Safety of Reduced Infliximab Infusion Time

NCT ID: NCT05340764

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2023-05-04

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

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Infliximab

Intervention Type: DRUG

Infliximab is an effective and commonly used medication to treat patients with IBD

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.

Group Type: EXPERIMENTAL

Infliximab

Intervention Type: DRUG

Infliximab is an effective and commonly used medication to treat patients with IBD

Interventions

Infliximab

Infliximab is an effective and commonly used medication to treat patients with IBD

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chien-Huan Chen

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

Abushamma S, Walker T, Garza K, Chen L, Nix D, Chen CH. Accelerated Infliximab Infusion Safety and Tolerability Is Non-inferior to Standard Infusion Protocol in Inflammatory Bowel Disease Patients: A Randomized Controlled Study. Crohns Colitis 360. 2023 May 3;5(3):otad022. doi: 10.1093/crocol/otad022. eCollection 2023 Jul.

Reference Type: DERIVED

PMID: 37288326 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

202007200

Identifier Type: -

Identifier Source: org_study_id