Biomarker to Predict the Response to Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients: a Transcriptomic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 18
- 主要终点
- blood-levels of biomarkers of Intravenous immunoglobulin response
研究概览
简要总结
This study aims analyze the transcriptome to identify predictive biomarkers of IVIG in CIDP patients. 25 patients with a diagnosis of CIDP according to European criteria, naïve of treatment, will be included and followed for 1 year. Clinical assessment (RT-MRC ; Martin vigorimeter, RT-mISS,R-ODS,TW25, 9hole-peg test) will be performed at baseline and at 3, 6 and 12 months after the first IVIG course. Responder/No responder status will be defined at 3 month and confirmed at 12 months. Blood samples will be collected before the IVIG course at baseline, and at 2months and 6 months. At the end of the first IVIG course a blood sample will be collected to assess early changes of transcriptome. The CIDP diagnosis and responder/no responder status will be confirmed by an independent committee. The transcriptome of the patients will be individually analyzed and compared regarding Responder/Non responder status to a control groups of 20 healthy subjects
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •chronic inflammatory demyelinating polyradiculoneuropathy (according to european criterions)
- •first line of treatment
- •treatment with intravenous immunoglobulin required
- •healthy subjects matched for age and gender
排除标准
- •For CIDP patients
- •uncontrolled diabetes, monoclonal spike with anti-ganglioside activity, anti myelin-associated glycoprotein antibodies, HIV infection, HBV infection, HCV infection, connective tissue disease, hemopathy, evolutive disease)
- •For healthy subjects:
- •any chronic or autoimmune disease
- •For all subjets viral or bacterial infection in the last 30 days chemotherapy in the last 5 years immunosuppressive therapy
结局指标
主要结局
blood-levels of biomarkers of Intravenous immunoglobulin response
时间窗: 8 weeks
次要结局
未报告次要终点