The study is designed to provide pivotal efficacy data supporting four proposed claims reducing signs symptoms inhibiting the progression of structural damage inducing major clinical response improvement in physical function 2 yr safety data for CP 690550 dosed at 5 10 mg BID in patients with inadequate response to stable weekly doses of background methotrexate The primary objectives are to compare both doses of CP-690550 versus placebo in patients with active RA on a stable background of methotrexate: 1 For signs symptoms as measured by ACR20 response rates at Month 6 2 For evidence of joint structure preservation as measured by changes from baseline using a validated method such as the van der Heijde modified Sharp score 3 For physical function status of patients using the HAQ DI at Month 3 compared to baseline 4 For safety tolerability
Data and Resources
- PHASE 3 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEjson
The study is designed to provide pivotal efficacy data supporting four...
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