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 METHOTREXATE WITH INADEQUATE ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-014296-40

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 METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS

Femme et Homme

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Extrait

1. To compare efficacy of CP 690,550 5 mg BID & 10 mg BID vs placebo for treatment of signs & symptoms of RA, in patients with RA on background MTX who have had an inadequate response (IR) to a TNF-i as measured by ACR20 response rates at M3 2. To compare physical function status of patients with active RA on bkg MTX who have had IR to a TNF-i after administration of CP 690,550 5 mg BID & 10 mg BID vs placebo, as measured by HAQ DI response at M3 3. To compare rate of achieving DAS284(ESR) <2.6 at Month 3 in patients with active RA on bkg MTX who have had IR to a TNF-i after administration of CP-690,550 5 mg BID & 10 mg BID vs placebo 4. To compare the safety and tolerability of CP-690,550, in doses of 5 mg BID and 10 mg BID, vs placebo in patients with RA on background methotrexate who have had an inadequate response to a TNF inhibitor.


Critère d'inclusion

  • Rheumatoid Arthritis