A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients with Rheumatoid Arthritis: The RAPRO PRagmatic trial (RA-PROPR)

When funded, this will be a 4-year PCORI contract with no allowance for no-cost extension. PCORI contract mandates adherence to strict milestones and deliverables from the primary site. The anticipated period of funding is from Aug 2021 to July 2024. We need 1 person randomized per site per month for the 28-month randomization period (n=26 at least per site; randomized in years 1-3 of the contract period). Sites will oversample for people 50 years of younger to get every other patient randomized to be in this age group. RA-PRO is a 12-month, 2-arm, open-label, RCT pragmatic study to test whether adding TNF- biologic strategy is superior to the alternative approach of small molecule Jak-kinase inhibitor in RA patients with active disease despite adequate trial of methotrexate, i.e. MTX-inadequate responder (IR), in a variety of clinical care settings across the U.S. at multiple sites. There is equipoise between these two strategies in RA. Patients with active RA despite a stable MTX dose of at least 15 mg weekly (oral or subcutaneous) for at least 3-months will be recruited at 28-30 geographically-diverse RA/rheumatology clinics in the U.S. All study procedures, including study enrollment including randomization, patient assessments including surveys, and study follow-up assessments will be done at the time of regular clinic visits by the patients. Both strategies are standard of care treatment options in MTX-IR. All standard care costs (medication, laboratory monitoring etc.) will be covered by patient’s insurance coverage (or patient assistance programs), as the standard of care practice. Participants randomized/assigned to each arm will be started on the standard approved doses of one of the small molecule Jak-kinase inhibitor or one of the TNFi-biologic as chosen by the patient-physician dyad, based on age/sex/comorbidity and preferences (self-injections vs. IV; frequency; type of drug) and insurance co-pay/deductible, added to background MTX (oral or subcut