A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
Public ClinicalTrials.gov record NCT02620046. 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 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis (UC) and Crohn's disease (CD). Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant's condition remains under control or improves during and after treatment with Vedolizumab SC. Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study. For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens. Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study. After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems.
Study identification
- NCT ID
- NCT02620046
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 746 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
- Apr 14, 2016
- Primary completion
- Jun 11, 2024
- Completion
- Jun 11, 2024
- Last update posted
- Apr 2, 2025
2016 – 2024
United States locations
- U.S. sites
- 47
- U.S. states
- 28
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix | Arizona | 85307 | — |
| Arkansas Primary Care Clinic, PA | Little Rock | Arkansas | 72204 | — |
| Rocky Mountain Clinical Research, LLC | Wheat Ridge | Colorado | 80033 | — |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | — |
| 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 | — |
| BRCR Medical Center, Inc. | Pembroke Pines | Florida | 33028 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Florida Medical Clinic, P.A. | Zephyrhills | Florida | 33542 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | — |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 30024 | — |
| Grand Teton Research Group, PLL | Idaho Falls | Idaho | 83404 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| 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 | — |
| Lafayette General Medical Center | Lafayette | Louisiana | 70503 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71103 | — |
| 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 | — |
| Huron Gastroenterology Associates | Ypsilanti | Michigan | 48197 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Digestive Health Center PA | Ocean Springs | Mississippi | 39564 | — |
| Ehrhardt Clinical Research, LLC | Belton | Missouri | 64012 | — |
| AGA Clinical Research Associates, LLC | Egg Harbor | New Jersey | 08234 | — |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | — |
| Premier Medical Group of the Hudson Valley, PC | Poughkeepsie | New York | 12601 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Dayton Gastroenterology, Inc | Dayton | Ohio | 45415 | — |
| Gastro-Enterology Research of Lima | Lima | Ohio | 45806 | — |
| Options Health Research | Tulsa | Oklahoma | 74104 | — |
| Main Line Gastroenterology Associates | Perkasie | Pennsylvania | 18944 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
| Gastroenterology Center of the MidSouth PC | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| San Antonio Gastroenterology | San Antonio | Texas | 78212 | — |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
| Virginia Mason Seattle Main Clinic | Seattle | Washington | 98101 | — |
| Allegiance Research Specialists, LLC | Milwaukee | Wisconsin | 53226 | — |
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 254 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02620046, 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 Apr 2, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02620046 live on ClinicalTrials.gov.