● Recruiting

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

Condition: Uncontrolled Gout · Sponsor: Amgen

PhasePhase 3

Planned participants270

Who can joinAll sexes, 18 Years to no upper limit

Healthy volunteersNo

About this study

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.

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

Talk to the study team

Amgen Call Center · 866-572-6436 · medinfo@amgen.com

Always discuss trial participation with your own doctor first.

Locations (57)

University of Alabama at Birmingham	Birmingham, Alabama, United States	Recruiting
Orthopedic Physicians Alaska	Anchorage, Alaska, United States	Recruiting
Advanced Clinical Research Center, LLC dba TriWest Research Associates	Chula Vista, California, United States	Recruiting
Solace Clinical Research	Tustin, California, United States	Recruiting
Denver Arthritis Clinic PC	Denver, Colorado, United States	Recruiting
D and H Pompano Research Center	Aventura, Florida, United States	Recruiting
Bay Pines Veterans Affairs Healthcare System	Bay Pines, Florida, United States	Recruiting
Hillcrest Medical Research	DeLand, Florida, United States	Recruiting
New Generation of Medical Research	Hialeah, Florida, United States	Recruiting
Homestead Associates In Research Inc	Homestead, Florida, United States	Recruiting
Pharmax Research Clinic	Miami, Florida, United States	Recruiting
Well Pharma Medical Research Corp	Miami, Florida, United States	Recruiting

+ 45 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07388498