Safety of Reduced Infliximab Infusion Time
Primary Purpose
Inflammatory Bowel Diseases
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Infliximab
Sponsored by
About this trial
This is an interventional other trial for Inflammatory Bowel Diseases
Eligibility Criteria
Inclusion Criteria:
- Must be at least 18 years of age
- Must have a diagnosis of IBD
- Must be receiving Infliximab or biosimilar drug infusions for IBD at one of the study infusion centers - Center for Advanced Medicine, Barnes-Jewish West County, Barnes-Jewish South County infusion centers, or receiving infusion through BJC Home Care Services/ Barnes Home Health Company.
- Must tolerate the three induction doses or be tolerating current maintenance dosing without an infusion reaction to qualify for randomization.
Exclusion Criteria:
- Those receiving Infliximab for an indication other than IBD (the investigators will include patients receiving infliximab or biosimilar drug for both IBD and an additional autoimmune disease)
- Patients with history of a moderate or severe infusion reactions to infliximab or to an infliximab biosimilar as defined in section 7
- Patients with known antidrug antibodies to infliximab
- Patients who are restarting infliximab (patients who have received infliximab within the past year but have now had an interval greater than 13 weeks between prior dose) must tolerate the three induction doses to qualify for randomization
- Patients receiving an additional infusion concomitant with infliximab (e.g. IV iron)
- Patients who decline to participate in the trial
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
2-hour infusion of infliximab
1-hour infusion of infliximab
Arm Description
2 hour infusion of infliximab
1 hour infusion of infliximab
Outcomes
Primary Outcome Measures
Number of participants with acute infusion reaction as assessed by the nursing staff of the infusion unit
Acute infusion reaction is defined as any reaction occurring during or within 1 hour after completion of the infusion. It will be separated into mild reactions and moderate/severe reactions as outlined below.
Mild/Localized Reaction Pruritus Flushing (facial erythema) Rash/Urticaria Rigors Swelling Moderate/Severe Reaction Fever (temperature > 38.3 degree Celsius) Heart Rate greater than 120 Dyspnea/Shortness of breath Decrease in consciousness Hypotension defined as decrease in baseline SBP by >20 mmHg or SBP <85 Bronchospasm or laryngospasm Anaphylactic shock of one hour, to the standard two-hour infusion.
Secondary Outcome Measures
Cost saving analysis
Direct costs of the 2 hour infusion per-infusion per-patient in dollar amount will be compared to direct costs of the 1 hour infusion per-infusion per-patient in dollar amount in our institution and the difference will be reported.
Effect of concomitant immunomodulators and pre-medications on rate of infusion reactions
Assess effect of concomitant immunomodulators and pre-medications on rate of infusion reactions
Full Information
NCT ID
NCT05340764
First Posted
April 7, 2022
Last Updated
May 4, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05340764
Brief Title
Safety of Reduced Infliximab Infusion Time
Official Title
Safety, Efficacy, and Cost-effectiveness of a Reduced Infliximab Infusion Time Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
May 4, 2023 (Actual)
Study Completion Date
May 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Remicade is a common medicine used for the treatment of inflammatory bowel disease. This medication is given as an intravenous infusion over 2 hours. Studies have suggested it is safe to give the infusion at a faster rate. The investigators would like to see if the infusion can be given over 1 hour. The investigators expect that increasing the rate of infusion WILL NOT lead to an increase in infusion reactions and will be just as safe and effective as the standard 2 hours dose.
Detailed Description
1.1 Infliximab use in IBD
Inflammatory bowel disease (IBD) affects 349 per 100,000 adults in the United States and is associated with significant morbidity and mortality. Infliximab is an effective and commonly used medication to treat patients with IBD, but a main safety concern is an antibody-induced infusion reaction. The incidence of infusion reactions is ~6.5%, with mild, moderate, or severe reactions occurring in 3.1%, 1.2%, and 1% of infusions, respectively. Because of the concern for infusions reactions, infliximab is FDA approved to be infused over 2 hours or more. The typical interval for infusions is every eight weeks but is at times reduced to every 4 weeks in patients with IBD. This infusion time represents a significant inconvenience to patients who receive regular maintenance infusions.
1.2 Accelerated Infliximab Infusions
Multiple studies outside of the United States have demonstrated that a shortened infusion time to one hour, and even thirty minutes is safe and tolerable with similar rates of infusion reactions compared to an infusion time of two hours. However, these studies have differed in dosing, interval, pre-medication allowed in the study, and they are not randomized controlled studies. It has also been shown that reducing infusion times leads to cost savings and increased patient satisfaction. A recent study conducted in the United States at the University of California in San Francisco, confirmed that a shortened infusion time of one hour is safe and tolerated.
1.3 Rationale
The hypothesis is that a shortened infusion time to one hour will be safe and tolerated, with equal infusion reaction rates compared to two-hour infusion
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2-hour infusion of infliximab
Arm Type
Active Comparator
Arm Description
2 hour infusion of infliximab
Arm Title
1-hour infusion of infliximab
Arm Type
Experimental
Arm Description
1 hour infusion of infliximab
Intervention Type
Drug
Intervention Name(s)
Infliximab
Intervention Description
Infliximab is an effective and commonly used medication to treat patients with IBD
Primary Outcome Measure Information:
Title
Number of participants with acute infusion reaction as assessed by the nursing staff of the infusion unit
Description
Acute infusion reaction is defined as any reaction occurring during or within 1 hour after completion of the infusion. It will be separated into mild reactions and moderate/severe reactions as outlined below.
Mild/Localized Reaction Pruritus Flushing (facial erythema) Rash/Urticaria Rigors Swelling Moderate/Severe Reaction Fever (temperature > 38.3 degree Celsius) Heart Rate greater than 120 Dyspnea/Shortness of breath Decrease in consciousness Hypotension defined as decrease in baseline SBP by >20 mmHg or SBP <85 Bronchospasm or laryngospasm Anaphylactic shock of one hour, to the standard two-hour infusion.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Cost saving analysis
Description
Direct costs of the 2 hour infusion per-infusion per-patient in dollar amount will be compared to direct costs of the 1 hour infusion per-infusion per-patient in dollar amount in our institution and the difference will be reported.
Time Frame
Through study completion, an average of 1 year
Title
Effect of concomitant immunomodulators and pre-medications on rate of infusion reactions
Description
Assess effect of concomitant immunomodulators and pre-medications on rate of infusion reactions
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be at least 18 years of age
Must have a diagnosis of IBD
Must be receiving Infliximab or biosimilar drug infusions for IBD at one of the study infusion centers - Center for Advanced Medicine, Barnes-Jewish West County, Barnes-Jewish South County infusion centers, or receiving infusion through BJC Home Care Services/ Barnes Home Health Company.
Must tolerate the three induction doses or be tolerating current maintenance dosing without an infusion reaction to qualify for randomization.
Exclusion Criteria:
Those receiving Infliximab for an indication other than IBD (the investigators will include patients receiving infliximab or biosimilar drug for both IBD and an additional autoimmune disease)
Patients with history of a moderate or severe infusion reactions to infliximab or to an infliximab biosimilar as defined in section 7
Patients with known antidrug antibodies to infliximab
Patients who are restarting infliximab (patients who have received infliximab within the past year but have now had an interval greater than 13 weeks between prior dose) must tolerate the three induction doses to qualify for randomization
Patients receiving an additional infusion concomitant with infliximab (e.g. IV iron)
Patients who decline to participate in the trial
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety of Reduced Infliximab Infusion Time
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