drugset / Trial / NCT01331837
A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).
Timeline
- Start
- 2011-08-02
- Primary completion
- 2016-03-25
- Completion
- 2016-03-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |