Lupus Clinical Trials

这项研究评估了系统性红斑狼疮(SLE)患者及其亲属，以研究该疾病的发病机制和自然病史，以及导致器官损害加重的机制。通过病史和体检对患者进行评估，并根据需要进行常规实验室检查，以评估疾病活动性或疾病并发症，并监测与药物有关的毒性。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几项测试，以了解影响他们血管的致病变化，以及SLE过早动脉粥样硬化的自然病史。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与。向患者推荐或提供的任何医疗护理都符合常规实践标准，并在咨询转诊医生的患者后提供。血液、尿样采集和心血管测试由健康志愿者完成，用于研究目的，并支持识别和验证新的生物标记物候选。 在过去的一年里，我们继续收集研究样本和数据，并与我们的不同合作者一起在更好地了解SLE中调节失调的免疫系统方面取得了进展。此外，我们已经完成了四项针对SLE的临床试验，这些试验招募了这项自然历史研究的受试者。这些发现和临床试验列在本报告所附出版物中。 此外，我们还参与了一项观察性研究，以表征新冠肺炎如何调节先前诊断为系统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，以及他们的总体结果，包括对潜在的抗病毒治疗或疫苗的反应。我们还完成了一项研究，以了解糖皮质激素在SLE患者中的作用机制。

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. We have also completed a study to understand the mechanism of action of glucocorticoids in SLE patients.