A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis
Public ClinicalTrials.gov record NCT02790138. 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 Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.
Study identification
- NCT ID
- NCT02790138
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 102 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 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
- Oct 12, 2016 (Actual)
- Primary completion
- Jun 11, 2020 (Actual)
- Completion
- Feb 2, 2021 (Actual)
- Last update posted
- Feb 24, 2022
2016 – 2021
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Northshore University HealthSystem | Evanston | Illinois | 60201 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of North Carolina GI | Chapel Hill | North Carolina | 27599 | — |
| Carolinas HealthCare System Digestive Health | Charlotte | North Carolina | 28204 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212-1375 | — |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | — |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | — |
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 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02790138, 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 Feb 24, 2022 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02790138 live on ClinicalTrials.gov.