Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
Public ClinicalTrials.gov record NCT02611830. 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 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Study identification
- NCT ID
- NCT02611830
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 383 participants
Conditions and interventions
Conditions
Interventions
- Vedolizumab 300 mg IV Drug
- Placebo IV Drug
- Vedolizumab 108 mg SC Drug
- Placebo SC Drug
Drug
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
- Dec 17, 2015
- Primary completion
- May 29, 2018
- Completion
- Aug 20, 2018
- Last update posted
- May 24, 2022
2015 – 2018
United States locations
- U.S. sites
- 28
- U.S. states
- 18
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Primary Care Clinic, PA | Little Rock | Arkansas | 72204 | — |
| Rocky Mountain Clinical Research, LLC | Wheat Ridge | Colorado | 80033 | — |
| Middlesex Gastroenterology Associates | Middletown | Connecticut | 06457 | — |
| Nature Coast Clinical Research, LLC | Inverness | Florida | 34452 | — |
| Florida Center for Gastroenterology | Largo | Florida | 33777 | — |
| L & L Research Choices, Inc. | Miami | Florida | 33176 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | — |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 30024 | — |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | 66606 | — |
| Tri-State Gastroenterology Associates | Crestview Hills | Kentucky | 41017 | — |
| Research Concierge, LLC | Owensboro | Kentucky | 42303 | — |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | — |
| Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Gastroenterology Associates of Western Michigan, P.L.C. | Wyoming | Michigan | 49519 | — |
| Ehrhardt Clinical Research, LLC | Belton | Missouri | 64012 | — |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | — |
| Premier Medical Group of the Hudson Valley, PC | Poughkeepsie | New York | 12601 | — |
| Dayton Gastroenterology, Inc | Dayton | Ohio | 45415 | — |
| Options Health Research | Tulsa | Oklahoma | 74104 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
| Virginia Mason Seattle Main Clinic | Seattle | Washington | 98101 | — |
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 146 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02611830, 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 May 24, 2022 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02611830 live on ClinicalTrials.gov.