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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
270
Participants will receive pegloticase either SC or IV.
MTX will be administered orally.
D and H National Research Centers
Miami, Florida, United States
RECRUITINGNumber of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24
Defined as Achieving and Maintaining sUA \< 6 mg/dL for at Least 80% of the Time During Month 6.
Time frame: Month 6 (Weeks 20, 21, 22, 23, and 24)
Number of Participants With Serious Injection Site Reactions Through Week 48
Time frame: Up to Week 48
Number of Participants With Serious Adjudicated Infusion Reactions (Including Adjudicated Anaphylaxis) Through Week 48
Time frame: Up to Week 48
Number of Participants With Adjudicated Anaphylaxis Through Week 48
Time frame: Up to Week 48
Serum Concentrations of Pegloticase Following SC and IV Administration
Time frame: Up to Week 48
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