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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05660746
The ClinicalTrials.gov registry entry for NCT05660746 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (11% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
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 reports 11 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.