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NCT05340764 · ClinicalTrials.gov registry record · Phase 4
Safety of Reduced Infliximab Infusion Time
A Phase 4 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 96
- Enrollment target
NCT05340764: Completed Phase 4 study, sponsored by Washington University School of Medicine.
NCT05340764 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 96 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05340764, a Phase 4 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 96 participants
- Enrollment target
Study 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.
Primary Outcome
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 b
Interventions
- DRUG Infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2023-05-04 |
| Phase | Phase 4 |
What the finished NCT05340764 record still lists
NCT05340764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Infliximab is the first listed.
NCT05340764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05340764 about?
NCT05340764 is a clinical study titled "Safety of Reduced Infliximab Infusion Time". 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....
What is the current status of trial NCT05340764?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 96 participants. The study started on 2020-08-01. Estimated completion is 2023-05-04.
What interventions are being tested in trial NCT05340764?
The interventions under investigation include: Infliximab (DRUG).
Who is sponsoring clinical trial NCT05340764?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05340764's enrollment target sits among peer trials
96 863rd of 2000 higher than 1,132 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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