Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2022
• Main ID: NCT02862132
• Date of registration: 31/07/2016
• Prospective Registration: Yes
• Primary sponsor: Shaare Zedek Medical Center
• Public title: Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases
• Scientific 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)
• Date of first enrolment: January 2017
• Target sample size: 142
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02862132
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Denmark, Finland, Ireland, Israel, Slovenia, United Kingdom, United States

Contacts

• Name: Dan Turner, MD
• Affiliation: Shaare Zedek Medical Center

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Ulcerative Colitis

Inflammatory Bowel Disease

Intervention(s)

Drug: Vedolizumab

Primary Outcome(s)

Complete remission at week 108 [Time Frame: weeks 108]

Complete remission at week 54 [Time Frame: weeks 54]

Complete remission at week 14 [Time Frame: weeks 14]

Complete remission at week 162 [Time Frame: weeks 162]

Complete remission at week 30 [Time Frame: weeks 30]

Secondary Outcome(s)

Adverse events [Time Frame: week 30, week 54, week 108, week 162]

Fecal calprotectin levels [Time Frame: week 30, week 54, week 108, week 162]

serum CRP levels [Time Frame: week 30, week 54, week 108, week 162]

Longitudinal Physician Global Assessment (PGA) [Time Frame: 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. [Time Frame: week 30, week 54, week 108, week 162]

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]

Time to induction of remission [Time Frame: week 30, week 54, week 108, week 162]

Height velocity as compared with the year prior to commencing VDZ [Time Frame: week 30, week 54, week 108, week 162]

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]

Need for surgical interventions (including resections, colectomy, and dilatations) [Time Frame: week 30, week 54, week 108, week 162]

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]

Rate of loss of response including drug levels [Time Frame: week 30, week 54, week 108, week 162]

Secondary ID(s)

VEDOKIDS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors