthritis and Reiter’s syndrome. Results: Eleven iridoid glycosides, two phenylethanoids and two phytosterols were isolated and identified for the first time from the rhizomes of EL. After 14 days of treatment with the EL and piroxicam ointments, all groups showed significant improvements compared to the control groups. EL (5% ointment induced better initial therapeutic response than piroxicam (5% onitment. Conclusion: This clinical trial established that EL was suitable for topical applications as a safe and effective complementary therapy for inflammatory diseases.

  14. Job retention vocational rehabilitation for employed people with inflammatory arthritis (WORK-IA): a feasibility randomized controlled trial.

    Science.gov (United States)

    Hammond, Alison; O'Brien, Rachel; Woodbridge, Sarah; Bradshaw, Lucy; Prior, Yeliz; Radford, Kate; Culley, June; Whitham, Diane; Ruth Pulikottil-Jacob

    2017-07-21

    Inflammatory arthritis leads to work disability, absenteeism and presenteeism (i.e. at-work productivity loss) at high cost to individuals, employers and society. A trial of job retention vocational rehabilitation (VR) in the United States identified this helped people keep working. The effectiveness of this VR in countries with different socioeconomic policies and conditions, and its impact on absenteeism, presenteeism and health, are unknown. This feasibility study tested the acceptability of this VR, modified for the United Kingdom, compared to written advice about managing work problems. To help plan a randomized controlled trial, we tested screening, recruitment, intervention delivery, response rates, applicability of the control intervention and identified the relevant primary outcome. A feasibility randomized controlled trial with rheumatoid, psoriatic or inflammatory arthritis patients randomized to receive either job retention VR or written information only (the WORK-IA trial). Following three days VR training, rheumatology occupational therapists provided individualised VR on a one to one basis. VR included work assessment, activity diaries and action planning, and (as applicable) arthritis self-management in the workplace, ergonomics, fatigue and stress management, orthoses, employment rights and support services, assistive technology, work modifications, psychological and disclosure support, workplace visits and employer liaison. Fifty five (10%) people were recruited from 539 screened. Follow-up response rates were acceptable at 80%. VR was delivered with fidelity. VR was more acceptable than written advice only (7.8 versus 6.7). VR took on average 4 h at a cost of £135 per person. Outcome assessment indicated VR was better than written advice in reducing presenteeism (Work Limitations Questionnaire (WLQ) change score mean: VR = -12.4 (SD 13.2); control = -2.5 (SD 15.9), absenteeism, perceived risk of job loss and improving pain and health status

  15. Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment.

    Science.gov (United States)

    Abbas, Ismail; Rovira, Joan; Casanovas, Josep

    2007-05-01

    The patient recruitment process of clinical trials is an essential element which needs to be designed properly. In this paper we describe different simulation models under continuous and discrete time assumptions for the design of recruitment in clinical trials. The results of hypothetical examples of clinical trial recruitments are presented. The recruitment time is calculated and the number of recruited patients is quantified for a given time and probability of recruitment. The expected delay and the effective recruitment durations are estimated using both continuous and discrete time modeling. The proposed type of Monte Carlo simulation Markov models will enable optimization of the recruitment process and the estimation and the calibration of its parameters to aid the proposed clinical trials. A continuous time simulation may minimize the duration of the recruitment and, consequently, the total duration of the trial.

  16. Septic arthritis of the knee: clinical and laboratory comparison of groups with different etiologies

    Directory of Open Access Journals (Sweden)

    Camilo Partezani Helito

    Full Text Available OBJECTIVES: To clinically and epidemiologically characterize a population diagnosed with and treated for septic arthritis of the knee, to evaluate the treatment results and to analyze the differences between patients with positive and negative culture results, patients with Gram-positive and Gram-negative bacterial isolates and patients with S. aureus- and non-S. aureus-related infections. METHODS: One hundred and five patients with septic knee arthritis were included in this study. The clinical and epidemiological data were evaluated. Statistical analysis was performed to compare patients with and without an isolated causative agent, patients with Gram-positive and Gram-negative pathogens and patients with S. aureus-related and non S. aureus-related infections. RESULTS: Causative agents were isolated in 81 patients. Gram-positive bacteria were isolated in 65 patients and Gram-negative bacteria were isolated in 16 patients. The most commonly isolated bacterium was S. aureus. Comparing cases with an isolated pathogen to cases without an isolated pathogen, no differences between the studied variables were found except for the longer hospital stays of patients in whom an etiological agent was identified. When comparing Gram-positive bacteria with Gram-negative bacteria, patients with Gram-positive-related infections exhibited higher leukocyte counts. Patients with S. aureus-related infections were more frequently associated with healthcare-related environmental encounters. CONCLUSION: S. aureus is the most common pathogen of septic knee arthritis. Major differences were not observed between infections with isolated and non-isolated pathogens and between infections with Gram-positive and Gram-negative bacteria. S. aureus infections were more likely to be associated with a prior healthcare environment exposure.

  17. Biomarkers in T cell therapy clinical trials

    Directory of Open Access Journals (Sweden)

    Kalos Michael

    2011-08-01

    Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.

  18. Effect of intermittent aerobic exercise on sleep quality and sleep disturbances in patients with rheumatoid arthritis – design of a randomized controlled trial

    OpenAIRE

    Løppenthin, Katrine; Esbensen, Bente Appel; Jennum, Poul; Østergaard, Mikkel; Christensen, Jesper Frank; Thomsen, Tanja; Bech, Julie Schjerbech; Midtgaard, Julie

    2014-01-01

    Background Poor sleep is prevalent in patients with systemic inflammatory disorders, including rheumatoid arthritis, and, in addition to fatigue, pain, depression and inflammation, is associated with an increased risk of co-morbidity and all-cause mortality. Whereas non-pharmacological interventions in patients with rheumatoid arthritis have been shown to reduce pain and fatigue, no randomized controlled trials have examined the effect of non-pharmacological interventions on improvement of sl...

  19. Inherited Retinal Degenerative Disease Clinical Trial Network

    Science.gov (United States)

    2012-10-01

    their retinoid treatment that has shown potential efficacy in LRAT LCA . Ql T and NNRI are in discussions on how to proceed in a partnership for this...into clinical trial protocol development and development of protocol related documents such as manuals of operations, electronic case report forms...collect data through electronic data capture system, drug accountability utilities, safety oversight, clinical site monitoring and they partner

  20. Lung Cancer Clinical Trials: Advances in Immunotherapy

    Science.gov (United States)

    New treatments for lung cancer and aspects of joining a clinical trial are discussed in this 30-minute Facebook Live event, hosted by NCI’s Dr. Shakun Malik, head of thoracic oncology therapeutics, and Janet Freeman-Daily, lung cancer patient activist and founding member of #LCSM.

  1. Quality assurance of asthma clinical trials.

    Science.gov (United States)

    Malmstrom, Kerstin; Peszek, Iza; Al Botto; Lu, Susan; Enright, Paul L; Reiss, Theodore F

    2002-04-01

    Accuracy and repeatability of spirometry measurements are essential to obtain reliable efficacy data in randomized asthma clinical trials. We report our experience with a centralized spirometry quality assurance program that we implemented in our phase III asthma trials. Six asthma trials of 4 to 21 weeks in duration were conducted at 232 clinical centers in 31 countries. Approximately 23,100 prebronchodilator and 13,700 postbronchodilator spirometry tests were collected from 2523 adult and 336 pediatric asthmatic patients. The program used a standard spirometer (the Renaissance spirometry system) with maneuver quality messages and automated quality grading of the spirometry tests. Each clinical center transmitted spirometry data weekly to a central database, where uniform monitoring of data quality was performed and feedback was provided in weekly quality reports. Seventy-nine percent of all patients performed spirometry sessions with quality that either met or exceeded American Thoracic Society standards and improved over time. Good-quality spirometry was associated with (1) less severe asthma; (2) active treatment; (3) infrequent nocturnal awakenings; (4) age above 15 years; and (5) low body weight. Maneuver-induced bronchospasm was rare. Good-quality spirometry was observed in multicenter asthma clinical trials that employed a standard spirometer and continuous monitoring. Both within- and between-patient variability decreased. Spirometry quality improved with time as study participants and technicians gained experience.

  2. Smart Technology in Lung Disease Clinical Trials.

    Science.gov (United States)

    Geller, Nancy L; Kim, Dong-Yun; Tian, Xin

    2016-01-01

    This article describes the use of smart technology by investigators and patients to facilitate lung disease clinical trials and make them less costly and more efficient. By "smart technology" we include various electronic media, such as computer databases, the Internet, and mobile devices. We first describe the use of electronic health records for identifying potential subjects and then discuss electronic informed consent. We give several examples of using the Internet and mobile technology in clinical trials. Interventions have been delivered via the World Wide Web or via mobile devices, and both have been used to collect outcome data. We discuss examples of new electronic devices that recently have been introduced to collect health data. While use of smart technology in clinical trials is an exciting development, comparison with similar interventions applied in a conventional manner is still in its infancy. We discuss advantages and disadvantages of using this omnipresent, powerful tool in clinical trials, as well as directions for future research. Published by Elsevier Inc.

