Conditions: Rheumatoid Arthritis
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 519
Healthy volunteers: no

Brief summary:
This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12 weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study treatment is 32 weeks.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: tocilizumab [RoActemra/Actemra] intervention 3: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 1 g intravenously at Week 16 and 18 intervention 2: 8 mg/kg intravenously every 4 weeks for 12 weeks. intervention 3: 8 mg/kg intravenously every 4 weeks from Week 16 to Week 28

Protocol document: