Infliximab Infusion Rates in Pediatric Inflammatory Bowel Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Infusion rate of infliximab: Infusion reactions of infliximab is compared between 30 and 60 minutes infliximab infusion-rates.

Study summary

OBJECTIVES OF THE STUDY

1. Investigate whether there are just as few infusion reactions with infliximab infusions of 60 min and 30 min.
2. Investigate patient and nurse satisfaction with infusions of 60 min and 30 min.
3. Investigate resource use in terms of total length of stay and use of nursing resources.

Eligibility

Primary outcome measure(s)

• Number of infusion reactions with infliximab infusions given over 60 minutes compared to 30 minutes. — depending on patients infusion intervals; 4 weeks x8 = 32 weeks, 8 weeks interval x8 = 64 weeks. The estimated time frame to complete the study for all included patients is april 2026.
  A randomized non-inferiotity trial designed to investigate whether there are just as few infusion reactions with infliximab-infusions given over standard 60 minutes as with 30 minutes infusion rate. All patients receive 8 infliximab infusions during the study. They are randomized either to a) 4 infliximab infusions over 30 minutes first and then 4 inflimab infusions over 60 minutes, or B) 4 infliximab infusions over 60 minutes first and then 4 inflimab infusions over 30 minutes. Each patients receive an infusion interval between 4 to 8 weeks, that is tailered to their disease and needs as judged by the clinician. Data will be collected through study completion (8 infusions), with a time frame between a total of 32 weeks til 64 weeks, depending on the patients infliximab infusion intervals. All infusions reactions that occur during the time frame of these 8 infusions will be included in the analysis.

Trial sites (1)

More University Hospital, Akershus trials in Norway