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Determination of the Optimal Treatment Target in Ulcerative Colitis
NCT04259138 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04259138
The ClinicalTrials.gov registry entry for NCT04259138 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 672 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alimentiv, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04259138 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Ontario, New York, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04259138?
This trial is sponsored by Alimentiv, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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