New Clinical Trial to Study Impact of Rheumatoid Arthritis Therapies on Cardiovascular Disease
NIH Grants $8.56 Million to Brigham and Women’s Hospital and Columbia University Medical Center for Clinical Trial
Nov 18, 2015
Brigham and Women’s Hospital and Columbia University Medical Center have received a four-year, $8.56 million grant from the National Institutes of Health (NIH) /National Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS) for a new, clinical trial examining Cardiovascular Disease (CVD) in patients with Rheumatoid Arthritis (RA).
CVD is the leading cause of death in patients with RA, a chronic inflammatory disease causing joint damage and disability. Most experts believe that enhanced vascular inflammation underpins accelerated atherosclerosis, hardening of the arteries, and cardiovascular events in patients with RA, but there is no direct proof of this hypothesis. With this grant, researchers will conduct one of the first randomized, clinical trials to explore whether existing RA therapies that reduce joint inflammation will also reduce inflammation in the blood vessels, thereby hopefully reducing CVD risk.
“This is the first trial of its kind in RA to compare two known arthritis treatment strategies’ effects on cardiovascular risk,” says Daniel Solomon, MD, rheumatologist at BWH and one of the principal investigators leading the trial.
Researchers from 40 sites across the country will enroll 200 RA patients to compare the impact of two different treatment regimens for RA on vascular inflammation using a PET-CT scan before patients begin the trial, and again at 24 weeks after starting treatment, to assess the difference in vascular inflammation, and determine whether one treatment is superior to the other.
Specifically, researchers will compare sulfasalazine (SSZ) plus hydroxychloroquine plus methotrexate (MTX), commonly referred to as triple therapy, to MTX in combination with a Tumor Necrosis Factor (TNF) inhibitor. Both regimens are recognized to suppress the inflammatory response.
“Another important feature of the trial is to understand whether reducing inflammation in the joints to a very low level is paralleled by a similar level of reduction in inflammation in the blood vessels, regardless of which treatment regimen the patients receive,” says Joan Bathon, MD, director of the Division of Rheumatology at NewYork-Presbyterian/Columbia University Medical Center, the other principal investigator leading the trial.
The trial, which is anticipated to begin in early 2016, will include a two year enrollment period. Once a participant has enrolled, researchers will conduct a 6 month follow up for each, accumulating enough data to analyze and review within the next 3 years. For more information, contact Alyssa Wohlfahrt at 617-525-8784.
Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 4.2 million annual patient visits, nearly 46,000 inpatient stays and employs nearly 16,000 people. The Brigham’s medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Brigham Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 1,000 physician-investigators and renowned biomedical scientists and faculty supported by nearly $600 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH continually pushes the boundaries of medicine, including building on its legacy in transplantation by performing a partial face transplant in 2009 and the nation’s first full face transplant in 2011. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative as well as the TIMI Study Group, one of the premier cardiovascular clinical trials groups. For more information, resources and to follow us on social media, please visit BWH’s online newsroom.
Columbia University Medical Center and NewYork-Presbyterian
Columbia University Medical Center provides international leadership in basic, preclinical, and clinical research; medical and health sciences education; and patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Columbia University Medical Center is home to the largest medical research enterprise in New York City and State and one of the largest faculty medical practices in the Northeast. For more information, visit cumc.columbia.edu or columbiadoctors.org.
NewYork-Presbyterian is one of the nation’s most comprehensive healthcare delivery networks, focused on providing innovative and compassionate care to patients in the New York metropolitan area and throughout the globe. In collaboration with two renowned medical school partners, Weill Cornell Medicine and Columbia University College of Physicians & Surgeons, NewYork-Presbyterian is consistently recognized as a leader in medical education, ground-breaking research and clinical innovation.
NewYork-Presbyterian has four major divisions: NewYork-Presbyterian Hospital is ranked #1 in the New York metropolitan area by U.S. News and World Report and repeatedly named to the magazine’s Honor Roll of best hospitals in the nation; NewYork-Presbyterian Regional Hospital Network is comprised of leading hospitals in and around New York and delivers high-quality care to patients throughout the region; NewYork-Presbyterian Physician Services connects medical experts with patients in their communities; and NewYork-Presbyterian Community and Population Health features the hospital’s ambulatory care network sites and operations, community care initiatives and healthcare quality programs, including NewYork Quality Care, established by NewYork-Presbyterian, Weill Cornell and Columbia.
NewYork-Presbyterian is one of the largest healthcare providers in the U.S. Each year, nearly 29,000 NewYork-Presbyterian professionals deliver exceptional care to more than 2 million patients.
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