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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:  NCT02862132
Date of registration: 31/07/2016
Prospective Registration: Yes
Primary sponsor: Shaare Zedek Medical Center
Public title: Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases
Scientific title: Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases (IBD) Including Drug Levels: a Multi-center Prospective Cohort Study, From the Pediatric IBD Porto Group of European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)
Date of first enrolment: January 2017
Target sample size: 120
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02862132
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Denmark Finland Ireland Israel Slovenia United Kingdom United States
Contacts
Name:     Zivia Shavit, Msc.
Address: 
Telephone: 972-2-5645524
Email: zivias@szmc.org.il
Affiliation: 
Name:     Dan Turner, MD
Address: 
Telephone:
Email:
Affiliation:  Shaare Zedek Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Children under the age of 18 years.

2. IBD Diagnosis

3. Initiating Vedolizumab therapy

Exclusion Criteria:

1. Starting Vedolizumab to prevent post operative recurrence



Age minimum: N/A
Age maximum: 18 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Inflammatory Bowel Disease
Ulcerative Colitis
Intervention(s)
Drug: Vedolizumab
Primary Outcome(s)
Complete remission at week 108 [Time Frame: weeks 108]
Complete remission at week 14 [Time Frame: weeks 14]
Complete remission at week 162 [Time Frame: weeks 162]
Complete remission at week 30 [Time Frame: weeks 30]
Complete remission at week 54 [Time Frame: weeks 54]
Secondary Outcome(s)
Adverse events [Time Frame: week 30, week 54, week 108, week 162]
Fecal calprotectin levels [Time Frame: week 30, week 54, week 108, week 162]
Height velocity as compared with the year prior to commencing VDZ [Time Frame: week 30, week 54, week 108, week 162]
Longitudinal Physician Global Assessment (PGA) [Time Frame: week 30, week 54, week 108, week 162]
Measures of mucosal inflammation as available as part of clinical care using endoscopy, imaging or capsule endoscopy. [Time Frame: week 30, week 54, week 108, week 162]
Need for surgical interventions (including resections, colectomy, and dilatations) [Time Frame: week 30, week 54, week 108, week 162]
Rate of loss of response including drug levels [Time Frame: week 30, week 54, week 108, week 162]
serum CRP levels [Time Frame: week 30, week 54, week 108, week 162]
Steroid and EEN free clinical remission (without the need for normal CRP) using PCDAI or PUCAI score and concomitant medication list. [Time Frame: week 30, week 54, week 108, week 162]
Steroid and EEN free clinical response (without the need for normal CRP) using PCDAI or PUCAI score and concomitant medication list. [Time Frame: week 30, week 54, week 108, week 162]
Steroid dependency (defined as cumulative use of >4 months in a year with at least one need to increase dose while weaning) [Time Frame: week 30, week 54, week 108, week 162]
Time to induction of remission [Time Frame: week 30, week 54, week 108, week 162]
Secondary ID(s)
VEDOKIDS
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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