WA25204 RA with CV outcomes (ENTRACTE Study)
Research type
Research Study
Full 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)
IRAS ID
80352
Contact name
Thomas Sheeran
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd.
Eudract number
2010-020065-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 27 days
Research summary
This study is being run by F.Hoffman-la Roche for to compare the effects of Tocilizumab (TCZ) to the effects of Etanercept (ETA) on the occurrence of cardiovascular illnesses, including heart attacks, strokes, and death, related to cardiovascular disease.
Eligible patients must be at least 50 years old, and have moderate to severe RA that is not being made better by the medications they are taking, or in the past they have taken medications called “disease modifying anti-rheumatic drugs” (DMARDs), and have at least one risk factor for coronary heart disease, which can lead to heart attacks or strokes.
During the study, patients will be placed into one of two treatment groups to eceive either TCZ or ETA. Patients will have an equal chance of being placed in either group.
The duration of this study will be approximately 5 years.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
11/EM/0180
Date of REC Opinion
15 Aug 2011
REC opinion
Further Information Favourable Opinion