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NCT07388498 · ClinicalTrials.gov registry record · Phase 3
A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
A Phase 3 study of Uncontrolled Gout, sponsored by Amgen.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
- 17
- Study locations
NCT07388498 is a Phase 3 study of Uncontrolled Gout that is actively recruiting participants, run by Amgen. The registered enrollment target is 270 participants. The trial reports 17 study locations across 6 states.
The verdict
NCT07388498, a Phase 3 study of Uncontrolled Gout, is actively recruiting participants, sponsored by Amgen.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
- 17
- Study locations
Study Summary
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to \< 6 mg/dL for at least 80% of the time during Month 6.
Conditions Studied
Interventions
- DRUG Methotrexate
- DRUG Pegloticase
Study Locations (17)
Florida
- D and H Pompano Research Center - Aventura
- New Generation of Medical Research - Hialeah
- Homestead Associates In Research Inc - Homestead
- Well Pharma Medical Research Corp - Miami
- D and H National Research Centers - Miami
- Advanced Clinical Research - Miami
- Felicidad Medical Research - Miami
- Decision Management International Research - Pinellas Park
- D and H Tamarac Research Center - Tamarac
- GCP Clinical Research, LLC - Tampa
- ClinPro Research Solutions LLC - Tampa
North Carolina
- Cape Fear Arthritis Care, PLLC - Leland
- Carolina Research Center Inc - Shelby
Colorado
- Denver Arthritis Clinic PC - Denver
Illinois
- Flourish Research Ravenswood - Chicago
Pennsylvania
- Altoona Center for Clinical Research - Duncansville
Texas
- Pioneer Research Solutions Inc - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2026-02-09 |
| Est. Completion | 2028-07-18 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07388498
The ClinicalTrials.gov registry entry for NCT07388498 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 270 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 1 condition, with Uncontrolled Gout appearing as the primary indexed condition, and to 2 interventions - of which Methotrexate is the first listed.
NCT07388498 reports 17 study locations spanning 6 distinct geographic areas - top geographies include Florida, North Carolina, Colorado.
Frequently Asked Questions
What is clinical trial NCT07388498 about?
NCT07388498 is a clinical study titled "A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout". The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum ...
What is the current status of trial NCT07388498?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2026-02-09. Estimated completion is 2028-07-18.
What conditions does trial NCT07388498 study?
This clinical trial studies the following conditions: Uncontrolled Gout.
What interventions are being tested in trial NCT07388498?
The interventions under investigation include: Methotrexate (DRUG), Pegloticase (DRUG).
Who is sponsoring clinical trial NCT07388498?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07388498 being conducted?
This trial has 17 study locations across Colorado, Florida, Illinois, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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