Clinical trial NCT05340764: Safety of Reduced Infliximab Infusion Time
Official title: Safety, Efficacy, and Cost-effectiveness of a Reduced Infliximab Infusion Time Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: Inclusion Criteria:

1. Must be at least 18 years of age
2. Must have a diagnosis of IBD
3. 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.
4. Must tolerate the three induction doses or be tolerating current maintenance dosing without an infusion reaction to qualify for randomization.

Exclusion Criteria:

1. 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)
2. Patients with history of a moderate or severe infusion reactions to infliximab or to an infliximab biosimilar as defined in section 7
3. Patients with known antidrug antibodies to infliximab
4. 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
5. Patients receiving an additional infusion concomitant with infliximab (e.g. IV iron)
6. Patients who decline to participate in the trial

Primary outcomes:
measure: Number of Participants With Acute Infusion Reaction as Assessed by the Nursing Staff of the Infusion Unit
timeFrame: Median of 12 months in the control and a median of 14 months in the study group.
Secondary outcomes:
measure: Cost Saving Analysis
timeFrame: Median of 12 months in the control and a median of 14 months in the study group.
measure: Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Median Number of Infusions
timeFrame: Median of 12 months in the control and a median of 14 months in the study group.
measure: Number of Infusions Where Concomitant Immunomodulators and Pre-medications Were Used
timeFrame: Median of 12 months in the control and a median of 14 months in the study group.
measure: Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Duration of Follow up (in Months)
timeFrame: Median of 12 months in the control and a median of 14 months in the study group.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References: