Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— ACTIVEDO  

Official title:

Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03839680
• Other study ID #: P/2019/412
• Status: Recruiting
• Start date: February 1, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab (VDZ) who achieve mucosal healing at week 54 of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Procedure:
• Endoscopy
The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body.

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	CHU de Montpellier	Montpellier
France	CHU de Nantes	Nantes
France	CHI de Haute-Saône	Vesoul

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Risk factors of mucosal healing	Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis: Demographic data: age, gender, smoking habit; Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS); Treatments: Previous therapy used including number of TNF ? antagonist and reason for failure; Concomitant drugs: corticosteroids, immunosuppressors; Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy.	14 weeks
Other	Risk factors of mucosal healing	Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis: Demographic data: age, gender, smoking habit; Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS); Treatments: Previous therapy used including number of TNF ? antagonist and reason for failure; Concomitant drugs: corticosteroids, immunosuppressors; Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy.	30 weeks
Other	Risk factors of mucosal healing	Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis: Demographic data: age, gender, smoking habit; Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS); Treatments: Previous therapy used including number of TNF ? antagonist and reason for failure; Concomitant drugs: corticosteroids, immunosuppressors; Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy.	54 weeks
Other	Endoscopic response defined by a decrease in Mayo endoscopic sub-score =1 or decrease in UCEIS = 2 points		14 weeks
Other	Endoscopic response defined by a decrease in Mayo endoscopic sub-score =1 or decrease in UCEIS = 2 points		30 weeks
Other	Endoscopic response defined by a decrease in Mayo endoscopic sub-score =1 or decrease in UCEIS = 2 points		54 weeks
Other	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		14 weeks
Other	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		30 weeks
Other	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		54 weeks
Other	Clinical remission defined by a total Mayo score = 2 with no sub-score > 1		14 weeks
Other	Clinical remission defined by a total Mayo score = 2 with no sub-score > 1		30 weeks
Other	Clinical remission defined by a total Mayo score = 2 with no sub-score > 1		54 weeks
Other	Histologic remission defined by a Nancy index score at 0 or 1		14 weeks
Other	Histologic remission defined by a Nancy index score at 0 or 1		30 weeks
Other	Histologic remission defined by a Nancy index score at 0 or 1		54 weeks
Primary	Mucosal healing at defined by Mayo endoscopic sub-score = 1 or UCEIS = 1		54 weeks
Secondary	Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0		14 weeks
Secondary	Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0		30 weeks
Secondary	Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0		54 weeks
Secondary	Endoscopic pattern of mucosal healing		54 weeks