Individualized Infiximab Dosing-Proof of Concept Study

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: No Intervention

• Registration Number: NCT02027727
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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

Our aims are:

1. 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.

2. 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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2014-01-02
• Study First Posted: 2014-01-06
• Primary Completion: 2017-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Males and females on IFX
2. Patients with IBD
3. Age 6-23
4. Able to obtain consent

Exclusion Criteria

1. Not receiving infliximab
2. On 10 mg/kg of IFX
3. Not able to obtain consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No intervention	No Intervention	No intervention- this is an observational study of patients receiving Infliximab.

Primary Outcome Measures

Name	Time	Method
Infliximab level and clinical remission at 54 weeks	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.
Infliximab level and clinical remission at 30 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Agreement between pk profiles predicted by the PK model and actual (measured) pk profiles	1 year	Secondary outcomes; 1. 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; 2. Comparison of software selected dose regimens with actual dose regimens for cost and overall drug exposure (AUC and Cmax)

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States