Precise Infliximab Exposure and Pharmacodynamic Control
NCT05660746
This study is recruiting at 11 US sites in 7 states, according to its ClinicalTrials.gov record last updated .
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Crohn Disease
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2/3
- Ages
- 6 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Last updated on ClinicalTrials.gov
- May 5, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 3
- Children's Hospital of Los Angeles · Los Angeles, CA
- Lucile Packard Children's Hospital Stanford · Palo Alto, CA
- Rady Children's Hospital San Diego · San Diego, CA
Delaware · 1
- Nemours Children's Health System-Wilmington · Wilmington, DE
Florida · 1
- Nemours Children's Health System-Jacksonville · Jacksonville, FL
Indiana · 1
- Riley Hospital for Children · Indianapolis, IN
Ohio · 3
- Cincinnati Children's Hospital · Cincinnati, OH
- Cleveland Clinic Children's Hospital · Cleveland, OH
- Nationwide Children's Hospital · Columbus, OH
Virginia · 1
- Children's Specialty Group · Norfolk, VA
Wisconsin · 1
- Medical College of Wisconsin, Children's of Wisconsin · Milwaukee, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.