Tests infliximab dosing in children with Crohn's disease
Tests infliximab dosing in children with Crohn's disease.
Plain-language title generated from the registry record
Registry title: Pro-RAPID
Key facts
- Where
- Amsterdam, Arnhem, Breda, Eindhoven, Leiden, Maastricht, Nieuwegein, Rotterdam, Utrecht, and Zwolle, NetherlandsSee the 12 sites
- Phase
- Phase 4
Where in Netherlands
- Amsterdam UMC StichtingAmsterdam, NetherlandsTaking people
- Rijnstate Ziekenhuis StichtingArnhem, NetherlandsTaking people
- Amphia HospitalBreda, NetherlandsTaking people
- Catharina Ziekenhuis StichtingEindhoven, NetherlandsTaking people
- Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsTaking people
- Academisch Ziekenhuis MaastrichtMaastricht, NetherlandsTaking people
- Sint Antonius Ziekenhuis StichtingNieuwegein, NetherlandsTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
- Maasstad Ziekenhuis StichtingRotterdam, NetherlandsTaking people
- Sint Franciscus Vlietland Groep StichtingRotterdam, NetherlandsTaking people
- Wilhelmina Childrens HospitalUtrecht, NetherlandsTaking people
- Isala Klinieken StichtingZwolle, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- NCT05552287EU 2023-507352-72-00
- Record updated
- 7 April 2026
- Original description
To assess the proportion of patients with IFX trough level ≥ 5 µg/mL at week 12 without treatment escalationRead full original descriptionShow less
Prospective Analysis of Pharmacokinetic Infliximab data in Paediatric Inflammatory Bowel Disease patients (Pro-RAPID)
To assess the proportion of patients with IFX trough level ≥ 5 µg/mL at week 12 without treatment escalation
Inclusion: Anti-TNF-α naïve children (age 1-15 years) with CD or IBD-U and an indication to start IFX treatment will be eligible for inclusion after a diagnosis of CD is made based on the Porto criteria [10]. Indications of starting IFX treatment as per ECCO-ESPGHAN guidelines [9] include non-response after induction with exclusive enteral nutrition or steroids, non-response to immunomodulators, severe growth delay, extensive disease and/or structuring or penetrating disease, with or without perianal disease. Evaluation of the indication to start IFX is performed at the discretion of the attending physician.
Exclusion: Patients with the following characteristics will be excluded: - Established monogenetic IBD - Diagnosis with UC or IBD-U, ulcerative colitis like - Severe comorbidity (not related to IBD) - Immediate need for surgery (i.e., symptomatic stenosis or stricture in the bowel) - Severe infection such as sepsis or opportunistic infections, positive tuberculin test or a chest radiograph consistent with tuberculosis or malignancy - Pregnancy, suspected or definitive - Treatment with anti-TNF or other biological drugs in the past - Start of corticosteroids or mesalazine less than 2 weeks prior to first IFX infusion - Start of Exclusive Enteral Nutrition less than 2 week prior to first IFX infusion.