Clinical and Diagnostic Value of Ribosomal p2 Autoantibodies in Systemic Lupus Erythematosus: Case Control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- a. Primary (main): Assessment of diagnostic value (sensitivity and specificity) of serum ribosomal p2 autoantibody level in SLE patients in comparison to healthy controls
研究概览
简要总结
Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder characterized by production of autoantibodies directed against nuclear and cytoplasmic antigens. Clinically, this disorder is characterized by periods of remission and relapse (1). The early and accurate diagnosis of SLE is challenging (2).
The SLE pathogenesis involves multiple cellular components of the innate and immune systems, presence of autoantibodies and immune complexes, engagement of the complement system and cytokine dysregulation (3). About 180 autoantibodies have been identified in SLE patients, 102 of which are reported to have an organ-specific correlation with SLE disease identified in SLE patients, with SLE disease activity (4). However, with the exception of autoantibodies such as antinuclear antibody (ANA), anti double stranded DNA (dsDNA), anti-smith and antiphospholipid antibodies, currently proposed by the American college of rheumatology (ACR) (5)
详细描述
systemic lupus international collaborating clinics (SLICC) (6) for the diagnosis of SLE, most of these autoantibodies lack sufficient sensitivity and/or specificity for use in clinical diagnosis. Discovery of additional autoantibodies with high sensitivity and specificity is important for early diagnosis and assessment of the prognosis of SLE (7).
Anti-ribosomal P(Anti-Rib-P) antibody, routinely tested in SLE, targets a homologous 22-amino acid C-terminal (C-22) sequence shared by three ribosomal phosphoproteins known as P0, P1, and P2 (8).
The prevalence of anti-Rib-P antibody is about 15-40% in SLE patients and varies with the ethnicity, disease activity and detection method (9). Studies have disclosed that anti-P antibodies react with activated T cells but not with B cells, suggesting possible direct effects of anti-P antibodies on immune regulation (10).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who fulfilled the 2012 SLICC criteria (6).
- •SLE Patients >= 18 years old.
排除标准
- •1-SLE Patients < 18 years old. 2- Patients with other autoimmune diseases or malignancy.
结局指标
主要结局
a. Primary (main): Assessment of diagnostic value (sensitivity and specificity) of serum ribosomal p2 autoantibody level in SLE patients in comparison to healthy controls
时间窗: Baseline
The importance of Ribosomal p2 autoantibodies in diagnosis of SLE
次要结局
- b. Secondary (subsidiary): correlation between serum ribosomal p2 autoantibody level and SLE clinical, laboratory data, disease activity and severity.(Baseline)
研究者
Menna Allah Nashaat
Principal investigator
Assiut University