  3. Adverse event development in clinical oncology trials

    NARCIS (Netherlands)

    Walraven, I.; Aaronson, N.; Sonke, J.-J.; Verheij, M.; Belderbos, J.

    Gita Thanarajasingam and colleagues' Article1 in The Lancet Oncology reports on a novel longitudinal approach for adverse event analysis and reporting. Comprehensive adverse event reporting in clinical oncology trials is essential to monitor tolerability of new cancer treatments. In view of the

  4. Acute gouty arthritis and rapidly progressive renal failure as manifestation of multiple myeloma: clinical case description

    Directory of Open Access Journals (Sweden)

    O.V. Gudym

    2017-08-01

    Full Text Available The article describes a clinical case of multiple myeloma in 78-year-old man, its clinical onset was as an acute attack of gout. The patient was admitted to hospital due to the development of the first acute attack of gout. The attack was characterized by polyarthricular joint lesion of the upper and lower extremities, pronounced inflammatory reaction, insufficient response to the use of non-steroidal anti-inflammatory drugs, and a high level of hyperuricemia. The serum uric acid concentration ranged from 636 to 712 μmol/l. The study of the synovial fluid of the inflamed knee joint made it possible to reveal uric acid crystals and to confirm the diagnosis of acute gouty arthritis. Simultaneously, the patient had significant renal impairment: creatinine was 574 μmol/l, urea — 39.9 mmol/l, glomerular filtration rate according to CKD-EPI — 8 ml/min. The daily proteinuria was 1.8 g. A retrospective assessment of laboratory parameters allowed to reveal completely normal indicators of renal function 6 months ago. Considering the development of acute gouty arthritis, its polyarticular nature, persistent course, rapid involvement of new joints, high uric acid levels during an acute attack exceeding 600 μmol/l (10 mg/dL, rapid development of renal failure within 6 months until the terminal stage, it was suggested the secondary nature of gout on the background of kidney damage by another pathological process. Further clinical, laboratory and instrumental studies allowed verifying multiple myeloma with renal damage. Bence Jones protein in the urine was not detected, there was also no evidence of hyperproteinemia. However, pain in the spine, ribs and chest was the basis for carrying out an X-ray study of the bones of the skeleton. Changes in the skeleton typical for multiple myeloma have been identified. Myelogram showed a high content of plasma cells (21.1 %, electrophoresis of blood proteins showed a high M-gradient (30.42 %, and a cytochemical

  5. Information on blinding in registered records of clinical trials

    Directory of Open Access Journals (Sweden)

    Viergever Roderik F

    2012-11-01

    Full Text Available Abstract Information on blinding is part of the data that should be provided upon registration of a trial at a clinical trials registry. Reporting of blinding is often absent or of low quality in published articles of clinical trials. This study researched the presence and quality of information on blinding in registered records of clinical trials and highlights the important role of data-recording formats at clinical trial registries in ensuring high-quality registration.

  6. Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention--ISRCTN89936343.

    Science.gov (United States)

    Adams, Jo; Bridle, Chris; Dosanjh, Sukhdeep; Heine, Peter; Lamb, Sarah E; Lord, Joanne; McConkey, Christopher; Nichols, Vivien; Toye, Francine; Underwood, Martin R; Williams, Mark A; Williamson, Esther M

    2012-11-24

    Rheumatoid Arthritis (RA) commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH) trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA. 480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices) or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel. This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care.

  7. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    International Nuclear Information System (INIS)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina

    2016-01-01

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

  8. Optimizing biologically targeted clinical trials for neurofibromatosis

    Science.gov (United States)

    Gutmann, David H; Blakeley, Jaishri O; Korf, Bruce R; Packer, Roger J

    2014-01-01

    Introduction The neurofibromatoses (neurofibromatosis type 1, NF1 and neurofibromatosis type 2, NF2) comprise the most common inherited conditions in which affected children and adults develop tumors of the central and peripheral nervous system. In this review, the authors discuss how the establishment of the Neurofibromatosis Clinical Trials Consortium (NFCTC) has positively impacted on the design and execution of treatment studies for individuals with NF1 and NF2. Areas covered Using an extensive PUBMED search in collaboration with select NFCTC members expert in distinct NF topics, the authors discuss the clinical features of NF1 and NF2, the molecular biology of the NF1 and NF2 genes, the development and application of clinically relevant Nf1 and Nf2 genetically engineered mouse models and the formation of the NFCTC to enable efficient clinical trial design and execution. Expert opinion The NFCTC has resulted in a more seamless integration of mouse preclinical and human clinical trials efforts. Leveraging emerging enabling resources, current research is focused on identifying subtypes of tumors in NF1 and NF2 to deliver the most active compounds to the patients most likely to respond to the targeted therapy. PMID:23425047

  9. Arthritis - resources

    Science.gov (United States)

    Resources - arthritis ... The following organizations provide more information on arthritis : American Academy of Orthopaedic Surgeons -- orthoinfo.aaos.org/menus/arthritis.cfm Arthritis Foundation -- www.arthritis.org Centers for Disease Control and Prevention -- www. ...

  10. Spa therapy adjunct to pharmacotherapy is beneficial in rheumatoid arthritis: a crossover randomized controlled trial

    Science.gov (United States)

    Karagülle, Mine; Kardeş, Sinan; Dişçi, Rian; Karagülle, Müfit Zeki

    2018-02-01

    This study aims to investigate whether 2-week spa therapy, as an adjunct to usual pharmacological therapy, has any beneficial effect in patients with rheumatoid arthritis (RA). In this single-blind crossover study, 50 patients were randomly assigned in a 1:1 manner to receive usual pharmacological therapy plus 2-week spa therapy or usual pharmacological therapy alone (period 1.6 months); after a 9-month washout, patients were crossed over to the opposite assignment (period 2.6 months). Spa therapy program included a daily saline balneotherapy session at 36-37 °C for 20 min except Sundays. The clinical outcomes were evaluated at baseline, after spa therapy (2 weeks) and 3 and 6 months after the spa therapy in both period and were pain (Visual Analogue Scale (VAS)), patient and physician global assessments (VAS), Health Assessment Questionnaire (HAQ), and Disease Activity Score (DAS28). Spa therapy was superior to control therapy in improving all the assessed clinical outcomes at the end of the spa therapy. This superiority persisted significantly in physician global assessment ( p = 0.010) and with a trend in favor of spa group in patient global assessment ( p = 0.058), function ( p = 0.092), and disease activity ( p = 0.098) at 3 months. Statistically significant improvements were found in spa therapy compared to control in disease activity ( p = 0.006) and patient ( p = 0.020) and physician global ( p = 0.011) assessments, and a trend toward improvements in pain ( p = 0.069) and swollen joints ( p = 0.070) at 6 months. A 2-week spa therapy adjunct to usual pharmacological therapy provided beneficial clinical effects compared to usual pharmacological therapy alone, in RA patients treated with traditional disease-modifying antirheumatic drugs. These beneficial effects may last for 6 months.

  11. Effects of Teriparatide on Joint Erosions in Rheumatoid Arthritis: A Randomized Controlled Trial.

    Science.gov (United States)

    Solomon, D H; Kay, J; Duryea, J; Lu, B; Bolster, M B; Yood, R A; Han, R; Ball, S; Coleman, C; Lo, E; Wohlfahrt, A; Sury, M; Yin, M; Yu, Z; Zak, A; Gravallese, E M

    2017-09-01

    Articular erosions correlate with disability in rheumatoid arthritis (RA). Biologic agents reduce erosion progression in RA, but erosion healing occurs infrequently. This study was undertaken to assess the effects of the anabolic agent teriparatide on joint erosion volume in RA patients treated with a tumor necrosis factor inhibitor (TNFi). We conducted a randomized controlled trial in 24 patients with erosive RA, osteopenia, and disease activity controlled by TNFi treatment for at least 3 months. Half were randomized to receive teriparatide for 1 year and the others constituted a wait-list control group. Subjects and primary rheumatologists were not blinded with regard to treatment assignment, but all outcomes were assessed in a blinded manner. The primary outcome measure was change in erosion volume determined by computed tomography at 6 anatomic sites. Significance within each hand and anatomic site was based on a 2-tailed test, with P values less than 0.05 considered significant. Baseline characteristics of the treatment groups were well balanced. After 52 weeks, the median change in erosion volume in the teriparatide group was -0.4 mm 3 (interquartile range [IQR] -34.5, 29.6) and did not differ significantly from that in controls (median change +9.1 mm 3 [IQR -29.6, 26.4]) (P = 0.28). No significant difference in change in erosion volume was noted at the radius, ulna, or metacarpophalangeal joints. Bone mineral density improved at the femoral neck and lumbar spine in the teriparatide group. Our findings indicate that teriparatide treatment for 1 year does not significantly reduce erosion volume in the hands or wrists of patients with established RA with disease activity controlled by TNFi treatment. © 2017, American College of Rheumatology.

  12. Adjuvant auricular electroacupuncture and autogenic training in rheumatoid arthritis: a randomized controlled trial

    DEFF Research Database (Denmark)

    Bernateck, M.; Becker, M.; Schwacke, C.

