Individualized Infiximab Dosing-Proof of Concept Study

July 18, 2017 updated by: Namita Singh, M.D., Cedars-Sinai Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 23 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Males and females patients age 6 to 23

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No intervention
No intervention- this is an observational study of patients receiving Infliximab.
Other: No Intervention
no intervention- tihs is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infliximab level and clinical remission at 54 weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Namita Singh, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

May 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

January 2, 2014

First Posted (Estimate)

January 6, 2014

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Infiximab Dosing

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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