Inflammatory Bowel Diseases Clinical Trial
Official title:
Safety, Efficacy, and Cost-effectiveness of a Reduced Infliximab Infusion Time Protocol
Verified date | May 2023 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 4, 2023 |
Est. primary completion date | May 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Through study completion, an average of 1 year | |
Secondary | Cost saving analysis | Direct costs of the 2 hour infusion per-infusion per-patient in dollar amount will be compared to direct costs of the 1 hour infusion per-infusion per-patient in dollar amount in our institution and the difference will be reported. | Through study completion, an average of 1 year | |
Secondary | Effect of concomitant immunomodulators and pre-medications on rate of infusion reactions | Assess effect of concomitant immunomodulators and pre-medications on rate of infusion reactions | Through study completion, an average of 1 year |
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