    2008-01-01

    BACKGROUND: In contrast to psychological interventions the usefulness of acupuncture as an adjuvant therapy in rheumatoid arthritis (RA) has not yet been demonstrated. OBJECTIVE: The efficacy of auricular electroacupuncture (EA) was directly compared with autogenic training (AT). METHODS: Patients...

  13. Autologous stromal vascular fraction therapy for rheumatoid arthritis: rationale and clinical safety

    Directory of Open Access Journals (Sweden)

    Rodriguez Jorge

    2012-02-01

    Full Text Available Abstract Advancements in rheumatoid arthritis (RA treatment protocols and introduction of targeted biological therapies have markedly improved patient outcomes, despite this, up to 50% of patients still fail to achieve a significant clinical response. In veterinary medicine, stem cell therapy in the form of autologous stromal vascular fraction (SVF is an accepted therapeutic modality for degenerative conditions with 80% improvement and no serious treatment associated adverse events reported. Clinical translation of SVF therapy relies on confirmation of veterinary findings in targeted patient populations. Here we describe the rationale and preclinical data supporting the use of autologous SVF in treatment of RA, as well as provide 1, 3, 6, and 13 month safety outcomes in 13 RA patients treated with this approach.

  14. Application of the GRAPPA psoriatic arthritis treatment recommendations in clinical practice.

    LENUS (Irish Health Repository)

    Mumtaz, Aizad

    2012-02-01

    Psoriatic disease presents with a complex array of clinical features, including peripheral synovitis and skin psoriasis, but there is also variable involvement of the nail, dactylitis, enthesitis, and spinal disease. Composite assessment of disease activity and response taking into account the impact of the disease as a whole on an individual\\'s health and quality of life is of vital importance. Following an extensive literature review, discussions, and consensus, the Group for Research in Psoriasis and Psoriatic Arthritis (GRAPPA) published guidelines to help clinicians make treatment decisions. The utility of these guidelines in routine clinical practice is further enhanced by incorporating them into a Composite Psoriatic Disease Activity Index (CPDAI). The potential application of the CPDAI in typical psoriatic disease patients is presented and discussed. Validation and possible modification of a composite disease activity and responder index is currently being undertaken by GRAPPA.

  15. Antibodies to Infliximab and Adalimumab in Patients with Rheumatoid Arthritis in Clinical Remission

    DEFF Research Database (Denmark)

    Eng, Grith P; Bendtzen, Klaus; Bliddal, Henning

    2015-01-01

    Objective. To investigate if antibodies towards biological TNF-α inhibitors (anti-TNFi Abs) are present in patients with rheumatoid arthritis (RA) in clinical remission and to relate any anti-TNFi Abs to circulating level of TNF-α inhibitor (TNFi). Methods. Patients with RA, treated with infliximab....../44 patients (18%) treated with infliximab and 1/49 patients (2%) treated with adalimumab (p = 0.012). In the former group, anti-TNFi Abs corresponded with low levels of TNFi (p = 0.048). Anti-TNFi Ab-positive patients had shorter disease duration at initiation of TNFi therapy (p = 0.023) but were similar...... for the rest of the compared parameters. Conclusions. In RA patients in clinical remission, anti-TNFi Abs occur frequently in patients treated with infliximab, while they occur rarely in patients treated with adalimumab. Presence of anti-infliximab Abs is accompanied by low or undetectable levels of infliximab...

  16. Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA: A randomised placebo-controlled crossover trial

    Directory of Open Access Journals (Sweden)

    Richmond Stewart J

    2008-09-01

    Full Text Available Abstract Background Rheumatoid arthritis is a common inflammatory autoimmune disease. Although disease activity may be managed effectively with prescription drugs, unproven treatments such as magnet therapy are sometimes used as an adjunct for pain control. Therapeutic devices incorporating permanent magnets are widely available and easy to use. Magnets may also be perceived as a more natural and less harmful alternative to analgesic compounds. Of interest to health service researchers is the possibility that magnet therapy might help to reduce the economic burden of managing chronic musculoskeletal disorders. Magnets are extremely cheap to manufacture and prolonged treatment involves a single cost. Despite this, good quality scientific evidence concerning the safety, effectiveness and cost-effectiveness of magnet therapy is scarce. The primary aim of the CAMBRA trial is to investigate the effectiveness of magnet therapy for relieving pain and inflammation in rheumatoid arthritis. Methods/Design The CAMBRA trial employs a randomised double-blind placebo-controlled crossover design. Participant will each wear four devices: a commercially available magnetic wrist strap; an attenuated wrist strap; a demagnetised wrist strap; and a copper bracelet. Device will be allocated in a randomised sequence and each worn for five weeks. The four treatment phases will be separated by wash out periods lasting one week. Both participants and researchers will be blind, as far as feasible, to the allocation of experimental and control devices. In total 69 participants will be recruited from general practices within the UK. Eligible patients will have a verified diagnosis of rheumatoid arthritis that is being managed using drugs, and will be experiencing chronic pain. Outcomes measured will include pain, inflammation, disease activity, physical function, medication use, affect, and health related costs. Data will be collected using questionnaires, diaries, manual

  17. Randomization in substance abuse clinical trials

    Directory of Open Access Journals (Sweden)

    Woolson Robert F

    2006-02-01

    Full Text Available Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Results Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. Conclusion We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn

  18. Centralized National Ethical Review of Clinical Trials in Croatia

    Science.gov (United States)

    Vitezić, Dinko; Lovrek, Maja; Tomić, Siniša

    2009-01-01

    Aim To present the Croatian system of ethical review of clinical trials and assessment outcomes of the applications reviewed by the Croatian Central Ethics Committee. Methods Clinical trial applications reviewed by the Croatian Central Ethics Committee, which has the legal mandate to review clinical trials of medicinal products and medical devices, were retrospectively analyzed from May 2004 to the end of 2008 according to the number, research area, and type of opinion issued. Applications from 2008 were analyzed separately according to the study phase, participants (adult trials vs pediatric trials), and sponsor (commercial trials vs academic trials). Data were analyzed by descriptive statistics. Results Since its establishment in 2004, the Croatian Central Ethics Committee has reviewed 407 trials. The greatest number of clinical trials was in the field of oncology (n = 69), mental and behavioral disorders (n = 52), and endocrine, nutritional, and metabolic diseases (n = 50). In the initial assessment of clinical trials, 60% applications received a conditionally positive opinion. In 28% of applications, the opinion had to be postponed because additional documentation or explanations were required. In 2008, the Croatian Central Ethics Committee reviewed 99 trials, most of which were phase III trials (n = 57). Five clinical trials included pediatric population and 3 were academic clinical trials. Conclusion The model of centralized clinical trial review seems to be appropriate for the current number of clinical trials conducted in Croatia. The efficient and standardized review process of clinical trials by the Central Ethics Committee may positively affect the increasing number of clinical trials conducted in Croatia. Future development includes the transparency of the clinical trials through a publically available database and establishing the basis for conducting academic clinical trials. PMID:19399943

  19. Low vaccination rates among patients with rheumatoid arthritis in a German outpatient clinic.

    Science.gov (United States)

    Krasselt, Marco; Ivanov, Jean-Philipp; Baerwald, Christoph; Seifert, Olga

    2017-02-01

    Patients with rheumatoid arthritis (RA) are at an increased risk of acquiring infections due to two reasons: the disease itself and the immunosuppressive therapy. Vaccinations against preventable diseases are therefore of utmost importance for these group of patients. To estimate vaccination frequencies among patients with rheumatoid arthritis, we studied patients in a survey and calculated vaccination rates based on their vaccination documents. Patients have been recruited from our outpatient clinic during one of their routine visits. For the statistical analysis, they have been divided by age (≥60 vs vaccination rates, in particular for the strongly recommended vaccines against Pneumococcus and Influenza (33 and 53%, respectively). Furthermore, protection rates for important basic vaccinations, e.g. against Pertussis, were found to be very low with 12% only. Beside these findings, we saw age-dependent differences for a variety of vaccines: while Pneumococcus and Influenza vaccines were more often given to patients ≥60 years, MMR, Pertussis, Diphtheria and Hepatitis were significantly more often applied to younger patients. Vaccination rates have to be improved among RA patients, in particular for vaccines protecting from respiratory tract infections such as Pneumococcus.

  20. Privacy and confidentiality in pragmatic clinical trials.

    Science.gov (United States)

    McGraw, Deven; Greene, Sarah M; Miner, Caroline S; Staman, Karen L; Welch, Mary Jane; Rubel, Alan

    2015-10-01

    With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations. © The Author(s) 2015.

  1. Clinical trials for stem cell therapies.

    Science.gov (United States)

    Trounson, Alan; Thakar, Rahul G; Lomax, Geoff; Gibbons, Don

    2011-05-10

    In recent years, clinical trials with stem cells have taken the emerging field in many new directions. While numerous teams continue to refine and expand the role of bone marrow and cord blood stem cells for their vanguard uses in blood and immune disorders, many others are looking to expand the uses of the various types of stem cells found in bone marrow and cord blood, in particular mesenchymal stem cells, to uses beyond those that could be corrected by replacing cells in their own lineage. Early results from these trials have produced mixed results often showing minor or transitory improvements that may be attributed to extracellular factors. More research teams are accelerating the use of other types of adult stem cells, in particular neural stem cells for diseases where beneficial outcome could result from either in-lineage cell replacement or extracellular factors. At the same time, the first three trials using cells derived from pluripotent cells have begun.

