Lupus Clinical Trials

本研究对系统性红斑狼疮（SLE）患者及其亲属进行评估，以研究该病的发病机制、自然史以及导致器官损伤加重的机制。通过病史和体格检查对患者进行评估，并根据需要进行常规实验室研究，以评估疾病活动或疾病并发症，并监测药物相关毒性。血液、皮肤或尿液样本被要求用于研究目的，包括基因研究。此外，这些患者中的一部分接受了多项测试，以了解影响其血管的致病性变化，进而了解SLE中过早动脉粥样硬化的自然史。在签署知情同意书后，有资格参加其他研究的患者将有机会参加。向患者推荐或提供的任何医疗护理均应符合常规执业标准，并与患者的转诊医生协商后提供。血液、尿液样本采集和心血管测试由健康志愿者完成，用于研究目的，并支持新的生物标志物候选物的鉴定和验证。

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.