Clinical trial NCT01346826: Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)
Official title: Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn's Disease
Ulcerative Colitis
Keywords: Crohn's disease
Ulcerative colitis
Infliximab
Infusion reaction
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-05-03
Enrollment: 145
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total numbers of infusion reactions related with infliximab infusion
timeFrame: Within14 days after infliximab infusion
Secondary outcomes:
measure: Numbers of severe infusion reactions related with infliximab infusion
timeFrame: Within14 days after infliximab infusion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine
name: Suk-Kyun Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.