The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry. This study is limited to four study centers in the US.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
pegloticase 8 mg i.v. every 2 weeks for 24 weeks
University of Chicago- Dept. Biological Services
Chicago, Illinois, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Duke University Medical Center
Durham, North Carolina, United States
Portland Rheumatology Clinic, L.L.C.
Lake Oswego, Oregon, United States
Adverse Event Profile
Number of participants reporting events
Time frame: 6 months
Mean Plasma Uric Acid
This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion.
Time frame: Baseline, Week 3 and Week 7
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