Analysis of a Biomarker Signature in Patients With Multiple Sclerosis (MS) Treated With Gilenya (FTY720) (MS)
Analysis of a Biomarker Signature, Consisting of Toll-like Receptor 2 (TLR2), TLR4 and CCR1, by Flow Cytometry in Patients With MS Treated With Gilenya (FTY720)
研究概览
地位
条件
详细说明
Gilenya modulates expression of the sphingosine-1-phosphate receptor and inhibits egress of several lymphocyte subsets from lymph nodes. This results in immunosuppression that has a beneficial effect in patients with multiple sclerosis.
Our laboratory reported that increased expression of a possible biomarker signature, consisting of TLR2, TLR4 and CCR1, in a T-subset is associated with rapid MS progression. The investigators will test whether a significant proportion of patients at baseline upregulate this biomarker signature in one or more T-subsets, whether expression of this biomarker signature changes with treatment with Gilenya and whether expression levels of this signature predict disease activity or progression over a 12 month followup period. The investigators will study patients who are already being treated with Gilenya by their neurologists or who are already being treated with Gilenya as part of a clinical trial sponsored by Novartis Pharmaceuticals Canada. Patients will not be treated with Gilenya for the purposes of our study.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Quebec
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Montreal、Quebec、加拿大、H3A 2B4
- 招聘中
- McGill University
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接触:
- Leslie Fitz-Gerald, MSc
- 电话号码:00510 5143987192
- 邮箱:leslie.fitz-gerald@mail.mcgill.ca
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首席研究员:
- David Haegert, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Treatment with Gilenya
Exclusion Criteria:
- Subject is under 18 or over 65.
- Subject has less than 4 weeks of discontinuation with steroid treatment for a relapse.
- Subject cannot communicate reliably with investigator.
- Vulnerable subjects exclude, namely patients defined as those without freedom by the law (e.g. prisoners or by administrative decision) or people hospitalized without their consent.
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Change in expression of a biomarker signature
大体时间:12 months
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12 months
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合作者和调查者
调查人员
- 首席研究员:David Haegert, MD、MUHC Research Institute
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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