Infliximab Infusion Rates in Pediatric Inflammatory Bowel Disease

NCT06839820 | Active Not Recruiting

• 1 other identifier: 812756
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES OF THE STUDY

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

Conditions

Infliximab; Infusion; IBD (Inflammatory Bowel Disease); Patient Satisfaction

Keywords

ibd; pediatric ibd; infliximab; infusion rate

Outcome Measures

Primary Outcomes (1)

• Number of infusion reactions with infliximab infusions given over 60 minutes compared to 30 minutes.

  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.

  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.

Secondary Outcomes (3)

• Investigate patient satisfaction with infliximab infusions of 60 minutes and 30 minutes

  During the 8 infliximab infusions, with a time frame between 32 weeks til 64 weeks, depending on the patients infliximab infusion intervalls that may range from every 4th to every 8th week.

• Investigate nurse satisfaction with infliximab infusions of 60 minutes and 30 minutes

  During the 8 infliximab infusions, with a time frame between 32 weeks til 64 weeks, depending on the patients infliximab infusion intervalls that may range from every 4th to every 8th week.

• Investigate resource use in terms of total length of stay and costs

  During the 8 infliximab infusions, with a time frame between 32 weeks til 64 weeks, depending on the patients infliximab infusion intervalls that may range from every 4th to every 8th week.

Study Arms (2)

Rapid first

ACTIVE COMPARATOR

4 infusions of infliximab given over 30 minutes, then 4 infusions of infliximab given over 60 minutes. Totally 8 infusions of infliximab is given during the study, according to the randomized cross-over design.

Other: Infusion rate of infliximab

Slow infusion first

ACTIVE COMPARATOR

4 infusions of infliximab given over 60 minutes, then 4 infusions of infliximab given over 30 minutes. Totally 8 infusions of infliximab is given during the study, according to the randomized cross-over design.

Other: Infusion rate of infliximab

Interventions

Infusion rate of infliximab OTHER

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

Rapid first; Slow infusion first

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric IBD patients on infliximab
• years
• Received at least 5 infusions of infliximab prior to entry in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

Akershus University Hospital

Lørenskog, 1478, Norway

Location

Related Publications (6)

• Lichtenstein L, Ron Y, Kivity S, Ben-Horin S, Israeli E, Fraser GM, Dotan I, Chowers Y, Confino-Cohen R, Weiss B. Infliximab-Related Infusion Reactions: Systematic Review. J Crohns Colitis. 2015 Sep;9(9):806-15. doi: 10.1093/ecco-jcc/jjv096. Epub 2015 Jun 19.

  PMID: 26092578 BACKGROUND

• Jagt JZ, Galestin SE, Claesen J, Benninga MA, de Boer NKH, de Meij TGJ. Safety of Accelerated Infliximab Infusions in Children With Inflammatory Bowel Disease: A Retrospective Cohort Study. J Pediatr Gastroenterol Nutr. 2023 Sep 1;77(3):373-380. doi: 10.1097/MPG.0000000000003865. Epub 2023 Jun 15.

  PMID: 37319101 BACKGROUND

• Fukuyo S, Saito K, Yamaoka K, Sawamukai N, Hirata S, Nawata M, Iwata S, Tanaka Y. Efficacy and safety of reducing duration of infliximab infusion. Mod Rheumatol. 2014 Mar;24(2):275-80. doi: 10.3109/14397595.2013.843747. Epub 2013 Oct 11.

  PMID: 24251990 BACKGROUND

• Neef HC, Riebschleger MP, Adler J. Meta-analysis: rapid infliximab infusions are safe. Aliment Pharmacol Ther. 2013 Aug;38(4):365-76. doi: 10.1111/apt.12389. Epub 2013 Jul 1.

  PMID: 23815183 BACKGROUND

• El-Matary W, Dykes DMH, Bauman L, Elkadri A, Carroll MW, Izaguirre MR, deBruyn J, Samson CM, Crim AM, Ali S, Grossman A. Rapid Infliximab Infusion in Children with Inflammatory Bowel Disease: A Multicenter North American Experience. Inflamm Bowel Dis. 2017 Dec;23(12):2104-2108. doi: 10.1097/MIB.0000000000001259.

  PMID: 29140940 BACKGROUND

• Bohra A, Rizvi QA, Keung CYY, Vasudevan A, van Langenberg DR. Transitioning patients with inflammatory bowel disease from hospital-based to rapid home-based infliximab: A stepwise, safety and patient-orientated process towards sustainability. World J Gastroenterol. 2020 Sep 28;26(36):5437-5449. doi: 10.3748/wjg.v26.i36.5437.

  PMID: 33024395 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Patient Satisfaction; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Colonic Diseases, Functional; Colonic Diseases

Study Officials

• Akershus University Hospital REK comittee

  Akerhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator. Consultant, MD, phd at Department of Pediatrics, Akershus University hospital

Model Details: randomized, crossover, non-inferiority open-label study

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 21, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)