Comparing 30-minute and 60-minute infliximab infusions for pediatric IBD
IRAPID: Infliximab Infusion Rate in Pediatric Inflammatory Bowel Disease. a Randomized Non-inferiority Trial of Infusion Reactions with Infliximab Infusion-rates of 30 Minutes and 60 Minutes
This study is testing if giving infliximab infusions for 30 minutes instead of 60 minutes is safe and effective for kids with inflammatory bowel disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Akershus Academic / other |
| Drugs / interventions | infliximab |
| Locations | 1 site (Lørenskog) |
| Trial ID | NCT06839820 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the safety and effectiveness of infliximab infusions administered over 30 minutes versus the standard 60 minutes in pediatric patients with inflammatory bowel disease (IBD). It will assess the incidence of infusion reactions, patient and nurse satisfaction, and resource utilization during outpatient clinic visits. The study employs a prospective, randomized, open-label, non-inferiority crossover design, where participants will receive both infusion rates in a controlled manner. The research will also explore how demographic factors and treatment history may influence outcomes.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 1-17 years with a diagnosis of inflammatory bowel disease who have received at least five prior infliximab infusions.
Not a fit: Patients receiving infliximab for non-IBD conditions or those with a history of severe infusion reactions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to shorter infusion times for pediatric IBD patients, improving their overall treatment experience.
How similar studies have performed: Previous studies have shown promising results with shorter infusion times for other medications, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric IBD patients on infliximab * 1-17 years * Received at least 5 infusions of infliximab prior to entry in the study Exclusion Criteria: * Receiving infliximab for non-IBD condition (reumatological or other causes) * previous severe infliximab infusion reaction * need for an interpreter * heart failure with hemodynamic impact * unwillingness to participate
Where this trial is running
Lørenskog
- Akershus University Hospital — Lørenskog, Norway (Recruiting)
Study contacts
- Study coordinator: Charlotte K Knatten, Cosultant, phd
- Email: chakna@ahus.no
- Phone: +0047-67964348
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.