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NCT04762498 · ClinicalTrials.gov registry record · Phase 4
A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
A Phase 4 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 54
- Enrollment target
NCT04762498: Completed Phase 4 study, sponsored by Amgen.
NCT04762498 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 54 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04762498, a Phase 4 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 54 participants
- Enrollment target
Study Summary
This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4 Weeks) for up to 6 months (Day 1 to 24 weeks with an optional 24 - 48 weeks treatment duration) when given in combination with weekly oral doses of methotrexate (MTX). The goal is to identify an appropriate dose to be administered every 4 weeks to be used for future clinical trials for patients with chronic gout that does not adequately respond to conventional therapy.
Primary Outcome
Responders are defined as participants achieving and maintaining sUA \< 6 mg/dL for at least 80% of the time during Month 6. Participants meeting the sUA discontinuation criteria (pre-infusion sUA \>6 mg/dL at 2 consecutive scheduled trial visits beginning with the Week 1 Visit) were counted as non-responders.
Interventions
- DRUG Methotrexate (MTX)
- BIOLOGICAL Pegloticase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-01-26 |
| Est. Completion | 2023-12-20 |
| Phase | Phase 4 |
What the finished NCT04762498 record still lists
NCT04762498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Methotrexate (MTX) is the first listed.
NCT04762498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04762498 about?
NCT04762498 is a clinical study titled "A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)". This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4 Weeks) for up to 6 months (Day 1 to 24 weeks with an optional 24 - 48 weeks treatment duration) when given in combinati...
What is the current status of trial NCT04762498?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2021-01-26. Estimated completion is 2023-12-20.
What interventions are being tested in trial NCT04762498?
The interventions under investigation include: Methotrexate (MTX) (DRUG), Pegloticase (BIOLOGICAL).
Who is sponsoring clinical trial NCT04762498?
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 NCT04762498's enrollment target sits among peer trials
54 1223rd of 2000 higher than 772 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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