Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT03839680
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- Brief Summary
Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab (VDZ) who achieve mucosal healing at week 54 of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mucosal healing at defined by Mayo endoscopic sub-score ≤ 1 or UCEIS ≤ 1 54 weeks
- Secondary Outcome Measures
Name Time Method Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0 54 weeks Endoscopic pattern of mucosal healing 54 weeks
Trial Locations
- Locations (4)
CHI de Haute-Saône
🇫🇷Vesoul, France
CHU de Besançon
🇫🇷Besançon, France
CHU de Montpellier
🇫🇷Montpellier, France
CHU de Nantes
🇫🇷Nantes, France