Individualized Infiximab Dosing-Proof of Concept Study

Cedars-Sinai Medical Center

Status: Unknown

Conditions: Inflammatory Bowel Diseases

Treatments: Other: No Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02027727

Infiximab Dosing

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 6 to 23 years old

Volunteers: No Healthy Volunteers

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

Trial design

56 participants in 1 patient group

No intervention

Description:

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

Treatment:

Other: No Intervention