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).
- Conditions
- inflammation of the synovium in jointsrheumatoid arthritis1002859310003816
- Registration Number
- NL-OMON39743
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1. Patients with RA of > 6 months duration at the time of the baseline visit. RA must be diagnosed according to the revised 1987 American College of Rheumatology (ACR; formerly American Rheumatism Association) criteria (Appendix 3)
2. Inadequate response to at least one non-biologic DMARD
3. Have a CRP > 0.3 mg/dL at screening or at the baseline visit
4. Receiving treatment on an outpatient basis
5. Swollen joint count (SJC) * 8 (66 joint count) and tender joint count (TJC) * 8 (68 joint count) during screening or at the baseline visit.
6. Males and females, age * 50 years
7. Presence of one or more additional Coronary Heart Disease (CHD) risk factor including:
* Cigarette smoking (current)
* Hypertension (BP ><=140/90 mm Hg or on antihypertensive medication)
* Low HDL cholesterol (HDL <50 mg/dL for women; HDL <40 mg/dL for men)
* Family history of premature CHD (CHD in male first-degree relative <55 years of age; CHD in female first-degree relative <65 years of age)
* Diabetes
* Presence of extra-articular disease associated with RA (e.g., rheumatoid nodules, secondary Sjogren's syndrome, serositis, rheumatoid lung disease/ interstitial lung disease, vasculitis, inflammatory peripheral neuropathy, or scleritis/ episcleritis) ;* History of at least one of the following:
o Myocardial infarction
o Stroke of atherothrombotic origin
o Coronary revascularization procedure
o Hospitalization for unstable angina
* The presence of at least one of the following clinical atherosclerotic diseases that confers high risk for coronary heart disease (CHD) events:
o Clinical CHD
o Symptomatic carotid artery disease
o Peripheral arterial disease
o Abdominal aortic aneurysm;8. At the time of randomization, will have discontinued:
* infliximab, adalimumab, golimumab, or certolizumab for * 4 weeks
1. Major surgery (including joint surgery or coronary revascularization) within eight weeks prior to screening or planned major surgery within one year of baseline
2. Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), Mixed Connective Tissue Disease (MCTD), scleroderma or variants, and polymyositis. Patients with systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis) and secondary Sjögren*s syndrome, and/or nodulosis with RA are permitted (see Inclusion #7). Patients with Felty*s syndrome are not permitted
3. History of or current inflammatory joint disease other than RA (e.g., tophaceous gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease, pseudogout, arthropathy of inflammatory bowel disease)
4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
5. Current or recent (within the past 3 months) evidence of serious uncontrolled concomitant cardiovascular or cerebrovascular disease (MI, revascularization, ischemic stroke, transient ischemic attack, or acute coronary syndrome)
6. Current or previous (within the past 2 years) evidence of serious uncontrolled concomitant pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or gastrointestinal disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>This event-driven study will continue until 131 adjudicated endpoint events<br /><br>have been confirmed. The end of data collection for the study will occur when<br /><br>the last patient, last visit (LPLV) occurs. The LPLV is either the date of the<br /><br>last patient visit, or the date at which the last data point from the last<br /><br>patient, which is required for statistical analysis, is received, whichever is<br /><br>the later date. </p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>