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Lupus Clinical Trials

狼疮临床试验

基本信息

批准号：
10928539
负责人：
Sarfaraz Hasni
金额：
$ 289.32万
依托单位：
NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
依托单位国家：
美国
项目类别：
财政年份：
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/10928539
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 Glucocorticoids 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 Recommendation 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 Viral biomarker identification 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

项目摘要

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.

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。

项目成果

期刊论文数量（8）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Health disparities in systemic lupus erythematosus-a narrative review.

DOI：
10.1007/s10067-022-06268-y
发表时间：
2022-11
期刊：
Clinical rheumatology
影响因子：
3.4
作者：
通讯作者：

Correspondence on 'Blood-brain barrier leakage in systemic lupus erythematosus is associated with gray matter loss and cognitive impairment'.

关于“系统性红斑狼疮的血脑屏障渗漏与灰质损失和认知障碍相关”的通讯。

DOI：
10.1136/annrheumdis-2021-220031
发表时间：
2021
期刊：
Annals of the rheumatic diseases
影响因子：
27.4
作者：
Pamuk,OmerNuri;Hasni,Sarfaraz
通讯作者：
Hasni,Sarfaraz

Does hydroxychloroquine improve patient reported outcomes in patients with lupus?

羟氯喹是否可以改善狼疮患者报告的预后？

DOI：
10.1177/09612033211033983
发表时间：
2021
期刊：
Lupus
影响因子：
2.6
作者：
Jolly,Meenakshi;Sehgal,Vinay;Arora,Shilpa;Azizoddin,Desiree;Pinto,Benzeeta;Sharma,Aman;Devilliers,Herve;Inoue,Mitsuyo;Toloza,Sergio;Bertoli,Ana;Blazevic,Ivana;Vilá,LuisM;Moldovan,Ioana;Torralba,KarinaD;Mazzoni,Davide;Cicogn
通讯作者：
Cicogn

Clinical Images: Cardiovascular magnetic resonance to detect and monitor inflammatory myocarditis in systemic lupus erythematosus.