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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
Sponsor: Amgen
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.
Official title: A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2026-02-09
Completion Date
2028-07-18
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Pegloticase
Participants will receive pegloticase either SC or IV.
Methotrexate
MTX will be administered orally.
Locations (25)
Denver Arthritis Clinic PC
Denver, Colorado, United States
D and H Pompano Research Center
Aventura, Florida, United States
New Generation of Medical Research
Hialeah, Florida, United States
Homestead Associates In Research Inc
Homestead, Florida, United States
Well Pharma Medical Research Corp
Miami, Florida, United States
D and H National Research Centers
Miami, Florida, United States
Advanced Clinical Research
Miami, Florida, United States
Felicidad Medical Research
Miami, Florida, United States
Decision Management International Research
Pinellas Park, Florida, United States
D and H Tamarac Research Center
Tamarac, Florida, United States
GCP Clinical Research, LLC
Tampa, Florida, United States
ClinPro Research Solutions LLC
Tampa, Florida, United States
Conquest Research - Winter Park
Winter Park, Florida, United States
Vista Clinical Research
Newnan, Georgia, United States
Charter Research
Chicago, Illinois, United States
Flourish Research Ravenswood
Chicago, Illinois, United States
Willow Rheumatology and Wellness
Willowbrook, Illinois, United States
MD Medical Research
Oxon Hill, Maryland, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
Cape Fear Arthritis Care, PLLC
Leland, North Carolina, United States
Accellacare Salisbury
Salisbury, North Carolina, United States
Carolina Research Center Inc
Shelby, North Carolina, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Pioneer Research Solutions Inc
Houston, Texas, United States
Overlake Arthritis and Osteoperosis Center
Bellevue, Washington, United States