CTRI/2012/01/002371
Completed
Phase 4
A clinical outcomes study to evaluate the effects of IL-6receptor blockade with tocilizumab (TCZ) in comparison withetanercept (ETA) on the rate of cardiovascular events inPatients with moderate to severe rheumatoid arthritis (RA)
F HoffmannLa Roche Ltd0 sites2,800 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Rheumatoid ArthritisHealth Condition 2: M069- Rheumatoid arthritis, unspecified
- Sponsor
- F HoffmannLa Roche Ltd
- Enrollment
- 2800
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients, greater or equal 50 years of age
- •Patients with moderate to severe rheumatoid arthritis greater or equal 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
Outcomes
Primary Outcomes
Not specified
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