Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease Ulcerative Colitis	Drug: Standard 2 hours-infusion Drug: Accelerated 1 hour-infusion Drug: Accelerated 30 minutes-infusion	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease ulcerative colitis

MedlinePlus related topics: Crohn's Disease Ulcerative Colitis

Drug Information available for: Infliximab

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

Total numbers of infusion reactions related with infliximab infusion [ Time Frame: Within14 days after infliximab infusion ] [ Designated as safety issue: Yes ]
Total numbers of infusion reactions (including acute and delayed reactions) related with infliximab infusion

Secondary Outcome Measures:

Numbers of severe infusion reactions related with infliximab infusion [ Time Frame: Within14 days after infliximab infusion ] [ Designated as safety issue: Yes ]
Numbers of severe infusion reactions (Systolic blood pressure < 80 mmHg with severe symptoms and signs necessiating stopping of infliximab infusion) related with infliximab infusion

Estimated Enrollment:	156
Study Start Date:	May 2011
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 2 hours-infusion group Number of patients: 57	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. Other Name: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)
Experimental: 1 hour-infusion group Number of patients: 59	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. Other Name: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)
Experimental: 30 minutes-infusion group Number of patients: 59	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. Other Name: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)

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

Ages Eligible for Study:	16 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346826

Contacts

Contact: Suk-Kyun Yang, MD, PhD	82-2-3010-3901	sky@amc.seoul.kr
Contact: Byong Duk Ye, MD, PhD	82-2-3010-3181	bdye@amc.seoul.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138736
Contact: Suk-Kyun Yang, MD, PhD 82-2-3010-3901 sky@amc.seoul.kr
Contact: Byong Duk Ye, MD, PhD 82-2-3010-3181 bdye@amc.seoul.kr
Principal Investigator: Suk-Kyun Yang, MD, PhD
Sub-Investigator: Byong Duk Ye, MD, PhD

Sponsors and Collaborators

Asan Medical Center

Investigators

Principal Investigator:

Suk-Kyun Yang, MD, PhD

Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine

More Information

Publications:

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.

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. 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.

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. Epub 2011 Mar 15.

Responsible Party:	Suk-Kyun Yang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT01346826 History of Changes
Other Study ID Numbers:	2011-0181
Study First Received:	May 2, 2011
Last Updated:	November 18, 2012
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:

Crohn's disease
Ulcerative colitis
Infliximab
Infusion reaction

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

Colonic Diseases
Pathologic Processes
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013