Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis (ACTIVEDO)

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

Study Overview

• Status: Unknown
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Procedure: Endoscopy

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • Recruiting
    • CHU de Besancon
    • Contact: Lucine Vuitton, MD; Phone Number: 0381667322; Email: vuitton@chu-besancon.fr
  • Montpellier, France
    • Recruiting
    • CHU de Montpellier
    • Contact: Lucine Vuitton; Phone Number: 0381667322; Email: lvuitton@chu-besancon.fr
  • Nantes, France
    • Recruiting
    • CHU de Nantes
    • Contact: Lucine Vuitton; Phone Number: 0381667322; Email: lvuitton@chu-besancon.fr
  • Vesoul, France
    • Recruiting
    • CHI de Haute-Saône
    • Contact: Lucine Vuitton; Phone Number: 0381667322; Email: lvuitton@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients suffering from ulcerative colitis for who an endoscopic examen is performed

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mucosal healing at defined by Mayo endoscopic sub-score ≤ 1 or UCEIS ≤ 1	54 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0	14 weeks
Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0	30 weeks
Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0	54 weeks
Endoscopic pattern of mucosal healing	54 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 ɑ 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
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 ɑ 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
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 ɑ 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
Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points		14 weeks
Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points		30 weeks
Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points		54 weeks
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
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
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
Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1		14 weeks
Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1		30 weeks
Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1		54 weeks
Histologic remission defined by a Nancy index score at 0 or 1		14 weeks
Histologic remission defined by a Nancy index score at 0 or 1		30 weeks
Histologic remission defined by a Nancy index score at 0 or 1		54 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): April 15, 2019
• Study Completion (Anticipated): April 15, 2019

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: ulcerative colitis, endoscopic activity, mucosal healing, vedolizumab
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: P/2019/412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No