Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 127
Healthy volunteers: no

Brief summary:
This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled. Screening evaluations were performed within approximately 28 days of randomization. The duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 (Baricitinib) or placebo.

Detailed description:

Arms:
arm 1: INCB028050 4mg Once daily (QD) arm 2: INCB028050 7mg QD arm 3: INCB028050 10mg QD arm 4: Placebo group may 'cross-over' following 3 months of treatment to receive either active arm #2 (7mg QD) or active arm #3 (10mg QD) of INCB028050 capsules.

Interventions: intervention 1: INCB028050 intervention 2: INCB028050 intervention 3: INCB028050 intervention 4: Placebo
Intervention descriptions: intervention 1: 4 mg capsules QD intervention 2: 7 mg capsules QD intervention 3: 10 mg capsule QD intervention 4: Placebo matching INCB028050 QD

Protocol document: