CompletedNot Applicable

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

Japan1,110 participantsStarted 2019-02-01

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

What they're measuring

Number of Participants Who Experienced at Least One Adverse Events (AEs)

Timeframe: Up to Week 54

Number of Participants Who Experienced at Least One Adverse Drug Reactions

Timeframe: Up to Week 54

Trial details

NCT IDNCT03824561

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02-12

Results submitted2025-08-03

View on ClinicalTrials.gov More Ulcerative Colitis trials