At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI)
In Brief
A Phase 3 clinical trial evaluating rituximab [MabThera/Rituxan] and tocilizumab [RoActemra/Actemra] for Rheumatoid Arthritis. Completed, enrolled 519 participants across 83 sites.
Detailed Summary
This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12 weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study treatment is 32 weeks.
Study Details
Timeline
Interventions
1 g intravenously at Week 16 and 18
8 mg/kg intravenously every 4 weeks for 12 weeks.
8 mg/kg intravenously every 4 weeks from Week 16 to Week 28