  2. Activating clinical trials: a process improvement approach.

    Science.gov (United States)

    Martinez, Diego A; Tsalatsanis, Athanasios; Yalcin, Ali; Zayas-Castro, José L; Djulbegovic, Benjamin

    2016-02-24

    The administrative process associated with clinical trial activation has been criticized as costly, complex, and time-consuming. Prior research has concentrated on identifying administrative barriers and proposing various solutions to reduce activation time, and consequently associated costs. Here, we expand on previous research by incorporating social network analysis and discrete-event simulation to support process improvement decision-making. We searched for all operational data associated with the administrative process of activating industry-sponsored clinical trials at the Office of Clinical Research of the University of South Florida in Tampa, Florida. We limited the search to those trials initiated and activated between July 2011 and June 2012. We described the process using value stream mapping, studied the interactions of the various process participants using social network analysis, and modeled potential process modifications using discrete-event simulation. The administrative process comprised 5 sub-processes, 30 activities, 11 decision points, 5 loops, and 8 participants. The mean activation time was 76.6 days. Rate-limiting sub-processes were those of contract and budget development. Key participants during contract and budget development were the Office of Clinical Research, sponsors, and the principal investigator. Simulation results indicate that slight increments on the number of trials, arriving to the Office of Clinical Research, would increase activation time by 11 %. Also, incrementing the efficiency of contract and budget development would reduce the activation time by 28 %. Finally, better synchronization between contract and budget development would reduce time spent on batching documentation; however, no improvements would be attained in total activation time. The presented process improvement analytic framework not only identifies administrative barriers, but also helps to devise and evaluate potential improvement scenarios. The strength

  3. Disclosure of investigators' recruitment performance in multicenter clinical trials

    DEFF Research Database (Denmark)

    Dal-Ré, Rafael; Moher, David; Gluud, Christian

    2011-01-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....

  4. THE FIRST RUSSIAN STRATEGIC STUDY OF PHARMACOTHERAPY FOR RHEUMATOID ARTHRITIS (REMARCA TRIAL: RESULTS OF 12-MONTH TREATMENT IN 130 PATIENTS

    Directory of Open Access Journals (Sweden)

    D. E. Karateev

    2014-01-01

    Full Text Available To introduce treat-to-target recommendations is an important task of modern rheumatology; however, there is still a diversity of serious problems relating to a scientific rationale and a clinical one for this strategy and to the possibilities of its implementation in real clinical practice, in the rheumatology service of the Russian Federation in particular, by taking into account the specific features of funding for high-tech medical care.Objective: to determine the efficiency and safety of combined therapy with subcutaneous methotrexate (MT and biological agents (BA when using the treat-to-target strategy in patients with active early and extended-stage rheumatoid arthritis (RA who have risk factors for a poor prognosis.Subjects and methods.The results of the REMARCA (Russian InvEstigation of MethotrexAte and biologicals in eaRly aCtive inflammatory Arthritis trial of 130 patients followed up for 12 months or more were given. There was a female preponderance; mean age 48.9±13.9 years, rheumatoid factor positivity (86.9%; anti-cyclic citrullinated peptide antibody positivity (89.2%. Seventy patients formed a subgroup of early RA (disease duration ≤6 months (mean 4.17±1.39 months; 60 patients were a subgroup of advanced-stage RA (disease duration >6 months (mean 30.8±32.7 months. In all the patients, therapy was initiated by using subcutaneous MT with its rapid dose escalation up to 20–30 mg/week and the achievement of the treatment goal (low disease activity or remission was checked every 3 months and depending on the result a decision had been taken to add or not to add a biological agent (BA (a tumor necrosis factor inhibitor or abatacept. If the former was insufficiently effective, it was substituted for a BA from another class.Results. Subcutaneous MT monotherapy provided remission or low disease activity in 49 (37.7% patients; a BA was given to 81 (62.3% patients. Following 6 and 12 months, low activity or remission

  5. Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative.

    Science.gov (United States)

    Huang, Grant D; Bull, Jonca; Johnston McKee, Kelly; Mahon, Elizabeth; Harper, Beth; Roberts, Jamie N

    2018-03-01

    Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  6. Safety, Effectiveness, and Treatment Persistence of Golimumab in Elderly Patients with Rheumatoid Arthritis in Real-World Clinical Practice in Japan.

    Science.gov (United States)

    Okazaki, Masateru; Kobayashi, Hisanori; Shimizu, Hirohito; Ishii, Yutaka; Yajima, Tsutomu; Kanbori, Masayoshi

    2018-03-02

    Golimumab has been proven as an effective treatment for rheumatoid arthritis in clinical trials. However, there is a scarcity of data regarding its use in elderly patients in a real-world setting. This study aims to evaluate the safety, effectiveness, and treatment persistence of golimumab in elderly Japanese patients (≥ 75 years) with rheumatoid arthritis. This study was a post hoc analysis of post-marketing surveillance data on 5137 Japanese patients with active rheumatoid arthritis who received golimumab for 24 weeks. The study population was divided into two age groups (younger: effectiveness, and treatment persistence of golimumab were assessed. Also, the reasons for discontinuing golimumab treatment were analyzed by multi-logistic regression. During golimumab treatment over 24 weeks, younger and elderly groups exhibited comparable improvement of disease activity as measured by EULAR response criteria with similar overall rates of adverse events. However, the survival curve of golimumab for elderly patients was significantly different from that for younger patients due largely to the discontinuation at 4 weeks. The most common reason for discontinuation in elderly patients was patient choice, while it was disease progression in younger patients. Analysis of elderly patients who discontinued treatment by their own decision identified EULAR good response as a factor associated with continuation of golimumab treatment whereas no predictive factor associated with discontinuation was identified. The safety and effectiveness of golimumab treatment in elderly Japanese patients aged 75 years or older were comparable to those in younger patients in real-world clinical practice. Analysis of the survival curves suggested that continuous use of golimumab might further improve clinical benefit of golimumab in elderly patients, underpinning the importance of effective communication between physicians and elderly patients based on the treat-to-target strategy

  7. Clinical significance of delta neutrophil index in the differential diagnosis between septic arthritis and acute gout attack within 24 hours after hospitalization.

    Science.gov (United States)

    Pyo, Jung Yoon; Kim, Dae Sik; Jung, Seung Min; Song, Jason Jungsik; Park, Yong-Beom; Lee, Sang-Won

    2017-07-01

    The most important differential diagnoses of acute monoarticular arthritis are septic arthritis and acute gout attack. Identifying infection is crucial in preventing the devastating outcome of septic arthritis. The delta neutrophil index (DNI) is a value that corresponds to the fraction of circulating immature granulocytes. As DNI reflects the burden of infection, we evaluated this index as a differentiating marker between septic arthritis and acute gout attack.The medical records of 149 patients with septic arthritis and 194 patients with acute gout attack were reviewed. A specific cell analyzer, ADVIA 2120, was used to measure DNI. Clinical and laboratory markers associated with predicting septic arthritis were assessed by using logistic regression.Patients with septic arthritis showed higher levels of DNI than those with acute gout attack (3.3 vs 0.6%, P septic arthritis. In the multivariate analysis, DNI was the most powerful independent value for predicting septic arthritis (odds ratio 14.003).This study showed the possibility of using DNI as a differentiating marker between septic arthritis and acute gout attack at the crucial early phase. DNI showed its relevance regardless of confirmation of MSU crystal deposition or serum level of uric acid.

  8. Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity

    OpenAIRE

    Pope, Janet; Bingham, Clifton O.; Fleischmann, Roy M.; Dougados, Maxime; Massarotti, Elena M.; Wollenhaupt, J?rgen; Duncan, Benjamin; Coteur, Geoffroy; Weinblatt, Michael E.

    2015-01-01

    Introduction The effect of certolizumab pegol (CZP) on patient-reported outcomes (PROs) was investigated in 1063 patients with rheumatoid arthritis (RA) from the REALISTIC trial (double-blind, placebo-controlled to week 12, open-label to week 28; randomized 4:1 [CZP:placebo]). Correlations between PROs and RA signs and symptoms, and the relative efficacy of these measures, were examined. Methods Adults with RA and an inadequate response to at least one disease-modifying antirheumatic drug wer...

  9. Screening for amyloid in subcutaneous fat tissue of Egyptian patients with rheumatoid arthritis : clinical and laboratory characteristics

    NARCIS (Netherlands)

    El Mansoury, T.M.; Hazenberg, B. P. C.; Badawy, S. A. El; Ahmed, A.H.; Bijzet, J.; Limburg, P.C.; Van Rijswijk, M.H.

    Objective: To screen for amyloid and to assess associated clinical and laboratory characteristics in Egyptian patients with rheumatoid arthritis (RA). Methods: Abdominal subcutaneous fat aspirates were consecutively collected from 112 patients (103 women, nine men) having RA for five years or more.

  10. QUEST-RA: quantitative clinical assessment of patients with rheumatoid arthritis seen in standard rheumatology care in 15 countries

    DEFF Research Database (Denmark)

    Sokka, Tuulikki; Kautiainen, Hannu; Toloza, Sergio

    2007-01-01

    OBJECTIVE: To conduct a cross-sectional review of non-selected consecutive outpatients with rheumatoid arthritis (RA) as part of standard clinical care in 15 countries for an overview of the characteristics of patients with RA. METHODS: The review included current disease activity using data from...

