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Trial record 4 of 49 for:    vedolizumab

Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by Shaare Zedek Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr Dan Turner, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT02862132
First received: July 31, 2016
Last updated: October 10, 2016
Last verified: October 2016
  Purpose

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 Intervention
Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Disease
Drug: Vedolizumab

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Complete remission at week 14 [ Time Frame: weeks 14 ] [ Designated as safety issue: No ]

    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)


  • Complete remission at week 30 [ Time Frame: weeks 30 ] [ Designated as safety issue: No ]

    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)


  • Complete remission at week 54 [ Time Frame: weeks 54 ] [ Designated as safety issue: No ]

    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)


  • Complete remission at week 108 [ Time Frame: weeks 108 ] [ Designated as safety issue: No ]

    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)


  • Complete remission at week 162 [ Time Frame: weeks 162 ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Fecal calprotectin levels [ Time Frame: week 30, week 54, week 108, week 162 ] [ Designated as safety issue: No ]
    Levels of calprotectin will be measured in the lab using calprotectin kit.

  • serum CRP levels [ Time Frame: week 30, week 54, week 108, week 162 ] [ Designated as safety issue: No ]
    CRP levels will be measured in the lab

  • Rate of loss of response including drug levels [ Time Frame: week 30, week 54, week 108, week 162 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: week 30, week 54, week 108, week 162 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to induction of remission [ Time Frame: week 30, week 54, week 108, week 162 ] [ Designated as safety issue: No ]
  • Longitudinal Physician Global Assessment (PGA) [ Time Frame: week 30, week 54, week 108, week 162 ] [ Designated as safety issue: No ]
    PGA will be measured using Visual analogue scale (VAS)

  • Height velocity as compared with the year prior to commencing VDZ [ Time Frame: week 30, week 54, week 108, week 162 ] [ Designated as safety issue: No ]
  • Need for surgical interventions (including resections, colectomy, and dilatations) [ Time Frame: week 30, week 54, week 108, week 162 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2016
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

This is a multi-center prospective cohort study in which the investigators are aim to enroll 120 children under the age of 18 years, diagnosed with CD, inflammatory bowel disease unclassified (IBDU) or UC (approximately 60 in UC/IBDU and 60 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.

  Eligibility

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

Inclusion Criteria:

  1. Children under the age of 18 years.
  2. IBD Diagnosis
  3. Initiating Vedolizumab therapy

Exclusion Criteria:

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02862132

Contacts
Contact: Dana Marcus, Msc. 972-2-5645524 danam@szmc.org.il

Locations
Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Dana Marcus, Msc.    972-2-5645524    danam@szmc.org.il   
Principal Investigator: Dan Turner, MD         
Sub-Investigator: Oren Ledder, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Dan Turner, MD Shaare Zedek Medical Center
  More Information

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: Vedolizumab - prospective 
Study First Received: July 31, 2016
Last Updated: October 10, 2016
Health Authority: Israel: Ministry of Health
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Shaare Zedek Medical Center:
VDZ: Vedolizumab
UC: Ulcerative colitis
CD: Crohn's disease
TDM: Therapeutic drug monitoring

Additional relevant MeSH terms:
Vedolizumab
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Gastrointestinal Agents

ClinicalTrials.gov processed this record on December 07, 2016