Van Vleck

Researchers are evaluating the effectiveness and safety of current standard treatments for adults with active systemic lupus erythematosus SLE, including lupus nephritis, who have not responded adequately to glucocorticoids and at least two immunosuppressant therapies. The study focuses on participants with ongoing active disease despite prior treatments, aiming to better understand treatment outcomes in this population. The study is observational and sponsored by Bristol-Myers Squibb. Participants will continue to receive their current standard of care treatments as prescribed, which may include biologic therapies and other immunosuppressants, according to product labels and treatment guidelines. Those with lupus nephritis must have had a recent renal biopsy confirming specific kidney involvement. The study observes participants over time without altering their treatment, collecting data on disease activity and response. During the study, participants will be monitored regularly for up to five years. Assessments include clinical evaluations, laboratory tests, and disease activity questionnaires to track remission status, kidney function, disease flare-ups, and fatigue levels. The primary outcome is the number of participants achieving remission at six months. Secondary outcomes include long-term remission, kidney response, disease activity states, and patient-reported fatigue. Safety and treatment response duration will also be recorded throughout the study period.

This research aims to evaluate the effectiveness and safety of LUPKYNIS combined with belimumab, obinutuzumab, or anifrolumab in adults with lupus nephritis LN. The study focuses on how well these combinations induce a rapid kidney response in patients diagnosed with LN, a condition affecting kidney health. It is a phase 4 clinical trial sponsored by Aurinia Pharmaceuticals Inc. that assesses treatment approaches for this condition. Participants will receive LUPKYNIS along with one of the biologic agents belimumab, obinutuzumab, or anifrolumab. In addition, all patients will be treated with a mycophenolic acid analog MPAA, such as mycophenolate mofetil or mycophenolic acid, and corticosteroids like prednisone or an equivalent. The biologic treatment schedules vary depending on the specific drug, with some patients already receiving treatment before the study starts or beginning it at the start of the trial. During the study, participants will be monitored for kidney response over 24 weeks, including complete and partial renal responses. Researchers will assess safety by tracking treatment-emergent adverse events up to 28 weeks. Other assessments include measuring changes in kidney-related antibodies and complement levels at baseline, 12 weeks, and 24 weeks. The total participation duration extends to about 28 weeks, during which various evaluations, laboratory tests, and safety monitoring will occur to understand treatment effects and patient outcomes.