Recruiting
Sponsor ID
20230219
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
Study Details
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.
Protocol Summary
Primary Outcome Measures
Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24
Timeframe: Month 6 (Weeks 20, 21, 22, 23, and 24)
Secondary Outcome Measures
Number of Participants With Serious Injection Site Reactions Through Week 48
Timeframe: Up to Week 48
Number of Participants With Serious Adjudicated Infusion Reactions (Including Adjudicated Anaphylaxis) Through Week 48
Timeframe: Up to Week 48
Number of Participants With Adjudicated Anaphylaxis Through Week 48
Timeframe: Up to Week 48
Serum Concentrations of Pegloticase Following SC and IV Administration
Timeframe: Up to Week 48
Locations
Location
D and H National Research Centers
Miami, FL, United States, 33155
Status
Recruiting
Location
Altoona Center for Clinical Research
Duncansville, PA, United States, 16635
Status
Recruiting
Location
Cape Fear Arthritis Care, PLLC
Leland, NC, United States, 28451
Status
Recruiting
Location
ClinPro Research Solutions LLC
Tampa, FL, United States, 33613
Status
Recruiting
Location
D and H Pompano Research Center
Aventura, FL, United States, 33180
Status
Recruiting
Location
D and H Tamarac Research Center
Tamarac, FL, United States, 33321
Status
Recruiting
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