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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: Recruiting Phase 3 study of Uncontrolled Gout, sponsored by Amgen.
NCT07388498 is a Phase 3 study of Uncontrolled Gout that is actively recruiting participants, run by Amgen. The registered enrollment target is 270 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). The trial reports 17 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as Achieving and Maintaining sUA \< 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 |
What NCT07388498 shows while recruiting
NCT07388498 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
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 lists 17 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Uncontrolled Gout
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07388498's enrollment target sits among peer trials
270 1218th of 2000 higher than 781 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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