Status:
UNKNOWN
Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Brief Summary
Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab (VDZ) who achieve mucosal healing at week 54 of treatment.
Eligibility Criteria
Inclusion
- age over 18 years,
- established diagnosis of ulcerative colitis for at least 3 months
- moderate to severe active ulcerative colitis with a Mayo endoscopic sub-score ≥ 1 before vedolizumab introduction
- patients receiving vedolizumab according to French drug labelling (previous exposure to anti-TNF, contraindicated or intolerant to anti-TNF),
- possibility of concomitant therapy including corticosteroids and immunosuppressors,
- patients naive to anti-integrin,
- no contraindication to proctosigmoidoscopy
Exclusion
- age under 18 years
- ulcerative colitis not proven, Crohn's disease, or inderterminate colitis
- personal history of high-grade dysplasia or colorectal cancer
- surgery with ileo-anal anastomosis
- patients' refusal to participate in the study
Key Trial Info
Start Date :
February 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 15 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03839680
Start Date
February 1 2018
End Date
April 15 2019
Last Update
February 15 2019
Active Locations (4)
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1
CHU de Besançon
Besançon, France
2
CHU de Montpellier
Montpellier, France
3
CHU de Nantes
Nantes, France
4
CHI de Haute-Saône
Vesoul, France