Overview

A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
Phase:
Phase 3
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Methotrexate