NCT02862132

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
6 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

5 years

First QC Date

July 31, 2016

Last Update Submit

October 24, 2022

Conditions

Crohn's DiseaseUlcerative ColitisInflammatory Bowel Disease

Keywords

VDZ: VedolizumabUC: Ulcerative colitisCD: Crohn's diseaseTDM: Therapeutic drug monitoring

Outcome Measures

Primary Outcomes (5)

  • Complete remission at week 14

    As defined by all three criteria: i. Steroids and Exclusive enteral nutrition (EEN) (defined as \>50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \<12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) \<10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)

    weeks 14

  • Complete remission at week 30

    As defined by all three criteria: i. Steroids and Exclusive enteral nutrition (EEN) (defined as \>50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \<12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) \<10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)

    weeks 30

  • Complete remission at week 54

    As defined by all three criteria: i. Steroids and Exclusive enteral nutrition (EEN) (defined as \>50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \<12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) \<10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)

    weeks 54

  • Complete remission at week 108

    As defined by all three criteria: i. Steroids and Exclusive enteral nutrition (EEN) (defined as \>50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \<12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) \<10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)

    weeks 108

  • Complete remission at week 162

    As defined by all three criteria: i. Steroids and Exclusive enteral nutrition (EEN) (defined as \>50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \<12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) \<10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)

    weeks 162

Secondary Outcomes (12)

  • Steroid and EEN free clinical remission (without the need for normal CRP) using PCDAI or PUCAI score and concomitant medication list.

    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.

    week 30, week 54, week 108, week 162

  • Fecal calprotectin levels

    week 30, week 54, week 108, week 162

  • serum CRP levels

    week 30, week 54, week 108, week 162

  • Rate of loss of response including drug levels

    week 30, week 54, week 108, week 162

  • +7 more secondary outcomes

Study Arms (1)

Vedolizumab

EXPERIMENTAL

IV Vedolizumab 177mg/m2 Body Surface Area (BSA), max. 300mg Induction regimen: 0,2,6 and then every 8 weeks

Drug: Vedolizumab

Interventions

VedolizumabDRUG
Also known as: Entyvio
Vedolizumab

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Connecticut Children's Medical Center

Hartford, Connecticut, 06032, United States

Location

Atlantic Children's Health-Goryeb Children's Hospital

Morristown, New Jersey, United States

Location

Cohen Children's Medical Center of NY, Northwell

New York, New York, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Location

Hvidovre University Hospital

Copenhagen, Denmark

Location

Our Lady's Children's Hospital Crumlin

Dublin, Ireland

Location

Rambam Medical Cener

Haifa, Israel

Location

Wolfson Medical Center

Holon, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Schneider Medical Center

Petah Tikva, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Ichilov

Tel Aviv, Israel

Location

Assaf Harofeh

Tzrifin, Israel

Location

University Children's Hospital Ljubljana

Ljubljana, Slovenia

Location

The Royal Hospital for Children Glasgow

Glasgow, United Kingdom

Location

Related Publications (3)

  • D'Arcangelo G, Turner D, Ledder O, Orlanski-Meyer E, Broide E, Granot M, Matar M, Hussey S, Yerushalmy-Feler A, Norden C, Miele E, Aloi M. Vedolizumab for extraintestinal manifestations in pediatric inflammatory bowel disease: Results from the VedoKids study. J Pediatr Gastroenterol Nutr. 2025 Nov 18. doi: 10.1002/jpn3.70276. Online ahead of print.

    PMID: 41251034DERIVED

  • 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.

    PMID: 39788134DERIVED

  • 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.

    PMID: 36306803DERIVED

MeSH Terms

Conditions

Crohn DiseaseColitis, UlcerativeInflammatory Bowel Diseases

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Dan Turner, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, The Juliet Keidan Institute of Pediatric Gastroenterology, Hepatology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel

Study Record Dates

First Submitted

July 31, 2016

First Posted

August 10, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

October 25, 2022

Record last verified: 2022-10

Locations

DK(1)SL(1)GB(1)US(4)IE(1)IL(7)