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Study identifier: NCT06229145 Synced from ClinicalTrials.gov · August 04, 2026
● Completed

A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout

Condition: Gout  ·  Sponsor: Amgen

PhasePhase 4
Planned participants262
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to \< 6 mg/dL for at least 80% of the time.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Locations (74)

The University of Alabama at Birmingham (UAB)Birmingham, Alabama, United States
Orthopedic Physicians Alaska - Rheumatology and InfusionAnchorage, Alaska, United States
Arizona Arthritis and Rheumatology Associates - ChandlerChandler, Arizona, United States
Arizona Arthritis and Rheumatology ReseFlagstaff, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLCGilbert, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLCMesa, Arizona, United States
Arizona Arthritis and Rheumatology Research, PLLCMesa, Arizona, United States
Arizona Arthritis and Rheumatology Research, PLLCPhoenix, Arizona, United States
Arizona Arthritis and Rheumatology ResearchPhoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLCSun City, Arizona, United States
Arizona Arthritis and RheumatologyTucson, Arizona, United States
Covina Arthritis ClinicCovina, California, United States

+ 62 more locations — full list on the registry record.

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