The overarching goal of this trial is to examine the effect of RA disease modifying drugs (DMARDs) on vascular inflammation. We will accomplish this goal by comparing two treatment regimens for RA in the setting of an RCT in patients with inadequate response to methotrexate (MTX) monotherapy. These are: a tumor necrosis factor inhibitor (TNFi) + MTX versus triple therapy (MTX + sulfasalazine [SSZ] + hydroxychloroquine [HCQ]). The trial design is a two-arm RCT with blinded joint assessment and blinded FDG PET/CT readers. Subjects and rheumatologists will be unblinded to treatment assignment but will be blinded to FDG PET/CT results. Joint count assessors will be blinded to treatment assignment. The trial will be conducted at multiple sites across the US, with a duration of six months. Recruitment will be over 24 months with six more months of follow-up.
|Effective start/end date||9/28/15 → 6/30/19|
- Brigham and Womens Hospital (ps#113296//5U01AR068043-03 REVISED)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (ps#113296//5U01AR068043-03 REVISED)