NCT02674308

Entyvio (Vedolizumab) Long Term Safety Study

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT02674308

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

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

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).

Eligibility

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.

Disease(s) and\or Condition(s)

Ulcerative Colitis and Crohn's Disease

Primary Purpose

Intervention/Treatment

- Type: DRUG
- Name: Vedolizumab
- Description:
- Arm Group Labels: Vedolizumab
- Type: OTHER
- Name: Other Biologic Agents
- Description: Other biologic agents include: Adalimumab, Certolizumab pegol, Golimumab, and Infliximab
- Arm Group Labels: Other Biologic Agents

Sponsor

Takeda