StopRA is a multi-site 3-year double-blinded placebo controlled randomized trial to determine whether a 12-month course of hydroxychloroquine (HCQ), an FDA approved drug, is safe and effective at preventing the development of clinically-apparent rheumatoid arthritis (RA) in people that are at high risk for this disease based on having a positive RA-related antibody, CCP, without prior evidence of RA or inflammatory arthritis. Participants are over the age of 18 years and have Anti-CCP3 ≥ 40 units at screening.
- Study population: CCP-positive individuals without inflammatory arthritis
- Principal investigator: Dr. Jeffrey Sparks
- Samples available: blood and survey data (demographics, joint symptoms, MDHAQ, epidemiologic exposures, Food Frequency Questionnaire, PROMIS measures for physical, mental and social health)
- Target number of subjects: 200
Although pain is the most common presenting symptom of rheumatoid arthritis (RA), little is known about the role of central nervous system pathways in the clinical pain experience and drug response. This study examines the association between central pain mechanisms, the clinical pain experience and the assessment of treatment response in RA. The identification of central pain mechanisms associated with clinical pain and drug response will enable us to take the next step in tailoring pain management, using treatments targeted to specific pain pathways.
- Principal Investigator: Dr. Yvonne Lee
- Diseases: rheumatoid arthritis
- Samples available: blood, plasma and buffy coat, survey data (PROMIS measures (global health, pain intensity, pain interference, pain behavior, depression, anxiety, sleep disturbance, sleep-related impairment, fatigue), fibromyalgia survey questionnaire, pain catastrophizing scale) and quantitative sensory testing measures (pain thresholds, temporal summation, conditioned pain modulation) at baseline and approximately 12 weeks after DMARD initiation
- Target number of subjects: 272
This research study is determining whether certain clinical characteristics and different blood test markers of lung inflammation can predict disease characteristics and response to treatment in patients with RA and interstitial lung disease (ILD).
- Study population: rheumatoid arthritis with interstitial lung disease
- Principal Investigator: Dr. Paul Dellaripa
- Samples available: blood
BWH in collaboration with the National Institute of Environmental Health Sciences is studying antisynthetase syndrome, which often involves interstitial lung disease. Scientists believe that differences in environmental exposures or differences in individuals’ genetically predisposed responses to environmental exposures may determine whether or not they develop the disease. Patient Criteria: Recently developed (within 1 year) myositis associated with interstitial lung disease (ILD)
- Study population: idiopathic inflammatory myositis with interstitial lung disease
- Principal investigator: Dr. Paul Dellaripa
- Samples: blood, urine and survey data
This six month study seeks to provide insights into better clinical management of cardiovascular risk among patients with rheumatoid arthritis by determining if reduced inflammation is associated with reduced cardiovascular risk in rheumatoid arthritis, despite increases in low-density lipoprotein cholesterol (LDL-C) levels. All subjects have RA, are 35 years or older, biologic and tofacitinib DMARD-naive and cannot be taking a statin or PCSK9 inhibitor.
- Study population: rheumatoid arthritis starting a new disease-modifying antirheumatic drug
- Principal Investigator: Dr. Katherine Liao
- Samples: HAQ, DAS28, and cardiac PET scans
- Target number of subjects: 75
This randomized controlled trial will compare the effect two different RA treatment strategies on cardiovascular health. Patients who have poorly controlled RA on methotrexate will be randomized to receive a TNF inhibitor (etanercept or adalimumab) in addition to methotrexate or to take triple therapy (methotrexate + sulfasalazine + hydroxychloroquine). The primary outcome is FDG-PET/CT scan of the vasculature at 6 months.
- Study population: rheumatoid arthritis starting a new disease-modifying antirheumatic drug
- Principal Investigator: Dr. Daniel Solomon at BWH and Dr. Joan Bathon at Columbia University
- Samples: survey data, joint counts, DAS, CRP, blood, and FDG-PET/CT scans
- Target number of subjects: 200
BWH is conducting a research study to understand changes in mental and physical health and medication use among patients with lupus over time. Participants are at least 18 years or older, receive rheumatology care at Brigham and Women’s Hospital, and take any medication for lupus.
- Study population: systemic lupus erythematosus
- Principal Investigator: Dr. Candace Feldman
- Samples: survey data (demographics, Beliefs about Medications, SLAQ, Lorig Self Efficacy Scale, MMAS-8)
- Target number of subjects: 150
Gout is a common inflammatory arthritis caused by high uric acid levels. Recent evidence has shown that high levels of uric acid may also be associated with other health risks, especially increased risk of cardiovascular disease and type 2 diabetes. HUMETS is a study that investigates the associations between high levels of uric acid ans systemic inflammation, high blood sugar, impaired kidney function and cardiovascular disease.
- Study population: individuals with metabolic syndrome and elevated uric acid without gout (aged 40 years or older)
- Principal Investigators: Dr. Seoyoung Kim and Dr. Daniel Solomon
- Samples: survey data, including social variables, smoking history, and medical history; blood; and dual energy CT scans
- Target number of subjects: 50
The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial among first-degree relatives of rheumatoid arthritis (RA) patients who do not have RA to compare the willingness to change behaviors after an educational program. Consented subjects are randomized to receive two types of educational programs concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics and biomarkers or to receive standard RA information.
- Study population: individuals without rheumatoid arthritis who have a parent, sibling, or child with rheumatoid arthritis
- Principal Investigator: Dr. Elizabeth Karlson
- Samples available: baseline blood, PBMC samples; HLA DRB1 shared epitope/CCP/RF results (baseline); survey data collected at 5 time points (joint symptoms, perceived MDHAQ, affected RA proband characteristics/disease activity, RA risk knowledge/attitudes, decisional balance of RA-related behaviors, epidemiologic exposures, RA lifetime risk estimate)
- Number of subjects: 238
