An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
Public ClinicalTrials.gov record NCT02497469. 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, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.
Study identification
- NCT ID
- NCT02497469
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 771 participants
Conditions and interventions
Conditions
Interventions
- Vedolizumab Drug
- Adalimumab placebo Drug
- Adalimumab Drug
- Vedolizumab placebo Drug
Drug
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
- Jun 28, 2015
- Primary completion
- Sep 25, 2018
- Completion
- Jan 17, 2019
- Last update posted
- Jan 27, 2020
2015 – 2019
United States locations
- U.S. sites
- 77
- U.S. states
- 33
- U.S. cities
- 73
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| IMC - Diagnostic and Medical Clinic | Mobile | Alabama | 36604 | — |
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix | Arizona | 85037 | — |
| Arkansas Primary Care Clinic, PA | Little Rock | Arkansas | 72204 | — |
| WCCT Global (PH 1 Unit) | Costa Mesa | California | 92626 | — |
| California Medical Research Associates Inc. | Northridge | California | 91324 | — |
| Sutter Institute for Medical Research | Sacramento | California | 95816 | — |
| Rocky Mountain Gastroenterology | Lakewood | Colorado | 80214-5434 | — |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | — |
| Innovative Medical Research of South Florida, Inc. | Aventura | Florida | 33180 | — |
| Advanced Clinical Research of Miami | Doral | Florida | 33172 | — |
| Wellness Clinical Research | Hialeah Gardens | Florida | 33016 | — |
| Nature Coast Clinical Research, LLC | Inverness | Florida | 34452 | — |
| Florida Center for Gastroenterology | Largo | Florida | 33773-1615 | — |
| Gastro Health | Miami | Florida | 33143 | — |
| Medical Professional Clinical Research | Miami | Florida | 33165 | — |
| Tellus Clinical Research, Inc. | Miami | Florida | 33173 | — |
| South Florida Research Phase I-IV | Miami Springs | Florida | 33166 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Internal Medicine Specialists | Orlando | Florida | 32806 | — |
| BRCR Medical Center, Inc. | Plantation | Florida | 33322 | — |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| Gastroenterology of Southern Associates | New Albany | Indiana | 47150 | — |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | — |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | 66606 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Research Concierge, LLC | Owensboro | Kentucky | 42303 | — |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | — |
| Lafayette General Medical Center | Lafayette | Louisiana | 70503 | — |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71103 | — |
| Digestive Disease Associates | Catonsville | Maryland | 21228 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Center for Digestive Health and Nutritional Excellence | Troy | Michigan | 48098 | — |
| Gastroenterology Associates of Western Michigan, P.L.C. | Wyoming | Michigan | 49519 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Digestive Health Center PA | Ocean Springs | Mississippi | 39564 | — |
| Ehrhardt Clinical Research, LLC | Belton | Missouri | 64012 | — |
| Truman Medical Centers, Inc. | Kansas City | Missouri | 64108 | — |
| Alegent Creighton Clinic Gastroenterology | Omaha | Nebraska | 68124 | — |
| AGA Clinical Research Associates, LLC | Egg Harbor | New Jersey | 08234 | — |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | — |
| Mount Sinai - PRIME | Lake Success | New York | 10029 | — |
| Digestive Disease Care | New Hyde Park | New York | 11040 | — |
| Premier Medical Group of the Hudson Valley, PC | Poughkeepsie | New York | 12601 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599-7080 | — |
| Consultants for Clinical Research Inc. | Cincinnati | Ohio | 45219 | — |
| Ohio State University Clinical Trials Management Office | Columbus | Ohio | 43210 | — |
| Dayton Gastroenterology, Inc | Dayton | Ohio | 45415 | — |
| Gastro-Enterology Research of Lima | Lima | Ohio | 45806 | — |
| Options Health Research | Tulsa | Oklahoma | 74104 | — |
| The Oregon Clinic-West Hills Gastroenterology | Portland | Oregon | 97225 | — |
| Main Line Gastroenterology Associates | Malvern | Pennsylvania | 19355 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
| Invocare Clinical Research Center | West Columbia | South Carolina | 29169 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212-1375 | — |
| Texas Digestive Disease Consultants - Dallas | Dallas | Texas | 75231 | — |
| Baylor University Hospital | Dallas | Texas | 75246 | — |
| MedResearch, Inc | El Paso | Texas | 79935 | — |
| Gastroenterology Consultants of South Texas, PA | Harlingen | Texas | 78550 | — |
| Gulf Coast Research Group LLC | Houston | Texas | 77098 | — |
| Texas Digestive Disease Consultants - Irving | Irving | Texas | 75039 | — |
| Advanced Clinical Research Associates | Plano | Texas | 75093 | — |
| Gastroenterology Research of San Antonio, LLC | San Antonio | Texas | 78229 | — |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | — |
| Digestive Health Specialists of Tyler | Tyler | Texas | 75701 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
| Virginia Mason Seattle Main Clinic | Seattle | Washington | 98101 | — |
| Wenatchee Valley Hospital & Clinics | Wenatchee | Washington | 98801 | — |
| University of Wisconsin | Madison | Wisconsin | 53705 | — |
| 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 253 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02497469, 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 Jan 27, 2020 · Synced Sep 2, 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 protocol, eligibility criteria, and contact information for NCT02497469 live on ClinicalTrials.gov.