Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease]

Takeda

Status: Active, not recruiting

Conditions: Crohn's Disease

Treatments: Drug: Vedolizumab (Genetical Recombination)

Study type: Observational

Funder types: Industry

Identifiers

NCT04002180

jRCT1080224753 (Registry Identifier)

Vedolizumab-4021

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 Crohn's disease (CD) patients in the routine clinical setting.

Full description

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

This survey 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 300.

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

Enrollment: 335 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Patients with any contraindication for vedolizumab

Trial design

335 participants in 1 patient group

Vedolizumab 300 mg

Description:

Vedolizumab (Genetical Recombination) 300 mg, IV infusion, 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 (Genetical Recombination)