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

Phase 3

Recruiting

• Conditions: ulcerative colitis; D003093

• Registration Number: JPRN-jRCT1051210145
• Lead Sponsor: ooi makoto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-28
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified