Study Design and End Points for Rheumatoid Arthritis Trials

  • Pieter Geusens
  • Colin G. Miller
Part of the Clinical Trials book series (CLINICAL)


Disease Activity Score Swell Joint Count Tender Joint Count Physician Global Assessment Longitudinal Observational Study 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Wolfe F, Lassere M, van der Heijde D, et al. Preliminary Core Set of Domains and Reporting Requirements for Longitudinal Observational Studies in Rheumatology. J Rheumatol 1999;26:484–489. Available at: Accessed on December 21, 2007.PubMedGoogle Scholar
  2. 2.
    FDA. Guidance for industry clinical development programs for drugs, devices, and biological products for the treatment of rheumatoid arthritis (RA). Available at Accessed 16 November 2006.Google Scholar
  3. 3.
    Committee for the proprietary medicinal products (CPMP). Points to consider on clinical investigation of medicinal products other than NSAIDS for the treatment of rheumatoid arthritis. Available at: Accessed on December 21, 2007.Google Scholar
  4. 4.
    Dougados M, Betteridge N, Burmester GR, et al. EULAR standardised operating procedures for the elaboration, evaluation, dissemination and implementation of recommendations endorsed by the EULAR standing committee. Ann Rheum Dis 2004;63:1172–1176.PubMedCrossRefGoogle Scholar
  5. 5.
    Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatold arthritis. Arthritis Rheum. 1995;38(6):727–735. Available at: Accessed on December 21, 2007.PubMedCrossRefGoogle Scholar
  6. 6.
    van Gestel AM, Anderson JJ, van Riel PL, et al. ACR and EULAR improvement criteria have comparable validity in rheumatoid arthritis trials. American College of Rheumatology European League of Associations for Rheumatology. J Rheumatol 1999;26(3):705–711.PubMedGoogle Scholar
  7. 7.
    Gülfe A, Geborek P, Saxne T. Response criteria for rheumatoid arthritis in clinical practice: how useful are they? Ann Rheum Dis 2005;64(8):1186–1189.PubMedCrossRefGoogle Scholar
  8. 8.
    Pincus T, Strand V, Koch G, Amara I, Crawford B, Wolfe F, Cohen S, Felson D. An index of the three core data set patient questionnaire measures distinguishes efficacy of active treatment from that of placebo as effectively as the American College of Rheumatology 20{%} response criteria (ACR20) or the Disease Activity Score (DAS) in a rheumatoid arthritis clinical trial. Arthritis Rheum 2003;48(3):625–630.PubMedCrossRefGoogle Scholar
  9. 9.
    Carr A, Hewlett S, Hughes R, Mitchell H, Ryan S, Carr M, Kirwan J. Rheumatology outcomes: the patient’s perspective. J Rheumatol 2003;30(4):880–883.PubMedGoogle Scholar
  10. 10.
    Drazen JM. Cox-2 inhibitors – a lesson in unexpected problems. N Engl J Med 2005;352:1131–1132.PubMedCrossRefGoogle Scholar
  11. 11.
    Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA 2006;295:2275–2285.PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag London Limited 2008

Authors and Affiliations

  • Pieter Geusens
    • 1
  • Colin G. Miller
  1. 1.Department of Rheumatology, University Hospital, Maastricht, The Netherlands and Biomedical Research InstituteUniversity HasseltDiepenbeekBelgium

Personalised recommendations