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

Phase 4

Completed

• Conditions: Crohn's Disease; Ulcerative Colitis
• Interventions: Drug: Accelerated 1 hour-infusion; Drug: Accelerated 30 minutes-infusion; Drug: Standard 2 hours-infusion

• Registration Number: NCT01346826
• Lead Sponsor: Asan Medical Center

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.

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-02
• Study First Submitted QC: 2011-05-02
• Study First Posted: 2011-05-03
• Primary Completion: 2015-10
• Study Completion: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 hour-infusion group	Accelerated 1 hour-infusion	Number of patients: 59 (1 hour-infusion group)
30 minutes-infusion group	Accelerated 30 minutes-infusion	Number of patients: 59 (30 minutes-infusion group)
2 hours-infusion group	Standard 2 hours-infusion	Number of patients: 57 (Standard 2 hours-infusion group)

Primary Outcome Measures

Name	Time	Method
Total numbers of infusion reactions related with infliximab infusion	Within14 days after infliximab infusion	Total numbers of infusion reactions (including acute and delayed reactions) related with infliximab infusion

Secondary Outcome Measures

Name	Time	Method
Numbers of severe infusion reactions related with infliximab infusion	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of