An Open Label Phase 4 Study to Evaluate Efficacy of Early Versus Late Use of Vedolizumab in Ulcerative Colitis
Status:
Completed
Trial end date:
2020-08-01
Target enrollment:
Participant gender:
Summary
This multi-centre open label study will involve a minimum of 120 patients in 2 cohorts: 60
patients with 'early UC' defined as disease duration < 4 years and no other treatments than
aminosalicylates and/or corticosteroids and 60 patients with 'late UC' defined as active
disease despite treatment with immunosuppressives (IS) and/or anti-TNF. Patients wih
intolerance to IS AND anti-TNF will also be allowed in the latter group. Participants will be
treated with 12 months of open label vedolizumab and undergo monitoring of endoscopic,
histological and clinical disease parameters. No randomization or blinding will be performed
but the study management will make sure recruitment in either study group is comparable for
number and profile of patients (extent of disease and on/off corticosteroids).