Multiple epidemiologic studies have demonstrated an increased risk of cardiovascular disease (CVD) in rheumatoid arthritis (RA);it is the number one cause of death in RA. The elevated inflammatory burden of RA is postulated to contribute to this risk, supported by a number of observational studies supporting the benefits of aggressive immunosuppression on CVD risk. However, there are conflicting findings among the observational studies regarding the effect of treatment on CVD risk, and, importantly, none provides a sufficient evidence-base to inform providers how to manage this risk. Currently, there is general enthusiasm regarding Treat to Target (TTT) in RA for managing articular signs and symptoms. However, there are no data whether TTT may improve non-articular outcomes, such as atherosclerosis. This proposal describes the rationale and design of a randomized controlled trial testing the effects of TTT versus usual care on the progression of carotid thickness (IMT) and other secondary measures of atherosclerosis progression. We request 24 months of funding to further plan this trial. The planning period will entail many activities, including selecting a core vascular laboratory, determining the best imaging protocol, developing training materials for the imaging, finalizing trial design and procedures, developing a Manual of Operating Procedures, and site recruitment/selection. We anticipate submission of a trial proposal early during year 2 and then continuing with IRB work, site subcontracting, and creating trial materials. This will allow us to be ready to recruit early in the trial period. Thetrial will be the first of its kind in RA and will provide important clinical information for the management of CV risk in RA patients.

Public Health Relevance

This planning grant will allow the investigators to prepare for a randomized controlled trial examining the effects of aggressive immunosuppression on atherosclerosis in RA. The trial will be the first of its kind in RA and will provide important cliical information.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Clinical Planning Grant Cooperative Agreement (U34)
Project #
1U34AR063911-01
Application #
8435756
Study Section
Special Emphasis Panel (ZAR1-HL (M1))
Program Officer
Witter, James
Project Start
2013-04-01
Project End
2015-03-31
Budget Start
2013-04-01
Budget End
2014-03-31
Support Year
1
Fiscal Year
2013
Total Cost
$369,319
Indirect Cost
$108,939
Name
Brigham and Women's Hospital
Department
Type
DUNS #
030811269
City
Boston
State
MA
Country
United States
Zip Code
02115