Intensified Infliximab Treatment for Children with Crohn's Disease
Prospective Analysis of Pharmacokinetic Infliximab Data in Pediatric CD Patients (ProRAPID)
This study is testing if giving a stronger dose of infliximab helps children with Crohn's disease feel better compared to the usual dose.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 1 Year to 15 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | Infliximab, ustekinumab, vedolizumab, methotrexate |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT05552287 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics of infliximab in pediatric patients with Crohn's disease, focusing on the effectiveness of an intensified induction dosing regimen compared to standard dosing. The trial aims to address the issue of lower drug exposure in children, which can lead to reduced efficacy and complications. By enrolling anti-TNF-α naïve children aged 1-15 years, the study will evaluate the impact of this new dosing strategy on treatment outcomes. The research is conducted at Erasmus Medical Center in Rotterdam.
Who should consider this trial
Good fit: Ideal candidates are anti-TNF-α naïve children aged 1-15 years diagnosed with Crohn's disease who require infliximab treatment.
Not a fit: Patients with established monogenetic IBD, ulcerative colitis, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and quality of life for children suffering from Crohn's disease.
How similar studies have performed: While studies on infliximab in adults have shown success, this specific approach in pediatric patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Anti-TNF-α naïve children (age 1-15 years) with CD and an indication to start IFX treatment will be eligible for inclusion after a diagnosis of CD is made based on the Porto criteria. Indications of starting IFX treatment as per ECCO-ESPGHAN guidelines 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 Criteria: * Established monogenetic IBD * Diagnosis with UC or IBD-U, ulcerative colitis like * Active fistulizing/perianal disease at start of IFX treatment (patients with inactive fistulizing/perianal disease are allowed to participate) * 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
Where this trial is running
Rotterdam
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Lissy de Ridder, PhD — Erasmus Medical Center - Sophia Children's Hospital
- Study coordinator: Lissy de Ridder, PhD
- Email: l.deridder@erasmusmc.nl
- Phone: 0107036076
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.