Conditions: Arthritis, Rheumatoid
Keywords: long-term open-label safety
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4488
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550

A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550

Detailed description:

Arms:
arm 1: Patients enrolling from Phase 2 studies arm 2: Patients enrolling from Phase 3 studies

Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550
Intervention descriptions: intervention 1: 5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs. intervention 2: 10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Protocol document: