NCT03824561

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,110 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Vedolizumab	Vedolizumab IV infusion

Timeline

• Start date: 2019-02-01
• Primary completion: 2025-02-12
• Completion: 2025-02-12
• First posted: 2019-01-31
• Last updated: 2025-09-11
• Results posted: 2025-09-11

Locations

1 site across 1 country: Japan