Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases

  • STATUS
    Recruiting
  • End date
    Jul 25, 2022
  • participants needed
    120
  • sponsor
    Shaare Zedek Medical Center
Updated on 25 March 2021
Investigator
Zivia Shavit, Msc.
Primary Contact
Schneider Medical Center (6.6 mi away) Contact
+13 other location
remission
monoclonal antibodies
ulcerative colitis
inflammatory bowel disease
vedolizumab
crohn's disease
enteropathy
colitis
ulceration

Summary

Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against 47 integrin which modulates lymphocyte trafficking in the gut.

Results from the adult GEMINI-1 and GEMINI-2 trials demonstrated clinical efficacy in induction and maintenance of remission in both ulcerative colitis (UC) and Crohn's disease (CD), respectively.

Recent real life cohorts in adults support the effectiveness of VDZ in inducing and maintaining remission, both in CD and UC. In pediatrics, there are very limited data on the use of VDZ besides two retrospective case series.

Data on immunogenicity and therapeutic drug monitoring (TDM) of VDZ is conflicting in adults and practically non-existent in children.

The investigators aim to prospectively explore the real life short and longer term outcomes of VDZ in pediatric IBD (including growth) and to develop a prediction model for treatment success based on VDZ trough levels and other clinical and laboratory variables.

Description

This is a multi-center prospective cohort study in which the investigators are aim to enroll 140 children under the age of 18 years, diagnosed with CD, inflammatory bowel disease unclassified (IBDU) or UC (approximately 70 in UC/IBDU and 70 in the CD group) who commenced on Vedolizumab for any reason at the discretion of the treating physician.

Patients will be followed up to 3 years at 8 different time points: week 0, week 2, week 6, week 14, week 30, week 54 (1 year), week 108 (2 years) and week 162 (3 years). Blood work will be collected at each visit during the time of venous access insertion for the drug infusion for serum and stool sample will be collected at visits 0, 14, 30, and 54. In addition, at week 0 and 14 whole blood will be collected into a PaxGene tube for gene expression analysis.

Details
Condition Gastroenteritis, Intestinal Diseases, Ulcerative Colitis, Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), Ulcerative Colitis (Pediatric), Bowel Dysfunction, inflammatory bowel diseases, crohns disease
Treatment Vedolizumab
Clinical Study IdentifierNCT02862132
SponsorShaare Zedek Medical Center
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Children under the age of 18 years
IBD Diagnosis
Initiating Vedolizumab therapy

Exclusion Criteria

Starting Vedolizumab to prevent post operative recurrence
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