Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
Public ClinicalTrials.gov record NCT02611817. 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 to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease 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) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Study identification
- NCT ID
- NCT02611817
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 644 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
- Jan 4, 2016 (Actual)
- Primary completion
- May 6, 2019 (Actual)
- Completion
- Aug 6, 2019 (Actual)
- Last update posted
- May 25, 2022
2016 – 2019
United States locations
- U.S. sites
- 30
- U.S. states
- 20
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix | Arizona | 45806 | — |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 11021 | — |
| Middlesex Gastroenterology Associates | Middletown | Connecticut | — | — |
| Nature Coast Clinical Research, LLC | Inverness | Florida | 55905 | — |
| L & L Research Choices, Inc. | Miami | Florida | — | — |
| Gastroenterology Group of Naples | Naples | Florida | 30342 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 70809 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 33176 | — |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 53226 | — |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 48047 | — |
| Grand Teton Research Group, PLL | Idaho Falls | Idaho | — | — |
| Rush University Medical Center | Chicago | Illinois | 33028 | — |
| Carle Foundation Hospital | Urbana | Illinois | 74104 | — |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | 06518 | — |
| Tri-State Gastroenterology Associates | Crestview Hills | Kentucky | 06457 | — |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 85307 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 32789 | — |
| Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research | Chevy Chase | Maryland | — | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 49519 | — |
| Gastroenterology Associates of Western Michigan, P.L.C. | Wyoming | Michigan | 34102 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 30024 | — |
| Ehrhardt Clinical Research, LLC | Belton | Missouri | 60612 | — |
| Long Island Clinical Research Associates | Great Neck | New York | 71105 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 41017 | — |
| Gastro-Enterology Research of Lima | Lima | Ohio | 39581 | — |
| Options Health Research | Tulsa | Oklahoma | 83404 | — |
| Gastroenterology Center of the MidSouth PC | Germantown | Tennessee | 78212 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 61801 | — |
| San Antonio Gastroenterology | San Antonio | Texas | — | — |
| Allegiance Research Specialists, LLC | Milwaukee | Wisconsin | 64012 | — |
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 164 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02611817, 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 25, 2022 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02611817 live on ClinicalTrials.gov.