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Pharmacokinetic study of Infliximab in young IBD patients below the age of 9 years to construct a dosing algorithm model for IFX


- candidate number22866
- NTR NumberNTR5491
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-sep-2015
- Secondary IDsMEC-2015-503 Erasmus MC Rotterdam
- Public TitlePharmacokinetic study of Infliximab in young IBD patients below the age of 9 years to construct a dosing algorithm model for IFX
- Scientific TitleRetrospective Analysis of Pharmacokinetic Infliximab Data in young IBD patients below the age of 9 years to construct a dosing algorithm model for IFX
- ACRONYMRAPID - IBD
- hypothesisAnti-TNF treatment (infliximab (IFX), adalimumab (ADA)) has become standard therapy for refractory pediatric and adult Crohn¡¯s disease (CD) patients, and is used for the induction and maintenance of remission. When effective, clinical and endoscopic remission is reached within weeks. In ulcerative colitis anti-TNF treatment is also increasingly used, and has been shown to induce remission in active disease. Early IFX pharmacokinetic (PK) data showed a consistent trend towards lower mean serum IFX concentrations after a single dose of 5 and 10 mg/kg in pediatric compared to adult CD patients. Over time some papers have suggested IFX PK are not statistically different between pediatric and adult CD or UC patients. However recent data suggests decreased sustained IFX efficacy in early-onset IBD patients (< 8 years), specifically in children 5 years old and younger. Alternate absorption, distribution, metabolism and excretion between children and adults may all play a role.(Shi and Derendorf 2010). The exact underlying mechanisms are currently incompletely understood. Our primary aim is to assess pharmacokinetics of IFX, based on existing therapeutic drug monitoring (TDM) data, in relation to efficacy and safety in pediatric IBD patients below the age of 9 years. Our secondary aim is to construct a dosing guideline based on these retrospectively collected data for more accurate IFX dosing.
- Healt Condition(s) or Problem(s) studiedChildren, IBD, Chronic inflammatory bowel disease
- Inclusion criteriaPediatric IBD patients (¡Ü 9 years) who have initiated IFX treatment because of active luminal disease, failing treatment with immunomodulators and corticosteroids
- Exclusion criteria- IFX treatment started for a condition other than IBD
- Missing data on IFX dosing or levels
- Age > 9 years when IFX treatment was initiated
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2015
- planned closingdate
- Target number of participants50
- InterventionsRetrospective collection of data
- Primary outcomeClinical efficacy of IFX treatment in pediatric IBD patients (¡Ü 9 years) in relation to
- Antropometric data
- Clinical data
- Pharmacokinetics (including the presence of antibodies to IFX)
- Safety
o Number of (serious) adverse events
- Secondary outcomeNot Applicable
- TimepointsNot Applicable
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES L. de Ridder
- CONTACT for SCIENTIFIC QUERIES L. de Ridder
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD12-sep-2015 - 5-jan-2016


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