Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- the proportion of circulating TFH in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after 3 months of treatment with steroids
研究概览
简要总结
T follicular helper (TFH) cells represent a T cell subset dedicated to the activation of B cells. They have been involved in the pathogenesis of autoimmune diseases in humans such as lupus and Sjögren disease. We recently showed that TFH are implicated in the activation of autoreactive B lymphocytes during ITP. Autoimmune hemolytic anemia (AIHA) is an autoimmune disease due to antibodies targeting red blood cells. To date, the role of TFH in the pathogenesis of AIHA is not known.
We hypothesize that AIHA is associated with an increase in the number and/or function of TFH, that could participate in the activation of autoreactive B lymphocytes.
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
- •Patients with a diagnosis of warm AIHA defined by
- •Hemoglobin <11 g/dl
- •Low haptoglobin level
- •Positive direct antiglobulin test (IgG or IgG + complement)
- •Reticulocyte count >120 G/L
- •naive to treatment for hemolytic anemia or a in relapse
- •Older than 18 years
- •Able to understand written and spoken French
- •Persons who have provided written consent
- •Control population
- •Patients who have given consent
- •Patients over 18 years
- •Patients with cold agglutinin disease (progressive AIHA and different treatments of warm autoantibody AIHA) can be included as a sub-group of controls
- •Patients with non-auto-immune hemolytic anemia (constitutional of enzymatic origin, membrane-related,...) can be included as a sub-group of controls
排除标准
- •Patients without national health insurance
- •Pregnancy or breast-feeding women
- •Adults under guardianship
- •Patients with cancer or malignant hemopathy
- •Patients with an on-going infection
- •Patients treated with corticoids or immunosuppressants
结局指标
主要结局
the proportion of circulating TFH in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after 3 months of treatment with steroids
时间窗: through study completion, an average of 1 year
the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA) and in control subjects.
时间窗: baseline
次要结局
未报告次要终点