Ulcerative colitis
Conditions
Brief summary
At week 48 success defined by Endoscopic remission defined by an endoscopic Mayo score 0
Detailed description
Clinical remission (Clinical remission is defined as a total Mayo score ≤ 2 points, with no individual sub score > 1, and a Mayo endoscopy sub score of 0 or 1), Remission without steroids, Endoscopic healing rate with Mayo score 0 or 1, UCEIS score, Histological healing (Nancy score), Remission rate and remission rate without steroids at study visits and W48, Quality of life evolution (evaluate visit 0 vs W14, W26, W38 and W48), Patients satisfaction, Continuous response, Safety and tolerability, Anti-TNF pharmacokinetics, Number of visits in trial, Number of UC related hospitalizations, Number of colectomies, Treatment compliance (questionnaire), Patient adhesion (questionnaire), Medico-economic analysis
Interventions
Sponsors
Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At week 48 success defined by Endoscopic remission defined by an endoscopic Mayo score 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical remission (Clinical remission is defined as a total Mayo score ≤ 2 points, with no individual sub score > 1, and a Mayo endoscopy sub score of 0 or 1), Remission without steroids, Endoscopic healing rate with Mayo score 0 or 1, UCEIS score, Histological healing (Nancy score), Remission rate and remission rate without steroids at study visits and W48, Quality of life evolution (evaluate visit 0 vs W14, W26, W38 and W48), Patients satisfaction, Continuous response, Safety and tolerability, Anti-TNF pharmacokinetics, Number of visits in trial, Number of UC related hospitalizations, Number of colectomies, Treatment compliance (questionnaire), Patient adhesion (questionnaire), Medico-economic analysis | — |
Countries
France
Outcome results
None listed