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NCT05660746 · ClinicalTrials.gov registry record · Phase 2
Precise Infliximab Exposure and Pharmacodynamic Control
A Phase 2 study of Crohn Disease, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 11
- Study locations
NCT05660746: Recruiting Phase 2 study of Crohn Disease, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT05660746 is a Phase 2 study of Crohn Disease that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 180 participants, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (11% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05660746, a Phase 2 study of Crohn Disease, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 11
- Study locations
Study 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).
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Infliximab
- DEVICE RoadMAB
Study Locations (11)
California
- Children's Hospital of Los Angeles - Los Angeles
- Lucile Packard Children's Hospital Stanford - Palo Alto
- Rady Children's Hospital San Diego - San Diego
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Cleveland Clinic Children's Hospital - Cleveland
- Nationwide Children's Hospital - Columbus
Delaware
- Nemours Children's Health System-Wilmington - Wilmington
Florida
- Nemours Children's Health System-Jacksonville - Jacksonville
Indiana
- Riley Hospital for Children - Indianapolis
Virginia
- Children's Specialty Group - Norfolk
Wisconsin
- Medical College of Wisconsin, Children's of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2023-07-01 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
What NCT05660746 shows while recruiting
NCT05660746 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which Infliximab is the first listed.
NCT05660746 lists 11 locations in 7 states (California, Ohio, Delaware).
Frequently Asked Questions
What is clinical trial NCT05660746 about?
NCT05660746 is a clinical study titled "Precise Infliximab Exposure and Pharmacodynamic Control". 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 ma...
What is the current status of trial NCT05660746?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2023-07-01. Estimated completion is 2027-03-31.
What conditions does trial NCT05660746 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT05660746?
The interventions under investigation include: Infliximab (DRUG), RoadMAB (DEVICE).
Who is sponsoring clinical trial NCT05660746?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05660746 being conducted?
This trial has 11 study locations across California, Delaware, Florida, Indiana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05660746's enrollment target sits among peer trials
180 23rd of 71 higher than 49 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease 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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A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
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