Conditions: Rheumatoid Arthritis
Keywords: Musculoskeletal Disease Arthritis Joint Diseases anti-inflammatory agents antirheumatic agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 300
Healthy volunteers: no

Brief summary:
The primary objective of the study was to compare the safety and efficacy of multiple doses of upadacitinib versus placebo in adults with moderately to severely active rheumatoid arthritis (RA) on stable background methotrexate therapy who had not shown an adequate response to methotrexate alone.

Detailed description:

Arms:
arm 1: Participants received placebo capsules twice daily for 12 weeks. arm 2: Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks. arm 3: Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks. arm 4: Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks. arm 5: Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks. arm 6: Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.

Interventions: intervention 1: Placebo intervention 2: Upadacitinib
Intervention descriptions: intervention 1: Tablets for oral administration intervention 2: Tablets for oral administration

Protocol document: