Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 185
- 试验地点
- 14
- 主要终点
- Proportion of anti-Ro/SSA IgE positive patients
研究概览
简要总结
Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to life-threatening conditions and is always responsible for a decreased quality of life. Its evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be carried out routinely is major in patients' follow-up. Because of the existence of autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for anti-Ro/SSA antibodies in inducing interferon alpha (IFNα) signaling and the specific pharmacologic properties of IgE, anti-Ro/SSA IgE should be an interesting biomarker to determine pSS's activity. The aim of the study is to evaluate whether the proportion of anti-Ro/SSA IgE positive patients is higher in patients with active disease (i.e. Eular Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or already known diagnosis) will be included, Anti-Ro/SSA IgE titers will be determined, the disease's features will be collected (including Eular Sjögren Syndrome Disease Activity Index/Eular Sjogren's Syndrome Patient Reported Index).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Primary Sjögren's syndrome according to the American-European Consensus Criteria)
- •Informed and having signed the study consent form
排除标准
- •Secondary Sjögren's syndrome
- •Other systemic autoimmune disease (e.g. rheumatoid arthritis, AntiNeutrophil Antibodies (ANCA) -associated vasculitis, mixed connective tissue disease…)
- •Incapacity or refusal to sign the informed consent form
- •Incapacity or refusal to perform the follow-up examinations required by the study
- •Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, Tumor Necrosis Factor (TNF) antagonists or interferon during the 6 months prior to the inclusion
- •Has any current signs or symptoms of active infection
研究组 & 干预措施
patients with primary Sjögren's syndrome
Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA) in patients with primary Sjögren's syndrome according to the American-European Consensus Criteria.
干预措施: Blood samples (Other)
结局指标
主要结局
Proportion of anti-Ro/SSA IgE positive patients
时间窗: Day 1
Comparison of proportion of anti-Ro/SSA IgE positive patients between patients with active pSS and patient without active pSS anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Active pSS is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI) ≥ 5
次要结局
- Correlation between anti-Ro/SSA IgE positive patients and interferon alpha signature(Day 1)
- Comparison between anti-La/SSB IgE positive patients and clinical and biologic characteristics(Day 1)
- Correlation between anti-Ro/SSA IgE titers and pSS's activity.(Day 1)
- Correlation between anti-Ro/SSA IgE positive patients and the symptomatology level(Day 1)
- Correlation between anti-Ro/SSA IgE positive patients and onset of lymphoma(5 years)
- Comparison between anti-Ro/SSA IgE positive patients and clinical and biologic characteristics(Day 1)