Trial Outcomes & Findings for Safety of Reduced Infliximab Infusion Time (NCT NCT05340764)
NCT ID: NCT05340764
Last Updated: 2024-08-29
Results Overview
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.
COMPLETED
PHASE4
96 participants
Median of 12 months in the control and a median of 14 months in the study group.
2024-08-29
Participant Flow
Participants were recruited from 2020 to 2021 and followed throughout the study after enrollment. Patients aged 18 years or older with an established diagnosis of IBD, receiving infliximab at one of our infusions centers and have tolerated the 3 induction doses and current maintenance dosing were eligible for inclusion in the study.
Patients were excluded if they were receiving infliximab exclusively for a non-IBD indication, had a history of moderate or severe infusion reactions to infliximab (or biosimilar), had known antidrug antibodies to infliximab, had an interval greater than 13 weeks from prior dose of infliximab, were receiving an additional infusion concomitant with infliximab (eg, IV iron), or declined to participate in the trial.
Participant milestones
| Measure |
2-hour Infusion of Infliximab
2 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the standard 2 hour infusion of infliximab and serves as the control group.
|
1-hour Infusion of Infliximab
1 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the reduced 1 hour infusion of infliximab and serves as the study group.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
51
|
|
Overall Study
COMPLETED
|
45
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
2-hour Infusion of Infliximab
n=45 Participants
2 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the standard 2 hour infusion of infliximab and serves as the control group.
|
1-hour Infusion of Infliximab
n=51 Participants
1 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 15.5 • n=45 Participants
|
47 years
STANDARD_DEVIATION 15.5 • n=51 Participants
|
47 years
STANDARD_DEVIATION 15.5 • n=96 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=45 Participants
|
23 Participants
n=51 Participants
|
45 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=45 Participants
|
28 Participants
n=51 Participants
|
51 Participants
n=96 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
45 participants
n=45 Participants
|
51 participants
n=51 Participants
|
96 participants
n=96 Participants
|
|
Inflammatory Bowel Disease Type
Ulcerative Colitis patients
|
11 Participants
n=45 Participants
|
10 Participants
n=51 Participants
|
21 Participants
n=96 Participants
|
|
Inflammatory Bowel Disease Type
Crohn's Disease patients
|
34 Participants
n=45 Participants
|
41 Participants
n=51 Participants
|
75 Participants
n=96 Participants
|
|
Concomitant Immunomodulator
6-MP
|
8 Participants
n=45 Participants
|
5 Participants
n=51 Participants
|
13 Participants
n=96 Participants
|
|
Concomitant Immunomodulator
AZA
|
9 Participants
n=45 Participants
|
11 Participants
n=51 Participants
|
20 Participants
n=96 Participants
|
|
Concomitant Immunomodulator
MTX
|
5 Participants
n=45 Participants
|
10 Participants
n=51 Participants
|
15 Participants
n=96 Participants
|
|
Concomitant Immunomodulator
None
|
23 Participants
n=45 Participants
|
25 Participants
n=51 Participants
|
48 Participants
n=96 Participants
|
PRIMARY outcome
Timeframe: Median of 12 months in the control and a median of 14 months in the study group.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.
Outcome measures
| Measure |
2-hour Infusion of Infliximab
n=45 Participants
2 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the standard 2 hour infusion of infliximab and serves as the control group.
|
1-hour Infusion of Infliximab
n=51 Participants
1 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the reduced 1 hour infusion of infliximab and serves as the study group.
|
|---|---|---|
|
Number of Participants With Acute Infusion Reaction as Assessed by the Nursing Staff of the Infusion Unit
Mild Acute Infusion Reaction
|
27 Participants
|
30 Participants
|
|
Number of Participants With Acute Infusion Reaction as Assessed by the Nursing Staff of the Infusion Unit
Moderate/Severe Infusion Reaction
|
0 Participants
|
0 Participants
|
|
Number of Participants With Acute Infusion Reaction as Assessed by the Nursing Staff of the Infusion Unit
No Infusion Reaction
|
18 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Median of 12 months in the control and a median of 14 months in the study group.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. Nursing Cost and Chair Occupancy Cost obtained from BJH Human Resources Department.
