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NCT03994731 · ClinicalTrials.gov registry record · Phase 4
Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout
A Phase 4 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 152
- Enrollment target
NCT03994731: Completed Phase 4 study, sponsored by Amgen.
NCT03994731 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 152 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03994731, a Phase 4 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 152 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the potential for pegloticase with methotrexate (MTX) to increase the response rate seen with pegloticase alone, and to characterize the safety, tolerability and pharmacokinetics (PK) of the concomitant use of pegloticase with MTX, by comparing pegloticase co-administered with MTX to pegloticase co-administered with placebo for MTX in adults with uncontrolled gout.
Primary Outcome
Responders are defined as participants achieving and maintaining sUA \< 6 mg/dL for at least 80% of the time during Month 6. Month 6 includes pre- and post-infusion sUA assessments at Weeks 20 and 22, non-infusion sUA at Weeks 21 and 23, pre-infusion sUA at Week 24 and any unscheduled sUA between Week 20 and Week 24. A participant must have had ≥ 2 sUA observations from different visits in order to be eligible as a responder. Participants meeting the stopping rule (those with a pre-infusion sUA
Interventions
- DRUG placebo
- BIOLOGICAL Pegloticase
- DRUG methotrexate
- DIETARY_SUPPLEMENT folic acid
- DRUG gout flare prophylaxis regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2019-06-13 |
| Est. Completion | 2022-04-11 |
| Phase | Phase 4 |
What the finished NCT03994731 record still lists
NCT03994731 is an interventional study that assigns participants to a tested intervention. The registered 152 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 (71% lower).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT03994731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03994731 about?
NCT03994731 is a clinical study titled "Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout". The purpose of this study is to assess the potential for pegloticase with methotrexate (MTX) to increase the response rate seen with pegloticase alone, and to characterize the safety, tolerability and pharmacokinetics (PK) of the concomitant use of pegloticase with MTX, by comparing pegloticase co-a...
What is the current status of trial NCT03994731?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 152 participants. The study started on 2019-06-13. Estimated completion is 2022-04-11.
What interventions are being tested in trial NCT03994731?
The interventions under investigation include: placebo (DRUG), Pegloticase (BIOLOGICAL), methotrexate (DRUG), folic acid (DIETARY_SUPPLEMENT), gout flare prophylaxis regimen (DRUG).
Who is sponsoring clinical trial NCT03994731?
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 NCT03994731's enrollment target sits among peer trials
152 530th of 2000 higher than 1,468 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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