Clinical trials in rheumatoid arthritis: A status report from the ClinicalTrials.gov website

Rheumatology International

Volumn 32, Issue 6, 2012, Pages 1831-1835

  Paul, Jisna R ^a   Ranganathan, Prabha ^b  

^a ST LUKE S HOSPITAL   (United States)

^b WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Clinical trials; Registry; Rheumatoid arthritis

Indexed keywords

ADENOSINE RECEPTOR BLOCKING AGENT; ANTIRHEUMATIC AGENT; BIOLOGICAL PRODUCT; CD20 ANTIGEN; CD28 ANTIGEN; CD3 ANTIGEN; CURCUMIN; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; INFLIXIMAB; INTERLEUKIN 17; JANUS KINASE 3 INHIBITOR; METHOTREXATE; MONOCLONAL ANTIBODY; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; PROTEIN TYROSINE KINASE INHIBITOR; ROSIGLITAZONE; TUMOR NECROSIS FACTOR INHIBITOR; VITAMIN D;

ARTICLE; BIOLOGICAL THERAPY; CLINICAL TRIAL (TOPIC); DIABETES MELLITUS; DISEASE ACTIVITY; DOUBLE BLIND PROCEDURE; DRUG APPROVAL; DRUG EFFICACY; DRUG INDICATION; DRUG INDUSTRY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TARGETING; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEART INFARCTION; HUMAN; MOLECULARLY TARGETED THERAPY; MULTICENTER STUDY (TOPIC); OPEN STUDY; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; RHEUMATOID ARTHRITIS; SINGLE BLIND PROCEDURE; STROKE; TREATMENT RESPONSE; TUBERCULOSIS; UNIVERSITY;

ARTHRITIS, RHEUMATOID; CLINICAL TRIALS AS TOPIC; CONFLICT OF INTEREST; DRUG INDUSTRY; EVIDENCE-BASED MEDICINE; FINANCING, GOVERNMENT; HEALTH CARE SURVEYS; HUMANS; INTERNET; REGISTRIES; RESEARCH DESIGN; RESEARCH SUPPORT AS TOPIC; TIME FACTORS; TREATMENT OUTCOME; UNIVERSITIES;

EID: 84863877174     PISSN: 01728172     EISSN: 1437160X     Source Type: Journal    
DOI: 10.1007/s00296-011-2027-3     Document Type: Article

References (25)

1. Hootman J, Bolen J, Helmick C, Langmaid G (2006) Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation-United States, 2003-2005. MMWR 55(40):1089-1092
2. Myasoedova E, Crowson CS, Kremers HM, Therneau TM, Gabriel SE (2010) Is the incidence of rheumatoid arthritis rising? Results from Olmsted County, Minnesota, 1955-2007. Arthritis Rheum 62(6):1576-1582
3. van Vollenhoven RF (2009) Treatment of rheumatoid arthritis: state of the art 2009. Nat Rev Rheumatol 5:531-541
4. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R (2004) International committee of medical journal editors. Clinical trial registration: a statement from the international committee of medical journal editors. JAMA 292:1363-1364
5. Schulz KF, Altman DG, Moher D, CONSORT Group (2010) CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 63(8):834-840
6. Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM et al (2010) Methods work group, third US preventive services task force. Current methods of the US preventive services task force: a review of the process. Am J Prev Med 3(Suppl):21-35
7. Bourgeois FT, Murthy S, Mandl KD (2010) Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 153(3):158-166
8. Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 326:1167-1170
9. Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC et al (2000) A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 343(22):1586-1593
10. Maini R, St Clair EW, Breedveld F, Furst D, Kalden J, Weisman M et al (1999) Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT study group. Lancet 354(9194):1932-1939
11. Keane J, Gershon S, Wise RP, Mirabile-Levens E, Kasznica J, Schwieterman WD et al (2001) Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 345(15):1098-1104
12. Recommendations for Regulatory Action for Rosiglitazone and Rosiglitazone containing Products (NDA 21-071, supplement 035, incoming submission dated August 25, 2009)-9/12/2010. Gerald J. Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, Federal Drug Administration
13. Van der Kooij SM, le Cessie S, Goekoop-Ruiterman YPM, de Vries-Bouwstra JK, van Zeben D, Kerstens PJSM (2009) Clinical and radiological efficacy of initial versus delayed treatment with infliximab plus methotrexate in patients with early rheumatoid arthritis. Ann Rheum Dis 68(7):1153-1158
14. St Clair EW, van der Heijde DM, Smolen JS, Maini RN, Bathon JM, Emery P et al (2004) Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum 50(11):3432-3443
15. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, Vollenhoven R et al (2006) The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 54:26-37
16. Emery P, Breedveld FC, Hall S, Durez P, Chang DJ, Robertson D et al (2008) Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet 372:375-382
17. Tak PP, Rigby WF, Rubbert-Roth A, Peterfy CG, van Vollenhoven RF, Stohl W et al (2010) For the IMAGE investigators. Extended report: inhibition of joint damage and improved clinical outcomes with rituximab plus methotrexate in early active rheumatoid arthritis: the IMAGE trial. Ann Rheum Dis. (annrheumdis 137703: Published Online First: 11 October 2010)
18. Wolfe F, Cathey MA (1991) The assessment and prediction of functional disability in rheumatoid arthritis. J Rheumatol 18(9):1298-1306
19. Hulsmans HM, Jacobs JW, van der Heijde DM, van Albada-Kuipers GA, Schenk Y, Bijlsma JW (2000) The course of radiologic damage during the Wrst six years of rheumatoid arthritis. Arthritis Rheum 43(9):1927-1940
20. Weinblatt ME, Kremer JM, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Fox RI et al (1999) A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. New Eng J Med 340:253-259
21. Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA et al (2003) Adalimumab, a fully human antitumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 48:35-45
22. Kremer JM, Westhovens R, Leon M, Di Giorgio E, Alten R, Steinfeld S et al (2003) Treatment of rheumatoid arthritis by selective inhibition of T-cell activation with fusion protein CTLA4Ig. New Eng J Med 349:1907-1915
23. Peto R, Baigent C (1998) Trials: the next 50 years. Large scale randomized evidence of moderate benefits. BMJ 317(7167):1170
24. Miller JD (2010) Registering clinical trial results: the next step. JAMA 303:773-774
25. O'Connor AB (2009) The need for improved access to FDA reviews. JAMA 302:191-193