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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)
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (12)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Amsterdam UMC Stichting
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AmsterdamNetherlandsRecruiting
Rijnstate Ziekenhuis Stichting
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ArnhemNetherlandsRecruiting
Amphia Hospital
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BredaNetherlandsRecruiting
Catharina Ziekenhuis Stichting
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EindhovenNetherlandsRecruiting
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsRecruiting
Academisch Ziekenhuis Maastricht
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MaastrichtNetherlandsRecruiting
Sint Antonius Ziekenhuis Stichting
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NieuwegeinNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Coordinator of this site? Confirm its status
RotterdamNetherlandsRecruiting
Sint Franciscus Vlietland Groep Stichting
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RotterdamNetherlandsRecruiting
Maasstad Ziekenhuis Stichting
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RotterdamNetherlandsRecruiting
Wilhelmina Childrens Hospital
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UtrechtNetherlandsRecruiting
Isala Klinieken Stichting
Coordinator of this site? Confirm its status
ZwolleNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.