Miamisburg

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are evaluating the long-term safety of avacopan in adults with antineutrophil cytoplasmic antibody ANCA-associated vasculitis AAV, a condition requiring immunosuppressive therapy. This Phase 4 clinical trial aims to assess how participants tolerate avacopan combined with standard care over an extended period. The study involves participants diagnosed with granulomatosis with polyangiitis or microscopic polyangiitis who need induction treatment with cyclophosphamide or rituximab. Participants are randomly assigned to one of three groups avacopan 30 mg twice daily for five years plus standard care, avacopan 30 mg twice daily for one year followed by placebo twice daily for four years plus standard care, or placebo twice daily for five years plus standard care. Standard care involves background immunosuppressive therapy guided by current guidelines and tailored to each participants needs. Treatments are administered orally, and the study is double-blind to ensure objective assessment. During the study, participants will be monitored regularly for treatment-emergent adverse events, serious adverse events, and changes in vital signs and laboratory tests over up to 60 months. Researchers will also evaluate remission rates, relapse timing, kidney function, health perception scores, and medication use. Safety and efficacy data will be collected through clinical assessments, laboratory evaluations, and questionnaires, with follow-up continuing for the full duration of the trial.

Researchers are evaluating the potential benefits and risks of active sub-threshold wireless neuromodulation stimulation for treating chronic knee pain caused by osteoarthritis. This trial aims to compare active stimulation versus no stimulation sham in reducing pain, with the primary goal of measuring the number of participants who experience at least a 50% decrease in pain on a visual analog scale after one month. Participants first undergo a diagnostic injection to confirm temporary pain relief before receiving a 7-day trial implant of the stimulation device near the target nerve. Those reporting more than 50% pain relief during this test proceed to receive a permanent implant under sedation. After a healing period of 10 days, participants are randomized to receive either active sub-threshold stimulation or sham stimulation for 30 days while both participants and staff remain unaware of group assignments. Stimulation programs include various high-frequency options. Throughout the study, participants attend in-person visits at 1 week, 1 month, 3 months, and 6 months post-randomization for physical exams, pain scales, knee function assessments, range of motion, work status, and medication use. Additional phone follow-ups are conducted at 12, 18, and 24 months to assess long-term pain relief and any adverse events. The study collects multiple outcome measures to evaluate the treatments impact on pain and physical function over time.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating a stepped care approach called STARRS-PC Stepped Approach to Reducing Risk of Suicide in Primary Care to reduce suicide risk among youth aged 12 to 17 years receiving primary care. This study aims to compare the effectiveness of STARRS-PC against usual treatment TAU in lowering suicide attempts, suicidal thoughts, and self-injury over a 12-month period. The study also explores factors that affect how well the clinical pathway can be put into practice and sustained in primary care settings. The study is conducted over five years at 14 pediatric primary care clinics. It includes three phases treatment as usual TAU, intervention, and sustainability. During TAU, usual depression and suicide risk screening is performed. In the intervention phase, STARRS-PC is implemented, which involves universal suicide risk screening with a brief questionnaire, followed by a detailed risk assessment and care decisions based on risk level. Providers receive training and participate in interviews to identify challenges and supports for implementing the clinical care pathway. The final sustainability phase focuses on maintaining improvements without enrolling new participants. Participants include 2,572 adolescents identified at risk for suicide along with their parents or guardians. They complete interviews and questionnaires at baseline, 3, 6, and 12 months. Medical records are reviewed throughout the study. Youth outcomes measured include suicide attempts, suicidal thoughts, and non-suicidal self-injury, while family satisfaction is also assessed. Providers are evaluated on knowledge and attitudes about suicide risk management. The study includes ongoing monitoring, data collection, and a 6-month follow-up after the intervention phase for sustainability analysis.