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Completed Phase 3 Interventional Results available

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

ClinicalTrials.gov ID: NCT00783692

Public ClinicalTrials.gov record NCT00783692. 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 26, 2026, 1:47 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 Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response and remission at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.

Study identification

NCT ID
NCT00783692
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
1,116 participants

Conditions and interventions

Interventions

Drug · Other

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
Nov 30, 2008
Primary completion
Feb 29, 2012
Completion
Apr 30, 2012
Last update posted
Jul 20, 2014

2008 – 2012

United States locations

U.S. sites
110
U.S. states
33
U.S. cities
94
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
Apex Clinical Trials Birmingham Alabama 35234 —
Gastrointestinal Bioscience Los Angeles California 90067 —
Paramount Medical Specialty Montebello California 90640 —
Capital Gastroenterology Consultants Medical Group Sacramento California 95815 —
Clinical Applications Laboratories Inc. San Diego California 92103 —
Desta Digestive Disease Medical Center San Diego California 92114 —
University of Colorado Health Sciences Center Aurora Colorado 80045 —
Rocky Mountain Clinical Research, LLC Golden Colorado 80401 —
Gastroenterology of the Rockies Lafayette Colorado 80026 —
Arapahoe Gastroenterology Associates P.C. Littleton Colorado 80120 —
South Denver Gastroenterology Lone Tree Colorado 80124 —
Lynn Institute of Pueblo Pueblo Colorado 81007 —
Connecticut Gastroenterology Institute Bristol Connecticut 06010 —
Gastroenterology Center of Connecticut, P.C. Hamden Connecticut 06518 —
University of Florida Gainesville Florida 32608 —
University of Florida, Jacksonville Jacksonville Florida 32209 —
East Coast Institute for Research Jacksonville Florida 32223 —
Borland-Groover Clinic Jacksonville Florida 32256 —
Center for Advanced Gastroenterology Maitland Florida 32751 —
Osler Clinical Research Melbourne Florida 32901 —
University of Miami Miller School of Medicine Miami Florida 33136 —
United Medical Research Institute New Smyrna Beach Florida 32168 —
Compass Research LLC Orlando Florida 32806 —
Internal Medicine Specialists Orlando Florida 32806 —
University of South Florida Tampa Florida 33606 —
West Wind'r Research & Development, LLC Tampa Florida 33607 —
Shafran Gastroenterology Center Winter Park Florida 32789 —
Atlanta Gastroenterology Associates Atlanta Georgia 30342 —
Southeast Regional Research Group Columbus Georgia 31904 —
Atlanta Center for Gastroenterology, P.C. Decatur Georgia 30033 —
Gastroenterology Associates of Central Georgia Macon Georgia 31201 —
Digestive Research Associates Newnan Georgia 30263 —
St. Joseph's/Candler Health System Savannah Georgia 31405 —
DLW Research System Snellville Georgia 30039 —
Rush University Medical Center Chicago Illinois 60612 —
University of Chicago Medical Center Chicago Illinois 60637 —
Carle Clinic Association P.C. Urbana Illinois 58150 —
Indianapolis Gastroenterology & Hepatology, Inc.- ARC Indianapolis Indiana 46237 —
Digestive & Liver Consultants Clive Iowa 50325 —
Iowa Digestive Disease Center Clive Iowa 50325 —
University Of Kansas Kansas City Kansas 66160 —
Cotton O'Neil Digestive Health Center Topeka Kansas 66606 —
University of Kentucky Medical Center Lexington Kentucky 40536 —
University Of Louisville Louisville Kentucky 40202 —
Gastroenterology Associates Baton Rouge Louisiana 70809 —
Metropolitan Gastroenterology Group, P.C. Chevy Chase Maryland 20815 —
Shah Associates Prince Frederick Maryland 20678 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Boston Medical Center Boston Massachusetts 02118 —
The Center for Clinical Studies Dearborn Michigan 48124 —
