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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 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 152 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03994731
The ClinicalTrials.gov registry entry for NCT03994731 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 152 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 5 interventions - of which placebo is the first listed.
NCT03994731 reports 0 study locations.
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.
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