At a glance
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A Mechanism of Action Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) on Lipids, Arterial Stiffness, and Markers of Atherogenic Risk in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA).
In Brief
A Phase 3 clinical trial evaluating Tocilizumab, Placebo, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 132 participants across 40 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Administered by intravenous infusion, 8 mg/kg every 4 weeks.
Placebo to tocilizumab administered by intravenous infusion every 4 weeks.
Administered orally or parenterally, 7.5-25 mg weekly.