Follow-up of Clinical Manifestations and Inflammation-related Parameters in Individuals with Autoantibodies Against Ro/SSA and La/SSB
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Development of a rheumatic disease
研究概览
简要总结
In this study, individuals with autoantibodies against Ro/SSA and La/SSB will be followed with regard to clinical manifestations and immunological parameters to identify immunological changes, environmental factors, and early clinical symptoms that characterize the progression from serological autoreactivity to clinically manifest disease.
详细描述
Autoimmune diseases are a diverse group of conditions characterized by chronic inflammation and tissue damage. In systemic autoimmune diseases such as Sjögren disease and systemic lupus erythematosus (SLE), two specific types of autoantibodies targeting the bodys own proteins, Ro/SSA and La/SSB, are often present.
It is well known that some individuals with autoantibodies against Ro/SSA and/or La/SSB never develop any systemic rheumatic disease, while in others, the presence of these autoantibodies is a sign of impending disease. The condition of so-called serological autoreactivity, which can persist for decades, and how clinical disease subsequently develops is very little studied. There is currently a lack of knowledge regarding the environmental factors that contribute to the emergence of autoantibodies against Ro/SSA and/or La/SSB and the immunological mechanisms that lead to disease development in some individuals but not in others.
This project aims to enhance the understanding of the condition of serological autoreactivity against Ro/SSA and La/SSB. The specific goal is to identify immunological changes, environmental factors, and early clinical symptoms that characterize the progression from serological autoreactivity to clinically apparent disease. Understanding the immunological mechanisms that trigger the transition to disease is crucial for enabling earlier diagnosis and treatment, as well as for better comprehending the fundamental mechanisms underlying the development of autoimmune disease.
This will be achieved by:
- Clinically characterizing at-risk individuals who carry autoantibodies against Ro/SSA and/or La/SSB through medical consultations at a rheumatology specialist clinic.
- Immunologically characterizing at-risk individuals in comparison with healthy individuals through blood sampling and immunological analyses.
- Collecting data on exposure to environmental and lifestyle factors that could potentially increase the risk of autoimmunity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be included in the risk group, the following criteria must be met:
- •At least one instance of testing positive for Ro/SSA or La/SSB, regardless of the method used.
- •To be included in the control group, the individual must:
- •Have no rheumatologic disease and no autoantibodies against Ro/SSA or La/SSB.
排除标准
- •Below 18 years of age
- •Inability to consent to their own participation
- •Ongoing infection or severe illness where the study physician deems participation in the study not to be in the individuals best interest
- •Inability to read and understand Swedish, and therefore unable to complete the forms and questionnaires included in the project
结局指标
主要结局
Development of a rheumatic disease
时间窗: From enrolment to a maximum of 9 years of follow-up.
The number of participants that develop rheumatic disease among the individuals with autoantibodies will be assessed
次要结局
- Frequency of clinical symptoms(From enrolment to a maximum of 9 years of follow-up.)
研究者
Albin Björk
Principal Investigator
Karolinska Institutet