drugset / Trial / NCT02820493

Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF

NCT02820493

Phase 4 Withdrawn University of Genoa
NaSingle-groupOpen-labelTreatment

Summary

Anti-cytokine antibodies, such as Infliximab (an anti TNF alfa chimeric antibody) and Adalimumab (an anti TNF alfa humanize antibody), have been developed and used in clinical practice for the treatment of patients with Crohn disease (CD). Unfortunately, their efficacy is limited. Based on these concepts, a new drug has been developed for IBD treatment. Vedolizumab (VDZ) is able to recognize the α4β7 heterodimer, and selectively blocks gut lymphocyte trafficking. The hypothesis of this study is that VDZ therapy may be to halt CD disease progression during time and modifying its natural history, using Lemann Index.

Timeline

Start
2016-09
Primary completion
2019-03
Completion
2019-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Vedolizumab Monoclonal antibody 300 mg Intravenous

Indications