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Precision Dosing for Crohn's Disease with Infliximab

This study is looking at a new way to give infliximab, a medicine for Crohn's disease (a type of inflammatory bowel disease). It compares a computer program called RoadMAB, which helps doctors give you a personalized dose of infliximab based on your blood tests (precision dosing), to the standard way of giving infliximab (conventional dosing). The goal is to see if precision dosing can better help patients achieve deep remission, meaning both their symptoms improve and their intestines heal. The study plans to enroll 180 participants aged 6 to 22 years old who have been recently diagnosed with Crohn's disease. The study's status is currently unclear.

Study design
This is an open-label, cluster randomized clinical trial, meaning participants will be assigned to one of two groups by chance, and both you and your doctor will know which treatment you are receiving. It aims to enroll 180 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at Week 52, which suggests participants will be followed for at least one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05660746

Precise Infliximab Exposure and Pharmacodynamic Control

Recruiting
PHASE2Ages 6–22InterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~180 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:RoadMABInfliximab

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Deep Remission
Measured over Week 52

Conditions

Crohn Disease

Explore related trials

Crohn Disease

Where it's being run

11 sites across 7 states
California3
Ohio3
Delaware1
Florida1
Indiana1
Virginia1
Wisconsin1

Study leadership

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

Who to contact

Phillip Minar, MD, MS
[email protected]
513-636-4415
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

(1) PCDAI≥10 (\<18 years old) or CDAI ≥150 (≥18 years old) in last 60 days before the decision to start infliximab
(2) SES-CD\>6, or SES-CD\>3 for isolated ileal disease (or a report of large intestinal ulcerations)\* within the last 60 days or a fecal calprotectin \>250 μg/g within last 75 days prior to screening 6. C-reactive protein \>1.0 mg/dL in last 30 days and/or fecal calprotectin \>250 μg/g within last 75 days prior to screening 7. Negative TB (tuberculosis) interferon-gamma release test and a negative urine pregnancy test for female patients (if menstruation has started)

What this trial measures

  • Rate of Deep RemissionWeek 52

    Pediatric Crohn's disease activity index (PCDAI) \<10 (child) or Crohn's disease activity index\<150 (adult), off prednisone/budesonide for \>8 weeks and Simple Endoscopic Scorer Crohn's Disease (SES-CD) SES-CD≤2