Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF

• Status: Withdrawn
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universita degli Studi di Genova
• Treatments: Vedolizumab

Criteria

Inclusion Criteria:

• Have given written informed consent to participate

• Be aged between 18 and 80

• Have a moderate/severe CD defined by an HBI >7 CD

Exclusion Criteria:

• previous treatment with anti-TNF drugs,

• concomitant use of immune-modulator drugs for CD (azathioprine/6-mercaptopurine, methotrexate)

• ulcerative colitis (UC) or inflammatory bowel disease undetermined (IBD-U) diagnosis

• symptomatic obstructive disease

• bowel resection within the past 6 months

• ileostomy

• extensive small bowel resection (as determined by the investigator) or a short bowel syndrome

• patients who are currently receiving total parenteral nutrition

• history of cancer in the past 5 years

• pregnancy known at the study inclusion

• positive Clostridium difficile stool assay

• Listeria, human immunodeficiency virus, central nervous system demyelinating disease, untreated tuberculosis