Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis
Public ClinicalTrials.gov record NCT03029143. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4 Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes In Nonresponders With Moderately to Severely Active Ulcerative Colitis (ENTERPRET)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03029143
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 278 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 29, 2017 (Actual)
- Primary completion
- Oct 16, 2020 (Actual)
- Completion
- Oct 16, 2020 (Actual)
- Last update posted
- Jul 28, 2023
2017 – 2020
United States locations
- U.S. sites
- 44
- U.S. states
- 26
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Clinical Therapeutics, LLC | Tucson | Arizona | 85712 | — |
| Arkansas Primary Care Clinic, PA | Little Rock | Arkansas | 72204 | — |
| Care Access Research LLC | San Pablo | California | 94806 | — |
| Care Access Research, San Pablo | San Pablo | California | 94806 | — |
| Gastroenterology Associates of Fairfield County | Bridgeport | Connecticut | 06066 | — |
| Gastro Florida | Clearwater | Florida | 33756 | — |
| Florida Research Network, LLC | Gainesville | Florida | 32605 | — |
| Wellness Clinical Research, LLC | Hialeah | Florida | 33016 | — |
| Center for Advanced Gastro | Maitland | Florida | 32751 | — |
| Center for Interventional Endo | Orlando | Florida | 32803 | — |
| BRCR Medical Center, Inc. | Pembroke Pines | Florida | 33028 | — |
| Gastro Florida | Tampa | Florida | 33626 | — |
| Atlanta Gastroenterology Specialists, PC | Atlanta | Georgia | 30308 | — |
| Atlanta Center for Gastroenterology | Decatur | Georgia | 30033 | — |
| Grand Teton Research Group, PLLC | Idaho Falls | Idaho | 83404 | — |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | — |
| Aquiant Research | New Albany | Indiana | 47150 | — |
| Iowa Digestive disease center | Clive | Iowa | 50325 | — |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66604 | — |
| Gastroenterology Associates LLC | Baton Rouge | Louisiana | 70809 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | — |
| 4940 Eastern Ave A building | Baltimore | Maryland | 21224 | — |
| Gastro Center of Maryland | Columbia | Maryland | 20721 | — |
| Woodholme Gastroenterology Associates | Glen Burnie | Maryland | 21061 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Las Vegas Medical Research | Las Vegas | Nevada | 89113 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Charlotte Gastroenterology and Hepatology | Charlotte | North Carolina | 28207 | — |
| Dayton Gastroenterology, Inc | Dayton | Ohio | 45415 | — |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| Gastroenterology Associates PA | Greenville | South Carolina | 29615 | — |
| Midwest Medical Care | Sioux Falls | South Dakota | 57105 | — |
| Vanderbilt Medical Center | Nashville | Tennessee | 37212 | — |
| Texas Digestive Disease Consultants - Dallas | Dallas | Texas | 75231 | — |
| Ygenics | Decatur | Texas | 76234 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Texas Digestive Disease Consultants | Keller | Texas | 76248 | — |
| DHAT Research Institute | Richardson | Texas | 75082 | — |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | — |
| BaylorScott&White Research Institute | Temple | Texas | 76508 | — |
| GI Liver Research LLC | Webster | Texas | 77598 | — |
| Gastroenterology Associates of Northern Virginia, Ltd. | Fairfax | Virginia | 22031 | — |
| Swedish Medical Center | Seattle | Washington | 98104 | — |
| Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | 53266 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03029143, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03029143 live on ClinicalTrials.gov.