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

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Ulcerative Colitis

Treatments: Procedure: Endoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT03839680

P/2019/412

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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