Overview

Safety of Reduced Infliximab Infusion Time

Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Washington University School of Medicine
Treatments:
Infliximab
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