臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 28, 2021
Last modified on	Oct. 24, 2024
Trial ID	jRCT1051210145

Scientific Title	Efficacy of therapeutic intervention with vedolizumab for ulcerative colitis patients with no or mild symptom and uncontrolled endoscopic activity: A multicenter- non-randomized trial
Public Title	Efficacy of therapeutic intervention with vedolizumab for ulcerative colitis patients with no or mild symptom and uncontrolled endoscopic activity: A multicenter- non-randomized trial

Contact for Scientific Queries	Name	ooi makoto
	Affiliation	Kobe University Hospital
	Address	7-5-2 Kusunoki-cho,Chuo-ku,Kobe,Hyogo
	Telephone	+81-783826305
	E-mail	makotooi@med.kobe-u.ac.jp
Contact for Public Queries	Name	Miyazaki Haruka
	Affiliation	Kobe University Hospital
	Address	7-5-2 Kusunoki-cho,Chuo-ku,Kobe,Hyogo
	Telephone	+81-78-382-6305
	E-mail	miyaharu@med.kobe-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 28, 2021
Actual date of first enrollment		May. 30, 2022
Target sample size		150
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) patients from 18 to 80 years (2) patients with clinical diagnosis of ulcerative colitis (3) patients treated with mesalazine and/or thiopurine over 6 months (4) Mayo endoscopic score of 2 or more (5) Mayo score of 2 or less with each sub-score of 1 or less (6) Those who can fill out the consent form about participation in this clinical research by themselves.
	Exclusion Criteria	(1)pregnant or breastfeeding women (2)patients with active infection (3)patients with malignancy or history of malignancy (4)patients treated with corticosteroid within 12 weeks before the commencement of the study (5)patients treated with cyclosporine or tacrolimus within 2 weeks before the commencement of the study (6)patients with the past history of anti TNF alpha antibody, JAK inhibitor, or ustekinumab treatment (7)patients with the past history of vedolizumab treatment (8)inappropriate patients by doctor's judgement
	Age Minimum	18age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		ulcerative colitis
Intervention(s)		Administration of vedolizumab 300mg/day at 0,2, and 6 weeks, then at 8-week intervals for up to 54 weeks
Health Condition(s) Keyword		ulcerative colitis
Intervention(s) Keyword		vedolizumab
Health Condition(s) Code		D003093
Intervention(s) Code		C543529
Primary Outcome(s)		Clinical relapse rate at 54 weeks
Secondary Outcome(s)		mucosal healing rate at 54 weeks histological remission rate at 54 weeks partial Mayo score at each point of the study

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kobe University Clinical research Ethical Committee
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan, Hyogo
Telephone	+81-78-382-6669
E-Mail	cerb@med.kobe-u.ac.jp
Approval Status	Approval
Date of approval	July. 30, 2021

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
13	Oct. 24, 2024	(this page)	Changes
12	Oct. 09, 2024	Detail	Changes
11	July. 01, 2024	Detail	Changes
10	June. 13, 2024	Detail	Changes
9	June. 10, 2024	Detail	Changes
8	Feb. 26, 2024	Detail	Changes
7	Feb. 20, 2024	Detail	Changes
6	Nov. 17, 2023	Detail	Changes
5	Nov. 15, 2023	Detail	Changes
4	Dec. 02, 2022	Detail	Changes
3	Nov. 25, 2022	Detail	Changes
2	Nov. 25, 2022	Detail	Changes
1	Dec. 28, 2021	Detail

List of change history