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Completed Phase 3 Interventional Results available

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

ClinicalTrials.gov ID: NCT02497469

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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:43 AM EDT

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
Lead sponsor
Takeda
Industry
Enrollment
771 participants

Conditions and interventions

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

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02497469 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →