EUCTR2010-020065-24-ES
Active, not recruiting
Phase 1
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). - ENTRACTE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- F. Hoffmann-La Roche Ltd.
- Enrollment
- 2800
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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)
- •\- Presence of one or more additional Coronary Heart Disease (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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 2000
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 800
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 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)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.EUCTR2010-020065-24-CZF. Hoffmann-La Roche Ltd.3,080
Active, not recruiting
Phase 1
A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.Rheumatoid ArthritisMedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]EUCTR2010-020065-24-GRF. Hoffmann-La Roche Ltd.2,800
Active, not recruiting
Phase 1
A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.Rheumatoid ArthritisMedDRA version: 17.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]EUCTR2010-020065-24-ATF. Hoffmann-La Roche Ltd.3,080
Active, not recruiting
Phase 1
A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.Rheumatoid ArthritisMedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]EUCTR2010-020065-24-GBF. Hoffmann-La Roche Ltd.3,080
Completed
Phase 4
A Study of RoActemra/Actemra (Tocilizumab) in Comparison to Etanercept in Patients With Rheumatoid Arthritis and Cardiovascular Disease Risk FactorsHealth Condition 1: null- Rheumatoid ArthritisHealth Condition 2: M069- Rheumatoid arthritis, unspecifiedCTRI/2012/01/002371F HoffmannLa Roche Ltd2,800