Lupus Clinical Trials

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This research study evaluates subjects with systemic lupus erythematosus (SLE) and their relatives to study the pathogenesis and natural history of the disease and the mechanisms leading to enhanced organ damage. Patients are evaluated by a history and physical examination and routine laboratory studies are obtained as needed to assess disease activity or complications of the disease and to monitor for drug-related toxicities. Blood, skin, or urine specimens are requested for research purposes, including genetic studies. In addition, a subset of these patients undergoes several tests to understand the pathogenic changes affecting their blood vessels and furthermore, the natural history of premature atherosclerosis in SLE. Patients who are eligible for other research studies are offered the opportunity to participate after signed informed consent. Any medical care recommended or provided to the patient is consistent with routine standards of practice and provided in consultation with the patients referring physician. Blood, urine sample collection, and cardiovascular testing is completed with healthy volunteers for research purposes and to support the identification and validation of new biomarker candidates. During the past year we have continued to collect research samples and data and make progress in better understanding the dysregulated immune system in SLE with our various collaborators. In addition, we have completed four clinical trials in SLE which enrolled subjects from this Natural History study. The discoveries and clinical trials are listed in publications attached to this report. Furthermore, we are also participating in an observational study to characterize how COVID-19 modulates systemic inflammation, autoimmune features, and vasculopathy in adult and pediatric patients with a prior diagnosis of systemic autoimmunity, and their overall outcomes including response to potential antiviral treatments or vaccines.