Conditions: Arthritis, Rheumatoid
Keywords: Phase II MTX add-on study in Japan
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 140
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Placebo intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: CP-690,550
Intervention descriptions: intervention 1: 0 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 2: 10 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 3: 1 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 4: 3 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 5: 5 mg BID, 3 blinded tablets administered BID for 12 weeks

Protocol document: