Informations générales (source: ClinicalTrials.gov)
Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis (ACTIVEDO)
Observational
Centre Hospitalier Universitaire de Besancon (Voir sur ClinicalTrials)
février 2018
avril 2019
29 juin 2024
Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab
(VDZ) who achieve mucosal healing at week 54 of treatment.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Besançon - Besançon - France | Lucine Vuitton, MD | Contact (sur clinicalTrials) | |||
| CHU de Montpellier - Montpellier - France | Lucine Vuitton | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Nantes - France | Lucine Vuitton | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHI de Haute-Saône - Vesoul - France | Lucine Vuitton | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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