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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23711

Enrollment

Registered

2015-09-12

Start date

2015-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease, pediatric, anti-TNF therapy, IBD Kinderen, chronische darmziekten

Interventions

Retrospective collection of data

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Clinical 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	—

Contacts

Public ContactL. de Ridder

l.deridder@erasmusmc.nltel 010 703 60 49

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)