Entyvio (Vedolizumab) Long Term Safety Study



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:8/3/2018
Start Date:March 31, 2015
End Date:June 30, 2022
Contact:Takeda Study Registration Call Center
Email:medicalinformation@tpna.com
Phone:+1-877-825-3327

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Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease

The purpose of this study is to assess the long-term safety of vedolizumab versus other
biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).

The drug being tested in this prospective, observational study is called vedolizumab.
Vedolizumab is being used to treat people who have UC or CD. This study will look at the
long-term safety of vedolizumab versus other biologic agents in participants with UC or CD.
The study will enroll approximately 5000 participants. All participants enrolled in this will
belong to one of the two treatment group:

- Vedolizumab

- Other Biologic Agents -adalimumab, certolizumab pegol.

Golimumab and infliximab. Study drugs will be prescribed by the physician according to local
prescribing information in the participating countries. This multi-centre trial will be
conducted worldwide. The overall time to participate in this study is 7 years. Participants
will make visits at every 6 months to their treating physician.

Inclusion Criteria:

1. Signed informed consent, by the participant or a legally acceptable representative.

2. Aged at least 18 years.

3. Initiating vedolizumab or another biologic agent for UC or CD.

4. Signed release form, by the participant or a legally acceptable representative,
permitting abstraction of the participant's medical records at Baseline and during
participation in the study.

Exclusion Criteria:

1. The participant is enrolled in a clinical trial in which treatment for CD or UC is
managed through a protocol.

2. Prior treatment with vedolizumab.

3. Any other reason that, in the Investigator's opinion, makes the participant unsuitable
to participate in this study.
We found this trial at
67
sites
Atlanta, Georgia 30342
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Arlington Heights, IL
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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Birmingham, Alabama 35294
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Boston, Massachusetts 02114
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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4130 Dry Ridge Road
Cincinnati, Ohio 45242
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Columbia, South Carolina 29203
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Englewood, New Jersey 07631
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Evanston, Illinois 60201
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Fishkill, New York 12524
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Fort Sam Houston, TX
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Grand Rapids, Michigan 48525
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Great Neck, New York 11021
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Greenville, North Carolina 27834
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Hamden, Connecticut 06518
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1 Baylor Plaza
Houston, Texas 77030
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Houston, Texas 77030
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Humble, Texas 77338
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Maywood, Illinois 60153
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Metairie, Louisiana 70006
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410 Saybrook Road
Middletown, Connecticut 06457
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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307 N University Blvd
Mobile, Alabama 36688
(251) 460-6101
University of South Alabama "University of South Alabama is a public institution that was founded...
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Morristown, New Jersey 07962
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Naples, Florida 34102
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New York, New York 10016
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New York, New York 10021
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Oak Lawn, Illinois 60453
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Ocean Spring, Mississippi 39564
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Omaha, Nebraska 68124
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Orlando, Florida 32803
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Palo Alto, California 94304
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Philadelphia, Pennsylvania 19104
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Philadelphia, Pennsylvania 19104
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, New York 14618
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Saint Louis, Missouri 63110
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Saint Louis, Missouri 63110
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Shreveport, Louisiana 71103
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Suwanee, Georgia 30024
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Torrance, California 90505
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Tucson, Arizona 85724
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Wichita, Kansas 67226
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Winston-Salem, North Carolina 26157
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Worcester, Massachusetts 01605
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