Precision IFX: Using a Dashboard to Individualize Infliximab Dosage

NCT02624037 | Completed

• 1 other identifier: GCO 15-1475
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel Disease, Ulcerative Colitis; Crohn's Disease; Pharmacokinetics, Individualized Dosage, Dashboard System; Remicade, Infliximab

Outcome Measures

Primary Outcomes (1)

• drug trough levels

  use of Precision IFX dashboard - frequency of attaining and maintaining target drug trough levels

  Week 54

Secondary Outcomes (1)

• anti-drug antibody level

  Week 54

Study Arms (1)

Individualized Dosage Precision IFX Dashboard

EXPERIMENTAL

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

Interventions

Individualized Dosage Precision IFX Dashboard OTHER

Pharmacokinetic Dashboard Recommended Dosage and Dosing Frequency of Infliximab

Individualized Dosage Precision IFX Dashboard

Eligibility Criteria

• Age: 6 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Prometheus Laboratories: collaborator

Study Sites (1)

Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center

New York, New York, 10029, United States

Location

Related Publications (18)

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MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Marla C Dubinsky, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics Gastroenterology

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 8, 2015
• Study Start: January 1, 2015
• Primary Completion: October 21, 2020
• Study Completion: October 21, 2020
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

US (1)