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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02820493
Date of registration: 17/05/2016
Prospective Registration: Yes
Primary sponsor: Universita degli Studi di Genova
Public title: Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF
Scientific title: Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression
Date of first enrolment: September 2016
Target sample size: 0
Recruitment status: Withdrawn
URL:  https://clinicaltrials.gov/show/NCT02820493
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Contacts
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: vedolizumab
Primary Outcome(s)
Harvey Bradshaw index [Time Frame: Week 0-14]
Secondary Outcome(s)
anti-drug antibodies [Time Frame: Week 0-2-6-14-22-30-38-46-54]
fecal VDZ loss [Time Frame: Week 0-2-6-14-22-30-38-46-54]
Lèmann Index [Time Frame: Week 0 and Week 54]
VDZ trough levels [Time Frame: Week 0-2-6-14-22-30-38-46-54]
Secondary ID(s)
EVeA Study
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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