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

Asan Medical Center

Status and phase: Completed; Phase 4

Conditions: Ulcerative Colitis; Crohn's Disease

Treatments: Drug: Standard 2 hours-infusion; Drug: Accelerated 1 hour-infusion; Drug: Accelerated 30 minutes-infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01346826

2011-0181

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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145 participants in 3 patient groups

2 hours-infusion group

Active Comparator group

Description:

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

Treatment:

Drug: Standard 2 hours-infusion

1 hour-infusion group

Experimental group

Description:

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

Treatment:

Drug: Accelerated 1 hour-infusion

30 minutes-infusion group

Experimental group

Description:

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

Treatment:

Drug: Accelerated 30 minutes-infusion