Conditions: Rheumatoid Arthritis
Keywords: anti-inflammatory agents Joint Diseases Arthritis Musculoskeletal Disease antirheumatic agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 276
Healthy volunteers: no

Brief summary:
The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to anti-TNF biologic therapy.

Detailed description:

Arms:
arm 1: Placebo twice daily (BID) for 12 weeks. arm 2: ABT-494 3 mg twice daily (BID) for 12 weeks. arm 3: ABT-494 6 mg twice daily (BID) for 12 weeks. arm 4: ABT-494 12 mg twice daily (BID) for 12 weeks. arm 5: ABT-494 18 mg twice daily (BID) for 12 weeks.

Interventions: intervention 1: ABT-494 intervention 2: Placebo
Intervention descriptions: intervention 1: ABT-494 capsule administered orally twice daily (BID). intervention 2: Placebo for ABT-494 capsule administered orally twice daily (BID).

Protocol document: