A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Ischemic Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events of RoActemra/Actemra (tocilizumab) in comparison to etanercept in patients with rheumatoid arthritis. Patients will be randomized to receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks or 50 mg etane rcept subcutaneously weekly. The anticipated time on study drug is up to 5 years

Who is eligible to participate?

Inclusion Criteria: - Adult patients, >/=50 years of age - Patients with moderate to severe rheumatoid arthritis >/=6 months duration - Inadequate response to at least one non-biologic disease-modifying antirheumatic drug (DMARD) - History of Coronary Heart Disease (CHD) or presence of one or more additional CHD risk factors, including current cigarette smoking, hypertension, low HDL cholesterol, family history of premature CHD, diabetes, presence of extra-articular disease associated with rheumatoid arthritis Exclusion Criteria: - Major surgery within 8 weeks prior to screening or planned major surgery within 1 year of study start - Rheumatic autoimmune disease other than rheumatoid arthritis - History of, or current, inflammatory joint disease other than rheumatoid arthritis - Current or recent (within past 3 months) evidence of serious uncontrolled concomitant cardiovascular or cerebrovascular disease (Myocardial infarction, revascularization, stroke, transient ischaemic attack, or acute coronary syndrome) - History of diverticulitis, diverticulosis requiring treatment or other lower gastrointestinal tract conditions that might predispose to perforations - Active current infection or history of recurrent bacterial infection - Previous treatment with tocilizumab or etanercept

Last updated:

7/14/2014

NCT ID:

NCT01331837

IRB Number:

12-001621