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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: Completed Phase 4 study of Colitis, Ulcerative, sponsored by Takeda.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mucosal healing is defined as Mayo endoscopic subscore \<=1 point. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
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 |
What the finished NCT03029143 record still lists
NCT03029143 is an interventional study that assigns participants to a tested intervention. The registered 278 participants enrollment target is mid-sized for trials with a published cap, below the 396-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (30% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
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Where NCT03029143's enrollment target sits among peer trials
278 14th of 28 higher than 15 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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