Special Drug-Use Surveillance Study on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]

Takeda

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Drug: Vedolizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT03824561

jRCT1080224534 (Registry Identifier)

Vedolizumab-5033

Details and patient eligibility

About

The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in ulcerative colitis (UC) patients in the routine clinical setting.

Full description

The drug being tested in this study is called vedolizumab for IV infusion 300 mg. This drug is being tested to treat patients who have UC.

This study is an observational (non-interventional) study and will look at the long-term safety and effectiveness of vedolizumab for IV infusion 300 mg in the routine clinical setting. The planned number of observed patients will be approximately 1,000.

This multi-center observational trial will be conducted in Japan.

Enrollment: 1,110 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have moderate or severe active UC
2. Have inadequate response to existing therapies

Exclusion criteria

Patients with any contraindication for vedolizumab

Trial design

1,110 participants in 1 patient group

Vedolizumab 300 mg

Description:

Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care.

Treatment:

Drug: Vedolizumab