Conditions: Arthritis, Rheumatoid
Keywords: double-blind placebo-controlled investigational drug oral therapy safety and efficacy hand and feet x-rays
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 800
Healthy volunteers: no

Brief summary:
This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.

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: CP-690,550 intervention 4: CP-690,550 intervention 5: Placebo intervention 6: CP-690,550 intervention 7: Placebo intervention 8: CP-690,550
Intervention descriptions: intervention 1: Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. intervention 2: Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period. intervention 3: Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. intervention 4: Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period. intervention 5: Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. intervention 6: Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period. intervention 7: Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. intervention 8: Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.

Protocol document: