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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346826
• Other study ID #: 2011-0181
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2011
• Last updated: July 11, 2016
• Start date: May 2011
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total numbers of infusion reactions related with infliximab infusion	Total numbers of infusion reactions (including acute and delayed reactions) related with infliximab infusion	Within14 days after infliximab infusion	Yes
Secondary	Numbers of severe infusion reactions related with 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	Within14 days after infliximab infusion	Yes