Evaluation of Type I IFN Level and Disease Activity in SLE Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 主要终点
- Pathogenetic, clinical and prognostic significance of IFN stimulated genes expression - IFNGS biomarkers in SLE patients
研究概览
简要总结
Elevated level of IFN type I in SLE patients associated with certain serum biomarkers (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α, TNF-RII, BAFF, APRIL), clinical and laboratory manifestations, activity and duration pf the disease and SLE patients quality of life. Standard immunosuppressive and anti-B-cell therapy can reduce the IFN type I and associated biomarkers levels in patients with high and moderate disease activity (SLEDAI-2К ≥6).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years old
- •Patients with SLE (SLICC/ACR 2012) confirmed by rheumatologist
- •Provided written informed consent before any study-related procedures are performed.
- •Ability to attend scheduled visits
- •No positive changes in the course of standard of care SLE therapy (glucocorticoids in stable doses, hydroxychloroquine and/or immunosuppressant therapy) at least 30 days before screening.
排除标准
- •Participation in any other clinical study
- •Pregnancy or pregnancy planning in next 12 months, lactation
- •Acute infectious disease or relapse of chronic infectious disease.
- •Receiving any of biologic agent or Janus-kinases inhibitors during 24 months prior to screening.
- •Active severe or unstable neuropsychiatric SLE manifestations (convulsion, psychosis, delirium, hallucinations, coma, transverse myelitis).
结局指标
主要结局
Pathogenetic, clinical and prognostic significance of IFN stimulated genes expression - IFNGS biomarkers in SLE patients
时间窗: Sept 1 2022 - Nov 1 2022
Pathogenetic, clinical and prognostic significance of IFN stimulated genes expression - IFNGS biomarkers (IFI44L, MX1, IFIT 1, RSAD2, EPSTI1), serum biomarkers (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α), TNF-α receptors type II (TNF-RII), В-cell activation factors (BAFF, APRIL) in SLE patients.
次要结局
- Rate of IFN stimulated genes(Nov 1 2022 - Oct 31 2024)
- IFN stimulated genes hyper-expression and serum biomarkers level(Nov 1 2022 - Oct 31 2024)
- IFNGS(Nov 1 2022 - Oct 31 2024)
研究者
Popkova Tatiana
MD PhD Professor
V.A. Nasonova Research Institute of Rheumatology, Moscow