Role of Interleukin 18 (IL-18) and Interleukin 18 Binding Protein (IL-18BP) in the Diagnostic Work-up of Systemic Juvenile Idiopathic Arthritis and Autoinflammatory Diseases: Possible Biomarkers in the Differential Diagnosis of Other Febrile Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Serum levels of IL-18, and IL-18BP
研究概览
简要总结
Literature data suggest that elevated blood values of IL-18 and IL-18 Binding Protein and alterations in their ratio may be significantly correlated with various autoinflammatory diseases, such as systemic juvenile idiopathic arthritis, recurrent autoinflammatory fevers etc. In this view, the clinical implication of this observational, prospective, single-centre, non-pharmacological study will be the definition of new laboratory markers that may be useful in the early differential diagnosis of certain rare and serious paediatric diseases.
详细描述
The primary aim of this study is to investigate the role of IL-18 and IL-18 Binding Protein as biomarkers of systemic Juvenile Idiopathic Arthritis and recurrent autoinflammatory fevers, while the secondary one is to investigate the superiority of IL-18 and IL-18 Binding Protein over other cytokines and inflammatory indexes in the differential diagnosis of systemic Juvenile Idiopathic Arthritis and recurrent fevers of an autoinflammatory nature.
The study will enroll patients referred to the Pediatric Rheumatology Outpatient Clinic of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy, for suspected Juvenile Idiopathic Arthritis or suspected recurrent fever/self-inflammatory disease.
Patients will be enrolled during the acute phase of the disease and, prior to the start of immunosuppressive therapy (i.e. corticosteroids, colchicine, biological drugs), a blood sample will be taken for haematochemical investigations, according to clinical practice, as well as an additional blood sample for the assay of IL-18 and IL-18 Binding Protein.
The following variables will be considered for each patient: demographic data; key clinical features; haemochromocytometric test; liver and kidney function tests; indexes of inflammation and acute phase proteins; inflammatory cytokines panel; serum values of IL-18 and IL-18 Binding Protein.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2 years and 18 years;
- •Being affected by 1 of the following: Juvenile Idiopathic Arthritis; recurrent fever/ autoinflammatory disease; rheumatic disease; severe infectious diseases (sepsis, meningitis, urinary tract infection, lower respiratory tract infection);
- •Obtaining informed consent from parents/legal guardians of paediatric patients.
排除标准
- •Patients in whom the suspicion of rheumatic disease is based on a finding of subclinical carditis or chorea.
结局指标
主要结局
Serum levels of IL-18, and IL-18BP
时间窗: at T0 - T1(3 months) - T2(12 months)
pg/mL
次要结局
- Serum levels of inflammatory cytokines(at T0 - T1(3 months) - T2(12 months))
- Serum levels of acute phase proteins(at T0 - T1(3 months) - T2(12 months))
研究者
Angela Miniaci
MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna