UMIN-CTR Clinical Trial

Basic information
Public title	Follow-up of effectiveness in patients with inflammatory bowel diseases treated by ustekinumab and vedolizumab
Acronym	UV follow-up study in IBD
Scientific Title	Follow-up of effectiveness in patients with inflammatory bowel diseases treated by ustekinumab and vedolizumab
Scientific Title:Acronym	UV follow-up study in IBD
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 ustekinumab and vedolizumab-effects in prospective single-center observational study in IBD, such as ulcerative colitis and Crohn's disease patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Persistence of ustekinumab and vedolizumab at week 56
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Active IBD patients who will be treated with ustekinumab and vedolizumab
Key exclusion criteria	1. Patients with severe infection 2. Patients with active tuberculosis 3. Patients who has allergy against ustekinumab and vedolizumab 4. Maternal patients and patients with breastfeeding 5. Patients who has malignancy and who has past history of malignancy 6. Patients who has ostomy 7. Patients determined to be inappropriate for this study
Target sample size	80

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	Enrolling by invitation
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 18 Day
Last follow-up date	2025 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 UST and 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.

Management information
Registered date	2020 Year 03 Month 26 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=R000045550

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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