The Impact of Body Weight on Clinical and Immunological Outcomes in Relapse-Remitting Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Correlation between IL17 levels and patients' response to interferon beta 1a as measured by ELISA
研究概览
简要总结
Our study aimed to investigate the effect of interferon beta 1a on the clinical and immunological parameters in Egyptian relapse-remitting multiple sclerosis patients
详细描述
Until recently, relapsing-remitting multiple sclerosis (RRMS) was considered a homogeneous form of multiple sclerosis (MS). Variability both in the immunopathology of active demyelinating lesions in MS and in response to immunomodulatory treatments has demonstrated that RRMS is a heterogeneous form of MS. An overwhelming number of trials have supported the use of interferon-β (IFN-β) as a first-line immunomodulatory treatment in RRMS. Approximately 30% of IFN-β treated RRMS patients are non-responders (NR) to treatment. Despite vast clinical experience in the use of IFN-β, its mechanisms of action have not been fully clarified. Interleukin-17 (IL-17) is a proinflammatory cytokine that is secreted by a lineage of T cells named Th17 cells. The Th17 chemokine pathways are essential for the development of central nervous system (CNS) autoimmune diseases such as MS. A high IL-17 concentration in the serum. of people with RRMS is associated with nonresponse to IFN-β therapy. Some animal and human studies have shown that IFN-β inhibits the activity of Th17 cells.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years at time of signing informed consent form.
- •Relapsing- remitting multiple sclerosis as per the McDonald 2017 criteria, including an MRI brain satisfying the 2017 radiological criteria.
- •Kurtzke EDSS step 0.0 - 6.
- •At the time of screening, being treated with a stable dose of Interferon Beta 1a for at least 6 months.
排除标准
- •they had been treated in the last 30 days with methylprednisolone
- •they had changed their IFN-β preparation within the last 18 months
- •they had other chronic diseases associated with MS
- •they had been previously treated with immunosuppressive agents
结局指标
主要结局
Correlation between IL17 levels and patients' response to interferon beta 1a as measured by ELISA
时间窗: Patients were treated with INF B 1a for at least 6 months
Anti-inflammatory and disease activity biomarkers
次要结局
- Correlation between IL 22 levels and patients' response to interferon beta 1a, measured by ELISA(Patients were treated with INF B 1a for at least 6 months)
- Correlation between MRI load and Patients' response to interferon beta 1a(Patients were treated with INF B 1a for at least 6 months)
- Correlation between body mass index and patients' response to interferon beta 1 a(Patients were treated with INF B 1a for at least 6 months)
- Correlation between Expanded Disability Status Scale and patients' response to interferon beta 1a(Patients were treated with INF B 1a for at least 6 months)
- Correlation between malondialdehyde levels and patients' response to interferon beta 1a(Patients were treated with INF B 1a for at least 6 months)
研究者
Mohamed Youssef Elsayed
Research assistant in Clinical Pharmacology and Pharmacogenomics Research Gruop
German University in Cairo
