Conditions: Rheumatoid Arthritis
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 105
Healthy volunteers: no

Brief summary:
This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)
Intervention descriptions: intervention 1: 8mg/kg iv every 4 weeks for 6 months intervention 2: As prescribed

Protocol document: