PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-008337-11

Femme et Homme

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Extrait

1. To compare the efficacy of CP-690,550 in doses of 5 mg BID and 10 mg BID versus placebo for the treatment of signs and symptoms of RA in patients with active RA who have had an inadequate response to a DMARD (traditional or biologic), as measured by ACR20 response rates at Month 6. 2. To compare physical function status of patients after administration of CP-690,550 in doses of 5 mg BID or 10 mg BID versus placebo using the HAQ-DI at Month 3 compared to baseline in patients with active RA on background traditional DMARDs. 3. To compare the rate of achieving DAS 28-4(ESR) <2.6 at Month 6 in patients with active RA after administration of CP-690,550, in doses of 5 mg BID and 10 mg BID versus placebo. 4. To evaluate the safety and tolerability of CP-690,550 in doses of 5 mg BID and 10 mg BID versus placebo in patients with active RA on background traditional DMARDs.


Critère d'inclusion

  • Rheumatoid Arthritis