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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02820493 |
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Date of registration:
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17/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF
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Scientific title:
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Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02820493 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Drug: vedolizumab
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Primary Outcome(s)
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Harvey Bradshaw index
[Time Frame: Week 0-14]
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Secondary Outcome(s)
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Lèmann Index
[Time Frame: Week 0 and Week 54]
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anti-drug antibodies
[Time Frame: Week 0-2-6-14-22-30-38-46-54]
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VDZ trough levels
[Time Frame: Week 0-2-6-14-22-30-38-46-54]
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fecal VDZ loss
[Time Frame: Week 0-2-6-14-22-30-38-46-54]
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Secondary ID(s)
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EVeA Study
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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