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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 METHOTREXATE

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

FieldValue
Modified
2020-03-29
Release Date
2018-05-02
Identifier
01ae3ea1-6ef8-4468-a49e-637860820160
License
Public Access Level
Public