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NCT04835506 · ClinicalTrials.gov registry record · Phase 4
Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial
A Phase 4 study of Ulcerative Colitis and Crohn Disease, sponsored by Beth Israel Deaconess Medical Center.
- Active
- Registry status
- Phase 4
- Development phase
- 124
- Enrollment target
- 20
- Study locations
NCT04835506: Active Phase 4 study of Ulcerative Colitis and Crohn Disease, sponsored by Beth Israel Deaconess Medical Center.
NCT04835506 is a Phase 4 study of Ulcerative Colitis and Crohn Disease that is active but no longer recruiting, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 124 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04835506, a Phase 4 study of Ulcerative Colitis and Crohn Disease, is active but no longer recruiting, sponsored by Beth Israel Deaconess Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 124 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Proportion of subjects with sustained corticosteroid-free (no CS use from Week 14 through 52) clinical remission (CD: CDAI \<150 at Weeks 14, 26, 52; UC: PRO2 ≤ 1 with an RBS = 0) and no disease worsening
Conditions Studied
Interventions
- DRUG Infliximab
Study Locations (20)
Illinois
- University of Chicago Medicine - Chicago
- Northwestern University - Evanston
- Rockford GI - Rockford
Massachusetts
- Boston Children's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Lahey Hospital and Medical Center - Burlington
New York
- NYU Langone Health - New York
- Icahn School of Medicine at Mount Sinai - New York
- Weill Cornell Medical College - New York
Connecticut
- Yale University School of Medicine - New Haven
Florida
- University of Miami - Miami
Maryland
- University of Maryland Medical Center - Baltimore
Minnesota
- University of Minnesota - Minneapolis
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2026-09 |
| Phase | Phase 4 |
What the registry record for NCT04835506 still lists
NCT04835506 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Infliximab is the first listed.
NCT04835506 names 20 study sites across 14 states, led by Illinois, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT04835506 about?
NCT04835506 is a clinical study titled "Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial". 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.
What is the current status of trial NCT04835506?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 124 participants. The study started on 2021-11-01. Estimated completion is 2026-09.
What conditions does trial NCT04835506 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn Disease, Inflammatory Bowel Diseases.
What interventions are being tested in trial NCT04835506?
The interventions under investigation include: Infliximab (DRUG).
Who is sponsoring clinical trial NCT04835506?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04835506 being conducted?
This trial has 20 study locations across Connecticut, Florida, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04835506's enrollment target sits among peer trials
124 56th of 122 higher than 67 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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