Precise Infliximab Exposure and Pharmacodynamic Control
Status:
Not yet recruiting
Trial end date:
2027-03-31
Target enrollment:
Participant gender:
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).
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)