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NCT04974099 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.

Terminated
Registry status
Phase 2
Development phase
6
Enrollment target

NCT04974099: Clinical Trial Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT04974099 is a Phase 2 study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04974099, a Phase 2 study, was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.

TERMINATED
Registry status
Phase 2
Development phase
6 participants
Enrollment target

Study 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.

Primary Outcome

Percentage of total patients adverse and/or serious adverse events

Interventions

  • DEVICE RoadMAB precision dashboard
  • DRUG Infliximab precision dosing

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2021-10-01
Est. Completion 2024-08-01
Phase Phase 2

Why NCT04974099 stopped before completion

NCT04974099 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which RoadMAB precision dashboard is the first listed.

NCT04974099 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04974099 about?

NCT04974099 is a clinical study titled "Personalized Infliximab Induction Strategy With Model-informed Dosing in Patients With Crohn's Disease". 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 determ...

What is the current status of trial NCT04974099?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2021-10-01. Estimated completion is 2024-08-01.

What interventions are being tested in trial NCT04974099?

The interventions under investigation include: RoadMAB precision dashboard (DEVICE), Infliximab precision dosing (DRUG).

Who is sponsoring clinical trial NCT04974099?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04974099's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04974099, the US trial registry maintained by the National Library of Medicine. NCT04974099 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.