This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
Reference
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: http://www.jrheum.com/omeract/1-5toc.html. Accessed on December 21, 2007.
FDA. Guidance for industry clinical development programs for drugs, devices, and biological products for the treatment of rheumatoid arthritis (RA). Available at www.fda.gov/cder/guidance/index.htm. Accessed 16 November 2006.
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: http://emea.europa.eu/pdfs/human/ewp/055695en.pdf. Accessed on December 21, 2007.
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.
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: http://www.rheumatology.org/publications/guidelines/ra-improvement/Prelim_definition_improve%20RA.asp. Accessed on December 21, 2007.
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.
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.
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.
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.
Drazen JM. Cox-2 inhibitors – a lesson in unexpected problems. N Engl J Med 2005;352:1131–1132.
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.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2008 Springer-Verlag London Limited
About this chapter
Cite this chapter
Geusens, P., Miller, C.G. (2008). Study Design and End Points for Rheumatoid Arthritis Trials. In: Reid, D.M., Miller, C.G. (eds) Clinical Trials in Rheumatoid Arthritis and Osteoarthritis. Clinical Trials. Springer, London. https://doi.org/10.1007/978-1-84628-742-8_4
Download citation
DOI: https://doi.org/10.1007/978-1-84628-742-8_4
Publisher Name: Springer, London
Print ISBN: 978-1-85233-874-9
Online ISBN: 978-1-84628-742-8
eBook Packages: MedicineMedicine (R0)