At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...
In Brief
A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra], methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 556 participants across 137 sites in 20 countries.
Detailed Summary
This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.
Study Details
Timeline
Interventions
tocilizumab 8 mg IV every 4 weeks.
Approximately 15-17 mg methotrexate capsule orally once a week.
Placebo matching methotrexate capsule taken orally once a week.