Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
56 participants
OBSERVATIONAL
2013-11-30
2018-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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No intervention
No intervention- this is an observational study of patients receiving Infliximab.
No Intervention
no intervention- tihs is an observational study
Interventions
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No Intervention
no intervention- tihs is an observational study
Eligibility Criteria
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Inclusion Criteria
2. Patients with IBD
3. Age 6-23
4. Able to obtain consent
Exclusion Criteria
2. On 10 mg/kg of IFX
3. Not able to obtain consent
6 Years
23 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Namita Singh, M.D.
Attending Physician of Pediatrics IBD Center, Cedars Sinai Med Center
Principal Investigators
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Namita Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Countries
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Other Identifiers
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Infiximab Dosing
Identifier Type: -
Identifier Source: org_study_id
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