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A Non-Interventional Chart Review of EMPOWER CEP: Utility of a Precision-Guided Dosing Laboratory Developed Diagnostic Test for the Dose Optimization of Infliximab in a Real-World Inflammatory Bowel Disease Population

A Non-Interventional Chart Review of EMPOWER CEP: Utility of a Precision-Guided Dosing Laboratory Developed Diagnostic Test for the Dose Optimization of Infliximab in a Real-World Inflammatory Bowel Disease Population

  • Clinical Trial Information

    Trial Contact: Garcia de Djuro, Ginette; Shepherd, Adriane R

    Trial Phone: 321.841.6649 ; 321 841-2285

  • IRB No: Pending

    Protocol Abbrev: Empower-IFX-CEP

    Principal Investigator: Udayakumar Navaneethan, MD

    Age Group: Adult

    ClinicalTrials.gov ID: PENDING

  • Objective

    To determine the actual treatment disposition based on survey results on desired
    modifications to the treatment plan as reported by the participating gastroenterologist
    that utilized the laboratory developed diagnostic test (PredictrPK® IFX – PPK IFX;
    Prometheus Laboratories, Inc.) in their clinical care pathway of their inflammatory
    bowel disease (IBD) patients receiving infliximab (IFX) treatment.
    (2) Describe and compare the real-world IBD-related outcomes and reasons for these
    healthcare resource utilization (hospitalization, MD/ER visits, surgery, procedures),
    flare management, and status of IBD and adherence to patient’s biologic treatment
    before and after 1st PredictrPK® IFX testing.

  • Key Eligibility

    Inclusion Criteria:
    1. Males and females with a confirmed diagnosis of IBD that met the inclusion
    criteria for the EMPOWER CEP that received IFX treatment with or without
    concomitant immunotherapy.
    DocuSign Envelope ID: 27D11989-97B7-4018-B49C-909FFD41A93F
    Prometheus Laboratories Inc. 01 March, 2023
    Study Protocol: 23IBDRWD01
    Confidential Page 7 of 18
    2. A 12 month of history and continuous enrolment data prior to and 12 month
    of continuous enrolment data after the first EMPOWER CEP PredictrPK IFX
    test.
    3. Availability and access to patient charts