ATP Expression in Lymphocytes of MS Patients by Means of "ImmuKnow®" Assay. (Cylex)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Single Center, Pilot Study to Measure ATP Expression in Lymphocytes of MS Patients Undergoing Various Therapies by Means of Using the "ImmuKnow®" Test|
- 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. [ Time Frame: 1 blood draw ] [ Designated as safety issue: No ]
- Secondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count. [ Time Frame: 1 blood draw ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
About 1 ½ teaspoons of blood will be drawn.
|Study Start Date:||March 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618267
|United States, Massachusetts|
|Brigham and Women's Hospital - Partners MS Center|
|Brookline, Massachusetts, United States, 02445|
|Principal Investigator:||Samia J Khoury, MD||Harvard Medical School, Brigham and Women's Hospital - Partners MS Center|