Individualized Infiximab Dosing-Proof of Concept Study

Study Overview
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Brief Summary
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The purpose of this study is to determine which early infliximab pharmacokinetic level is most associated with clinical remission at weeks 30 and 54 in pediatric IBD patients.

Detailed Description
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Our aims are: to determine which early pk level; week 6 (peak), week 8 (2 week) or week 14 (trough), is most associated with week 30 and 54 outcomes in pediatric IBD patients. to determine if the forecasted PK determined by a newly developed Population PK Model software program is in agreement with the observed PK in IBD patients receiving infliximab. Subject recruitment is limited to patients of the principal investigator only. Subjects will be approached for participation in the research in person during a routine clinic visit by a member of the study team.

Official Title
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Individualized Infiximab Dosing-Proof of Concept Study

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females on IFX Patients with IBD Age 6-23 Able to obtain consent Exclusion Criteria: Not receiving infliximab On 10 mg/kg of IFX Not able to obtain consent

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 23 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No intervention<br>No intervention- this is an observational study of patients receiving Infliximab. | Other: No Intervention<br>* no intervention- tihs is an observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infliximab level and clinical remission at 54 weeks | Determine what level (peak, 2 week or trough) best correlates with clinical remission at week 54 Clinical remission definition: PCDAI < 10 or CDAI < 150 for Crohn's disease, or partial Mayo <2 points and no sub-score > 1 for ulcerative colitis. Fischer exact testing will be done to determine what detectable IFX level (week 6, week 8 or week 14) is most associated with week 54 clinical remission. Wilcoxon rank sum test will be performed to determine the median level that is most associated with week 54 clinical remission. Regression tree analysis will be performed to determine the optimal infliximab level cut point that predicts week 54 clinical remission. | 54 weeks | 
| Infliximab level and clinical remission at 30 weeks | Determine what level (peak, 2 week or trough) best correlates with clinical remission at week 30 Clinical remission definition: PCDAI < 10 or CDAI < 150 for Crohn's disease, or partial Mayo <2 points and no sub-score > 1 for ulcerative colitis. | 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between pk profiles predicted by the PK model and actual (measured) pk profiles | Secondary outcomes Agreement between pk profiles predicted by the PK model and actual (measured) pk profiles for all patients with at least 6 months in between levels Analysis: Bland Altman test will be used to quantify the agreement between the two methods: Software pk model vs actual measured pk profiles Comparison of software selected dose regimens with actual dose regimens for cost and overall drug exposure (AUC and Cmax) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory bowel disease, infliximab, trough level, crohn's disease, ulcerative colitis