Pharmacokinetic Infliximab Data in Pediatric Crohn's Disease

PHASE4RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 2, 2023

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2025

Conditions
Crohn DiseaseChild, OnlyBiologic; Inadequate
Interventions
DRUG

Infliximab

IFX will be given intravenously at 10 mg/kg at week 0, and 5 mg/kg at weeks 2, 4, and 8 to all patients (induction). Maintenance will start at week 12, and then ideally continue every 6 weeks till week 24 (end of study). IFX trough levels will be measured at weeks 4, 12, and 24. During the maintenance, the IFX dose and/or interval adjustments, the IFX discontinuation or the start of a co-medication (i.e., an immunomodulator) will be possible on indication (i.e., primary nonresponse, secondary loss of response, intolerance to study medication) at the physicians' discretion.

Trial Locations (1)

3015 GD

RECRUITING

Erasmus Medical Center, Rotterdam

Sponsors
All Listed Sponsors
lead

Erasmus Medical Center

OTHER

NCT05552287 - Pharmacokinetic Infliximab Data in Pediatric Crohn's Disease | Biotech Hunter | Biotech Hunter