  11. Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA): a randomised placebo-controlled crossover trial.

    Science.gov (United States)

    Richmond, Stewart J

    2008-09-12

    Rheumatoid arthritis is a common inflammatory autoimmune disease. Although disease activity may be managed effectively with prescription drugs, unproven treatments such as magnet therapy are sometimes used as an adjunct for pain control. Therapeutic devices incorporating permanent magnets are widely available and easy to use. Magnets may also be perceived as a more natural and less harmful alternative to analgesic compounds. Of interest to health service researchers is the possibility that magnet therapy might help to reduce the economic burden of managing chronic musculoskeletal disorders. Magnets are extremely cheap to manufacture and prolonged treatment involves a single cost. Despite this, good quality scientific evidence concerning the safety, effectiveness and cost-effectiveness of magnet therapy is scarce. The primary aim of the CAMBRA trial is to investigate the effectiveness of magnet therapy for relieving pain and inflammation in rheumatoid arthritis. The CAMBRA trial employs a randomised double-blind placebo-controlled crossover design. Participant will each wear four devices: a commercially available magnetic wrist strap; an attenuated wrist strap; a demagnetised wrist strap; and a copper bracelet. Device will be allocated in a randomised sequence and each worn for five weeks. The four treatment phases will be separated by wash out periods lasting one week. Both participants and researchers will be blind, as far as feasible, to the allocation of experimental and control devices. In total 69 participants will be recruited from general practices within the UK. Eligible patients will have a verified diagnosis of rheumatoid arthritis that is being managed using drugs, and will be experiencing chronic pain. Outcomes measured will include pain, inflammation, disease activity, physical function, medication use, affect, and health related costs. Data will be collected using questionnaires, diaries, manual pill counts and blood tests. Magnetism is an inherent

  12. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial.

    Science.gov (United States)

    Mease, P J; Goffe, B S; Metz, J; VanderStoep, A; Finck, B; Burge, D J

    2000-07-29

    Etanercept, a tumour-necrosis-factor inhibitor, has shown efficacy in the treatment of rheumatoid arthritis. Psoriatic arthritis and psoriasis are disease states in which tumour necrosis factor, a proinflammatory cytokine, is present in increased concentrations in joints and in the skin. Therefore, psoriatic arthritis and psoriasis may be appropriate therapeutic targets for etanercept. This randomised, double-blind, placebo-controlled, 12 week study assessed the efficacy and safety of etanercept (25 mg twice-weekly subcutaneous injections) or placebo in 60 patients with psoriatic arthritis and psoriasis. Psoriatic arthritis endpoints included the proportion of patients who met the Psoriatic Arthritis Response Criteria (PsARC) and who met the American College of Rheumatology preliminary criteria for improvement (ACR20). Psoriasis endpoints included improvement in the psoriasis area and severity index (PASI) and improvement in prospectively-identified individual target lesions. In this 12 week study, 26 (87%) of etanercept-treated patients met the PsARC, compared with seven (23%) of placebo-controlled patients. The ARC20 was achieved by 22 (73%) of etanercept-treated patients compared with four (13%) of placebo-treated patients. Of the 19 patients in each treatment group who could be assessed for psoriasis (> or = 3% body surface area), five (26%) of etanercept-treated patients achieved a 75% improvement in the PASI, compared with none of the placebo-treated patients (p=0.015). The median PASI improvement was 46% in etanercept-treated patients versus 9% in placebo-treated patients; similarly, median target lesion improvements were 50% and 0, respectively. Etanercept was well tolerated. Etanercept offers patients with psoriatic arthritis and psoriasis a new therapeutic option for control of their disease.

  13. An overview of incretin clinical trials.

    Science.gov (United States)

    Garber, Alan J; Spann, Stephen J

    2008-09-01

    This article reviews many of the key incretin clinical trials, with a focus on the efficacy and safety of glucagon-like peptide-1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors compared with placebo and other glucose-lowering agents used as comparators. These agents have been tested either as monotherapy or in combination with one or more oral antidiabetic drugs (OADs). The article also discusses some of the important clinical differences between GLP-1 receptor agonists and DPP-4 inhibitors.

  14. Voltaren in the Treatment of Rheumatoid Arthritis

    African Journals Online (AJOL)

    hours the excretion is almost complete.-. A short pilot study by one of us (L.S.) showed that the drug was effective in patients with rheumatoid arthritis. (RA), and suggested that a full clinical trial was warranted. Department of Orthopaedic Surgery, Medical School,. University of the Witwatersrand, Johannesburg. L. SOLOMO.

  15. The Clinical Application of Anti-CCP in Rheumatoid Arthritis and Other Rheumatic Diseases

    Directory of Open Access Journals (Sweden)

    CT Chou

    2007-01-01

    Full Text Available Rheumatoid arthritis (RA is a common rheumatic disease in Caucasians and in other ethnic groups. Diagnosis is mainly based on clinical features. Before 1998, the only serological laboratory test that could contribute to the diagnosis was that for rheumatoid factor (RF. The disease activity markers for the evaluation of clinical symptoms or treatment outcome were the erythrocyte sedimentation rate (ESR and C-reactive protein (CRP. As a matter of fact, the diagnosis of early RA is quite impossible, as the clinical criteria are insuffi cient at the beginning stage of the disease. In 1998, Schelleken reported that a high percentage of RA patients had a specifi c antibody that could interact with a synthetic peptide which contained the amino acid citrulline. The high specifi city (98% for RA of this new serological marker, anti-cyclic citrullinated antibody (anti-CCP antibody, can be detected early in RA, before the typical clinical features appear. The presence or absence of this antibody can easily distinguish other rheumatic diseases from RA. Additionally, the titer of anti-CCP can be used to predict the prognosis and treatment outcome after DMARDs or biological therapy. Therefore, with improvement of sensitivity, the anti-CCP antibody will be widely used as a routine laboratory test in the clinical practice for RA.

  16. Interleukins and interleukin receptors in rheumatoid arthritis: Research, diagnostics and clinical implications.

    Science.gov (United States)

    Magyari, Lili; Varszegi, Dalma; Kovesdi, Erzsebet; Sarlos, Patricia; Farago, Bernadett; Javorhazy, Andras; Sumegi, Katalin; Banfai, Zsolt; Melegh, Bela

    2014-09-18

    Rheumatoid arthritis (RA) is an autoimmune disease, resulting in a chronic, systemic inflammatory disorder. It may affect many tissues and organs, but it primarily affects the flexible joints. In clinical practice patient care generates many questions about diagnosis, prognosis, and treatment. It is challenging for health care specialists to keep up to date with the medical literature. This review summarizes the pathogenesis, the polymorphisms of interleukin and interleukin genes and the standard available and possible future immunologic targets for RA treatment. The identification of disease-associated interleukin and interleukin receptor genes can provide precious insight into the genetic variations prior to disease onset in order to identify the pathways important for RA pathogenesis. The knowledge of the complex genetic background may prove useful for developing novel therapies and making personalized medicine based on the individual's genetics.

  17. Study of correlation between bone mineral density and clinical and laboratory indices of rheumatoid arthritis activity

    Directory of Open Access Journals (Sweden)

    D. A. Gukasyan

    2005-01-01

    Full Text Available Objective. To study association between bone mineral density (BMD and clinical and laboratory indices of rheumatoid arthritis (RA activity Material and methods. 60 women with RA who had not received glucocorticoid and anti-osteoporotic therapy were included. 30 had unchanged menstrual cycle and 30 were postmenopausal. Lumbar spine BMD and proximal femur was studied with double radiological absorptiometry (QDR 1000 Hologic apparatus. W.Wilke indices were used to characterize activity and severity of RA. CRP level was evaluated with quantitative immunoenzyme method. Results. Significant negative association was revealed between spine and femoral neck BMD and RA severity so as between femoral neck BMD and CRP level in pts with unchanged menstrual cycle and in postmenopausal pts.

  18. To fail or not to fail : clinical trials in depression

    NARCIS (Netherlands)

    Santen, Gijs Willem Eduard

    2008-01-01

    To fail or not to fail – Clinical trials in depression investigates the causes of the high failure rate of clinical trials in depression research. Apart from the difficulties in the search for new antidepressants during drug discovery, faulty clinical trial designs hinder their evaluation during

  19. Publication trends of clinical trials performed in South Africa ...

    African Journals Online (AJOL)

    Background. Investigators and sponsors of clinical trials have an ethical obligation to disseminate clinical trial results, whether positive or negative, in a timely manner. Objectives. To determine the publication rate and average time to reporting for clinical trials carried out in South Africa (SA) and to explore factors indicating ...

  20. Treatment of severe rheumatoid arthritis

    International Nuclear Information System (INIS)

    Wright, V.

    1986-01-01

    Current practices in treating severe rheumatoid arthritis are reviewed, including remarks on controlled trials of methotrexate, total lymphatic irradiation trials at Stanford and Harvard, and total body irradiation trials. U.K

  1. The effects of the spleen tyrosine kinase inhibitor fostamatinib on ambulatory blood pressure in patients with active rheumatoid arthritis: results of the OSKIRA-ABPM (ambulatory blood pressure monitoring) randomized trial.

