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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial

Conditions
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Crohn's Disease, Ulcerative Colitis

Intervention / Treatment
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* Drug: Standard 2 hours-infusion
* Drug: Accelerated 1 hour-infusion
* Drug: Accelerated 30 minutes-infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 hours-infusion group<br>Number of patients: 57 (Standard 2 hours-infusion group) | Drug: Standard 2 hours-infusion<br>* 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.<br>* Other names: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA);|
| Experimental: 1 hour-infusion group<br>Number of patients: 59 (1 hour-infusion group) | Drug: Accelerated 1 hour-infusion<br>* 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.<br>* Other names: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA);|
| Experimental: 30 minutes-infusion group<br>Number of patients: 59 (30 minutes-infusion group) | Drug: Accelerated 30 minutes-infusion<br>* 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.<br>* Other names: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total numbers of infusion reactions related with infliximab infusion | Total numbers of infusion reactions (including acute and delayed reactions) related with infliximab infusion | Within14 days after infliximab infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of severe infusion reactions related with 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 | Within14 days after infliximab infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, Ulcerative colitis, Infliximab, Infusion reaction