RA-PRO PRAGMATIC TRIAL (RA-PROPR)

STUDY OVERVIEW

The study conducted by the University of Alabama at Birmingham aims to address current treatment gaps in rheumatoid arthritis by comparing patient-reported outcomes when switching from a TNFi-biologic to either a non-TNFi biologic or a targeted synthetic DMARD, as recommended by the 2021 ACR guidelines.

STUDY GOALS

To address current treatment gaps and inform clinical decision-making, this study aims to compare patient-reported outcomes and safety profiles between non-tumor necrosis factor biologics and targeted synthetic DMARDs in patients with active rheumatoid arthritis despite prior TNFi-biologic therapy.

LOCATION

El Paso, Texas: Texas Arthritis Center

INCLUSION CRITERIA

  • Patients must have active, disabling rheumatoid arthritis (CDAI ≥10 and HAQ ≥0.5) despite using a TNFi-biologic for ≥3 months, or having discontinued such medication(s) due to intolerability or toxicity before the first dose of study drug.

  • If using glucocorticoids (≤10 mg/day prednisone or equivalent) or NSAIDs, they must be on stable doses for ≥2 weeks prior to randomization.

  • Participants must have access to at least one drug from each of the two treatment strategies (TNFi-biologic vs. targeted synthetic DMARD) through insurance or a patient assistance program.

exclusion criteria

  • Previous treatment with more than three biologics (TNFi or non-TNFi biologics).

  • Previous treatment with targeted synthetic DMARDs.

  • Concurrent use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2 months before randomization.

  • History of hypersensitivity to all four non-TNF biologics or targeted synthetic DMARDs.

  • Glucocorticoid injections (IV, IM, or intraarticular) within 1 month of study entry.

  • Receipt of a live vaccine within 90 days of study entry.

  • Acute or chronic infections requiring parenteral antibiotics or hospitalization (including tuberculosis, bacterial sepsis, invasive fungal infections) within 1 month, or oral antibiotics within 2 weeks of study entry.

  • History of HIV or any opportunistic infection.

  • New York Heart Association Class III or IV heart failure.

  • Known latent TB without anti-tubercular treatment initiation.

  • Untreated hepatitis B or C infection.

  • History of deep venous thrombosis or pulmonary embolism.

  • Pregnant or nursing women.

  • History of herpes zoster or shingles.

For more information, visit ClinicalTrials.gov.