Precision IFX: Using a Dashboard to Individualize Infliximab Dosage
Completed · Not applicable
Conditions studied: Inflammatory Bowel Disease
In brief
The introduction of infliximab (IFX) and other monoclonal antibodies (MAbs) targeting tumor necrosis factor (TNF) was a major advancement in the management of inflammatory bowel disease (IBD). These biologics were able to improve the health outcomes of many IBD patients for whom other treatments were neither satisfactory nor sufficient. Despite clear advantages and increased use of these treatments, physicians still see a loss of response in up to 50% of their IBD patients within one year of initiating these therapies. Most of these phenomena are attributed to low drug concentrations in the presence or absence of anti-drug antibodies (ADA). The fundamental issue is that approved/on-label dosing of these drug therapies does not take into account the various factors that impact the way an individual's body responds and processes these therapies. Dashboard software systems can quickly integrate patient data and serve as a revolutionary decision-support tool for physicians. The Precision IFX dashboard prototype was specifically developed to facilitate dosing of therapeutic monoclonal antibodies by integrating patient's clinical characteristics and drug concentrations into pharmacokinetic (PK) algorithms. Using clinical observations and patient laboratories, the system provides multiple dosing regimens that could allow the patient to attain and sustain a therapeutic drug trough level. Using the Precision IFX dashboard to analyze and forecast optimal dosing regimens with prospectively collected individual patient data, the clinician will select an appropriate dose to actively maintain therapeutic drug trough levels throughout the infliximab maintenance period. This study aims to examine the outcomes of one year of maintenance infusions in IBD patients dosed using the Precision IFX dashboard prototype and compare the results with historical controls.
Key facts
- Study ID
- NCT02624037
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 189
- Starts
- 2015-01-01
- Expected to finish
- 2020-10-21
- Last updated by the study team
- 2021-05-18
Who can join
Age: 6 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with Inflammatory Bowel Disease
- Patients at least 6 years of age, upper limit of 45 years old
- Recently Indicated for (or already scheduled for) infliximab induction as per standard-of-care by treating gastroenterologist
- Patient consent/assent and/or parent/guardian consent
You may not qualify if…
- Patients do not consent to participate in study
- Patients unable to comply with protocol
Where it is running
- Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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