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| ID | Type | Description | Link |
|---|---|---|---|
| Biogen Idec 014-07-NAT |
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| Name | Class |
|---|---|
| Elan Pharmaceuticals | INDUSTRY |
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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:
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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 blood draw |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count. | 1 blood draw |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with Multiple Sclerosis
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| Name | Affiliation | Role |
|---|---|---|
| Samia J Khoury, MD | Harvard Medical School, Brigham and Women's Hospital - Partners MS Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital - Partners MS Center | Brookline | Massachusetts | 02445 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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About 1 ½ teaspoons of blood will be drawn.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |