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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000039916
Receipt No. R000045522
Scientific Title Prospective evaluation of vedolizumab-effects in patients with inflammatory bowel diseases
Date of disclosure of the study information 2020/05/11
Last modified on 2020/05/23

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Basic information
Public title Prospective evaluation of vedolizumab-effects in patients with inflammatory bowel diseases
Acronym VED IBD Cohort Study
Scientific Title Prospective evaluation of vedolizumab-effects in patients with inflammatory bowel diseases
Scientific Title:Acronym VED IBD Cohort Study
Region
Japan

Condition
Condition ulcerative colitis and Crohn's disease
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of vedolizumab-effects in prospective single-center cohort of IBD patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Persistence of vedolizumab at week 54
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with inflammatory bowel diseases, such as ulcerative colitis and Crohn's disease treated with vedolizumab
Key exclusion criteria 1. Patients without informed consent
2. Patients determined to be inappropriate by doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shingo
Middle name
Last name Kato
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Gastroenterology and Hepatology
Zip code 350-8550
Address 1981 Kamoda, Kawagoe City, Saitama 3508550, Japan
TEL 049-228-3564
Email skato@saitama-med.ac.jp

Public contact
Name of contact person
1st name Shingo
Middle name kato
Last name Kato
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Gastroenterology and Hepatology
Zip code 350-8550
Address 1981 Kamoda, Kawagoe City, Saitama 3508550, Japan
TEL 049-228-3564
Homepage URL
Email skato@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Saitama Medical Center
Address 1981 Kamoda, Kawagoe City, Saitama 3508550, Japan
Tel 049-228-3902
Email smcrinri@saitama-med.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2020 Year 05 Month 07 Day
Date of IRB
2020 Year 05 Month 14 Day
Anticipated trial start date
2020 Year 05 Month 11 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Decision of VED is determined by doctor in clinical practice. All patients determined to be treated by VED were able to be enrolled in this study regardless of their clinical activities or history of treatment after the acquisition of informed consent. Shortening of vedolizumab treatment ever 4 weeks were not permitted in Japan.

The name of this study was determined not to be appropriate by the IRB in Saitama Medical Center and was re-registered as UMIN000040175.

Management information
Registered date
2020 Year 03 Month 23 Day
Last modified on
2020 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045522

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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