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 2016
Estimated Primary Completion Date:	October 2015 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138736

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. 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.


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:	January 12, 2015
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, Ulcerative Inflammatory Bowel Diseases Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Infliximab Analgesics Analgesics, Non-Narcotic	Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antirheumatic Agents Central Nervous System Agents Dermatologic Agents Gastrointestinal Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015