Conditions: Rheumatoid Arthritis
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 39
Healthy volunteers: no

Brief summary:
This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on study treatment is 24 weeks.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: methotrexate
Intervention descriptions: intervention 1: 8 mg/kg iv every 4 weeks for a total of 6 infusions intervention 2: 10-25 mg orally weekly

Protocol document: