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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:  NCT03142321
Date of registration: 03/05/2017
Prospective Registration: Yes
Primary sponsor: Washington University School of Medicine
Public title: Defining Predictors of RT Response to Vedolizumab in IBD
Scientific title: Defining Predictors of Radiological Transmural Response to Vedolizumab in Small Bowel Crohn's Disease Through Serum Proteomic Biomarkers
Date of first enrolment: June 8, 2018
Target sample size: 80
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03142321
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
United States
Contacts
Name:     Darren Nix
Address: 
Telephone: 314-362-3201
Email: nixd@wustl.edu
Affiliation: 
Name:     Billy D Nix
Address: 
Telephone: 314-362-3201
Email: nixd@wustl.edu
Affiliation: 
Name:     Parakkal Deepak, MBBS, MS
Address: 
Telephone:
Email:
Affiliation:  Washington University School of Medicine
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Crohn Disease of Small Intestine
Intervention(s)
Drug: Vedolizumab 300 MG Injection [Entyvio]
Primary Outcome(s)
Radiological response [Time Frame: 16±2 weeks]
Secondary Outcome(s)
Secondary ID(s)
17-001
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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