Extrait

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 690,550 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-690,550 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.

Critère d'inclusion

• CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults

Liens

• ictrp
• ictrp
• euctr
• euctr
• euctr
• ictrp
• euctr