Clinical trial design in systemic lupus erythematosus
- 1 September 2006
- journal article
- review article
- Published by Ovid Technologies (Wolters Kluwer Health) in Current Opinion in Rheumatology
- Vol. 18 (5), 476-480
- https://doi.org/10.1097/01.bor.0000240357.22680.63
Abstract
The purpose of this review is to discuss the challenges inherent in the design of clinical trials for patients with systemic lupus erythematosus.Recent years have witnessed a renewed interest in the conduct of systemic lupus erythematosus clinical trials. Three key design decisions play particularly critical roles in determining the fate of these trials: selection of the study population from among patients with very heterogeneous disease manifestations; selection of the treatment and control regimens; and selection of the primary endpoint. Four recent randomized, controlled trials dealt with these decisions in the context of a variety of interventions, including new biologic agents, hormonal therapies, and anti-metabolites. These trials are informative about the implications of each approach.Systemic lupus erythematosus investigators are faced with substantial trial design challenges because of the inherently complex nature of this disease. The hope is that lessons learned from prior and ongoing trials will inform future trial design such that the efficacy of new agents can be determined and new therapies will become available for patients with SLE.Keywords
This publication has 6 references indexed in Scilit:
- Mycophenolate Mofetil or Intravenous Cyclophosphamide for Lupus NephritisThe New England Journal of Medicine, 2005
- LJP 394 for the prevention of renal flare in patients with systemic lupus erythematosus: Results from a randomized, double‐blind, placebo‐controlled studyArthritis & Rheumatism, 2003
- Treatment of systemic lupus erythematosus by inhibition of T cell costimulation with anti‐CD154: A randomized, double‐blind, placebo‐controlled trialArthritis & Rheumatism, 2002
- Effects of prasterone on corticosteroid requirements of women with systemic lupus erythematosus: A double‐blind, randomized, placebo‐controlled trialArthritis & Rheumatism, 2002
- The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trialsThe Lancet, 2001
- Endpoints: consensus recommendations from OMERACT IVLupus, 2000