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

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-007788-17

Femme et Homme

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Extrait

1. To compare the efficacy of CP 690,550, as monotherapy, in doses of 5 mg BID and 10 mg BID versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA), in subjects with RA who have had an inadequate response to a DMARD (traditional or biologic), as measured by ACR20 response rates at Month 3. 2. To compare physical function status of patients with active RA after administration of CP 690,550, as monotherapy, in doses of 5 mg BID and 10 mg BID versus placebo, as measured by the HAQ DI response at Month 3. 3. To compare the rate of achieving DAS28-4(ESR) <2.6 at Month 3 in patients with active RA after administration of CP-690,550, as monotherapy, in doses of 5 mg BID and 10 mg BID versus placebo. 4. To compare the safety of two doses of CP 690,550 monotherapy versus placebo monotherapy in patients with RA.


Critère d'inclusion

  • CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults