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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: 12 December 2020
Main ID:  NCT04002180
Date of registration: 26/06/2019
Prospective Registration: Yes
Primary sponsor: Takeda
Public title: Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease]
Scientific title: Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease]
Date of first enrolment: July 1, 2019
Target sample size: 300
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04002180
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Japan
Contacts
Name:     Takeda Study Registration Call Center
Address: 
Telephone: +1-877-825-3327
Email: medicalinformation@tpna.com
Affiliation: 
Name:     Study Director
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Have moderate or severe active CD

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
Crohn's Disease
Intervention(s)
Drug: Vedolizumab (Genetical Recombination)
Primary Outcome(s)
Number of Participants who have One or More Adverse Drug Reactions [Time Frame: Up to Week 54]
Number of Participants who have One or More Adverse Events [Time Frame: Up to Week 54]
Secondary Outcome(s)
Change from Baseline in Albumin [Time Frame: Baseline and up to Week 54]
Change from Baseline in C-reactive protein (CRP) [Time Frame: Baseline and up to Week 54]
Change from Baseline in Crohn's Disease Activity Index (CDAI) Score [Time Frame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)]
Change from Baseline in Hematocrit [Time Frame: Baseline and up to Week 54]
Change from Baseline in Hemoglobin [Time Frame: Baseline and up to Week 54]
Change from Baseline in Lymphocytes [Time Frame: Baseline and up to Week 54]
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 (or discontinuation of vedolizumab therapy)]
Change from Baseline in White Blood Cell Count [Time Frame: Baseline and up to Week 54]
Percentage of Participants with CDAI-100 Response [Time Frame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)]
Percentage of Participants with CDAI-70 Response [Time Frame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)]
Percentage of Participants with Clinical Remission [Time Frame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)]
Secondary ID(s)
JapicCTI-194830
Vedolizumab-4021
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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