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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Suk-Kyun Yang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01346826
First received: May 2, 2011
Last updated: November 18, 2012
Last verified: November 2012
  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:


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
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

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:
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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014