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NCT03029143 · ClinicalTrials.gov registry record · Phase 4
Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis
A Phase 4 study of Colitis, Ulcerative, sponsored by Takeda.
- Completed
- Registry status
- Phase 4
- Development phase
- 278
- Enrollment target
- 20
- Study locations
NCT03029143 is a Phase 4 study of Colitis, Ulcerative that has completed, run by Takeda. The registered enrollment target is 278 participants, below the 396-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT03029143, a Phase 4 study of Colitis, Ulcerative, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 278 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to investigate the efficacy and safety of vedolizumab intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen over a 30 week treatment period in participants with moderately to severely active ulcerative colitis (UC) and high vedolizumab clearance, based on a Week 5 predefined serum vedolizumab concentration threshold less than (\<) 50 microgram per milliliter (microg/mL) and who are Week 6 non-responders based on partial Mayo score.
Conditions Studied
Interventions
- DRUG Vedolizumab IV
Study Locations (20)
Florida
- Gastro Florida - Clearwater
- Florida Research Network, LLC - Gainesville
- Wellness Clinical Research, LLC - Hialeah
- Center for Advanced Gastro - Maitland
- Center for Interventional Endo - Orlando
- BRCR Medical Center, Inc. - Pembroke Pines
- Gastro Florida - Tampa
California
- Care Access Research LLC - San Pablo
- Care Access Research, San Pablo - San Pablo
Georgia
- Atlanta Gastroenterology Specialists, PC - Atlanta
- Atlanta Center for Gastroenterology - Decatur
Arizona
- Advanced Clinical Therapeutics, LLC - Tucson
Arkansas
- Arkansas Primary Care Clinic, PA - Little Rock
Connecticut
- Gastroenterology Associates of Fairfield County - Bridgeport
Idaho
- Grand Teton Research Group, PLLC - Idaho Falls
Illinois
- NorthShore University HealthSystem - Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2017-03-29 |
| Est. Completion | 2020-10-16 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03029143
The ClinicalTrials.gov registry entry for NCT03029143 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 278 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 396-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (30% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 1 intervention - of which Vedolizumab IV is the first listed.
NCT03029143 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT03029143 about?
NCT03029143 is a clinical study titled "Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis". The purpose of this study is to investigate the efficacy and safety of vedolizumab intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen over a 30 week treatment period in participants with moderately to severely active ulcerative colitis (UC)...
What is the current status of trial NCT03029143?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 278 participants. The study started on 2017-03-29. Estimated completion is 2020-10-16.
What conditions does trial NCT03029143 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT03029143?
The interventions under investigation include: Vedolizumab IV (DRUG).
Who is sponsoring clinical trial NCT03029143?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03029143 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.