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

NCT01346826 | Completed Phase 4 DMC

• 1 other identifier: 2011-0181
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease; Ulcerative Colitis

Keywords

Crohn's disease; Ulcerative colitis; Infliximab; Infusion reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Numbers of severe infusion reactions related with infliximab infusion

  Within14 days after infliximab infusion

Study Arms (3)

2 hours-infusion group

ACTIVE COMPARATOR

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

Drug: Standard 2 hours-infusion

1 hour-infusion group

EXPERIMENTAL

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

Drug: Accelerated 1 hour-infusion

30 minutes-infusion group

EXPERIMENTAL

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

Drug: Accelerated 30 minutes-infusion

Interventions

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.

Also known as: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)

2 hours-infusion group

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.

Also known as: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)

1 hour-infusion group

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.

Also known as: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)

30 minutes-infusion group

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138736, South Korea

Location

Related Publications (4)

• Clare DF, Alexander FC, Mike S, Dan G, Allan F, Lisa W, Peter HJ. Accelerated infliximab infusions are safe and well tolerated in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2009 Jan;21(1):71-5. doi: 10.1097/MEG.0b013e3283081afe.

  PMID: 19060632 BACKGROUND

• Van Assche G, Vermeire S, Noman M, Amant C, Weyts E, Vleminckx A, Vermeyen MJ, Rutgeerts P. Infliximab administered with shortened infusion times in a specialized IBD infusion unit: a prospective cohort study. J Crohns Colitis. 2010 Sep;4(3):329-33. doi: 10.1016/j.crohns.2009.12.012. Epub 2010 Jan 18.

  PMID: 21122522 BACKGROUND

• Bhat S, Sharma D, Doherty P, Tham TC, Caddy GR. Are accelerated infliximab infusions safe in patients with inflammatory bowel disease? Inflamm Bowel Dis. 2010 Nov;16(11):1922-5. doi: 10.1002/ibd.21279.

  PMID: 20848465 BACKGROUND

• Breynaert C, Ferrante M, Fidder H, Van Steen K, Noman M, Ballet V, Vermeire S, Rutgeerts P, Van Assche G. Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol. 2011 Apr;106(4):778-85. doi: 10.1038/ajg.2011.61. Epub 2011 Mar 15.

  PMID: 21407184 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Suk-Kyun Yang, MD, PhD

  Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: May 3, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)