NCT05552287RecruitingPhase 4
Pro-RAPID
Prospective Analysis of Pharmacokinetic Infliximab data in Paediatric Inflammatory Bowel Disease patients (Pro-RAPID)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 7 Apr 2026
Brief summary (registry, in English)
To assess the proportion of patients with IFX trough level ≥ 5 µg/mL at week 12 without treatment escalation
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 3 May 2024
- Start date
- 24 May 2024
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Crohn's disease
- NCT number
- NCT05552287
- EU CT number
- 2023-507352-72-00
- EudraCT number
- 2022-002648-35
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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.
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Rijnstate Ziekenhuis Stichting Coordinator of this site? Confirm its status | Arnhem | Netherlands | Recruiting |
| Amphia Hospital Coordinator of this site? Confirm its status | Breda | Netherlands | Recruiting |
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| Academisch Ziekenhuis Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Sint Antonius Ziekenhuis Stichting Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Sint Franciscus Vlietland Groep Stichting Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Maasstad Ziekenhuis Stichting Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Wilhelmina Childrens Hospital Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.