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Personalized Infliximab Induction Strategy With Model-informed Dosing in Patients With Crohn's Disease

NCT04974099 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-03-11

Study results available
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Summary

Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease, with many of those being young children and adolescents. Physicians need better ways to inform decisions on treatment.

The main reason for this research study is to determine if a computer program that formulates a dose based on a patient's blood testing results can better achieve the optimal drug level as compared to standard dosing.

Conditions

  • Crohn Disease

Interventions

DEVICE

RoadMAB precision dashboard

The RoadMAB Dashboard is a real-time decision support system that incorporates PK model-informed Bayesian estimation to provide precision dosing at the point of care.

DRUG

Infliximab precision dosing

The trial is testing whether precision dosing can more reliably achieve the targeted trough concentrations compared to standard dosing

Sponsors & Collaborators

  • Crohn's and Colitis Foundation

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Phillip Minar, MD, MS · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-08-01
Completion
2024-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04974099 on ClinicalTrials.gov