NCT05340764

Safety of Reduced Infliximab Infusion Time

Completed Phase 4 Results posted Last updated 29 August 2024

What this trial tests

Phase 4 trial testing Infliximab in Inflammatory Bowel Diseases in 96 participants. Completed in 4 May 2023.

Timeline

1 August 2020

Primary endpoint
4 May 2023

4 May 2023

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	96
Start date	1 August 2020
Primary completion	4 May 2023
Estimated completion	4 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Infliximab (infliximab) — full drug profile →

Conditions studied

• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Acute Infusion Reaction as Assessed by the Nursing Staff of the Infusion Unit Primary · 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

Group	Value	95% CI
2-hour Infusion of Infliximab	27
1-hour Infusion of Infliximab	30
2-hour Infusion of Infliximab	0
1-hour Infusion of Infliximab	0
2-hour Infusion of Infliximab	18
1-hour Infusion of Infliximab	21

Cost Saving Analysis Secondary · 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.

Nursing Cost

Group	Value	95% CI
2-hour Infusion of Infliximab	124.41	106 – 413
1-hour Infusion of Infliximab	72.57	53 – 207

Chair Occupancy Cost

Group	Value	95% CI
2-hour Infusion of Infliximab	350	145 – 544
1-hour Infusion of Infliximab	225	72.50 – 272

Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Median Number of Infusions Secondary · 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

Group	Value	95% CI
2-hour Infusion of Infliximab	7	5 – 8
1-hour Infusion of Infliximab	7	6 – 9

Number of Infusions Where Concomitant Immunomodulators and Pre-medications Were Used Secondary · 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

Premedications

Group	Value	95% CI
2-hour Infusion of Infliximab	175
1-hour Infusion of Infliximab	106

Acetaminophen

Group	Value	95% CI
2-hour Infusion of Infliximab	171
1-hour Infusion of Infliximab	99

Diphenhydramine

Group	Value	95% CI
2-hour Infusion of Infliximab	110
1-hour Infusion of Infliximab	69

Loratidine

Group	Value	95% CI
2-hour Infusion of Infliximab	7
1-hour Infusion of Infliximab	11

Ondansetron

Group	Value	95% CI
2-hour Infusion of Infliximab	4
1-hour Infusion of Infliximab	0

Methylprednisolone

Group	Value	95% CI
2-hour Infusion of Infliximab	4
1-hour Infusion of Infliximab	1

Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Duration of Follow up (in Months) Secondary · 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)

Group	Value	95% CI
2-hour Infusion of Infliximab	12	8 – 16
1-hour Infusion of Infliximab	14	8 – 16

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Accelerated Infliximab Infusion Safety and Tolerability Is Non-inferior to Standard Infusion Protocol in Inflammatory Bowel Disease Patients: A Randomized Controlled Study.
   Abushamma S, Walker T, Garza K, Chen L, et al · · 2023 · PMID 37288326 · DOI 10.1093/crocol/otad022