Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 27
Healthy volunteers: no

Brief summary:
The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA) receiving re-treatment with rituximab.

Detailed description:

Arms:
arm 1: Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32. arm 2: Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.

Interventions: intervention 1: Rituximab intervention 2: Atacicept intervention 3: Placebo matched to atacicept
Intervention descriptions: intervention 1: Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3. intervention 2: Atacicept will be administered at a dose of 150 mg subcutaneously once a week from Week 7 to 32. intervention 3: Placebo matched to atacicept will be administered subcutaneously once a week from Week 7 to 32.

Protocol document: