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RESPONDR ™ TNF EMPOWER

RESPONDR ™ TNF EMPOWER

  • Clinical Trial Information

    Trial Contact: Tilme, Linda

    Trial Phone: 321.843.5278

  • IRB No: 24.112.08

    Protocol Abbrev: Respondr TNF test

    Principal Investigator: Akash Pandey, MD

    Age Group: Pediatric

  • Objective

    1. Assess how health care providers (HCPs) integrate Respondr™ TNF into the clinical care
    pathway for patients with inflammatory bowel disease (IBD) who may be considered for
    biologic treatment, including anti-tumor necrosis factor antibodies (anti-TNF) such as
    infliximab or adalimumab and their biosimilars (referred to collectively as IFX and ADA,
    respectively).
    2. Assess the impact of Respondr TNF test results on HCP’s clinical decision-making.
    3. Evaluate patient outcomes at the first follow-up visit based on the patient’s standard of care
    after incorporating Respondr TNF test results into treatment decisions.
    4. Measure overall HCP satisfaction with the Respondr TNF test.

  • Key Eligibility

    The Respondr TNF test will be available to patients being considered for biologic therapy.
    The test predicts an individual patient’s likelihood of responding to anti-TNF therapies prior
    to treatment initiation. This information assists in therapy selection and patient management
    decisions, ultimately improving the likelihood of a patient achieving remission and doing so
    faster. The test considers intrinsic clearance and genetics to identify patients at an increased
    risk of poor anti-TNF response, immunogenicity, and inadequate disease control to evaluate
    likelihood to respond to anti-TNF therapies prior to treatment.