Clinical trial design in systemic lupus erythematosus

Current Opinion in Rheumatology

Volumn 18, Issue 5, 2006, Pages 476-480

  Dall'Era, Maria ^a   Wofsy, David ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Clinical trial design; Systemic lupus erythematosus; Therapeutic agents

Indexed keywords

ABETIMUS; ANTIMETABOLITE; BIOLOGICAL FACTOR; CD40 LIGAND MONOCLONAL ANTIBODY; CYCLOPHOSPHAMIDE; MONOCLONAL ANTIBODY IDEC 131; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PRASTERONE;

CLINICAL FEATURE; CLINICAL TRIAL; DECISION MAKING; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; HORMONAL THERAPY; HUMAN; LUPUS ERYTHEMATOSUS NEPHRITIS; PRIORITY JOURNAL; REMISSION; REVIEW; SYSTEMIC LUPUS ERYTHEMATOSUS; TREATMENT INDICATION; TREATMENT OUTCOME;

HUMANS; LUPUS ERYTHEMATOSUS, SYSTEMIC; RANDOMIZED CONTROLLED TRIALS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 33746864126     PISSN: 10408711     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.bor.0000240357.22680.63     Document Type: Review

References (7)

1. Karassa FB, Tatsioni A, Ioannidis JPA. Design, quality, and bias in randomized controlled trials of systemic lupus erythematosus. J Rheumatol 2003; 30: 979-984.
2. Moher D, Schulz K, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. Lancet 2001; 357:1191-1194.
3. Strand V, Gladman D, Isenberg D, et al. Endpoints: consensus recommendations from OMERACT IV. Lupus 2000; 9:322-327.
4. Kalunian KC, Davis JC, Merrill JT, et al. Treatment of systemic lupus erythematosus by inhibition of T cell costimulation with anti-CD154. Arthritis Rheum 2002; 46:3251-3258.
5. Petri MA, Lahita RG, van Hollenhoven RF, et al. Effects of prasterone on corticosteroid requirements of women with systemic lupus erythematosus. Arthritis Rheum 2002; 46:1820-1829.
6. Alarcon-Segovia D, Tumlin JA, Furie RA, et al. LJP 394 for the prevention of renal flare in patients with systemic lupus erythematosus. Arthritis Rheum 2003; 48:442-454.
7. Ginzler EM, Dooley MA, Aranow C, et al. Mycophenolate mofetil or intravenous cyclophosphamide for lupus nephritis. N Engl J Med 2005; 353:2219-2228. This large equivalence trial concluded that mycophenolate mofetil was as efficacious as intravenous pulse cyclophosphamide in the induction of remission of lupus nephritis.