NCT04974099

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 6 Years – 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Pilot study to evaluate safety, feasibility and efficacy of utilizing pharmacokinetic modeling to provide an individualized infliximab induction regimen in children and young adults with moderate to severe Crohn's disease. This clinical study is designed with the hypothesis that treatment regimens that account for individual (patient) drug clearance (pharmacokinetic modeling) will not only be safe and cost-effective, but also more effective in reducing intestinal inflammation than as-labeled dosing (ALD) regimens.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2021-07-23
• Last updated: 2026-03-11
• Results posted: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study