Conditions: Arthritis, Rheumatoid
Keywords: Antirheumatic Agents Clinical Trial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 611
Healthy volunteers: no

Brief summary:
This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies.

Detailed description:

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

Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: 5mg CP-690,550 BID PO for 6 months intervention 2: 10 mg CP-690,550 BID PO for 6 months intervention 3: Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit intervention 4: Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit

Protocol document: