Status:
COMPLETED
Safety of Reduced Infliximab Infusion Time
Lead Sponsor:
Washington University School of Medicine
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 infu...
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05340764
Start Date
August 1 2020
End Date
May 4 2023
Last Update
August 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110