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.
Denver Arthritis Clinic PC
Denver, Colorado, United States
RECRUITINGD and H Pompano Research Center
Aventura, Florida, United States
RECRUITINGNew Generation of Medical Research
Hialeah, Florida, United States
RECRUITINGHomestead Associates In Research Inc
Homestead, Florida, United States
Number 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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Well Pharma Medical Research Corp
Miami, Florida, United States
RECRUITINGD and H National Research Centers
Miami, Florida, United States
RECRUITINGAdvanced Clinical Research
Miami, Florida, United States
RECRUITINGFelicidad Medical Research
Miami, Florida, United States
RECRUITINGDecision Management International Research
Pinellas Park, Florida, United States
RECRUITINGD and H Tamarac Research Center
Tamarac, Florida, United States
RECRUITING...and 15 more locations