Outcome measures
| Measure |
2-hour Infusion of Infliximab
n=45 Participants
2 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the standard 2 hour infusion of infliximab and serves as the control group.
|
1-hour Infusion of Infliximab
n=51 Participants
1 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the reduced 1 hour infusion of infliximab and serves as the study group.
|
|---|---|---|
|
Cost Saving Analysis
Nursing Cost
|
124.41 dollars
Interval 106.0 to 413.0
|
72.57 dollars
Interval 53.0 to 207.0
|
|
Cost Saving Analysis
Chair Occupancy Cost
|
350 dollars
Interval 145.0 to 544.0
|
225 dollars
Interval 72.5 to 272.0
|
SECONDARY outcome
Timeframe: Median of 12 months in the control and a median of 14 months in the study group.Assess effect of concomitant immunomodulators and pre-medications on rate of infusion reactions - Median number of infusions
Outcome measures
| Measure |
2-hour Infusion of Infliximab
n=45 Participants
2 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the standard 2 hour infusion of infliximab and serves as the control group.
|
1-hour Infusion of Infliximab
n=51 Participants
1 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the reduced 1 hour infusion of infliximab and serves as the study group.
|
|---|---|---|
|
Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Median Number of Infusions
|
7 Infusions
Interval 5.0 to 8.0
|
7 Infusions
Interval 6.0 to 9.0
|
SECONDARY outcome
Timeframe: Median of 12 months in the control and a median of 14 months in the study group.Number of Infusions where Concomitant Immunomodulators and Pre-medications were used in the study
Outcome measures
| Measure |
2-hour Infusion of Infliximab
n=309 Total number of infusions
2 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the standard 2 hour infusion of infliximab and serves as the control group.
|
1-hour Infusion of Infliximab
n=376 Total number of infusions
1 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the reduced 1 hour infusion of infliximab and serves as the study group.
|
|---|---|---|
|
Number of Infusions Where Concomitant Immunomodulators and Pre-medications Were Used
Premedications
|
175 Total number of infusions
|
106 Total number of infusions
|
|
Number of Infusions Where Concomitant Immunomodulators and Pre-medications Were Used
Acetaminophen
|
171 Total number of infusions
|
99 Total number of infusions
|
|
Number of Infusions Where Concomitant Immunomodulators and Pre-medications Were Used
Diphenhydramine
|
110 Total number of infusions
|
69 Total number of infusions
|
|
Number of Infusions Where Concomitant Immunomodulators and Pre-medications Were Used
Loratidine
|
7 Total number of infusions
|
11 Total number of infusions
|
|
Number of Infusions Where Concomitant Immunomodulators and Pre-medications Were Used
Ondansetron
|
4 Total number of infusions
|
0 Total number of infusions
|
|
Number of Infusions Where Concomitant Immunomodulators and Pre-medications Were Used
Methylprednisolone
|
4 Total number of infusions
|
1 Total number of infusions
|
SECONDARY outcome
Timeframe: Median of 12 months in the control and a median of 14 months in the study group.Assess effect of concomitant immunomodulators and pre-medications on rate of infusion reactions - Duration of follow up (in months)
Outcome measures
| Measure |
2-hour Infusion of Infliximab
n=45 Participants
2 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the standard 2 hour infusion of infliximab and serves as the control group.
|
1-hour Infusion of Infliximab
n=51 Participants
1 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the reduced 1 hour infusion of infliximab and serves as the study group.
|
|---|---|---|
|
Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Duration of Follow up (in Months)
|
12 months
Interval 8.0 to 16.0
|
14 months
Interval 8.0 to 16.0
|
Adverse Events
2-hour Infusion of Infliximab
1-hour Infusion of Infliximab
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Chien-Huan Chen
Washington University School of Medicine GI Division
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place