Entyvio (Vedolizumab) Long Term Safety Study (Entyvio PASS)

Takeda

Status: Completed

Conditions: Ulcerative Colitis and Crohn's Disease

Treatments: Drug: Vedolizumab; Other: Other Biologic Agents

Study type: Observational

Funder types: Industry

Identifiers

NCT02674308

MLN0002-401 (Other Identifier)

MLN-0002_401

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5,302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

5,302 participants in 2 patient groups

Vedolizumab

Treatment:

Drug: Vedolizumab

Other Biologic Agents

Treatment:

Other: Other Biologic Agents