Safety of Reduced Infliximab Infusion Time

NCT05340764 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 202007200
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  Median of 12 months in the control and a median of 14 months in the study group.

Secondary Outcomes (4)

• Cost Saving Analysis

  Median of 12 months in the control and a median of 14 months in the study group.

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

  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

  Median of 12 months in the control and a median of 14 months in the study group.

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

  Median of 12 months in the control and a median of 14 months in the study group.

Study Arms (2)

2-hour infusion of infliximab

ACTIVE COMPARATOR

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.

Drug: Infliximab

1-hour infusion of infliximab

EXPERIMENTAL

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.

Drug: Infliximab

Interventions

Infliximab DRUG

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

1-hour infusion of infliximab; 2-hour infusion of infliximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 37288326 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

1. We excluded pts. receiving induction doses of INX, pts. with a history of infusion reactions (IRR) and pts. with known antidrug antibodies to INX, as studies have shown an increased infusion reaction rate in these pts. This may have contributed to the absence of clinically significant infusion reactions. 2. We did not assess delayed IRR, as they occur at a much lower rate than acute IRR. 3. Majority of pts. assessed for eligibility were excluded primarily due to various reasons.

Results Point of Contact

• Title: Dr. Chien-Huan Chen
• Organization: Washington University School of Medicine GI Division

chen330@wustl.edu

3143623201

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 22, 2022
• Study Start: August 1, 2020
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: August 29, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)