Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases
| Status: | Recruiting |
|---|---|
| Conditions: | Colitis, Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 1/20/2019 |
| Start Date: | January 2017 |
| End Date: | July 2022 |
| Contact: | Zivia Shavit, Msc. |
| Email: | zivias@szmc.org.il |
| Phone: | 972-2-5645524 |
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)
Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against α4β7
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.
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.
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.
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.
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
We found this trial at
3
sites
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Principal Investigator: Ronen Stein, MD
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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New York, New York
Principal Investigator: James Markowitz, MD
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