Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis

ClinicalTrials.gov ID

NCT03839680

Lead Sponsor

Centre Hospitalier Universitaire de BesanconOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

60Estimated

Last Update Posted

Feb 15, 2019Actual

Start Date

Feb 1, 2018Actual

Primary Completion Date

Apr 15, 2019Estimated

Completion Date

Apr 15, 2019Estimated

Official Title

Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis

Brief Summary

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

• Ulcerative Colitis

• Endoscopy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No data available

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Centre Hospitalier Universitaire de BesanconOTHER

lvuitton@chu-besancon.fr0381667322

lvuitton@chu-besancon.fr0381667322

lvuitton@chu-besancon.fr0381667322

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