Conditions: Rheumatoid Arthritis
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 201
Healthy volunteers: no

Brief summary:
This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: DMARDs (disease-modifying antirheumatic drugs)
Intervention descriptions: intervention 1: 8 mg/kg iv every 4 weeks for 24 weeks intervention 2: stable doses at investigator's prescription

Protocol document: