drugset / Trial / NCT00535782

A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis

NCT00535782 ↗

Phase 3 Completed 132 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness, and markers of atherogenic risk in patients with moderate to severe active rheumatoid arthritis. In Part 1 of the study, patients will be randomized to receive either tocilizumab 8mg/kg intravenously or placebo every 4 weeks, in combination with methotrexate 7.5-25 mg weekly. In Part 2, all patients will receive open-label treatment with tocilizumab plus methotrexate.

Timeline

Start
2007-10-31
Primary completion
2008-09-30
Completion
2011-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous
Background Methotrexate Small molecule 7.5 mg Oral
Background Methotrexate Small molecule 25 mg Oral

Indications