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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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4 March 2024 |
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Main ID: |
NCT03142321 |
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Date of registration:
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03/05/2017 |
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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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Defining Predictors of RT Response to Vedolizumab in IBD
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Scientific title:
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Defining Predictors of Radiological Transmural Response to Vedolizumab in Small Bowel Crohn's Disease Through Serum Proteomic Biomarkers |
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Date of first enrolment:
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June 8, 2018 |
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Target sample size:
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80 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03142321 |
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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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Countries of recruitment
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United States
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Contacts
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Name:
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Parakkal Deepak, MBBS, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Moderate to severe disease activity small bowel CD (small bowel only or ileocecal
only) visible on MRE
- Initiated on Vedolizumab with/without thiopurines or methotrexate
- =18 years old
Exclusion Criteria:
- Pregnancy
- Age <18
- Planned surgery prior to the first follow-up MRE
- Inability to provide informed consent.
- Perianal CD will be excluded since assessment requires performance of additional MRI
of the pelvis.
- Individuals with colonic involvement other than involvement of the ascending colon and
cecum.
- Inpatient scans will only be included if this is a MRE and adequate small bowel
distension with appropriate contrast has been achieved
- If unable to provide informed consent
- Contraindications for MRE including chronic kidney disease that precludes contrast
administration, implanted medical devices that are contraindicated for MRE.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease of Small Intestine
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Intervention(s)
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Drug: Vedolizumab 300 MG Injection [Entyvio]
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Primary Outcome(s)
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Radiological response
[Time Frame: 16±2 weeks]
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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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