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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 Oct 18, 2026, 12:33 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 29, 2015 (Actual)
Primary completion
Sep 26, 2018 (Actual)
Completion
Jan 18, 2019 (Actual)
Last update posted
Jan 28, 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 28, 2020 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02497469 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →