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
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Clinical Trial Information
Trial Contact: Garcia de Djuro, Ginette; Shepherd, Adriane R
Trial Phone: 321.841.6649 ; 321 841-2285
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IRB No: Pending
Protocol Abbrev: EMPOWER IFX CEP
Principal Investigator: Udayakumar Navaneethan, MD
Age Group: Adult
ClinicalTrials.gov ID: PENDING
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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
