Entyvio (Vedolizumab) Long Term Safety Study

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).

Eligibility 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.

Principal Investigator

Tuba Esfandyari, MD

Study Contact

Takeda Study Registration Call Center, medicalinformation@tpna.com, +1-877-825-3327

Estimated Completion Date

Thursday, July 1, 2021

ClinicalTrials.gov #