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

• Register: EUCTR
• Last refreshed on: 17 May 2016
• Main ID: EUCTR2010-020065-24-HU
• Date of registration: 02/05/2011
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd.
• Public title: A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.
• Scientific title: 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
• Date of first enrolment: 15/06/2011
• Target sample size: 3080
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020065-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Austria, Belgium, Bosnia and Herzegovina, Canada, Chile, 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, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & 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)
- 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 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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis
MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Trade Name: RoActemra®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: Enbrel®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Current Sponsor code: Ro 554-6023
Other descriptive name: Etanercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

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

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.

Primary end point(s): The primary endpoint is defined as the time to first cardiovascular event, cardiovasular death, myocardial infarction or stroke.

Secondary Outcome(s)

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.

Secondary ID(s)

2010-020065-24-GB

WA25204

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd.