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Trial record 1 of 1 for:    NCT02862132
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Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases

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ClinicalTrials.gov Identifier: NCT02862132
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : October 25, 2022
Sponsor:
Information provided by (Responsible Party):
Dr Dan Turner, Shaare Zedek Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease Drug: Vedolizumab Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : January 2017
Actual Primary Completion Date : January 2022
Actual Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vedolizumab
IV Vedolizumab 177mg/m2 Body Surface Area (BSA), max. 300mg Induction regimen: 0,2,6 and then every 8 weeks
 Drug: Vedolizumab
Other Name: Entyvio


Outcome Measures
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Primary Outcome Measures :
  1. Complete remission at week 14 [ Time Frame: weeks 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)


  2. Complete remission at week 30 [ Time Frame: weeks 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)


  3. Complete remission at week 54 [ Time Frame: weeks 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)


  4. Complete remission at week 108 [ Time Frame: weeks 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)


  5. Complete remission at week 162 [ Time Frame: weeks 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)



Secondary Outcome Measures :
  1. Steroid and EEN free clinical remission (without the need for normal CRP) using PCDAI or PUCAI score and concomitant medication list. [ Time Frame: week 30, week 54, week 108, week 162 ]
  2. Steroid and EEN free clinical response (without the need for normal CRP) using PCDAI or PUCAI score and concomitant medication list. [ Time Frame: week 30, week 54, week 108, week 162 ]
  3. Fecal calprotectin levels [ Time Frame: week 30, week 54, week 108, week 162 ]
    Levels of calprotectin will be measured in the lab using calprotectin kit.

  4. serum CRP levels [ Time Frame: week 30, week 54, week 108, week 162 ]
    CRP levels will be measured in the lab

  5. Rate of loss of response including drug levels [ Time Frame: week 30, week 54, week 108, week 162 ]
  6. Steroid dependency (defined as cumulative use of >4 months in a year with at least one need to increase dose while weaning) [ Time Frame: week 30, week 54, week 108, week 162 ]
  7. Adverse events [ Time Frame: week 30, week 54, week 108, week 162 ]
  8. Measures of mucosal inflammation as available as part of clinical care using endoscopy, imaging or capsule endoscopy. [ Time Frame: week 30, week 54, week 108, week 162 ]
  9. Time to induction of remission [ Time Frame: week 30, week 54, week 108, week 162 ]
  10. Longitudinal Physician Global Assessment (PGA) [ Time Frame: week 30, week 54, week 108, week 162 ]
    PGA will be measured using Visual analogue scale (VAS)

  11. Height velocity as compared with the year prior to commencing VDZ [ Time Frame: week 30, week 54, week 108, week 162 ]
  12. Need for surgical interventions (including resections, colectomy, and dilatations) [ Time Frame: week 30, week 54, week 108, week 162 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862132


Locations
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United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06032
United States, New Jersey
Atlantic Children's Health-Goryeb Children's Hospital
Morristown, New Jersey, United States
United States, New York
Cohen Children's Medical Center of NY, Northwell
New York, New York, United States
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Denmark
Hvidovre University Hospital
Copenhagen, Denmark
Ireland
Our Lady's Children's Hospital Crumlin
Dublin, Ireland
Israel
Rambam Medical Cener
Haifa, Israel
Wolfson Medical Center
Holon, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Schneider Medical Center
Petach Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Ichilov
Tel Aviv, Israel
Assaf Harofeh
Tzrifin, Israel
Slovenia
University Children's Hospital Ljubljana
Ljubljana, Slovenia
United Kingdom
The Royal Hospital for Children Glasgow
Glasgow, United Kingdom
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Dan Turner, MD Shaare Zedek Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Dan Turner, Head, The Juliet Keidan Institute of Pediatric Gastroenterology, Hepatology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02862132    
Other Study ID Numbers: VEDOKIDS
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dr Dan Turner, Shaare Zedek Medical Center:
VDZ: Vedolizumab
UC: Ulcerative colitis
CD: Crohn's disease
TDM: Therapeutic drug monitoring
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Vedolizumab
Gastrointestinal Agents