NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1051210145

Registered date:28/12/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedulcerative colitis
Date of first enrollment30/05/2022
Target sample size150
Countries of recruitment
Study typeInterventional
Intervention(s)Administration of vedolizumab 300mg/day at 0,2, and 6 weeks, then at 8-week intervals for up to 54 weeks

Outcome(s)

Primary OutcomeClinical relapse rate at 54 weeks
Secondary Outcomemucosal healing rate at 54 weeks histological remission rate at 54 weeks partial Mayo score at each point of the study

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 80age old
GenderBoth
Include 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.
Exclude 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

Related Information

Contact

Public contact
Name Haruka Miyazaki
Address 7-5-2 Kusunoki-cho,Chuo-ku,Kobe,Hyogo Hyogo Japan 650-0017
Telephone +81-78-382-6305
E-mail miyaharu@med.kobe-u.ac.jp
Affiliation Kobe University Hospital
Scientific contact
Name makoto ooi
Address 7-5-2 Kusunoki-cho,Chuo-ku,Kobe,Hyogo Hyogo Japan 650-0017
Telephone +81-783826305
E-mail makotooi@med.kobe-u.ac.jp
Affiliation Kobe University Hospital