PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-016987-34

Femme et Homme

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Extrait

1. To compare evidence of preservation of joint structure after administration of CP-690,550 in doses of 5 mg BID and 10 mg BID versus MTX alone in MTX-naïve patients with active RA, as measured by changes from baseline using a standardized, validated method, such as the van der Heijde modified Sharp score at Month 6. 2. To compare the efficacy of CP-690,550 in doses of 5 mg BID and 10 mg BID versus MTX alone for the treatment of signs and symptoms of rheumatoid arthritis (RA) in MTX-naïve patients with active RA, as measured by ACR70 response rates at Month 6. 3. To evaluate the safety and tolerability of CP-690,550 in doses of 5 mg BID and 10 mg BID versus MTX alone in MTX-naïve patients with active RA for 24 months.


Critère d'inclusion

  • Moderate to severe active rheumatoid arthritis