This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.
Febuxostat is an XO (Xanthine Oxidase) Inhibitor approved Urate Lowering Therapy (ULT) for patients with gout. Although febuxostat has been demonstrated to be superior to allopurinol in lowering serum urate (sUA) to \< 6mg/dL in 3 randomized, controlled clinical trials, proportions of subjects experiencing a reduction in tophus area and gout flares were not significantly different compared to allopurinol. Although this study will allow subjects who are naïve to ULT to enroll, it is anticipated that the majority of subjects will currently be taking or have previously experienced XO Inhibitor therapy. This trial will enroll a population of subjects with high uric acid body burden, as all must demonstrate the presence of tophi.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
330
Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6
Proportion of subjects with an sUA level that is \< 5.0 mg/dL by Month 6
Time frame: 6 months, analysis after all subjects complete 12 months
Complete Resolution of at Least One Target Tophus
Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12
Time frame: 12 Months
Complete or Partial Response of at Least One Tophus
Proportion of subjects with a best tophus response on at least 1 target tophus of complete (disappearance of at least 1 target tophus) or partial (≥ 50% decrease in the area of at least 1 target tophus) resolution by Month 12
Time frame: 12 Months
Quality of Life
Proportion of subjects with an improvement from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at least 0.25 at Month 12. The HAQ-DI assesses a patient's level of functional ability with items scores ranging from 0-3 with 0 being the least disability.
Time frame: 12 Months
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80 mg
Unnamed facility
Birmingham, Alabama, United States
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Goodyear, Arizona, United States
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Peoria, Arizona, United States
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Pheonix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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Glendale, California, United States
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Huntington Beach, California, United States
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Irvine, California, United States
...and 114 more locations