Rheumatoid Arthritis

RHEUMATOID ARTHRITIS (RA)

Therapeutics

Pain Assessment

Markers of Disease and Response to Treatment

Disease Risk and Prevention

Peer Support 

Cardiovascular Risk in RA

 

THERAPEUTICS 

ALLURE (A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept versus Subcutaneous Adalimumab, Both with Background Methotrexate, in Biologic-Naïve Subjects with Rheumatoid Arthritis

Principal Investigator: Elena M Massarotti, MD
Contact: Jade Cumberbatch (nhcumberbatch@partners.org; 617-732-5354)

Funding Agency: Sanofi US

Study summary: The purpose of this research study is to test the safety and effectiveness of: 

  • Subcutaneous injections of abatacept (subcutaneous abatacept) in subjects who are treating RA with methotrexate

COMPARED TO

  • Subcutaneous injections of adalimumab (subcutaneous adalimumab) in subjects who are treating RA with methotrexate.

Patient criteria: Adults with Rheumatoid Arthritis (RA) who are treating their RA with methotrexate.

Patient remuneration: $50 for each study visit to cover parking and travel expense for that day.

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

Principal Investigator:  Jeffrey A. Sparks, MD, MMSc
Contact:  Maria Prado, MPH (617-525-8783, mprado@partners.org)
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. 

Subject Criteria:
     -18 years or older
     -Anti-CCP3 ≥ 40 units at screening

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

Patient Remuneration:  $60 per study visit plus a voucher for parking

Clinicaltrials.gov: NCT02603146

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SANOFI (A Randomized, Double-Blind, Double-Dummy Study Assessing the Safety and Tolerability of Sarilumab and Tocilizumab in Patients with Rheumatoid Arthritis who are Inadequate Responders to or Intolerant of TNF Antagonists)

Principal Investigator: Elena M Massarotti, MD
Contact: Jade Cumberbatch (nhcumberbatch@partners.org; 617-732-5354)

Funding Agency: Sanofi US

Study summary: We are doing this research study to find out if a new drug called sarilumab can help people with rheumatoid arthritis.  In this study, we will compare sarilumab to tocilizumab.  Tocilizumab (sold under the brand name Actemra) is approved by the FDA for the treatment of rheumatoid arthritis.

Patient criteria: Patients with rheumatoid arthritis who are inadequate responders to or intolerant of TNF antagonists.

Patient remuneration: We will pay you $350.00 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.

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PAIN ASSESSMENT

CPIRA (Central Pain in Rheumatoid Arthritis)

Principal Investigator: Yvonne Lee, MD, MMSc
Contact: Alyssa Wohlfahrt (617-525-8784; awohlfahrt@partners.org)

Funding Agency: NIH 
 
Study Summary: In a previous study, we demonstrated that central nervous system (brain and spinal cord) pain mechanisms are altered in rheumatoid arthritis (RA) patients compared to healthy controls. We are now trying to understand whether central nervous system regulatory mechanisms impact: 1) the experience of pain, and 2) the magnitude of response to RA medications.

Subject Criteria: RA patients who are starting a new RA medication. Patients may not have Raynaud’s phenomenon, peripheral neuropathy, or severe peripheral vascular disease. Patients may not participate if they take an opioid medication chronically or more than 10 mg of prednisone.

Visit Summary: 2 visits, 12 weeks apart, each 1.5 hours. The first study visit must occur before the participant starts his/her new RA medication. The second study visit occurs 12 weeks after visit 1. There are 3 phone call check-ins during the 12 week period. Each visit includes a blood draw, questionnaires, and three tests to assess pain levels: pressure applied to joint and non-joint sites, taps using a wire probe, and immersing the hand in ice cold water.

Patient Remuneration: $75 per study visit and a parking sticker.

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MARKERS OF DISEASE AND RESPONSE TO TREATMENT 

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

Principal Investigator: Nancy A. Shadick, MD, MPH

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

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

Principle Investigator: Yvonne Lee, MD, MMSc

Study Contact: Project Manager, Fengxin Lu (617-525-8786)

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.

Population and inclusion criteria:

  • RA patients ≥ 18 years old
  • Taking a stable disease-modifying antirheumatic drug (DMARD) for RA for 12 weeks
  • Own a smart phone (Android or iPhone operating system)
  • English-speaking
  • Be receiving follow-up care with a BWH rheumatologist

Study Visit Schedule:

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

*All study visits last about 30 minutes and are scheduled along with routine checkups

  • Initial call to set up app and interim phone calls for follow-up if necessary

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

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PEER SUPPORT

PARASS (Patient Rheumatoid Arthritis Social Support Initiative)

Principal Investigator: Nancy A. Shadick, MD, MPH

Contact: Hannah Tadley (htadley@partners.org; 617-525-6608)

Funding Agency:  Amgen

Study Summary: Peer Support program where patients who are newly diagnosed or are having trouble with their RA can talk on the phone with a trained peer coach who also has RA. Coaches and Partners usually talk between once a week and once a month for a maximum of 6 months. Also looking for experienced patients comfortable talking about their RA who are interested in becoming a peer coach.

Patient Criteria: Over 18, diagnosis of Rheumatoid Arthritis

Visit Summary: Partners fill out application and pre-evaluation to begin and post-evaluation 6 months later. Coaches fill out application and attend 3 hour training session with a social worker. No in-person visits are necessary except for training for Coaches, the applications and questionnaires can be filled out through the mail.

Patient Remuneration: Partners receive $5 when sent post-evaluation. Coaches receive parking remuneration for training.

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Cardiovascular Risk In RA

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

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

Contact: Alyssa Wohlfahrt (617-525-8784; awohlfahrt@partners.org)

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 continue 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 three months. Subjects cannot have ever taken a biologic DMARD (e.g. Enbrel, Humira) or be taking a statin (cholesterol-lowering drug), had a cardiovascular event (e.g. heart attack, stroke), or have 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: $50 per study visit, free RA medications over the course of the trial, a TARGET tote and other TARGET paraphernalia

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LiiRA (Lipids, Inflammation and cardiovascular risk in Rheumatoid Arthritis)

Principal Investigator: Katherine Liao, MD, MPH

Contacts: Tim Chan (617-732-8169) and Gabrielle Cremone (617-525-7495)

 

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), 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.

 

Clinical Trials.gov: NCT02714881

For more details, visit: www.liira.org

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