Pharmacokinetic study of Infliximab in young IBD patients below the age of 9 years to construct a dosing algorithm model for IFX
- Conditions
- Inflammatory Bowel Disease, pediatric, anti-TNF therapy, IBD Kinderen, chronische darmziekten
- Registration Number
- NL-OMON23711
- Lead Sponsor
- Erasmus Medical Center, Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Pediatric 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical efficacy of IFX treatment in pediatric IBD patients (¡Ü 9 years) in relation to<br /><br>- Antropometric data<br /><br>- Clinical data<br /><br>- Pharmacokinetics (including the presence of antibodies to IFX)<br /><br>- Safety<br /><br>o Number of (serious) adverse events
- Secondary Outcome Measures
Name Time Method ot Applicable