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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: JPRN
Last refreshed on: 22 July 2019
Main ID:  JPRN-JapicCTI-194830
Date of registration: 27/06/2019
Prospective Registration: Yes
Primary sponsor: Takeda Pharmaceutical Company Limited
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: 01/7/2019
Target sample size: 300
Recruitment status: pending
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-194830
Study type:  OBSERVATIONAL
Study design:  Post-marketing surveillance  
Phase:  NA
Countries of recruitment
Japan
Contacts
Name: Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information   
Address:  https://www.takeda.com/who-we-are/contact-us/
Telephone: +81-6-6204-2111
Email: -
Affiliation: 
Name: Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information   
Address:  https://www.takeda.com/who-we-are/contact-us/
Telephone: +81-6-6204-2111
Email: -
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Have moderate or severe active CD
2. Have inadequate response to existing therapies

Exclusion criteria: 1. Patients with any contraindication for vedolizumab

Age minimum:
Age maximum:
Gender: BOTH
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
Intervention name : Vedolizumab (Genetical Recombination)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Vedolizumab (Genetical Recombination) 300 milligrams (mg), intravenous (IV) infusion, 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.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Primary Outcome(s)
safety
Number of Participants who have One or More Adverse Events
Timeframe: Up to Week 54
Adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
safety
Number of Participants who have One or More Adverse Drug Reactions
Timeframe: Up to Week 54
Adverse drug reaction refers to AE related to administered drug.
Secondary Outcome(s)
efficacy
Change from Baseline in Crohn's Disease Activity Index (CDAI) Score
Timeframe: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
CDAI is scoring system for the assessment of Crohn's Disease Activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
efficacy
Percentage of Participants with CDAI-100 Response
Timeframe: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
CDAI-100 response is defined as >=100-point decrease from baseline in the CDAI score.
efficacy
Percentage of Participants with CDAI-70 Response
Timeframe: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
CDAI-70 response is defined as >=70-point decrease from baseline in the CDAI score.
efficacy
Percentage of Participants with Clinical Remission
Timeframe: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
Clinical remission is defined as CDAI score of =<150 points.
efficacy
Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Timeframe: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
The SIBDQ is an instrument used to assess quality of life and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score will be reported and is ranging from 10 to 70 with a higher score indicates a better health-related quality of life.
efficacy
Change from Baseline in White Blood Cell Count
Timeframe: Baseline and up to Week 54
efficacy
Change from Baseline in Lymphocytes
Timeframe: Baseline and up to Week 54
efficacy
Change from Baseline in Hemoglobin
Timeframe: Baseline and up to Week 54
efficacy
Change from Baseline in Hematocrit
Timeframe: Baseline and up to Week 54
efficacy
Change from Baseline in Albumin
Timeframe: Baseline and up to Week 54
efficacy
Change from Baseline in Albumin
Timeframe: Baseline and up to Week 54
Secondary ID(s)
TBD
Source(s) of Monetary Support
-
Secondary Sponsor(s)
Ethics review
Status: NA
Approval date:
Contact:
-
Not applicable due to post-marketing surveillance.
-
-
Results
Results available:
Date Posted:
Date Completed: 31/10/2023
URL:
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