Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)

Overview

This study aims to test the hypothesis that the accelerated infusion of infliximab is not inferior to the conventional 2 hour infusion with respect to the frequency of infusion reaction.

Full Title of Study: “Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2015

Detailed Description

The standard protocol of infliximab administration is the infusion for 2 hours. However, due to the discomfort of patients and limitation of medical resources, the accelerated infusion is more desirable if accelerated infusion does not increase the frequency of infusion reaction. Recent observational studies showed that the accelerated infusion of infliximab for 1 hour or 30 minutes did not increase the frequency of infusion reaction if patients had not shown infusion reactions during previous 4 infusions for 2 hours. However, there are no randomized trials comparing the safety of accelerated infusion protocol and standard infusion protocol yet.

Interventions

  • Drug: Standard 2 hours-infusion
    • Patients without any infusion reactions during more than 4 infusions for 2 hours are randomized to one of three study groups. After randomization to 2 hours-infusion group, patients get 5 mg/kg infliximab infusion for 2 hours. Total infusion number after randomization is 7.
  • Drug: Accelerated 1 hour-infusion
    • Patients without any infusion reactions during more than 4 infusions for 2 hours are randomized to one of three study groups. After randomization to 1 hour-infusion group, patients get 5 mg/kg infliximab infusion for 1 hour. Total infusion number after randomization is 7.
  • Drug: Accelerated 30 minutes-infusion
    • Patients without any infusion reactions during more than 4 infusions for 2 hours are randomized to one of three study groups. After randomization to 30 minutes-infusion group, patients get 5 mg/kg infliximab infusion for 1 hour. If any infusion reactions do not develop during 2 infusions for 1 hour, patients get further 5 mg/kg infliximab infusion for 30 minutes. The total number of 30 minutes-infusion is 5.

Arms, Groups and Cohorts

  • Active Comparator: 2 hours-infusion group
    • Number of patients: 57 (Standard 2 hours-infusion group)
  • Experimental: 1 hour-infusion group
    • Number of patients: 59 (1 hour-infusion group)
  • Experimental: 30 minutes-infusion group
    • Number of patients: 59 (30 minutes-infusion group)

Clinical Trial Outcome Measures

Primary Measures

  • Total numbers of infusion reactions related with infliximab infusion
    • Time Frame: Within14 days after infliximab infusion
    • Total numbers of infusion reactions (including acute and delayed reactions) related with infliximab infusion

Secondary Measures

  • Numbers of severe infusion reactions related with infliximab infusion
    • Time Frame: Within14 days after infliximab infusion
    • Numbers of severe infusion reactions (Systolic blood pressure < 80 mmHg with severe symptoms and signs necessiating stopping of infliximab infusion) related with infliximab infusion

Participating in This Clinical Trial

Inclusion Criteria

  • Patients receiving infliximab for Crohn's disease or ulcerative colitis
  • Ethnicity: Korean
  • Patients who did not show any infusion reactions during 4 times of infliximab (5mg/kg) infusions for 2 hours
  • Informed consents

Exclusion Criteria

  • Sever cardiopulmonary diseases
  • Allergic diseases
  • Bronchial asthma
  • Allergic rhinitis
  • Atopic dermatitis
  • Other allergic diseases determined not suitable for study participation by investigators
  • Severe liver disease
  • Severe renal disease
  • Body weight over 100 kg
  • Other medical or surgical disease determined not suitable for study participation by investigators

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asan Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Suk-Kyun Yang, Professor – Asan Medical Center
  • Overall Official(s)
    • Suk-Kyun Yang, MD, PhD, Principal Investigator, Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine

References

Clare DF, Alexander FC, Mike S, Dan G, Allan F, Lisa W, Peter HJ. Accelerated infliximab infusions are safe and well tolerated in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2009 Jan;21(1):71-5. doi: 10.1097/MEG.0b013e3283081afe.

Van Assche G, Vermeire S, Noman M, Amant C, Weyts E, Vleminckx A, Vermeyen MJ, Rutgeerts P. Infliximab administered with shortened infusion times in a specialized IBD infusion unit: a prospective cohort study. J Crohns Colitis. 2010 Sep;4(3):329-33. doi: 10.1016/j.crohns.2009.12.012. Epub 2010 Jan 18.

Bhat S, Sharma D, Doherty P, Tham TC, Caddy GR. Are accelerated infliximab infusions safe in patients with inflammatory bowel disease? Inflamm Bowel Dis. 2010 Nov;16(11):1922-5. doi: 10.1002/ibd.21279.

Breynaert C, Ferrante M, Fidder H, Van Steen K, Noman M, Ballet V, Vermeire S, Rutgeerts P, Van Assche G. Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol. 2011 Apr;106(4):778-85. doi: 10.1038/ajg.2011.61. Epub 2011 Mar 15.

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