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Completed

NCT Number: NCT02862132

Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases

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.

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Key information

Conditions

Crohn's Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Starting Vedolizumab to prevent post operative recurrence

Treatment and study plan

Vedolizumab

Drug

Other names: Entyvio

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2016
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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