A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.

Phase 1

Conditions: Rheumatoid Arthritis
MedDRA version: 17.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2010-020065-24-NL

Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3080

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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 880

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke of all classifications;Secondary Objective: Composite endpoint of major cardiovascular events, non-elective coronary revascularization procedures and hospitalization for unstable angina;Primary end point(s): The primary endpoint is defined as the time to first cardiovascular event, cardiovasular death, myocardial infarction or stroke.;Timepoint(s) of evaluation of this end point: Monthly assessments for CV events with the onset date of the event based on the clinical presentation.<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The time to first occurrence of an expanded composite endpoint, defined as the primary endpoint with the addition of nonelective coronary revascularization procedures and hospitalization for unstable angina.;Timepoint(s) of evaluation of this end point: Monthly assessments for CV events with the onset date of the event based on the clinical presentation.<br>