Mapping Autoimmune Phenotypes in Multiplex Families (MADGC 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 817
- 试验地点
- 1
- 主要终点
- To identify biomarkers that can predict the future development of clinical disease in subjects at risk, or alternatively, indicate that progression to overt clinical disease is unlikely
研究概览
简要总结
This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood sample.
详细描述
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that causes inflammation and is accompanied by the development of autoantibodies. The inflammation caused by SLE may affect the skin, joints, lungs, blood, kidneys and nervous system. The cause of SLE is unknown, but research has indicated that it is caused by a combination of genetic and environmental factors.
Autoimmune diseases often run in families. Close relatives of people with these diseases are at greater risk of developing the same or another autoimmune disease. The study is designed to determine several things: If sisters of people with SLE make the same antibodies that are present in people with SLE, whether or not environmental factors affect the chances of developing these antibodies and if so what these environmental factors may be, if the presence of these antibodies in healthy people leads to increased risk for the development of SLE.
This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood sample.
Participation is voluntary and participants can stop participating at any time.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Proband must be a female and have documented SLE that meets ACR criteria. SLE must be diagnosed by and including age
- •Proband must have at least one biological sister ≥ 10 years of age and ≤ 45 who is available and willing to donate a blood sample and enroll in a longitudinal study. Both full and half siblings qualify.
排除标准
- •If inclusion criteria above are met for the proband, there are no exclusions.
- •Sister who does not have SLE:
- •Inclusion Criteria:
- •Female with a full or half sister who has been documented SLE that meets ACR criteria.
- •Sister must be currently between ages ≥ 10 and ≤ 45 at the time of enrollment and not have a diagnosis of SLE.
- •Sister must be able to complete questionnaires and should be willing to donate a blood sample at baseline and follow-up.
- •Sister should communicate to the recruiter that she is willing to be followed for a period of at least two years by phone and/or internet.
- •Exclusion Criteria:
- •If Sister meets inclusion criteria, there will be no exclusions.
结局指标
主要结局
To identify biomarkers that can predict the future development of clinical disease in subjects at risk, or alternatively, indicate that progression to overt clinical disease is unlikely
时间窗: 5 years
次要结局
- To understand the preclinical biological and immunological events that precede the development of systemic lupus(5 years)
研究者
Peter Gregersen
Principal Investigator
Northwell Health