Clinical trial NCT03839680: Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis
Official title: Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis, endoscopic activity, mucosal healing, vedolizumab
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from ulcerative colitis for who an endoscopic examen is performed

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 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

Primary outcomes:
measure: Mucosal healing at defined by Mayo endoscopic sub-score ≤ 1 or UCEIS ≤ 1
timeFrame: 54 weeks
Secondary outcomes:
measure: Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0
timeFrame: 14 weeks
measure: Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0
timeFrame: 30 weeks
measure: Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0
timeFrame: 54 weeks
measure: Endoscopic pattern of mucosal healing
timeFrame: 54 weeks
Other outcomes:
measure: Risk factors of mucosal healing
timeFrame: 14 weeks
measure: Risk factors of mucosal healing
timeFrame: 30 weeks
measure: Risk factors of mucosal healing
timeFrame: 54 weeks
measure: Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points
timeFrame: 14 weeks
measure: Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points
timeFrame: 30 weeks
measure: Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points
timeFrame: 54 weeks
measure: Clinical response defined by a decrease in the total Mayo score ≥ 3 points and ≥ 30 %, with a decrease in the sub score for rectal bleeding ≥ 1 or an absolute rectal-bleeding sub-score ≤ 1
timeFrame: 14 weeks
measure: Clinical response defined by a decrease in the total Mayo score ≥ 3 points and ≥ 30 %, with a decrease in the sub score for rectal bleeding ≥ 1 or an absolute rectal-bleeding sub-score ≤ 1
timeFrame: 30 weeks
measure: Clinical response defined by a decrease in the total Mayo score ≥ 3 points and ≥ 30 %, with a decrease in the sub score for rectal bleeding ≥ 1 or an absolute rectal-bleeding sub-score ≤ 1
timeFrame: 54 weeks
measure: Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1
timeFrame: 14 weeks
measure: Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1
timeFrame: 30 weeks
measure: Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1
timeFrame: 54 weeks
measure: Histologic remission defined by a Nancy index score at 0 or 1
timeFrame: 14 weeks
measure: Histologic remission defined by a Nancy index score at 0 or 1
timeFrame: 30 weeks
measure: Histologic remission defined by a Nancy index score at 0 or 1
timeFrame: 54 weeks
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Vesoul
country: France
facility: CHI de Haute-Saône
Study officials:
References: