At a glance
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Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDs
In Brief
A Phase 3 clinical trial evaluating methotrexate and tocilizumab [RoActemra/Actemra] for Rheumatoid Arthritis. Completed, enrolled 71 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
stable dose as prescribed
8 m/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions