Pilot Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target. C5-MAG4 Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Serum C5a concentration
研究概览
简要总结
This is a monocentric, comparative, cross-sectional, case-control study seeking to identify abnormalities of the C5a-C5aR1 axis between a population of patients with active IgG4-associated disease (MAG4) and two control groups: healthy subjects without MAG4 and patients with MAG4 in remission.
详细描述
IgG4-associated disease is a rare fibrosing and inflammatory disorder whose pathophysiology remains poorly understood. Activation of certain monocyte/macrophage populations (in particular M2-type macrophages) has been shown to be involved during the course of the disease. The mechanisms behind this monocyte/macrophage activation are not known. Expression of the C5aR receptor on the surface of these populations, and preliminary findings of elevated C5a in these patients, suggest a potential role for this C5a-C5aR axis. Demonstration of the involvement of this pathway would open a path to therapeutic perspetives (C5aR inhibitors) for these patients, who frequently suffer from cortico-dependence and relapses. The aim of this research is to use healthcare technologies to identify cellular and molecular therapeutic targets in the context of the IgG4-associated disease
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients suffering from IG4-related disease and patients in remission :
- •age > 18
- •diagnosis of IgG4-associated disease according to ACR/EULAR 2019 classification criteria (4,5) with a score ≥
- •disease activity score (IgG4-RD Responder Index) ≥2 in at least one affected organ
排除标准
- •for patients suffering from IG4-related disease and patients in remission :
- •presence of a differential diagnosis ("IgG4-RD mimicker") or exclusion criterion according to ACR/EULAR 2019 classification criteria (4,5).
- •systemic corticosteroid treatment ≥5 mg/day ongoing or < 1 month ; Study C5-MAG4_RCAPHM21_0433 Protocol Version 1.1 of 16/01/2024 Page 15 of 41
- •immunosuppressive therapy ongoing or < 3 months ;
- •current biotherapy treatment or < 6 months;
- •absence of signed informed consent;
- •absence of affiliation to a Social Security scheme.
- •patient participating in an ongoing therapeutic trial ;
- •any condition which, in the opinion of the investigator, could influence the results of the study.
- •Inclusion criteria for healthy volunteers :
- •- age > 18
- •Exclusion criteria for healthy volunteers :
- •infectious episode (temperature >38°C, flu-like signs) in the 30 days prior to inclusion;
- •known inflammatory (including IG4-related disease) or autoimmune pathology;
- •treatment with corticosteroids in progress or taken in the month prior to sampling, or immunosuppressants in progress or taken in the 3 months prior to sampling, or biotherapy in the 6 months prior to sampling;
- •absence of signed informed consent;
- •absence of affiliation to a Social Security scheme;
- •persons taking part in an ongoing therapeutic trial;
- •any condition which, in the opinion of the investigator, could influence the results of the study.
研究组 & 干预措施
IgG4-RD patient
Patients suffering from Immunoglobulin G4-related disease (IgG4-RD).
干预措施: Blood sampling (Procedure)
patient in remission
Patients suffering from Immunoglobulin G4-related disease (IgG4-RD) but in remission.
干预措施: Blood sampling (Procedure)
healthy volunteers
干预措施: Blood sampling (Procedure)
结局指标
主要结局
Serum C5a concentration
时间窗: 24 months
The C5a concentration in the serum will be compared between of healthy volunteers and patients suffering from IG4-related disease
次要结局
- frequency of C5aR1+ monocytes among total monocytes(24 months)
- frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytes(24 months)