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

Primary Purpose

Crohn's Disease, Ulcerative Colitis

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Standard 2 hours-infusion

Accelerated 1 hour-infusion

Accelerated 30 minutes-infusion

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, Ulcerative colitis, Infliximab, Infusion reaction

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

2 hours-infusion group

1 hour-infusion group

30 minutes-infusion group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Total numbers of infusion reactions related with infliximab infusion

Total numbers of infusion reactions (including acute and delayed reactions) related with infliximab infusion

Secondary Outcome Measures

Numbers of severe infusion reactions related with 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

Full Information

NCT ID

NCT01346826

First Posted

May 2, 2011

Last Updated

July 11, 2016

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01346826

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease, Ulcerative Colitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

145 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2 hours-infusion group

Arm Type

Active Comparator

Arm Description

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

Arm Title

1 hour-infusion group

Arm Type

Experimental

Arm Description

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

Arm Title

30 minutes-infusion group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Standard 2 hours-infusion

Other Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

Accelerated 1 hour-infusion

Other Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

Accelerated 30 minutes-infusion

Other Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Total numbers of infusion reactions related with infliximab infusion

Description

Total numbers of infusion reactions (including acute and delayed reactions) related with infliximab infusion

Time Frame

Within14 days after infliximab infusion

Secondary Outcome Measure Information:

Title

Numbers of severe infusion reactions related with infliximab infusion

Description

Numbers of severe infusion reactions (Systolic blood pressure < 80 mmHg with severe symptoms and signs necessiating stopping of infliximab infusion) related with infliximab infusion

Time Frame

Within14 days after infliximab infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suk-Kyun Yang, MD, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

138736

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19060632

Citation

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.

Results Reference

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PubMed Identifier

21122522

Citation

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.

Results Reference

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PubMed Identifier

20848465

Citation

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.

Results Reference

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PubMed Identifier

21407184

Citation

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.

Results Reference

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

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