Entyvio (Vedolizumab) Long Term Safety Study

• Status: Completed
• Trial end date: 2021-08-03
• Target enrollment: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Vedolizumab

Criteria

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.