Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells in the Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Percentage of regulatory B cells induced by JAKi in vitro
研究概览
简要总结
This study will investigate whether inhibitors of the JAK / STAT signaling pathway can increase anti-inflammatory functions of B cells in patients with RA using in vitro and in vivo experiments.
详细描述
This study will first analyze the effect of inhibitors of the JAK / STAT pathway in vitro on B-cell phenotypes and functions in 30 RA patients and 30 patients with osteoarthritis. It will also study the phenotypes and functions of B cells in RA patients for whom JAK / STAT inhibitor treatment has been prescribed by the patient's usual rheumatologist. The analysis will be done before the start of treatment and 3 months later. The phenotypes of B-cells will be assessed by flow cytometry with intra- and extra-cellular stainings. The functions of B cells will be assessed by their ability to differenciate naïve T cells in coculture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General criteria
- •Patient, of 18 and more years old
- •Subject affiliated to a social security system
- •Subject not being in period of exclusion with regard to another protocol
- •Absence of pregnancy in the inclusion (date of the last period, use of a contraceptive method, ß -HCG impulsive person in case of doubt)
- •Informed consent
- •Criteria of inclusion of the group rheumatoid arthritis (in vitro studies):
- •Rheumatoid arthritis, corresponding to the the classification ACR / EULAR 2010 criteria
- •Criteria of inclusion of the group arthritis (in vitro studies):
- •Spinal degenerative osteoarthritis or degenerative osteoarthritis of the members, according to the clinical and radiological elements.
- •Criteria of inclusion of the group rheumatoid arthritis, longitudinal study at the patients treated by JAK / STAT inhibitors :
- •Rheumatoid Polyarthritis, corresponding to the classification ACR / EULAR 2010 criteria
- •Patient to whom a treatment by inhibitor of the way JAK / STAT was proposed in current care of rheumatoid arthritis.
排除标准
- •General criteria
- •Corticosteroid therapy superior to 10 mg / j
- •Drip of corticoids in the previous month
- •Pregnant or breast-feeding Patients
- •Patient under protection(saving) of justice
- •Under guardianship Patient or guardianship
- •Current Infection
- •Criteria of non-inclusion of the group rheumatoid polyarthritis ( in vitro studies):
- •Treatment by immunomodulateur or biotherapics (anti-TNF alpha, tocilizumab, abatacept or rituximab) in the previous year
- •Criteria of non-inclusion of the group arthritis ( in vitro studies):
- •History of autoimmune disease or néoplasie
- •Treatment by immunomodulateur or biotherapics (anti-TNF alpha, tocilizumab, abatacept or rituximab)
- •Criteria of non-inclusion of the group rheumatoid arthritis, longitudinal study at the patients treated by JAK / STAT inhibitors :
- •Treatment by rituximab in the previous year
研究组 & 干预措施
Rheumatoid arthritis
Patients responding to ACR/EULAR 2010 criteria and Blood sample analysis of patients treated as standard care
干预措施: Blood sample analysis of patients treated as standard care (Other)
Osteoarthritis
Control patients and Blood sample analysis of patients treated as standard care
干预措施: Blood sample analysis of patients treated as standard care (Other)
Rheumatoid arthritis with JAK/STAT inhibitors
Standard use of JAK/STAT inhibitors and Blood sample analysis of patients treated as standard care
干预措施: Blood sample analysis of patients treated as standard care (Other)
结局指标
主要结局
Percentage of regulatory B cells induced by JAKi in vitro
时间窗: 4 months
IL-10+ CD19+ cells after in vitro exposure of JAKi
次要结局
- Percentage of Th1 induced by JAKi treated B cells in vitro(4 months)
- Percentage of regulatory T cells induced by JAKi treated B cells in vitro(4 months)