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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 June 2023 |
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Main ID: |
NCT03824561 |
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Date of registration:
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29/01/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]
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Scientific title:
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Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis] |
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Date of first enrolment:
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February 1, 2019 |
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Target sample size:
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1096 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03824561 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Japan
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Contacts
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Name:
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Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Have moderate or severe active UC
2. Have inadequate response to existing therapies
Exclusion Criteria:
Patients with any contraindication for vedolizumab
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Vedolizumab
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Primary Outcome(s)
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Number of Participants who have One or More Adverse Events
[Time Frame: Up to Week 54]
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Number of Participants who have One or More Adverse Drug Reactions
[Time Frame: Up to Week 54]
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Secondary Outcome(s)
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Number of Participants who have a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab
[Time Frame: After 3 doses of vedolizumab (Week 6 to 14)]
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Change from Baseline in Complete Mayo Scores
[Time Frame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54]
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Change from Baseline in Partial Mayo Scores
[Time Frame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54]
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Change from Baseline in Fecal Calprotectin
[Time Frame: Baseline and multiple time points up to Week 54]
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Number of Participants who continue the Therapy After 3 Doses of Vedolizumab
[Time Frame: After 3 doses of vedolizumab (Week 6 to 14)]
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Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
[Time Frame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54]
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Secondary ID(s)
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jRCT1080224534
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Vedolizumab-5033
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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