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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-04-30

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.

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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.

Conditions

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Crohn's Disease Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2 hours-infusion group

Number of patients: 57 (Standard 2 hours-infusion group)

Group Type ACTIVE_COMPARATOR

Standard 2 hours-infusion

Intervention Type DRUG

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.

1 hour-infusion group

Number of patients: 59 (1 hour-infusion group)

Group Type EXPERIMENTAL

Accelerated 1 hour-infusion

Intervention Type DRUG

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.

30 minutes-infusion group

Number of patients: 59 (30 minutes-infusion group)

Group Type EXPERIMENTAL

Accelerated 30 minutes-infusion

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA) Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA) Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No