etanercept
DrugParticipants will receive 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
NCT Number: NCT01331837
This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).
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Notify Me50 year and older
All sexes
Interventional
Phase 4
APRILLUS, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
Participants will receive 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
Other names: Actemra
Time frame: From baseline up to 4.9 years
Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke.
Time frame: From baseline up to 4.9 years
Percentage of patients reporting any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke
Time frame: From Baseline up to 4.9 years
Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis
Time frame: From Baseline up to 4.9 years
Percentage of patients with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis
Time frame: From baseline up to 4.9 years
Prospective comparison of time to first occurrence of any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses
Time frame: From baseline up to 4.9 years
Percentage of patients with any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses
Time frame: From Baseline up to 4.9 years
Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).
Time frame: From Baseline up to 4.9 years
Percentage of participants with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).
Time frame: From baseline up to 4.9 years
Prospective comparison of the time to first ccurrence of the expanded composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.
Time frame: From baseline up to 4.9 years
Percentages of participants with the expanded CV composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.
Time frame: From baseline up to 4.9 years
Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal Myocardial Infarction
Time frame: From baseline up to 4.9 years
Percentage of patients reporting Individual component of primary endpoint: non-fatal Myocardial Infarction
Time frame: From baseline up to 4.9 years
Prospective comparison of time to first occurrence of Individual component of primary endpoint: cardiovascular death
Time frame: From baseline up to 4.9 years
Percentage of patients reporting Individual component of primary endpoint: cardiovascular death
Time frame: From baseline up to 4.9 years
Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal stroke
Time frame: From baseline up to 4.9 years
Time frame: From baseline up to 4.9 years
Prospective comparison of time to first occurrence of Individual component of primary endpoint: All-cause mortality
Time frame: From baseline up to 4.9 years
Percentage of patients reporting Individual component of primary endpoint: All-cause mortality
Hoffmann-La Roche
Industry
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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