UMIN-CTR Clinical Trial

Basic information
Public title	Pharmacokinetics and efficacy of Vedolizumab in inflammatory bowel diseases
Acronym	Pharmacokinetics of Vedolizumab in inflammatory bowel diseases
Scientific Title	Pharmacokinetics and efficacy of Vedolizumab in inflammatory bowel diseases
Scientific Title:Acronym	Pharmacokinetics of Vedolizumab in inflammatory bowel diseases
Region	Japan

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

Objectives
Narrative objectives1	In inflammatory bowel disease patients, measure the serum level of vedolizumab, anti-vedolizumab antibody, and evaluate short-term and long-term efficacy and safety .In inflammatory bowel disease patients, measure the serum level of vedolizumab, anti-vedolizumab antibody, and evaluate short-term and long-term efficacy and safety . We also examine the relationship between serum levels of vedolizumab and anti-vedolizumab antibody with patient background, treatment history and concomitant drug.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical remission at 30 weeks from the start of administration
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	20 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	inflammatory bowel disease patient being treated with vedolizumab or scheduled for treatment with vedolizumab
Key exclusion criteria	none
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Ohno
Organization	Shiga University of Medical Science
Division name	Division of gastroenterology
Zip code	520-2192
Address	tukinowa-cho, otsu-shi, shiga, Japan
TEL	077-548-2111
Email	hqmed2@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Takayuki Middle name Last name Imai
Organization	Shiga University of Medical Science
Division name	Division of gastroenterology
Zip code	520-2192
Address	tukinowa-cho, otsu-shi, shiga, Japan
TEL	077-548-2111
Homepage URL
Email	hqmed2@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
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	Shiga University of Medical Science
Address	tukinowa-cho, otsu-shi, shiga, Japan
Tel	077-548-3576
Email	hqrec@belle.shiga-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	2021 Year 09 Month 08 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	Suspended
Date of protocol fixation	2020 Year 01 Month 14 Day
Date of IRB	2020 Year 02 Month 14 Day
Anticipated trial start date	2020 Year 02 Month 14 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 09 Month 08 Day
Last modified on	2021 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051865