Trial intelligence / Profile preview

Vedolizumab vs Infliximab in Ulcerative Colitis After Anti-TNF Failure

NCT03679546Phase 4

Key facts

Status: Completed
Start: Jan 2019
Primary completion: Dec 2024
Countries: 1
Sponsor: CHU Rennes
Modality: Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies

Drugs: vedolizumab
Conditions: ulcerative colitis (UC)

Overview

Phase 4, randomised, double-blind trial of vedolizumab in ulcerative colitis (UC) (2 arms), sponsored by CHU Rennes. Primary endpoint: Clinical Remission at 14 weeks. Started Jan 2019; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Vedolizumab
Vedolizumab IV induction and maintenance
Infliximab
Infliximab IV induction and maintenance

Who it enrols

Adult patients with moderate to severe ulcerative colitis who have failed a first subcutaneous anti-TNF (adalimumab or golimumab) and are naive to vedolizumab, infliximab, and JAK inhibitors.

Endpoints

Primary

Clinical Remission14 weeks

Secondary

Mayo Score54 weeks
Faecal Calprotectin Level54 weeks
Rate of Colectomy and Hospitalization1 year
Mayo Endoscopic Subscore54 weeks
Partial Mayo Score54 weeks
Inflammatory Bowel Disease Questionnaire54 weeks
Inflammatory Bowel Disease-Disk54 weeks
Inflammatory Bowel Disease-Disability Index54 weeks

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