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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama
Birmingham, Alabama, United States
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
Start Date
March 24, 2015
Primary Completion Date
July 30, 2021
Completion Date
July 30, 2021
Last Updated
October 31, 2024
5,302
ACTUAL participants
Vedolizumab
DRUG
Other Biologic Agents
OTHER
Lead Sponsor
Takeda
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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