Phase 4
N=96
Safety of Reduced Infliximab Infusion Time
Inflammatory Bowel Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05340764 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Number of Participants With Acute Infusion Reaction as Assessed by the Nursing Staff of the Infusion Unit — 27; 30; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Infliximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Infusion Reaction as Assessed by the Nursing Staff of the Infusion Unit |
27; 30; 0; 0; 18; 21 | — |
| SECONDARY Cost Saving Analysis |
124.41; 72.57; 350; 225 | — |
| SECONDARY Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Median Number of Infusions |
7; 7 | — |
| SECONDARY Number of Infusions Where Concomitant Immunomodulators and Pre-medications Were Used |
175; 106; 171; 99; 110; 69 | — |
| SECONDARY Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Duration of Follow up (in Months) |
12; 14 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05340764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.