Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases
NCT ID: NCT02862132
Last Updated: 2022-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
142 participants
INTERVENTIONAL
2017-01-31
2022-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vedolizumab
IV Vedolizumab 177mg/m2 Body Surface Area (BSA), max. 300mg Induction regimen: 0,2,6 and then every 8 weeks
Vedolizumab
Interventions
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Vedolizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. IBD Diagnosis
3. Initiating Vedolizumab therapy
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Dr Dan Turner
Head, The Juliet Keidan Institute of Pediatric Gastroenterology, Hepatology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel
Principal Investigators
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Dan Turner, MD
Role: PRINCIPAL_INVESTIGATOR
Shaare Zedek Medical Center
Locations
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Connecticut Children's Medical Center
Hartford, Connecticut, United States
Atlantic Children's Health-Goryeb Children's Hospital
Morristown, New Jersey, United States
Cohen Children's Medical Center of NY, Northwell
New York, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Hvidovre University Hospital
Copenhagen, , Denmark
Our Lady's Children's Hospital Crumlin
Dublin, , Ireland
Rambam Medical Cener
Haifa, , Israel
Wolfson Medical Center
Holon, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Schneider Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Ichilov
Tel Aviv, , Israel
Assaf Harofeh
Tzrifin, , Israel
University Children's Hospital Ljubljana
Ljubljana, , Slovenia
The Royal Hospital for Children Glasgow
Glasgow, , United Kingdom
Countries
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References
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Atia O, Shavit-Brunschwig Z, Lev-Tzion R, Stein R, Broide E, Urlep D, Hyams J, Weiss B, Aloi M, Assa A, Gerasimidis K, Nichols B, Russell RK, Turner D. Maintenance treatment with vedolizumab in paediatric inflammatory bowel disease (VEDOKIDS): 54-week outcomes of a multicentre, prospective, cohort study. Lancet Gastroenterol Hepatol. 2025 Mar;10(3):234-247. doi: 10.1016/S2468-1253(24)00319-4. Epub 2025 Jan 6.
Atia O, Shavit-Brunschwig Z, Mould DR, Stein R, Matar M, Aloi M, Ledder O, Focht G, Urlep D, Hyams J, Broide E, Weiss B, Levine J, Russell RK, Turner D. Outcomes, dosing, and predictors of vedolizumab treatment in children with inflammatory bowel disease (VEDOKIDS): a prospective, multicentre cohort study. Lancet Gastroenterol Hepatol. 2023 Jan;8(1):31-42. doi: 10.1016/S2468-1253(22)00307-7. Epub 2022 Oct 26.
Other Identifiers
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VEDOKIDS
Identifier Type: -
Identifier Source: org_study_id
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