Conditions: Arthritis, Rheumatoid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 294
Healthy volunteers: no

Brief summary:
The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI 695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.

Detailed description:

Arms:
arm 1: BI 695500, Two infusions separated by 2 weeks, Intravenous infusion arm 2: rituximab, Two infusions separated by 2 weeks, Intravenous infusion arm 3: rituximab, Two infusions separated by 2 weeks, Intravenous infusion arm 4: BI 695500, Two infusions separated by 2 weeks, Intravenous infusion arm 5: rituximab, Two infusions separated by 2 weeks, Intravenous infusion

Interventions: intervention 1: BI 695500 intervention 2: BI 695500 intervention 3: Rituxan® intervention 4: Rituxan® intervention 5: MabThera®
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol document: