|
Research Question
|
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 etanercept subcutaneously weekly. The
anticipated time on study drug is up to 5 years.
(from ClinicalTrials.gov)
|
|
Ethics Approval
|
Sorry, not currently available
|
|
Study Design
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Design Type
|
Sorry, not currently available
|
|
Design Details
|
Sorry, not currently available
|
|
Health Condition(s) or Problem
|
Cardiovascular Disease, Rheumatoid Arthritis
|
|
Participants Inclusion Criteria
|
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
|
|
Participants Exclusion Criteria
|
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
|
|
Participant Sex
|
Sorry, not currently available
|
|
Participant Age Range
|
Sorry, not currently available
|
|
Participant Type
|
Sorry, not currently available
|
|
Target Sample Size
|
2800
|
|
Date of First Enrolment
|
Sorry, not currently available
|
|
Date of Recruitment End
|
Sorry, not currently available
|
|
Date of End of Follow-up
|
Sorry, not currently available
|
|
Trial End Date
|
Sorry, not currently available
|
|
Recruitment Status
|
Recruiting
|
|
Overall Trial Status
|
Sorry, not currently available
|
|
Countries of Recruitment
|
United States; Argentina; Austria; Belgium; Bosnia and Herzegovina; Canada; Chile; China; 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
|
|
Nation
|
England
|
|
Location
|
Birmingham, Cambridge, Cannock, Dudley, Leicester, London, Newcastle upon Tyne, Salford, Southampton, Westcliff-on-sea, Wigan
|
|
Interventions
|
Drug; tocilizumab [RoActemra/Actemra]; 8 mg/kg intravenously every 4 weeks; 1; Drug; etanercept; 50 mg subcutaneously weekly; 2
|
|
Primary Outcome Measures
|
Time from randomization to occurrence of the primary major adverse adverse cardiac events, defined as a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
|
|
Secondary Outcome Measures
|
Time from randomization to occurrence of composite endpoint of major events, non-fatal coronary revascularization procedures and hospitalization for unstable angina; 5 years; No
|
|
Website
|
Sorry, not currently available
|