Entyvio (Vedolizumab) Long Term Safety Study

  • STATUS
    Not Recruiting
  • days left to enroll
    29
  • participants needed
    5000
  • sponsor
    Takeda
Updated on 21 April 2021
Investigator
Takeda Study Registration Call Center
Primary Contact
Universitatsklinikum Erlangen Medizinische Klinik I - Studien Ambulanz Ced (8.7 mi away) Contact
+286 other location

Summary

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).

Description

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.

Details
Condition Ulcerative Colitis and Crohn's Disease
Treatment Vedolizumab, Other Biologic Agents
Clinical Study IdentifierNCT02674308
SponsorTakeda
Last Modified on21 April 2021

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