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NCT04259138 · ClinicalTrials.gov registry record · Phase 4
Determination of the Optimal Treatment Target in Ulcerative Colitis
A Phase 4 study of Colitis, Ulcerative, sponsored by Alimentiv.
- Active
- Registry status
- Phase 4
- Development phase
- 672
- Enrollment target
- 20
- Study locations
NCT04259138: Active Phase 4 study of Colitis, Ulcerative, sponsored by Alimentiv.
NCT04259138 is a Phase 4 study of Colitis, Ulcerative that is active but no longer recruiting, run by Alimentiv. The registered enrollment target is 672 participants, above the 382-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (76% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04259138, a Phase 4 study of Colitis, Ulcerative, is active but no longer recruiting, sponsored by Alimentiv.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 672 participants
- Enrollment target
- 20
- Study locations
Study Summary
Disease activity and response to therapy in ulcerative colitis (UC) can be assessed by a range of endpoints including symptoms, endoscopic mucosal activity, histological disease activity, and biomarkers. This study aims to determine the optimal treatment target, which is a research priority for the management of UC both to inform clinical practice and to help inform regulatory endpoints and targets for drug development. Participants with active UC will be randomized in a 5:4:1 (initially 2:3:5) ratio to 1 of 3 groups, each with a different treatment target. Treatment targets will be defined as: * Group 1: corticosteroid-free symptomatic remission * Group 2: corticosteroid-free endoscopic + symptomatic remission * Group 3: corticosteroid-free histological + endoscopic + symptomatic remission An interim analysis was performed to assess the proportion of subjects that reached their assigned treatment target after 50 subjects in each group had reached the first 32-week assessment. The interim analysis and projections made based on target achievement rates for all subjects included in the interim analysis resulted in a recommendation to adjust the randomization ratio from 2:3:5 to 5:4:1 for Groups 1, 2 and 3 respectively as of May 5th, 2023. This change was necessary in order to complete the study with approximately 100 subjects achieving treatment target within each group.
Primary Outcome
Time to UC-related complication starting when a participant reaches their assigned treatment target, compared between treatment target groups 1 and 3.
Conditions Studied
Interventions
- BIOLOGICAL Treatment Algorithm A
- BIOLOGICAL Treatment Algorithm B
- BIOLOGICAL Treatment Algorithm C
Study Locations (20)
Ontario
- Barrie GI Associates Inc. - Barrie
- McMaster University Medical Centre - Hamilton
- London Health Sciences Centre - University Campus - London
- LHSC - Victoria Hospital - London
- ABP Research Services Corp. - Oakville
- Taunton Surgical Centre - Oshawa
- Toronto Immune and Digestive Health Institute (TIDHI) - Toronto
New York
- Icahn School of Medicine at Mt Sinai Hospital - New York
- New York-Presbyterian/Weill Cornell Medical Center - New York
North Carolina
- Digestive Health Partners - Asheville Gastroenterology Associate - Asheville
- Atrium Health (Carolinas HealthCare) - Charlotte
Michigan
- St. Joseph Mercy Hospital/Huron Gastroenterology Associates - Ypsilanti
Homiel
- Gomel Regional Clinical Hospital - Homyel
Vitebsk Oblast
- Vitebsk Regional Clinical Hospital - Vitebsk
Antwerp
- Imelda Ziekenhuis Bonheiden - Bonheiden
East Flanders
- University Hospital Ghent - Ghent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 672 participants |
| Start Date | 2020-02-18 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 4 |
What the registry record for NCT04259138 still lists
NCT04259138 is an interventional study that assigns participants to a tested intervention. The registered 672 participants enrollment target is mid-sized for trials with a published cap, above the 382-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (76% higher).
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 3 interventions - of which Treatment Algorithm A is the first listed.
NCT04259138 names 20 study sites across 12 states, led by Ontario, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04259138 about?
NCT04259138 is a clinical study titled "Determination of the Optimal Treatment Target in Ulcerative Colitis". Disease activity and response to therapy in ulcerative colitis (UC) can be assessed by a range of endpoints including symptoms, endoscopic mucosal activity, histological disease activity, and biomarkers. This study aims to determine the optimal treatment target, which is a research priority for the ...
What is the current status of trial NCT04259138?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 672 participants. The study started on 2020-02-18. Estimated completion is 2026-03-31.
What conditions does trial NCT04259138 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT04259138?
The interventions under investigation include: Treatment Algorithm A (BIOLOGICAL), Treatment Algorithm B (BIOLOGICAL), Treatment Algorithm C (BIOLOGICAL).
Who is sponsoring clinical trial NCT04259138?
This trial is sponsored by Alimentiv, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04259138 being conducted?
This trial has 20 study locations across Michigan, New York, North Carolina, Homiel, Vitebsk Oblast. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04259138's enrollment target sits among peer trials
672 7th of 28 higher than 22 of 28 other Colitis, Ulcerative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colitis, Ulcerative 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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