At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Moderate to severe active rheumatoid arthritis for at least 6 months
- ✓Inadequate response to stable-dose methotrexate
- ✕Major surgery (including joint surgery) within 8 weeks prior to study entry, or planned surgery within 6 months after entry
- ✕Prior treatment failure with an anti-TNF agent
- ✕Pregnancy or breast-feeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra], Placebo, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 1,196 participants across 152 sites in 16 countries.
Detailed Summary
This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. After completion of the 2 year study participants could participate in the optional 3 year open label extension phase (year 3 to 5).
Study Details
Timeline
Interventions
4 mg/kg or 8 mg/kg IV/month every 4 weeks.
IV/month
10-25 mg/week