    Science.gov (United States)

    Kitas, George D; Abreu, Gabriel; Jedrychowicz-Rosiak, Krystyna; Miller, Jeffrey L; Nakov, Roumen; Panfilov, Seva; Vencovsky, Jiri; Wang, Millie; Weinblatt, Michael E; White, William B

    2014-11-01

    Clinical trials of fostamatinib in patients with rheumatoid arthritis showed blood pressure (BP) elevation using clinic measurements. The OSKIRA-ambulatory BP monitoring trial assessed the effect of fostamatinib on 24-hour ambulatory systolic BP (SBP) in patients with active rheumatoid arthritis. One hundred thirty-five patients were randomized to fostamatinib 100 mg twice daily (bid; n = 68) or placebo bid (n = 67) for 28 days. Ambulatory, clinic, and home BPs were measured at baseline and after 28 days of therapy. Primary end point was change from baseline in 24-hour mean SBP. Fostamatinib increased 24-hour mean SBP by 2.9 mm Hg (P = .023) and diastolic BP (DBP) by 3.5 mm Hg (P < .001) versus placebo. Clinic/home-measured BPs were similar to those observed with ambulatory BP monitoring. After treatment discontinuation (1 week), clinic BP values returned to baseline levels. Fostamatinib induced elevations in 24-hour mean ambulatory SBP and DBP. BP elevations resolved with fostamatinib discontinuation. Copyright © 2014 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

  2. Pharmacogenomics of Methotrexate Membrane Transport Pathway: Can Clinical Response to Methotrexate in Rheumatoid Arthritis Be Predicted?

    Science.gov (United States)

    Lima, Aurea; Bernardes, Miguel; Azevedo, Rita; Medeiros, Rui; Seabra, Vitor

    2015-01-01

    Background: Methotrexate (MTX) is widely used for rheumatoid arthritis (RA) treatment. Single nucleotide polymorphisms (SNPs) could be used as predictors of patients’ therapeutic outcome variability. Therefore, this study aims to evaluate the influence of SNPs in genes encoding for MTX membrane transport proteins in order to predict clinical response to MTX. Methods: Clinicopathological data from 233 RA patients treated with MTX were collected, clinical response defined, and patients genotyped for 23 SNPs. Genotype and haplotype analyses were performed using multivariate methods and a genetic risk index (GRI) for non-response was created. Results: Increased risk for non-response was associated to SLC22A11 rs11231809 T carriers; ABCC1 rs246240 G carriers; ABCC1 rs3784864 G carriers; CGG haplotype for ABCC1 rs35592, rs2074087 and rs3784864; and CGG haplotype for ABCC1 rs35592, rs246240 and rs3784864. GRI demonstrated that patients with Index 3 were 16-fold more likely to be non-responders than those with Index 1. Conclusions: This study revealed that SLC22A11 and ABCC1 may be important to identify those patients who will not benefit from MTX treatment, highlighting the relevance in translating these results to clinical practice. However, further validation by independent studies is needed to develop the field of personalized medicine to predict clinical response to MTX treatment. PMID:26086825

  3. Development and delivery of an exercise intervention for rheumatoid arthritis: strengthening and stretching for rheumatoid arthritis of the hand (SARAH) trial.

    Science.gov (United States)

    Heine, P J; Williams, M A; Williamson, E; Bridle, C; Adams, J; O'Brien, A; Evans, D; Lamb, S E

    2012-06-01

    This paper describes the development and implementation of a hand exercise intervention for rheumatoid arthritis (RA) as part of a large multi-centred randomised controlled trial in a U.K. National Health Service (NHS) setting. Participants are eligible if diagnosed with RA according to American College of Rheumatology criteria, have a history of disease activity, functional deficit or impairment in the hand and/or wrist, and have been on a stable medication regime for at least 3 months. The intervention development was informed by the current evidence base, published guidelines, clinician and expert opinion, and a pilot study. The exercise programme targets known, potentially modifiable physical impairments of the hand with 5 exercise sessions and a home exercise component over a 12 week period. The intervention will be provided to 240 participants along with usual care. A further 240 will receive usual care only as part of the control arm. Specific details of the treatments delivered are described. [ISRCTN no: 89936343]. Copyright © 2011 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  4. Clinical Epidemiology of Septic Arthritis Caused byBurkholderia pseudomalleiand Other Bacterial Pathogens in Northeast Thailand.

    Science.gov (United States)

    Teparrukkul, Prapit; Nilsakul, Jiraphorn; Dunachie, Susanna; Limmathurotsakul, Direk

    2017-12-01

    Septic arthritis is a medical emergency, and if not treated appropriately, it can be associated with high morbidity and mortality. Melioidosis, a serious infectious disease caused by the Gram-negative bacillus Burkholderia pseudomallei , is highly endemic in South and Southeast Asia and northern Australia. We reviewed the medical charts of adult patients admitted with bacterial septic arthritis at Sunpasitthiprasong Hospital, Ubon Ratchathani, northeast Thailand from January 2012 to December 2014. Bacterial septic arthritis was defined as one or more hot swollen joints with isolation of a pathogenic organism from an affected joint or from blood. A total of 154 patients with septic arthritis were retrospectively evaluated. The most common causes were B. pseudomallei (48%, N = 74), Streptococcus spp. (29%, N = 44), and Staphylococcus aureus (10%, N = 16). Prevalence of diabetes, bacteremia, and pneumonia was higher in B. pseudomallei septic arthritis than in septic arthritis caused by the other bacteria (all P septic arthritis is common and associated with high mortality in northeast Thailand. Emergence of Streptococcus arthritis is observed. Difficulty in diagnosing melioidosis and identifying B. pseudomallei in areas where health care workers are not familiar with the disease is discussed. In melioidosis-endemic regions, parenteral ceftazidime could be considered as empirical antimicrobial therapy for patients with septic arthritis and underlying diseases.

  5. Huntington’s Disease Clinical Trials Corner: February 2018

    Science.gov (United States)

    Rodrigues, Filipe B.; Wild, Edward J.

    2018-01-01

    In the second edition of the Huntington’s Disease Clinical Trials Corner we list all currently registered and ongoing clinical trials, summarise the top-line results of the recently-announced IONIS-HTTRX trial (NCT02519036), expand on Wave Life Sciences’ PRECISION-HD1 (NCT03225833) and PRECISION-HD2 (NCT03225846), and cover one recently finished trial: the FIRST-HD deutetrabenazine trial (NCT01795859). PMID:29480210

  6. [PDCA Applied in Special Rectification of Medical Instrument Clinical Trial].

    Science.gov (United States)

    Wang, Lei; Qu, Xintao; Yu, Xiuchun

    2015-09-01

    PDCA cycle was applied in special rectification activities for medical instrument clinical trial, with quality criteria of implementation made. Completed medical instrument clinical trial from January 2011 to December 2012 was believed as control group, from January 2013 to December 2014 as PDCA group, the scores of clinical trial and the score rate of items were compared and analyzed. Results show quality scores of clinical trial in PDCA group are higher than that in control group (51 vs. 81, P PDCA applied in our department are feasible and effective. It significantly improves implement quality of medical instrument clinical trial.

  7. MODERN APPROACHES TO CLINICAL AND LABORATORY DIAGNOSTICS OF RHEUMATOID ARTHRITIS EARLY ONSET

    Directory of Open Access Journals (Sweden)

    D. G. Rekalov

    2013-10-01

    Full Text Available Rheumatoid arthritis (RA leads not only to a rapid development of disability, but can influence the life of these patients. One-third of patients with rheumatoid arthritis may have signs of disability during the first 3 years of the onset of the disease, while mortality in patients with RA almost two times higher in comparison with the general population. Analysis of recent prospective studies on the progression of the pathological process and predicting of the long-term outcomes in RA clearly indicate the need for clinical evaluation and a comprehensive laboratory and instrumental diagnosis of the disease in the initial manifestations of the most followed by early adequate pathogenetic therapy. The purpose of this survey was to determine modern clinical aspects of diagnosis, the possibility of standard and specialized instrumental examinations in patients with eRA, followed by predicting long-term results. We studied 52 specialized publications on clinical classification and a modern laboratory and diagnostic tests for eRA. This review presents the data of the importance of differentiation of several stages of RA in relation to the time factor. The data on the sensitivity and specificity of the diagnostic classification and clinical criteria of eRA and an algorithm for the identification of the disease were presented. It was shown prognostic value of the main serological markers of RA, and the predictive value for early detection of antibodies to the circulating peptide as a marker of the severity of bone-destructive changes in patients with certain clinical manifestations. Antibodies to the circulating peptide (ACPA can be detected many years before the onset of RA. Study of anti-citrulline mutated vimentin (anti-MCV in patients with eRA can be applied as a marker of activity of the process and the subsequent possibility of use for predicting long-term results. This review presents the major diagnostic errors using standard instrumental

  8. Effects of Person-Centered Physical Therapy on Fatigue-Related Variables in Persons With Rheumatoid Arthritis: A Randomized Controlled Trial.

