Lupus Clinical Trials

这项研究评估了系统性红斑狼疮（SLE）及其亲属的受试者，以研究疾病的发病机制和自然史以及导致器官损伤增强的机制。通过病史和体格检查对患者进行评价，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、皮肤或尿液标本用于研究目的，包括遗传学研究。此外，这些患者的一个子集进行了几项测试，以了解影响他们的血管的致病性变化，此外，在SLE过早动脉粥样硬化的自然史。有资格参加其他研究的患者在签署知情同意书后有机会参加。向患者推荐或提供的任何医疗护理均符合常规实践标准，并在与患者转诊医生协商后提供。血液、尿液样本采集和心血管检测由健康志愿者完成，用于研究目的，并支持新生物标志物候选物的鉴定和验证。 在过去的一年中，我们继续收集研究样本和数据，并与我们的各种合作者在更好地了解SLE免疫系统失调方面取得了进展。此外，我们已经完成了四项SLE临床试验，这些试验招募了本自然史研究的受试者。发现和临床试验列于本报告随附的出版物中。 此外，我们还参与了一项观察性研究，以描述COVID-19如何调节既往诊断为全身性自身免疫的成人和儿童患者的全身炎症、自身免疫特征和血管病变，以及他们的总体结局，包括对潜在抗病毒治疗或疫苗的反应。

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.