Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric Crohn's Disease/ REMODEL-CD Study
Phase: Recruiting
Condition(s): Crohn’s Disease
NCT Number: NCT05660746
What Is the Purpose of This Study?
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).
Who Can Take Part in This Study?
People who may be eligible are:
- Newly diagnosed Crohn’s disease starting infliximab
- Ages 6-22 years
What Will Happen During This Study?
- The study compares two ways to choose the dose of the same medicine, infliximab.
- After screened for eligibility, patients will be enrolled into the precision dosing arm and receive infliximab from the precision dosing protocol for 1 year.