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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.

Register:	ClinicalTrials.gov
Last refreshed on:	3 March 2025
Main ID:	NCT03824561
Date of registration:	29/01/2019
Prospective Registration:	Yes
Primary sponsor:	Takeda
Public title:	Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]
Scientific title:	Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]
Date of first enrolment:	February 1, 2019
Target sample size:	1096
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/ct2/show/NCT03824561
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Japan

Contacts

Name:	Study Director
Address:
Telephone:
Email:
Affiliation:	Takeda

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Vedolizumab

Primary Outcome(s)

Number of Participants who have One or More Adverse Events [Time Frame: Up to Week 54]

Number of Participants who have One or More Adverse Drug Reactions [Time Frame: Up to Week 54]

Secondary Outcome(s)

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]

Number of Participants who continue the Therapy After 3 Doses of Vedolizumab [Time Frame: After 3 doses of vedolizumab (Week 6 to 14)]

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)]

Change from Baseline in Partial Mayo Scores [Time Frame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54]

Change from Baseline in Complete Mayo Scores [Time Frame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54]

Change from Baseline in Fecal Calprotectin [Time Frame: Baseline and multiple time points up to Week 54]

Secondary ID(s)

Vedolizumab-5033

jRCT1080224534

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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