A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
This multi-centre open label study will involve a minimum of 260 patients in 2 cohorts: 86
patients with 'early CD' defined as disease duration < 24 months and no other treatments than
corticosteroids and/or thiopurines and 174 patients with 'late CD' defined as active disease
despite treatment with immunosuppressives and anti-TNF. Patients with 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 (study medication followed by commercial medication once
reimbursement is available) and undergo monitoring of endoscopic, histological and clinical
disease parameters. No randomization or blinding will be performed but the study management
will ensure that recruitment in either study group is comparable for number and profile of
patients (on/off steroids).