Clinical Trial

Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial

Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
The OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing (iDose-driven dosing) is more effective and safer than standard infliximab dosing for inducing and maintaining disease remission in inflammatory bowel disease.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2021-04-05; most recent amendment 2026-03-04.
Status change: Enrolling by Invitation → Active, Not Recruiting 2026-03-04
Status change: Recruiting → Enrolling by Invitation 2023-02-06
Status change: Not Yet Recruiting → Recruiting 2021-11-19
Trial Details
NCT Number NCT04835506
Lead Sponsor Beth Israel Deaconess Medical Center
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust, Icahn School of Medicine at Mount Sinai
Conditions Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
Enrollment 124 participants
Start Date 2021-11-01
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-05