ulcerative colitis ulcerative colitis
Conditions
Interventions
Administration of vedolizumab 300mg/day at 0,2, and 6 weeks, then at 8-week intervals for up to 54 weeks
C543529
vedolizumab
Sponsors
ooi makoto
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical relapse rate at 54 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| mucosal healing rate at 54 weeks histological remission rate at 54 weeks partial Mayo score at each point of the study | — |
Contacts
Public ContactHaruka Miyazaki
Kobe University Hospital
Outcome results
None listed