Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases

Completed · Not applicable

Conditions studied: Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel Disease

In brief

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.

Key facts

Study ID

NCT02862132

Run by

Shaare Zedek Medical Center

People needed

142

Starts

2017-01-01

Expected to finish

2022-01-01

Last updated by the study team

2022-10-25

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Starting Vedolizumab to prevent post operative recurrence

Where it is running

• 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

Full record on ClinicalTrials.gov

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