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Rheumatoid Arthritis

BRASS (Brigham and Women’s Rheumatoid Arthritis Sequential Study)

Principal Investigator: Nancy A. Shadick, MD, MPH

Study Contact: Joshua Colls (jcolls@bwh.harvard.edu)

Funding Agency: Crescendo Bioscience, MedImmune, Bristol Myers Squibb

Study Summary: The BRASS registry began recruitment in March 2003 establishing a prospective observational cohort of over 1,100 rheumatoid arthritis patients in order to:

  • Determine and validate biomarkers that predict drug response and toxicity in rheumatoid arthritis.
  • Determine and validate biomarkers that predict disease activity and prognosis in rheumatoid arthritis.
  • Evaluate the natural history of treated rheumatoid arthritis by measuring clinical, functional and economic outcomes.

Patient Criteria: Patients will be eligible to participate in the study if they are 18 years of age or older; are a patient registered at the R.B. Brigham Arthritis Center; have, at the time of enrollment, a diagnosis of RA made by a board-certified rheumatologist; are able and willing to provide informed consent.

Visit Summary: BRASS study visits are done on an annual basis and coincide with a regularly scheduled rheumatology appointment. Study visits take between 20 and 30 minutes and include a blood draw. Hand x-rays are done at baseline, year 2, year 5, year 7, and year 10.

Patient Renumeration: Parking

LiiRA (Lipids, Inflammation and Cardiovascular Risk in Rheumatoid Arthritis)

Principal Investigator: Katherine Liao, MD, MPH

Study Contacts: Thany Seyok (617-732-8169; tseyok@bwh.harvard.edu)

Funding Agency: NIH

Study Summary: Patients with RA are at 2x risk for heart disease compared to the general population. We believe chronic inflammation is a major driver for elevated heart disease risk, and that inflammation also worsens cholesterol profiles. The objective of LiiRA is to study the link between inflammation, cholesterol and heart disease. Data from this study will help us identify ways to reduce the risk of heart disease for patients with RA.

Subject Criteria: RA patients with active disease planning to start TNFi therapy. Patients may not participate if they are currently taking a statin, ³10mg prednisone (or equivalent), treated for cancer in the last five years, have chronic infection (e.g. tuberculosis, hepatitis B or C), had a coronary artery bypass graft (CABG), have chest pain, shortness of breath, or severe valvular heart disease.

Visit Summary: Four visits over 24 weeks (baseline, 6, 12 and 24 weeks). The first and last visit will include a cardiac PET scan and will take about 3.5 hours. The two middle visits will take about 30 minutes. All the visits will include a questionnaire, joint exam, and blood tests.

Patient Remuneration: $350 total for the study; $100 for the first and last visits, $75 for the two middle visits. Certolizumab (Cimzia), a TNFi, will be provided free of charge during the study. Reimbursement for parking or taxi vouchers.