Entyvio (Vedolizumab) Long Term Safety Study

Completed

Conditions studied: Ulcerative Colitis and Crohn's Disease

In brief

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).

Key facts

Study ID

NCT02674308

Run by

Takeda

People needed

5302

Starts

2015-03-24

Expected to finish

2021-07-30

Last updated by the study team

2024-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent, by the participant or a legally acceptable representative.
• Aged at least 18 years.
• Initiating vedolizumab or another biologic agent for UC or CD.
• 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.

You may not qualify if…

• The participant is enrolled in a clinical trial in which treatment for CD or UC is managed through a protocol.
• Prior treatment with vedolizumab.
• Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• University of Arizona Medical Center — Tucson, Arizona, United States
• Scripps Clinic — La Jolla, California, United States
• Stanford University — Palo Alto, California, United States
• South Bay Gastroenterology Medical Group — Torrance, California, United States
• Gastroenterology Center of Connecticut P.C. — Hamden, Connecticut, United States
• Middlesex Gastroenterology Associates, Llc — Middletown, Connecticut, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Florida Hospital Orlando — Orlando, Florida, United States
• Gulf Region Clinical Research Institute — Pensacola, Florida, United States
• Emory University Hospital, the Emory Clinic — Atlanta, Georgia, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Georgia Regents University — Augusta, Georgia, United States
• Atlanta Gastroenterology Associates — Suwanee, Georgia, United States
• Illinois Gastroenterology Groupllc Northwest Gastroenterologists — Arlington Heights, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Northshore University Health Systems — Evanston, Illinois, United States
• Loyola University — Maywood, Illinois, United States
• Southwest Gastroenterology — Oak Lawn, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Cotton O'Neil Digestive Health Center — Topeka, Kansas, United States
• Kansas Gastroenterology — Wichita, Kansas, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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