Conditions: Rheumatoid Arthritis
Keywords: oral DMARD JAK inhibitor clinical trial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 717
Healthy volunteers: no

Brief summary:
This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The 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 on background methotrexate 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 Rheumatoid Arthritis. An active comparator, adalimumab, is also included.

Detailed description:

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

Interventions: intervention 1: CP 690,550 intervention 2: CP-690,550 intervention 3: Placebo intervention 4: Placebo intervention 5: Biologic TNFi
Intervention descriptions: intervention 1: tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months intervention 2: tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months intervention 3: placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months intervention 4: tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months intervention 5: placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months

Protocol document: