Clinical Trial

Precise Infliximab Exposure and Pharmacodynamic Control

Study acronym: REMODEL-CD
Recruiting Phase 2/3
View on ClinicalTrials.gov →
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).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-12-19; most recent amendment 2026-04-29.
Status change: Not Yet Recruiting → Recruiting 2023-07-19
Trial Details
NCT Number NCT05660746
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Janssen Scientific Affairs, LLC
Conditions Crohn Disease
Enrollment 180 participants
Start Date 2023-07-01
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-05