Conditions: Arthritis, Rheumatoid
Keywords: Arthritis Rheumatoid Antirheumatic Agents Clinical Trial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 795
Healthy volunteers: no

Brief summary:
This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with 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: Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit. arm 4: Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.

Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Film coated tablet, 5 mg PO BID, 1 year intervention 2: Film coated tablet, 10 mg PO BID, 1 year intervention 3: Film coated tablet, 1 tablet PO BID, 3-6 months intervention 4: Film coated tablet, 1 tablet PO BID, 3-6 months

Protocol document: