Conditions: Rheumatoid Arthritis
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 71
Healthy volunteers: no

Brief summary:
This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: methotrexate intervention 2: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: stable dose as prescribed intervention 2: 8 m/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions

Protocol document: