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

Our primary objective in this study is to compare the incidence of infusion reactions of Infliximab when administered over 30 minutes versus 60 minutes. We hypothesize that there will be no significant differences between the two groups, demonstrating that 30-minute infusions are as safe and effective as the current standard of 60-minute infusions.

Secondary endpoints include evaluating patient and nurse satisfaction with both infusion rates, as well as assessing resource utilization by measuring total outpatient clinic stay and nursing staff allocation.

Additionally, we will explore whether satisfaction, infusion reactions and treatment effectiveness (asessed through clinical scoring systems, endoscopic findings and laboratory results) are affected by patient demographics (such as age, sex), disease type, infusion frequency, or co-treatment with immunomodulators.

Project methodology Study design and implementation Strategy The iRAPID study is designed as a prospective, randomized, open-label, non-inferiority crossover trial designed to compare the safety and effectiveness of 30-minute versus 60-minute infliximab infusions in pediatric IBD patients. The study will be conducted at the Akershus University Hospital Pediatric and Adolescent Outpatient Clinic, where all included patients already receive infliximab infusions for inflammatory bowel disease (IBD). Patients included in the study will be randomized to receiving four consecutive fast 30-minute infusions, or four consecutive standard 60-minute infusions, after which they will switch to the alternative regimen. Each patient will serve as their own control. Randomization will be performed using a validated computer-generated randomization program.

If the patient meets inclusion and exclusion criteria, they will be invited to participate in the study. Written consent will be obtained from parents for children under the age of 16, while patients aged 16 years or older will provide their own written consent. Participation is voluntary, and one may withdraw from the study and return to the standard infusion rate of 60 minutes at any time. Based on the power calculation, 60 patients will be included in the study. This sample size allows for adjustments in dosing, intervals, and concomitant medication according to standard clinical criteria, as well as a safety margin for dropouts.