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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 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 54 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04762498
The ClinicalTrials.gov registry entry for NCT04762498 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Methotrexate (MTX) is the first listed.
NCT04762498 reports 0 study locations.
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.
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