Individualized Infiximab Dosing-Proof of Concept Study

Inflammatory Bowel Diseases Clinical Trial

Official title:

Individualized Infiximab Dosing-Proof of Concept Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02027727
• Other study ID #: Infiximab Dosing
• Status: Active, not recruiting
• Phase: N/A
• First received: December 9, 2013
• Last updated: July 18, 2017
• Start date: November 2013
• Est. completion date: March 2018

Study information

• Verified date: July 2017
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: March 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 23 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• No Intervention
no intervention- tihs is an observational study

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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