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NCT04511702 · ClinicalTrials.gov registry record · Phase 4
Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
A Phase 4 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 191
- Enrollment target
NCT04511702: Completed Phase 4 study, sponsored by Amgen.
NCT04511702 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 191 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04511702, a Phase 4 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 191 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate.
Primary Outcome
IRs, including anaphylaxis, were assessed after each infusion for a period of 24 weeks. IRs were defined as any infusion-related adverse event (AE) or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and up to 2 hours post-infusion. Additional AEs occurring outside of the 2-hour window following infusion could also be categorized as an IR at the Principal Investigator's discretion.
Interventions
- BIOLOGICAL Pegloticase with MTX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2020-10-02 |
| Est. Completion | 2024-03-25 |
| Phase | Phase 4 |
What the finished NCT04511702 record still lists
NCT04511702 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Pegloticase with MTX is the first listed.
NCT04511702 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04511702 about?
NCT04511702 is a clinical study titled "Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate". The purpose of this study is to assess the safety, tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate.
What is the current status of trial NCT04511702?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 191 participants. The study started on 2020-10-02. Estimated completion is 2024-03-25.
What interventions are being tested in trial NCT04511702?
The interventions under investigation include: Pegloticase with MTX (BIOLOGICAL).
Who is sponsoring clinical trial NCT04511702?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04511702's enrollment target sits among peer trials
191 453rd of 2000 higher than 1,548 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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