Rheumatoid Arthritis

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

Principal Investigator: Nancy A. Shadick, MD, MPH 

Study Contact: Christine Iannaccone (617-732-5083; ciannaccone@partners.org)

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: Ethan Lam (617-732-8169; elam3@bwh.harvard.edu); Charlotte Golnick (cwestgolnik@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.

 

StopRA (Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis)

Principal Investigator:  Jeffrey A. Sparks, MD, MMSc

Study Contact: Maura Friedlander (617-264-5901; StopRA@bwh.harvard.edu)

Funding Agency: Autoimmunity Centers of Excellence, NIH/NIAID

Study Summary: We are conducting a 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.

Patient Criteria: Patient 18 years or older with positive CCP at >2x the upper limit of normal and does not have rheumatoid arthritis.

Visit Summary: Participants will first complete 12 months of HCQ or placebo. During this year, participants will be asked to do a screening study visit, 6 study visits and 3 phone evaluations.  Participants will then be followed for another 2 years of study drug during which they will be asked to do 2 study visits and 2 phone evaluations each year. 

Patient Remuneration: $70 per study visit, plus a voucher for parking.

 

TARGET (Treatments Against RA and Effect on FDG-PET/CT)

Principal Investigator: Daniel Solomon, MD, MPH  and Joan Bathon, MD

Study Contact: Fengxin Lu (617-525-8786; flu1@bwh.harvard.edu)

Funding Agency: NIH

Study Summary: Cardiovascular disease is the biggest health risk facing rheumatoid arthritis (RA) patients. We aim to determine if and how two RA treatments affect levels of cardiovascular inflammation and cardiac risk, with the hope of lowering this risk in future RA patients. Participants will be randomly assigned to take sulfasalazine and Plaquenil, Enbrel, or Humira in addition to methotrexate.

Subject Criteria: RA patients whose symptoms persist despite being on methotrexate for two months. Subjects cannot have taken a biologic DMARD (e.g. Enbrel, Humira) in the past six months, had a cardiovascular event (e.g. heart attack, stroke), or have insulin-dependent diabetes. Men must be at least 45 years old and women must be at least 50 years old.

Visit Summary: Six study visits, plus two FDG-PET/CT scans. The first visit will determine eligibility. The first scan will take place before the subject starts treatment. Remaining visits will occur every six weeks, lasting until the final scan and visit at 6 months. A typical study visit includes a blood draw, vitals, questionnaires, and a joint assessment.

Patient Remuneration: $350 total ($50 per study visit), travel reimbursement, parking during study visits, and free RA medications over the course of the trial.

 

RA Flare Study (A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares) (Closed to Enrollment)

Principal Investigator: Daniel Solomon, MD, MPH  

Study Contact: Fengxin Lu (617-525-8786; flu1@bwh.harvard.edu)

Funding Agency: Pfizer

Study Summary: We are conducting a 24-week study using a smartphone app and a care manager to monitor disease activity in individuals with rheumatoid arthritis (RA). Participants will answer 4 daily questions on their phones and complete a total of 3 visits (1 baseline visit and 2 follow-up visits) at the hospital. Our goal is to improve the assessment of RA disease activity between scheduled patient visits. This study does not substitute for routine clinical care. Half of the participants will receive the app, and half will not receive the app.

Patient Criteria: Rheumatoid Arthritis (RA) patients age 18 years and older taking a stable disease-modifying antirheumatic drug (DMARD) for 12 weeks. They must own a smartphone, be English-speaking and receive follow-up care with a BWH rheumatologist.

Visit Summary and Schedule: All study visits last about 30 minutes and are scheduled along with routine checkups with an Initial call to set up app and interim phone calls for follow-up if necessary.

  • Baseline session (Week 0)
  • Study Visit 1 (Week 12)
  • Study Visit 2 (Week 24)

Patient: Renumeration: Participants will receive $40 per visit and parking validation.

 

SANOFI Extension (Closed to Enrollment)

Principal Investigator: Elena M Massarotti, MD   

Funding Agency: Sanofi US

Study Contact: Jung Lee (617-525-7654; jlee181@partners.org)

Study Summary: A multi-center, uncontrolled extension study evaluating efficacy and safety of sarliumab on top of disease-modifying antirheumatic drugs (DMARDs) in patients with active rheumatoid arthritis. This is the extension study of the Sanofi study and is open label, which means you will know what treatment you will be getting.

Patient Criteria: Patients with rheumatoid arthritis who are inadequate responders to or intolerant of TNF antagonists and have completed the parent study and have completed the parent study of sarilumab.

Visit Summary: The visits will take place at the Rheumatology Clinic at BWH. We will ask you to make 29 study visits over 264 weeks (about 5 years). If the drug is not commercially available by the end of these 264 weeks, you can continue the study until that point in time or until 2020 when the study will be closed.

Patient Remuneration: We will pay you $750.00 if you complete the study. If you do not complete the study, we will pay you $25 per visit for each visit you complete plus $50 if you complete the final study visit.