ATP Expression in Lymphocytes of MS Patients by Means of "ImmuKnow®" Assay. (Cylex)
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Massachusetts
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Brookline、Massachusetts、アメリカ、02445
- Brigham and Women's Hospital - Partners MS Center
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
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.
時間枠：1 blood draw
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1 blood draw
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Secondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count.
時間枠：1 blood draw
|
1 blood draw
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Samia J Khoury, MD、Harvard Medical School, Brigham and Women's Hospital - Partners MS Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 014-07-NAT
- Biogen Idec 014-07-NAT
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