    Science.gov (United States)

    Feldthusen, Caroline; Dean, Elizabeth; Forsblad-d'Elia, Helena; Mannerkorpi, Kaisa

    2016-01-01

    To examine effects of person-centered physical therapy on fatigue and related variables in persons with rheumatoid arthritis (RA). Randomized controlled trial. Hospital outpatient rheumatology clinic. Persons with RA aged 20 to 65 years (N=70): intervention group (n=36) and reference group (n=34). The 12-week intervention, with 6-month follow-up, focused on partnership between participant and physical therapist and tailored health-enhancing physical activity and balancing life activities. The reference group continued with regular activities; both groups received usual health care. Primary outcome was general fatigue (visual analog scale). Secondary outcomes included multidimensional fatigue (Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire) and fatigue-related variables (ie, disease, health, function). At posttest, general fatigue improved more in the intervention group than the reference group (P=.042). Improvement in median general fatigue reached minimal clinically important differences between and within groups at posttest and follow-up. Improvement was also observed for anxiety (P=.0099), and trends toward improvements were observed for most multidimensional aspects of fatigue (P=.023-.048), leg strength/endurance (P=.024), and physical activity (P=.023). Compared with the reference group at follow-up, the intervention group improvement was observed for leg strength/endurance (P=.001), and the trends toward improvements persisted for physical (P=.041) and living-related (P=.031) aspects of fatigue, physical activity (P=.019), anxiety (P=.015), self-rated health (P=.010), and self-efficacy (P=.046). Person-centered physical therapy focused on health-enhancing physical activity and balancing life activities showed significant benefits on fatigue in persons with RA. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  9. Clinical profile of 266 Filipino patients with rheumatoid arthritis included in the rheumatoid arthritis database and registry (RADAR) of the Philippine General Hospital.

    Science.gov (United States)

    Penserga, Ester G; Natividad, Therese Aileen L; Salido, Evelyn S

    2015-05-01

    To describe Filipino patients with rheumatoid arthritis (RA) entered in the Rheumatoid arthritis database and registry (RADAR) of the Philippine General Hospital. Cases entered to RADAR from 2010-2012 were included. All fulfilled the 1987 American College of Rheumatology criteria for classification of RA. Included cases gave written infomed consent. Data extracted were demographics, clinical presentation, laboratory tests, treatment and disease course. Means and proportions were used for population characteristics. Two hundred and sixty-six cases were included. Mean age was 44 years, with 9 : 1 female preponderance and mean diagnosis time of 5 years. There was symmetrical polyarthritis with high tender and swollen joint count and mean Disease Activity Score of 28 joints, erythrocyte sedimentation rate of 5.27 (3.39, 8.13). Rheumatoid factor was positive in 2/3 of cases. Hypertension, tuberculosis and diabetes were important co-morbidities. Treatment included prednisone, non-steroidal anti-inflammatory drugs and methotrexate. At 12 months of treatment, evaluable cases (< 20%) showed improvement from high to moderate disease activity. Methotrexate average dose was 8.6 mg/week. Nine cases received biologic agents. Factors affecting treatment included access to rheumatology centers, low socioeconomic status, presence of co-morbid diseases and treatment adverse events. This study reports a cohort of Filipino RA patients seen in a government arthritis unit whose disease characteristics are similar to what is reported worldwide. This cohort differs from most studies in having a high female to male ratio, a long delay in diagnosis, and high attrition rate. Mean methotrexate dose was low and there was less access to biologic disease-modifying anti-rheumatic drugs. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

  10. Gateways to clinical trials. March 2003.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2003-03-01

    Gateways to clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the drug discovery and devlopment protal, http://integrity.prous.com. This issue focuses on the following selection of drugs: AAV-CF, adalimumab, ademetionine, afeletecan hydrochloride, agomelatine, alemtuzumab, almotriptan, amdoxovir, aplidine, aranose, arsenic sulfide, atazanavir, atlizumab; Bimatoprost, BMS-181176, BMS-188667, bortezomib, bryostatin 1; Combretastatin A-4 phosphate; Darbepoetin alfa, darusentan, deferasirox, desloratadine, DTaP-HBV-IPV/Hib-vaccine, DTI-0009; Eculizumab, edodekin alfa, emtricitabine, enfuvirtide, epoetin, esomeprazole magnesium etoricoxib; Fampridine, fenretinide, FR-146687; Galiximab, gamma-Hydroxybutyrate sodium, ganirelix acetate, gefitinib, Gemtuzumab ozogamicin, gimatecan; HEA125xOKT3, hIL-13-PE38QQR, HSV-2 theracine, Hu14.18-IL-2, human gammaglobulin; Idraparinux sodium, imatinib mesylate, IMiD3, insulin detemir, interleukin-4, irofulven, ISAtx-247; JT-1001; Levetiracetam, levosimendan, liposomal doxorubicin, liposomal vincristine sulfate, lixivaptan, lopinavir, lumiracoxib; Maxacalcitol, melatonin, midostaurin, MLN-518; Neridronic acid, nesiritide, nitronaproxen; Oblimersen sodium, oregovomab; PEG-filgrastim polyglutamate paclitaxel, prasterone, pregabalin; Rosuvastatin calcium, rotigotine hydrochloride; SGN-30; T-1249, tenofovir disoproxil fumarate, teriparatide, tiotropium bromide, tipranavir, TMC-114, trabectedin, transdermal selegiline; UK-427857; Valdecoxib, valganciclovir hydrochloride, vardenafil, vatalanib succinate, vincristine sulfate TCS; Zofenopril calcium.

  11. Clinical trials in rhinosinusitis: Identifying areas for improvement.

    Science.gov (United States)

    Ramsey, Tam; Lai, Wanda; Guo, Eric; Svider, Peter F; Zuliani, Giancarlo; Eloy, Jean Anderson; Folbe, Adam J

    2017-11-06

    To characterize trends in rhinosinusitis clinical trials to provide recommendations for therapeutic directions, highlight possible redundancy, and provide a framework for prioritization of future clinical trials. Database analysis. Data were collected from ClinicalTrials.gov including all clinical trials that focused on rhinosinusitis with the exclusion of trials withdrawn prior to enrollment. Variables recorded included study design, study population, pharmaceutical involvement, publication, and whether a trial was a medical or surgical intervention. Associated publications were identified using the PubMed, Embase, and Cochrane databases. There were 269 rhinosinusitis clinical trials, dating from 1993 to 2017, that met inclusion reauirements. Of the studies included in this analysis, 51.7% had at least one scientific publication, and of those with publications, 80.6% had positive results and 19.3% had negative results. Twenty-three clinical trials (8.5%) studied drugs already approved for rhinosinusitis, 113 (42.0%) trials studied drugs that were approved for other uses, 42 (15.6%) trials studied experimental drugs, and 102 (39.4%) studied surgical intervention. Of the trials studying drugs, the data showed many clinical trials that studied the same drug. The data demonstrate a steady decline in clinical trials with medical intervention and a rise in clinical trials with surgical intervention. This analysis is the first to characterize rhinosinusitis clinical trials, highlighting the over-representation of certain drugs and demonstrating an increased focus on clinical trials employing surgical intervention. We provide a framework to discuss prioritization of future studies to guide clinical and research practice. 4. Laryngoscope, 2017. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

  12. Re-Engineering Alzheimer Clinical Trials: Global Alzheimer's Platform Network.

    Science.gov (United States)

    Cummings, J; Aisen, P; Barton, R; Bork, J; Doody, R; Dwyer, J; Egan, J C; Feldman, H; Lappin, D; Truyen, L; Salloway, S; Sperling, R; Vradenburg, G

    2016-06-01

    Alzheimer's disease (AD) drug development is costly, time-consuming, and inefficient. Trial site functions, trial design, and patient recruitment for trials all require improvement. The Global Alzheimer Platform (GAP) was initiated in response to these challenges. Four GAP work streams evolved in the US to address different trial challenges: 1) registry-to-cohort web-based recruitment; 2) clinical trial site activation and site network construction (GAP-NET); 3) adaptive proof-of-concept clinical trial design; and 4) finance and fund raising. GAP-NET proposes to establish a standardized network of continuously funded trial sites that are highly qualified to perform trials (with established clinical, biomarker, imaging capability; certified raters; sophisticated management system. GAP-NET will conduct trials for academic and biopharma industry partners using standardized instrument versions and administration. Collaboration with the Innovative Medicines Initiative (IMI) European Prevention of Alzheimer's Disease (EPAD) program, the Canadian Consortium on Neurodegeneration in Aging (CCNA) and other similar international initiatives will allow conduct of global trials. GAP-NET aims to increase trial efficiency and quality, decrease trial redundancy, accelerate cohort development and trial recruitment, and decrease trial costs. The value proposition for sites includes stable funding and uniform training and trial execution; the value to trial sponsors is decreased trial costs, reduced time to execute trials, and enhanced data quality. The value for patients and society is the more rapid availability of new treatments for AD.

