Study of Neonatal Immunoglobulin G (IgG) Fc Receptor (FcRn) Expression in Natural Killer T Cells Expressing an Invariant T Receptor (iNKT): Implication in the Pathophysiology of Systemic Lupus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- FcRn Expression analysis in Circulating iNKT lymphocytes
研究概览
简要总结
This study evaluates the variation of expression of the neonatal Fc receptor (FcRn) in Natural Killer T Cells Expressing an Invariant T Receptor (iNKT) and monocytes along with the surface expression of Fc gamma type II receptor (RII) and RIII in active or newly diagnosed lupus patients compared to inactive lupus patients.
详细描述
The role of FcRn in autoimmune diseases remains to be clarified, but it has been implicated in numerous pathophysiological mechanisms, notably in the management of immune complexes or the recycling of autoantibodies. In humans, this role in the metabolism of autoantibodies has recently led to the development of therapeutic antibodies for autoimmune diseases such as autoimmune thrombocytopenia and myasthenia.
The lupus erythematosus is an auto-immune disease mediated by IgG and immune complexes characterized by a high diversity of autoantibodies and a large dysregulation of the immune system in all it's components, one of them being iNKT cells.
Studies in patients or in lupus mouse models have shown a decrease in iNKT cells correlated with disease activity as well as tissue infiltration in relation to clinical manifestations. Their actual role in this pathology remains to be clarified between regulatory or pro-inflammatory effect.
The possible role of iNKT as a regulatory cell in lupus pathology and the possible involvement of FcRn in their development reinforces the interest of their simultaneous study in humans.
The aim of this study will be to evaluate the impact of the expression of FcRn and other Fc gamma receptors cooperating with FcRn (Fc gamma RII and RIII) in iNKT cells in lupus patients in relation to disease activity and therapy. This study will be conducted in parallel on monocytes, cells involved in the metabolism of immune complexes and likely to be activated by iNKT cells. These results will be compared to healthy controls and integrated into mechanistic studies in a mouse model.
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
- •Age ≥ 18 years
- •Diagnosis of definite systemic lupus which may be associated with secondary antiphospholipid syndrome and/or secondary Gougerot-Sjögren's
- •Lupus patient, newly diagnosed or known, untreated or in relapse
- •Lupus patient considered stable by the treating practitioner
- •Requiring blood sampling for follow-up
排除标准
- •Main autoimmune disease other than lupus
- •Patient under legal protection, guardianship or curators
- •Opposition to data processing
研究组 & 干预措施
LUPUS PATIENTS
Three extra tubes of blood will be taken at each consultation or inpatient visit when routine blood samples are taken as part of lupus monitoring.
干预措施: Blood sample (Biological)
结局指标
主要结局
FcRn Expression analysis in Circulating iNKT lymphocytes
时间窗: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
FcRn Expression analysis in circulating monocytes
时间窗: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
FcgammaRII Expression analysis in Circulating iNKT lymphocytes
时间窗: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
FcgammaRII Expression analysis in circulating monocytes
时间窗: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
FcgammaRIII Expression analysis in Circulating iNKT lymphocytes
时间窗: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
FcgammaRIII Expression analysis in in circulating monocytes
时间窗: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
次要结局
- corticotherapy(through study completion, an average of 3 year)
- hydroxychloroquine(through study completion, an average of 3 year)
- immunosuppressants outside of biotherapy: methotrexate, azathioprine, mycophenolate mofetil(through study completion, an average of 3 year)
- biotherapy: belimumab and rituximab(through study completion, an average of 3 year)
- lupus disease activity(through study completion, an average of 3 year)
- albumin and IgG levels(through study completion, an average of 3 year)