NCT03322618已完成不适用
Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 (Monoclonal Antibody IPH4102 Targeting KIR3DL2) in Blood Samples Taken From Patients With Axial Spondyloarthritis and Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Characterize the present various immunizing populations in patients' blood SPA HLA-B27 + and HLA-B27-(Lymphocytes T CD4 (Th1 Th2, Th17, Tregs), lymphocytes T CD8, cells NK, lymphocytes B, monocytes)
研究概览
简要总结
the main objectives are
- to study the pathophysiological role of KIR3DL2 in axSpA and its relationship with Th17 immunity in HLA-B27 + and HLA-B27- patients and
- to assess the effect on the pro-inflammatory immune response of a cytotoxic monoclonal antibody IPH4102 (anti-KIR3DL2) in these patients.
The study will be carried out on blood samples from 24 patients with axSpA, 12 HLA-B27 + and 12 HLA-B27-, without any drug injection nor direct therapeutic benefit for the participating patients and 12 healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Informed consent of the patient signed before any procedure planned to the protocol
- •SPA axial according to the criteria of the ASAS (international Assessment of SpondyloArthritis Society)
- •Known Status HLA B27
- •Disease activates with a score of BASDAI = 4/
- •The BASDAI (Bath Ankylosing Spondylitis Disease Activity Score) is a composite indication(index), validated, used in the therapeutic essays and in current practice for the evaluation of the activity of the SPA.
- •Naive Patients of thorough treatment
- •Patients of 18 and more years old
排除标准
- •Pregnant or breast-feeding Women
- •Adults under guardianship
- •People staying in a sanitary or social establishment
- •People in emergency situation
- •Not profitable People of a national insurance scheme
- •Private persons of freedom
- •Treatment by corticoids during the last 30 days before the inclusion
- •Treatment by anti-TNF or quite different biomedicine
- •Treatment by sulfasalazine
- •Reached concomitant by another active chronic inflammatory disease
- •Infection chronicles by VHB, VHC or HIV
- •Patients included in another study of clinical trial
研究组 & 干预措施
SpA HLA-B27 +,
Experimental
干预措施: blood samples (Biological)
SpA HLA-B27-
Experimental
干预措施: blood samples (Biological)
healthy subject
Active Comparator
干预措施: blood samples (Biological)
结局指标
主要结局
Characterize the present various immunizing populations in patients' blood SPA HLA-B27 + and HLA-B27-(Lymphocytes T CD4 (Th1 Th2, Th17, Tregs), lymphocytes T CD8, cells NK, lymphocytes B, monocytes)
时间窗: 12 MONTHS
by flow cytometry.
次要结局
- Dosage of cytokines(12 MONTHS)
- Expression of the receivers involved in SPA on lymphocytes T CD4 in percentage of cells T CD4 expressing this markers(12 MONTHS)
研究者
研究点 (2)
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