RecruitingPhase 2Phase 3NCT05660746

Precise Infliximab Exposure and Pharmacodynamic Control

Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric Crohn's Disease


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

180 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease (CD). There are limited treatment options approved for use in children and adults with Crohn's disease. Physicians need better ways to inform decisions on treatment. The main reason for this research study is to determine if a computer program that calculates an individualized dose based on a patient's blood testing results (precision dosing) can better achieve the best possible response to infliximab compared to standard dosing (conventional dosing).


Eligibility

Min Age: 6 YearsMax Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study looks at the best way to dose infliximab (a biologic medication used to treat Crohn's disease) in children and young adults. Instead of using a fixed dose, researchers want to monitor drug levels in the blood and adjust doses individually to achieve better control of inflammation with fewer side effects. **You may be eligible if...** - You are 6–22 years old - You have been newly diagnosed with Crohn's disease within the last 90 days - You have never taken a biologic medication (like infliximab or adalimumab) before - You have active Crohn's disease confirmed by a colonoscopy or blood/stool tests - You have a negative tuberculosis (TB) test - If you are female and have started menstruating, you have a negative pregnancy test **You may NOT be eligible if...** - You have ulcerative colitis or indeterminate colitis (not Crohn's) - You have already received any biologic medication - You have had a recent abscess, internal fistula, or bowel complication requiring surgery - You have an active serious infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERoadMAB

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.

DRUGInfliximab

Conventional dosing. Induction: 5-7.5 mg/kg at 0, 2, and 6 weeks. Maintenance: 5-10 mg/kg at every 4-8 weeks based on results of drug concentration monitoring for a flat target of 5-10 μg/mL. Precision dosing. Induction: 5-12.5 mg/kg at 0, 2, and 6 weeks to target a week6 concentration of 18-24 μg/mL with dosing support provided by the RoadMABTM clinical decision support tool. Maintenance: 5-15 mg/kg every 4-8 weeks to achieve apriori pharmacokinetic and pharmacodynamic targets (CRP, disease activity scores and fecal calprotectin) with dosing support provided by the RoadMABTM clinical decision support tool.


Locations(11)

Children's Hospital of Los Angeles

Los Angeles, California, United States

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Rady Children's Hospital San Diego

San Diego, California, United States

Nemours Children's Health System-Wilmington

Wilmington, Delaware, United States

Nemours Children's Health System-Jacksonville

Jacksonville, Florida, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Cleveland Clinic Children's Hospital

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Specialty Group

Norfolk, Virginia, United States

Medical College of Wisconsin, Children's of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05660746


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