Trials / Unknown
UnknownNCT02027727
Individualized Infiximab Dosing-Proof of Concept Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 56 (estimated)
- Sponsor
- Cedars-Sinai Medical Center · Academic / Other
- Sex
- All
- Age
- 6 Years – 23 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No Intervention | no intervention- tihs is an observational study |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2017-05-01
- Completion
- 2018-03-01
- First posted
- 2014-01-06
- Last updated
- 2017-07-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02027727. Inclusion in this directory is not an endorsement.