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NCT Number: NCT01346826

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

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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Key information

Conditions

Crohn's Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, 138736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard 2 hours-infusion

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.

Other names: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)

Accelerated 1 hour-infusion

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.

Other names: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)

Accelerated 30 minutes-infusion

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.

Other names: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
May 3, 2011
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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