Precision IFX: Using a Dashboard to Individualize Infliximab Dosage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02624037
Recruitment Status : Recruiting
First Posted : December 8, 2015
Last Update Posted : December 24, 2018
Prometheus Laboratories
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Other: Individualized Dosage Precision IFX Dashboard Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Precision IFX: Using a Pharmacokinetic Dashboard to Optimize and Individualize Infliximab Dosage for Pediatric Inflammatory Bowel Disease Patients
Study Start Date : January 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: Individualized Dosage Precision IFX Dashboard
A clinician will select a dose and dosing frequency that is populated by a pharmacokinetic dashboard system that monitors and aims to dose patients to maintain a target trough infliximab concentration. Dosage and dosing frequency may vary from each patient.
Other: Individualized Dosage Precision IFX Dashboard
Pharmacokinetic Dashboard Recommended Dosage and Dosing Frequency of Infliximab

Primary Outcome Measures :
  1. drug trough levels [ Time Frame: Week 54 ]
    use of Precision IFX dashboard - frequency of attaining and maintaining target drug trough levels

Secondary Outcome Measures :
  1. anti-drug antibody level [ Time Frame: Week 54 ]
    use of Precision IFX dashboard reduce - frequency of anti-drug antibody development prior to one year of maintenance therapy

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients do not consent to participate in study
  • Patients unable to comply with protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02624037

Contact: Becky L Phan, BSc 212-824-7785
Contact: Marla C Dubinsky, MD 212-241-5415

United States, New York
Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center Recruiting
New York, New York, United States, 10029
Contact: Becky L Phan, BSc    212-842-7785   
Principal Investigator: Marla C Dubinsky, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Prometheus Laboratories
Principal Investigator: Marla C Dubinsky, MD Icahn School of Medicine at Mount Sinai

Holford SD, Holford NHG, Anderson BJ. Online dose calculation tool for determining dosing regimens in the very young. PAGANZ website. Accessed July 5, 2013.
Shaw G. Clinical modeling hits prime time. Drug Discovery and Development website. Published September 6, 2007. Accessed July, 5 2013.
Xu Z, Mould DR, Hu C, Ford J, Keen M, Davis HM, Zhou H. "A Population-Based Pharmacokinetic Pooled Analysis of Infliximab in Pediatrics" ACCP National Meeting 2012 San Diego CA.

Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT02624037     History of Changes
Other Study ID Numbers: GCO 15-1475
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
Inflammatory Bowel Disease, Ulcerative Colitis
Crohn's Disease
Pharmacokinetics, Individualized Dosage, Dashboard System
Remicade, Infliximab

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents