Lupus Clinical Trials

狼疮临床试验

• 批准号: 10709765
• 负责人: Sarfaraz Hasni
• 金额: $ 285.89万
• 依托单位: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10709765
• 关键词: Adult; Affect; Atherosclerosis; Autoimmune; Biological; Biological Markers; Blood; Blood Vessels; Blood flow; COVID-19; Cardiovascular system; Caring; Clinical; Clinical Trials; Consultations; Data; Diagnosis; Disease; Drug Monitoring; Eligibility Determination; Endothelium; Enrollment; Genetic study; Goals; Image; Immune system; Informed Consent; Laboratories; Laboratory Study; Longterm Follow-up; Lupus; Lupus Nephritis; Medical; Natural History; Observational Study; Organ; Outcome; Pathogenesis; Pathogenicity; Patients; Physical Examination; Physicians; Prognosis; Protocols documentation; Publications; Recording of previous events; Reporting; Research; Risk; Sampling; Severities; Skin; Specimen; Systemic Lupus Erythematosus; Testing; Therapeutic immunosuppression; Toxic effect; United States National Institutes of Health; Urine; Vaccines; Validation; Vascular Diseases; base; candidate marker; comorbidity; disease natural history; healthy volunteer; patient subsets; pediatric patients; premature atherosclerosis; research study; response; sample collection; systemic autoimmunity; systemic inflammatory response; vascular inflammation

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.

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史以及导致器官损伤加剧的机制。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，以评估疾病活动性或疾病并发症并监测与药物相关的毒性。出于研究目的（包括基因研究）需要提供血液、皮肤或尿液样本。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，以及系统性红斑狼疮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与。向患者推荐或提供的任何医疗护理均符合常规实践标准，并在咨询患者转诊医生后提供。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生物标志物候选物的识别和验证。 在过去的一年里，我们继续收集研究样本和数据，并与我们的各个合作者一起在更好地了解 SLE 失调的免疫系统方面取得进展。此外，我们还完成了四项 SLE 临床试验，其中纳入了本自然历史研究的受试者。本报告所附出版物中列出了这些发现和临床试验。 此外，我们还参与了一项观察性研究，以描述 COVID-19 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系统性炎症、自身免疫特征和血管病变，以及他们的总体结果，包括对潜在抗病毒治疗或疫苗的反应。