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

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ClinicalTrials.gov Identifier: NCT01346826
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Suk-Kyun Yang, Asan Medical Center

Study Description
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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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial
Study Start Date : May 2011
Actual Primary Completion Date : October 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 2 hours-infusion group
Number of patients: 57 (Standard 2 hours-infusion group)
 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 (1 hour-infusion group)
 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 (30 minutes-infusion group)
 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)


Outcome Measures
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Primary Outcome Measures :
  1. Total numbers of infusion reactions related with infliximab infusion [ Time Frame: Within14 days after infliximab infusion ]
    Total numbers of infusion reactions (including acute and delayed reactions) related with infliximab infusion


Secondary Outcome Measures :
  1. Numbers of severe infusion reactions related with infliximab infusion [ Time Frame: Within14 days after 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


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: May 3, 2011    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Suk-Kyun Yang, Asan Medical Center:
Crohn's disease
Ulcerative colitis
Infliximab
Infusion reaction

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Pathologic Processes
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents