Conditions: Rheumatoid Arthritis
Keywords: Tolerability Methotrexate Safety
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 158
Healthy volunteers: no

Brief summary:
This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized controlled trial, in which participants had been randomized to receive 1 of 3 doses of ABT-122 (60 mg every other week \[EOW\], 120 mg EOW, or 120 mg every week \[EW\]) or adalimumab 40 mg EOW given on background methotrexate.

Detailed description:

Arms:
arm 1: All subjects receive open-label ABT-122 120 mg EOW subcutaneously, with the first dose administered at the last visit of Study M12-963 randomized controlled trial.

Interventions: intervention 1: ABT-122
Intervention descriptions: intervention 1: None

Protocol document: