Precise Infliximab Exposure and Pharmacodynamic Control — REMODEL-CD  

Crohn Disease Clinical Trial

Official title: Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric Crohn's Disease

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

This is an open-label, cluster randomized clinical trial to test whether precision infliximab dosing with a targeted concentration intervention is superior in achieving deep remission (endoscopic healing and clinical remission) compared to patients receiving conventional infliximab dosing.

With recognition that CD patients who achieve the "target" of deep remission with anti-TNF dose optimizations following pharmacodynamic monitoring had a significant reduction in CD-related adverse events, our central hypothesis is precision dosing with infliximab during induction and maintenance will achieve superior rates of deep remission vs. conventional care (control arm) ;

Related Conditions & MeSH terms

• Crohn Disease

• NCT number: NCT05660746
• Study type: Interventional
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Phillip Minar, MD, MS
• Phone: 513-636-4415
• Email: phillip.minar@cchmc.org
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2023
• Completion date: March 31, 2027