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临床试验/NCT05735067
NCT05735067进行中(未招募)不适用

The Impact of Body Weight on Clinical and Immunological Outcomes in Relapse-Remitting Multiple Sclerosis Patients

German University in Cairo1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2022年2月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Youssef Elsayed

Research assistant in Clinical Pharmacology and Pharmacogenomics Research Gruop

German University in Cairo

研究点 (1)

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