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 subcutaneous). Both treatment strategies (under study) are in wide clinical use for treatment of patients with active RA with an inadequate response to MTX. This study will assess the impact of TNF-First treatment strategy vs. comparator on physical function (primary outcome), disease activity, inflammation (C-reactive protein), sleep, fatigue, quality of life, treatment satisfaction and adverse events. If the score on the Clinical Disease Activity Index (CDAI) decreases by ≥6 (moderate activity) or by ≥12 (high activity) at 4-months, the initial therapy will be continued. If CDAI improvements are lower, patient will be switched to the alternative regimen at 4-months. Participants will continue to receive nonsteroidal anti-inflammatory drugs (NSAIDs) and prednisone (up to 10 mg/day of prednisone of equivalent). For serious AEs or safety risk, patients can switch to the other arm sooner than 4-months, and in rare cases, be dropped from the study for patient safety.
|Effective start/end date||5/1/21 → 4/30/22|
- University of Alabama at Birmingham (00528200-SC0022-Rud//CER-2020C1-19193)
- Patient-Centered Outcomes Research Institute (00528200-SC0022-Rud//CER-2020C1-19193)
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