drugset / Trial / NCT01331837

A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

NCT01331837

Phase 4 Completed 3080 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
Comparator Etanercept Protein / enzyme biologic 50 mg Subcutaneous
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous

Indications