Individualized Infiximab Dosing-Proof of Concept Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 6 - 23 |
| Updated: | 7/20/2017 |
| Start Date: | November 2013 |
| End Date: | March 2018 |
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.
most associated with clinical remission at weeks 30 and 54 in pediatric IBD patients.
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.
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.
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
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