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Trial record 21 of 415 for:    shaare zedek

Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases

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ClinicalTrials.gov Identifier: NCT02862132
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Dan Turner, Shaare Zedek Medical Center

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

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




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 ]


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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


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


Contacts
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Contact: Zivia Shavit, Msc. 972-2-5645524 zivias@szmc.org.il

Locations
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United States, New York
Cohen Children's Medical Center of NY, Northwell Recruiting
New York, New York, United States
Contact: Kathy Grancher       kgranche@northwell.edu   
Principal Investigator: James Markowitz, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States
Contact: Caitlin Walsh       WALSHC6@EMAIL.CHOP.EDU   
Principal Investigator: Ronen Stein, MD         
Denmark
Hvidovre University Hospital Recruiting
Copenhagen, Denmark
Contact: Christoph Norden       christoph.norden@regionh.dk   
Principal Investigator: Christoph Norden, MD         
Finland
Hospital for Children and Adolescents Helsinki University Hospital Not yet recruiting
Helsinki, Finland
Contact: Kaija-Leena Kolho, MD       kaija-leena.kolho@helsinki.fi   
Principal Investigator: Kaija-Leena Kolho, MD         
Ireland
Our Lady's Children's Hospital Crumlin Recruiting
Dublin, Ireland
Contact: Sarah Cooper, PhD       Sarah.Cooper@olchc.ie   
Principal Investigator: Seamus Hussey, MD         
Israel
Rambam Medical Cener Recruiting
Haifa, Israel
Contact: Liat Pritzker       liat.rambam@gmail.com   
Principal Investigator: Ron Shaoul, MD         
Wolfson Medical Center Recruiting
Holon, Israel
Contact: Michal Yaakov       michal.yaakov@walla.com   
Principal Investigator: Arie Levine, MD         
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel
Contact: Dana Marcus, Msc.    972-2-5645524    danam@szmc.org.il   
Principal Investigator: Dan Turner, MD         
Schneider Medical Center Recruiting
Petach Tikva, Israel
Contact: Reut Klein    972-3-9253039    reutkl@clalit.org.il   
Contact: Sara Hadas    972-3-9253039    hadassa@clalit.org.il   
Principal Investigator: Amit Assa, MD         
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Shiri Lahav       Shiri.Lahav@sheba.health.gov.il   
Principal Investigator: Dror Shouval, MD         
Ichilov Recruiting
Tel Aviv, Israel
Contact: Shani Eldar       shaniel@tlvmc.gov.il   
Principal Investigator: Shlomi Cohen, MD         
Assaf Harofeh Recruiting
Tzrifin, Israel
Contact: Gilad Ben Yehuda       Gastrolab@asaf.health.gov.il   
Principal Investigator: Efrat Broide, MD         
Slovenia
University Children's Hospital Ljubljana Recruiting
Ljubljana, Slovenia
Contact: Darja Urlep       darja.urlep@gmail.com   
Principal Investigator: Darja Urlep, MD         
United Kingdom
The Royal Hospital for Children Glasgow Not yet recruiting
Glasgow, United Kingdom
Contact: Lisa Richmond, MD       lisa.richmond@nhs.net   
Principal Investigator: Richard Russell, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Dan Turner, MD Shaare Zedek Medical Center

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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     History of Changes
Other Study ID Numbers: VEDOKIDS
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
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
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Vedolizumab
Gastrointestinal Agents