Association Between the Presence of Autoantibodies Targeting Ficolin-2 and Active Nephritis in Patients With Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 主要终点
- Anti-ficolin-2 antibodies presence in SLE patients
研究概览
简要总结
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies. The prevalence and significance of antibodies against Ficolin-2 have not been yet investigated. The aims of this study were to determine the prevalence of anti-ficolin-2 antibodies among SLE patients and to investigate their potential as diagnostic and/or prognostic biomarkers in SLE.
This study is a secondary phase of a serum sample analysis done in early 2015 in order to determine the prevalence of anti-ficolin-2 antibodies among the same cohort as the previously declared study (ClinicalTrials.gov ID: NCT02625831; Unique Protocol ID: 1841851v0).
In this retrospective study, clinical data were obtained from medical files and blood samples were selected from preexisting biological collection. SLE patients (n=165) were informed and did not objected, they were matched to healthy controls (n=48). Disease activity was determined according to the SLEDAI score. Anti-ficolin-2 antibodies levels were measured in sera by ELISA and correlated to previously obtained Anti-ficolin-3, Anti-ficolin-2, anti-dsDNA and anti-C1q antibodies levels.
The titer of anti-ficolin-2 antibodies was correlated with the SLEDAI score (p<0.0001). The presence of anti-ficolin-2 antibodies was associated with anti-ficolin-3 antibodies, anti-C1q and anti-dsDNA antibodies.
Interestingly, the combination of anti-ficolin-3, anti-ficolin-2 and anti-C1q antibodies demonstrated higher specificity than any other traditional biomarker.
These results suggest that anti-ficolin-3 and anti-ficolin-2 antibodies could be useful for the diagnosis of active nephritis in SLE patients.
详细描述
For this retrospective study, the well written brief summary should be sufficient.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: ≥ 18 years old
- •Patients with lupus diagnostic criteria (ACR1997)
排除标准
- •Pregnant women
- •Patient with known evolutive cancer
- •48 healthy patients matched in age and sex with one or several SLE patients
结局指标
主要结局
Anti-ficolin-2 antibodies presence in SLE patients
时间窗: measured at day of inclusion = T0
Anti-ficolin-2 antibodies in SLE patients, considered positive if superior than 95 arbitrary units. This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.
次要结局
- Correlation of anti-ficolin-2 antibodies with anti-DNA antibodies in SLE patients(measured at day of inclusion = T0)
- Correlation of anti-ficolin-2 antibodies with anti-C1q antibodies in SLE patients(measured at day of inclusion = T0)
- Correlation of anti-ficolin-2 antibodies with lupus activity (SLEDAI score) in SLE(measured at day of inclusion = T0)
- Correlation of anti-ficolin-2 antibodies presence with active nephritis in SLE patients(measured at day of inclusion = T0)