  13. Managing Cardiovascular Disease Risk in Rheumatoid Arthritis: Clinical Updates and Three Strategic Approaches.

    Science.gov (United States)

    Chodara, Ann M; Wattiaux, Aimée; Bartels, Christie M

    2017-04-01

    ᅟ: The increase in cardiovascular disease (CVD) risk in rheumatoid arthritis (RA) is well known; however, appropriate management of this elevated risk in rheumatology clinics is less clear. By critically reviewing literature published within the past 5 years, we aim to clarify current knowledge and gaps regarding CVD risk management in RA. We examine recent guidelines, recommendations, and evidence and discuss three approaches: (1) RA-specific management including treat-to-target and medication management, (2) assessment of comprehensive individual risk, and (3) targeting traditional CVD risk factors (hypertension, smoking, hyperlipidemia, diabetes, obesity, and physical inactivity) at a population level. Considering that 75% of US RA visits occur in specialty clinics, further research is needed regarding evidence-based strategies to manage and reduce CVD risk in RA. This review highlights clinical updates including US cardiology and international professional society guidelines, successful evidence-based population approaches from primary care, and novel opportunities in rheumatology care to reduce CVD risk in RA.

  14. Psoriatic arthritis: a clinical, radiological and genetic study of 58 Italian patients.

    Science.gov (United States)

    Trabace, S; Cappellacci, S; Ciccarone, P; Liaskos, S; Polito, R; Zorzin, L

    1994-01-01

    It is well known that genetic heterogeneity and/or the complex interaction of several MCH-linked risk factors can explain the onset and the broad spectrum of Psoriatic Arthritis (PsA) from the clinical point of view. Fifty-eight patients with PsA (Moll and Wright criteria), 35 men and 23 women, mean age of 45, 14, were studied; all the patients were assessed by both clinical and radiological examination, with particular attention to the sacroiliac joints. HLA typing of the patients confirmed the association between PsA and HLA-B39 (p = 0.0008) and Cw6 (p = 0.0011). In addition a significant increase in DQ2 antigen (p = 0.004) has been found. No correlation of any particular HLA antigen with clinical subsets (oligo-polyarticular peripheral PsA, axial PsA and axial with peripheral PsA) or erosive incidence of joint involvement-generally related to the duration of the disease--was found.

  15. Clinical Efficacy of Acupuncture on Rheumatoid Arthritis and Associated Mechanisms: A Systemic Review

    Directory of Open Access Journals (Sweden)

    Pei-Chi Chou

    2018-01-01

    Full Text Available Objective. The objective of this review is to investigate the detailed existing scientific information about the clinical efficacy of acupuncture on rheumatoid arthritis (RA conditions and to reveal the proposed mechanisms. Methods. We searched the PubMed, EMBASE, Cochrane, AMED (Allied and Complementary Medicine, NCCAM (The National Center for Complementary and Alternative Medicine, and CNKI (China National Knowledge Infrastructure databases to identify relevant monographs and related references from 1974 to 2018. Chinese journals and theses/dissertations were hand searched. Results. 43 studies were recruited. Each research was analyzed for study design, subject characteristics, intervention, selected acupoints, assessment parameters, proposed mechanisms, and results/conclusions. Conclusions. In our review, we concluded that acupuncture alone or combined with other treatment modalities is beneficial to the clinical conditions of RA without adverse effects reported and can improve function and quality of life and is worth trying. Several important possible mechanisms were summarized including anti-inflammatory effect, antioxidative effect, and regulation of immune system function. However, there is still inconsistency regarding the clinical efficacy and lack of well-designed human/animal double-blinded RCTs. Future discussion for further agreement on taking traditional Chinese medicine (TCM theory into consideration as much as possible is a top priority.

  16. [Experience with a rheumatoid arthritis biobank: analysis of biological samples and clinical data of 204 patients].

    Science.gov (United States)

    Pál, Ildikó; Pusztai, Anita; Csomor, Péter; Szekanecz, Zoltán

    2017-02-01

    A biobank is a registry, which is suitable for the storage of biological samples (e.g. tissues, DNA, protein), genetical abnormalities and clinical data. Several biobanks have been created worldwide, which contribute to research and the better understanding of disease pathogenesis, genetical polymorphisms. Biobanking also helps to improve the efficacy of therapies. Our purpose was to create an internet-based biobank, in which laboratory test results, genetic alterations and related disorders of rheumatoid arthritis (RA) patients can be registered. This biobank would be able to make the research easier and it can help to improve our knowledge about diseases and it can inhibit loss of data. We have biological samples from 204 RA patients and we have entered their data in the biobank which can be found on the website http://rheuma.biobank.eu . Statistical analysis was performed by SPSS20 statistical programme. By the creation of biobank that contains clinical data and biological samples of 204 RA patients, we have a database which can help to improve our knowledge about the disease and help to develop new treatment strategies. Biobanking is suitable to analyze blood samples and clinical data together. Orv. Hetil., 2017, 158(7), 270-277.

  17. Slowing of bone loss in patients with rheumatoid arthritis by long-term high-intensity exercise: results of a randomized, controlled trial.

    NARCIS (Netherlands)

    Jong, Z. de; Munneke, M.; Lems, W.F.; Zwinderman, A.H.; Kroon, H.M.; Pauwels, E.K.; Jansen, A.; Ronday, K.H.; Dijkmans, B.A.C.; Breedveld, F.C.; Vliet Vlieland, T.P.M.; Hazes, J.M.W.

    2004-01-01

    OBJECTIVE: Patients with rheumatoid arthritis (RA) are more at risk for the development of osteoporosis and osteoporotic fractures than are their healthy peers. In this randomized, controlled, multicenter trial, the effectiveness of a 2-year high-intensity weight-bearing exercise program (the

  18. Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis : results of a multicentre, double-blind, randomised-withdrawal trial

    NARCIS (Netherlands)

    Brunner, Hermine I; Ruperto, Nicolino; Tzaribachev, Nikolay; Horneff, Gerd; Chasnyk, Vyacheslav G.; Panaviene, Violeta Vladislava; Abud-Mendoza, Carlos; Reiff, Andreas; Alexeeva, Ekaterina; Rubio-Pérez, Nadina; Keltsev, Vladimir; Kingsbury, Daniel J.; Del Rocio Maldonado Velázquez, Maria; Nikishina, Irina; Silverman, Earl D.; Joos, Rik; Smolewska, Elzbieta; Bandeira, Márcia; Minden, Kirsten; van Royen-Kerkhof, Annet; Emminger, Wolfgang; Foeldvari, Ivan; Lauwerys, Bernard R.; Sztajnbok, Flavio; Gilmer, Keith E.; Xu, Zhenhua; Leu, Jocelyn H.; Kim, Lilianne; Lamberth, Sarah L.; Loza, Matthew J.; Lovell, Daniel J.; Martini, Alberto

    2018-01-01

    OBJECTIVE: This report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA). METHODS: In this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received

  19. Slowing of bone loss in patients with rheumatoid arthritis by long-term high-intensity exercise: results of a randomized, controlled trial

    NARCIS (Netherlands)

    de Jong, Zuzana; Munneke, Marten; Lems, Willem F.; Zwinderman, Aeilko H.; Kroon, Herman M.; Pauwels, Ernest K. J.; Jansen, Annemarie; Ronday, Karel H.; Dijkmans, Ben A. C.; Breedveld, Ferdinand C.; Vliet Vlieland, Theodora P. M.; Hazes, Johanna M. W.

    2004-01-01

    OBJECTIVE: Patients with rheumatoid arthritis (RA) are more at risk for the development of osteoporosis and osteoporotic fractures than are their healthy peers. In this randomized, controlled, multicenter trial, the effectiveness of a 2-year high-intensity weight-bearing exercise program (the

  20. Future clinical trials in DIPG: bringing epigenetics to the clinic

    Directory of Open Access Journals (Sweden)

    Andres E. Morales La Madrid

    2015-07-01

    Full Text Available In spite of major recent advances in DIPG molecular characterization, this body of knowledge has not yet translated into better treatments.To date,more than 250 clinical trials evaluating radiotherapy along with conventional cytotoxic chemotherapy as well as newer biologic agents,have failed to improve the dismal outcome when compared to palliative radiation alone.The biology of DIPG remained unknown until recently when the neurosurgical expertise along with the recognition by the scientific and clinical community of the importance of tissue sampling at diagnosis;ideally in the context of a clinical trial and by trained neurosurgical teams to maximize patient safety.These pre-treatment tumor samples,and others coming from tissue obtained post-mortem,have yielded new insights into DIPG molecular biology.We now know that DIPG comprises a heterogeneous disease with variable molecular phenotypes, different from adult high grade glioma,other non-pontine pediatric high grade gliomas and even between pontine gliomas.The discovery of histone H3.3 or H3.1 mutations has been an important step forward in understanding tumor formation,maintenance and progression.Pharmacologic reversal of DIPG histone demethylation therefore offers an important potential intervention strategy for the treatment of DIPG.To date,clinical trials of newly diagnosed or progressive DIPG with epigenetic modifiers have been unsuccessful.Whether this failure represents limited activity of the agents used,their CNS penetration,redundant pathways within the tumor,or the possibility that histone mutations are necessary only to initiate DIPGs but not maintain their growth,suggest that a great deal still needs to be elucidated in both the underlying biology of these pathways,and the drugs designed to target them.In this review, we discuss the role of both epigenetic and genetic mutations within DIPG and the development of treatment strategies directed against the unique abnormalities