Health Condition 1: null- Rheumatoid Arthritis Health Condition 2: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: Tocilizumab[RoActemra/Actemra],: 8 mg/kg intravenously every 4 weeks for 5 years
Control Intervention1: Etanercept: 50mg subcutaneously weekly for 5 years
Sponsors
F HoffmannLa Roche Ltd
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomization to occurrence of the primary major adverse cardiac events, defined as a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal strokeTimepoint: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from randomization to occurrence of composite endpoint of major events, non-fatal coronary revascularization procedures and hospitalization for unstable anginaTimepoint: 5 years | — |
Countries
Argentina, Austria, Belgium, Bosnia and Herzegovina, Canada, Chile, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Philippines, Poland, Romania, Russian Federation, Serbia, South Africa, Spain, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Aditi Parekh
Roche Products (India) Private Limited
Outcome results
None listed