At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Rheumatoid arthritis diagnosed between 8 weeks and 4 years prior to baseline
- ✓Naive to methotrexate or not responding well to methotrexate
- ✓Swollen joint count ≥8 (66 joint count) AND tender joint count ≥8 (68 joint count) at screening and baseline
- ✕Rheumatic autoimmune disease other than rheumatoid arthritis
- ✕Functional class IV rheumatoid arthritis
- ✕History of or current inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Study to Evaluate the Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra] for Rheumatoid Arthritis. Completed, enrolled 29 participants across 4 sites.
Detailed Summary
This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Study Details
Timeline
Interventions
8mg/kg iv every 4 weeks for 24 weeks