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Title A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients with Rheumatoid Arthritis
Therapeutic Area Rheumatoid Arthritis
Principal Investigator Timothy E. McAlindon, MD, MPH
Min Age 18 Years
Gender Any
Contact Sarah Pilgrim, Study Coordinator
More Information


The purpose of the study is to assess whether the addition of a TNFi-biologic (tumor necrosis factor inhibitor) medication to methotrexate (MTX) is superior to adding a targeted synthetic DMARD (disease-modifying anti-rheumatic) medication to MTX for people with active RA despite current MTX treatment.

Study Details

Inclusion Criteria

  1. Patients with active, disabling RA despite the use of methotrexate ≥3 months
  2. If receiving glucocorticoids or NSAIDs, on stable doses for ≥2 weeks
  3. Insurance plan allows access to at least 1 drug in each of the two treatment strategies, TNFi-biologic vs. tsDMARD

Exclusion Criteria

  1. Use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2 months
  2. Prior treatment with a TNFi-biologic, non-TNFi biologic, or targeted synthetic DMARD
  3. History of HIV 

Study Requirements

This study involves up to 6 regularly scheduled clinic visits to Tufts over the course of 12 months. We will collect information about symptoms. At each visit, blood (about 2 teaspoons) and a urine sample will be collected. Patients will receive compensation for their time for study participation, $60 at the baseline visit and $50 for each subsequent visit.