A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors
This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events of tocilizumab in comparison to etanercept in participants with rheumatoid arthritis. Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 mg etanercept weekly, with or without non-biologic disease modifying anti-rheumatic drug (DMARD). The anticipated time on study drug is up to 5 years.
Cardiovascular Disease, Rheumatoid Arthritis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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 Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)|
- 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 stroke [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Time from randomization to occurrence of cardiovascular composite endpoint of major events, non-fatal coronary revascularization procedures and hospitalization for unstable angina [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Percentage of Participants with Adverse Events and Serious Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
|Active Comparator: Etanercept||
50 mg subcutaneously weekly until switch to another RA therapy or up to 5 years.
8 mg/kg intravenously every 4 weeks until switch to another RA therapy or up to 5 years.
Other Name: RoActemra/Actemra
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331837
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|Study Director:||Clinical Trials||Hoffmann-La Roche|