Special Drug-Use Surveillance Study on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]
NCT ID: NCT03824561
Last Updated: 2025-09-11
Study Results
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View full resultsBasic Information
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COMPLETED
1110 participants
OBSERVATIONAL
2019-02-01
2025-02-12
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Vedolizumab 300 mg
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.
Vedolizumab
Vedolizumab IV infusion
Interventions
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Vedolizumab
Vedolizumab IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have inadequate response to existing therapies
Exclusion Criteria
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Takeda Selected Site
Tokyo, , Japan
Countries
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References
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Matsuoka K, Hisamatsu T, Mikami Y, Yamamoto T, Motoya S, Shinzaki S, Iwakiri R, Sugiura K, Nishimura K, Kajita M, Fernandez JL. Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study. Adv Ther. 2023 Jun;40(6):2902-2914. doi: 10.1007/s12325-023-02500-6. Epub 2023 May 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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jRCT1080224534
Identifier Type: REGISTRY
Identifier Source: secondary_id
Vedolizumab-5033
Identifier Type: -
Identifier Source: org_study_id
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