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

JRCT ID: jRCT1051210145

Registered date:28/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ulcerative colitis
• Date of first enrollment: 30/05/2022
• Target sample size: 150
• Study type: Interventional
• 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 Outcome: Clinical relapse rate at 54 weeks

Secondary Outcome

mucosal 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
• Gender: Both

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

• Primary Sponsor: ooi makoto