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ATP Expression in Lymphocytes of MS Patients by Means of "ImmuKnow®" Assay. (Cylex)

2010年3月4日更新者：Biogen

Single Center, Pilot Study to Measure ATP Expression in Lymphocytes of MS Patients Undergoing Various Therapies by Means of Using the "ImmuKnow®" Test

The purpose of this study is to see if we can find a new way to test how certain Multiple Sclerosis (MS) medications work in the body and to better understand how the medicines change certain substances (cells) found in the immune (protective) system.

Blood test will be drawn by doing the following:

Use a new method called the "Immuknow®" Test to see if this method will help to better understand how MS medicines work.
Measure certain levels of immune cells in a new way, to see if it this will help to understand the body's response to MS medicines.

These methods will test those with MS who are not taking any MS medications, to help us compare the results.

About 100 subjects will be enrolled in this study at the Partners Multiple Sclerosis Center at Brigham and Women's Hospital. Biogen Idec, Inc. of Cambridge, MA, is paying for this study to be done.

研究概览

地位

完全的

条件

多发性硬化症

详细说明

The primary objective of this study is to determine the effects of various therapies (immunomodulatory as well as immunosuppressive) on ATP levels in CD4+ cells and to determine whether the "ImmuKnow®" assay is an appropriate screening tool to assess the immunocompetence of potential Tysabri patients.

Secondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count.

Tertiary objective is to examine the level of regulatory T-cells (CD4+ and CD25+) in MS patients and its possible correlation to the therapy used, and how well a recently proposed marker of regulatory T-cells, LAP, correlates with CD25 marker.

研究类型

观察性的

注册 (实际的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Massachusetts
  - Brookline、Massachusetts、美国、02445
    - Brigham and Women's Hospital - Partners MS Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients diagnosed with Multiple Sclerosis

描述

Inclusion Criteria:

Patients must be taking 1 of the following medications for 3 months or more: Cytoxan, Cellcept, Novantrone Betaseron, Rebif, Avonex or Copaxone.
Patients must be able to provide written informed consent.

Exclusion Criteria:

Patients on combination of multiple medications.
Restricted treatment whereby no use in 50 days prior to enrollment visit is permitted: systemic steroids.
With educational completion below 8th grade school equivalent or non-fluent in English.
Any other reason, in the opinion of both the Investigator and/or Sponsor, the patient is determined not suitable for study participation.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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
The primary objective of this study is to determine the effects of various therapies (immunomodulatory as well as immunosuppressive) on ATP levels in CD4+ cells. 大体时间：1 blood draw	1 blood draw

次要结果测量

结果测量	大体时间
Secondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count. 大体时间：1 blood draw	1 blood draw

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Biogen

合作者

Elan Pharmaceuticals

调查人员

首席研究员：Samia J Khoury, MD、Harvard Medical School, Brigham and Women's Hospital - Partners MS Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年3月1日

初级完成 (实际的)

2008年12月1日

研究完成 (实际的)

2008年12月1日

研究注册日期

首次提交

2008年2月8日

首先提交符合 QC 标准的