Center for Digestive Health Troy Michigan 48098 —
Gastroenterology Associates of Western Michigan, P.L.C. Wyoming Michigan 49519 —
Minnesota Gastroenterology, P.A. Plymouth Minnesota 55486 —
Mayo Clinic Rochester Minnesota 55905 —
Digestive Health Specialists Tupelo Mississippi 38801 —
Truman Medical Center Kansas City Missouri 64108 —
Center for Digestive and Liver Diseases, Inc. Mexico Missouri 65265 —
Washington University St Louis Missouri 63110 —
St. Louis Center for Clinical Research St Louis Missouri 63128 —
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756 —
Affiliates in Gastroenterology PA Morristown New Jersey 07960 —
University of Medicine and Dentistry of New Jersey-NJMS New Brunswick New Jersey 08903 —
The Gastroenterology Group of South Jersey Vineland New Jersey 08360 —
Hepatobiliary Associates of New York Bayside New York 11358 —
Digestive Health Physician Cheektowaga New York 14225 —
Long Island Clinical Research Associates Great Neck New York 11021 —
Long Island Gastroenterology Group, P.C. Merrick New York 11566 —
New York Presbyterian Hospital New York New York 10021 —
Present Chapman Marion Steinlauf MD PC New York New York 10028 —
Kim, Chung MD (Private Practice) Pittsford New York 14534 —
University of Rochester Rochester New York 14642 —
Long Island Digestive Disease Consultants Setauket New York 11733 —
SUNY Stony Brook University Medical Center Stony Brook New York 11794 —
Syracuse Gastroenterological Associates Syracuse New York 13210 —
Asheville Gastroenterology Associates, P.A. Asheville North Carolina 28801 —
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599 —
Charlotte Gastroentology and Hepatology, P.L.L.C Charlotte North Carolina 28207 —
Northwest Piedmont Clinical Research, Inc. Elkin North Carolina 28621 —
Burke Research Associates Morganton North Carolina 28655 —
Wake Forest University Baptist Medical Center Winston-Salem North Carolina 27157 —
Consultants for Clinical Research Inc. Cincinnati Ohio 45219 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Dayton Science Institute Dayton Ohio 45415 —
Options Health Research Tulsa Oklahoma 74104 —
The Oregon Clinic-West Hills Gastroenterology Portland Oregon 97225 —
University of Pittsburgh Medical Center - Cancer Centers Pittsburgh Pennsylvania 15213 —
Medical University Of SC CAR Charleston South Carolina 29425 —
Consultants in Gastroenterology Columbia South Carolina 29203 —
Gastroenterology Center of the MidSouth, PC Germantown Tennessee 38138 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
Austin Gastroenterology, PA Austin Texas 78705 —
Bayou City Research, Ltd. Houston Texas 77024 —
Gastroenterology Consultants Houston Texas 77034 —
Jacon Medical Research Associates Houston Texas 77090 —
Digestive Health Center Pasadena Texas 77504 —
Alamo Medical Research San Antonio Texas 78215 —
Gastroenterology Clinic of San Antonio San Antonio Texas 78229 —
Stone Oak Research Foundation San Antonio Texas 78258 —
Digestive Health Specialists of Tyler Tyler Texas 75701 —
Granite Peaks Gastroenterology Sandy City Utah 84094 —
University of Virginia Health System Charlottesville Virginia 22908 —
Gastroenterology Associates of Northern Virginia Fairfax Virginia 22031 —
Digestive and Liver Disease Specialist Ltd. Norfolk Virginia 23502 —
Hunter Holmes McGuire VA Medical Center Richmond Virginia 23249 —
Northwest Gastroenterology Associates Bellevue Washington 98004 —
Puget Sound Medical Research Edmonds Washington 98026 —
Pharmaseek, LLC Madison Wisconsin 53717 —
Wisconsin Center for Advanced Research Milwaukee Wisconsin 53215 —
Medical College Of Wisconsin 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 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00783692, 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 Jul 20, 2014 · Synced Sep 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00783692 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →