West Lake Hills

Researchers are evaluating the combined use of AR882 and xanthine oxidase inhibitors (XOI) in adults with uncontrolled gout who have previously failed uricase treatment, such as pegloticase. Failure of uricase treatment includes intolerance, allergic reactions, antibody development, or serum urate levels rising above 6 mg/dL during therapy. This Phase 2, open-label study aims to assess how well this combination lowers serum urate and reduces tophus burden in this population. Participants will receive AR882 75 mg as a solid oral capsule along with either a low or high dose of XOI tablets. The study involves co-administration of these drugs to evaluate their efficacy and safety in patients who have not responded adequately to prior uricase treatments. Treatment details such as dosing schedules are designed to monitor the impact of this combination therapy on urate levels and gout symptoms. During the study, participants will have their serum urate levels measured, with the primary goal of achieving levels below 6 mg/dL by 24 weeks (month 6). Researchers will also assess changes in tophus size and burden. Safety monitoring and evaluations will occur throughout the study period. Eligible adults aged 18 to 85 years with a history of uncontrolled gout and visible tophi who meet kidney function and weight criteria are invited to participate.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.