Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2
Healthy volunteers: no

Brief summary:
This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: DMARD
Intervention descriptions: intervention 1: 8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate) intervention 2: Non-biologic DMARDs (including methotrexate) according to current best practice

Protocol document: