Conditions: Arthritis, Rheumatoid
Keywords: randomized double-blind placebo-controlled investigational drug oral therapy safety and efficacy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 399
Healthy volunteers: no

Brief summary:
This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.

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: CP-690,550 intervention 5: Placebo intervention 6: CP-690,550
Intervention descriptions: intervention 1: Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period. intervention 2: Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period. intervention 3: Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period. intervention 4: Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period. intervention 5: Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period. intervention 6: Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.

Protocol document: