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Active, not recruiting Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT04835506

Public ClinicalTrials.gov record NCT04835506. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 2, 2026, 6:27 PM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04835506
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 4
Enrollment
124 participants

Conditions and interventions

Eligibility (public fields only)

Age range
16 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 1, 2021 (Actual)
Primary completion
Sep 2026 (Estimated)
Completion
Sep 2026 (Estimated)
Last update posted
Mar 5, 2026

2021 – 2026

United States locations

U.S. sites
23
U.S. states
17
U.S. cities
20
Facility City State ZIP Site status
Yale University School of Medicine New Haven Connecticut 06510 —
University of Miami Miami Florida 33136 —
University of Chicago Medicine Chicago Illinois 60637 —
Northwestern University Evanston Illinois 60208 —
Rockford GI Rockford Illinois 61107 —
University of Maryland Medical Center Baltimore Maryland 21201 —
Boston Children's Hospital Boston Massachusetts 02115 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Lahey Hospital and Medical Center Burlington Massachusetts 01805 —
University of Minnesota Minneapolis Minnesota 55455 —
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03766 —
NYU Langone Health New York New York 10016 —
Icahn School of Medicine at Mount Sinai New York New York 10029 —
Weill Cornell Medical College New York New York 10065 —
Atrium Health Center for Digestive Health Charlotte North Carolina 28204 —
Cleveland Clinic Cleveland Ohio 44195 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
LifeSpan Brown University Providence Rhode Island 02915 —
Medical University of South Carolina Charleston South Carolina 29425 —
Vanderbilt University Medical Center Nashville Tennessee 20500 —
University of Texas Southwestern Medical Center Dallas Texas 75390 —
University of Utah Salt Lake City Utah 84132 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04835506, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 5, 2026 · Synced Nov 2, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04835506 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →