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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Massachusetts
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Brookline, Massachusetts, Vereinigte Staaten, 02445
- Brigham and Women's Hospital - Partners MS Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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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.
Zeitfenster: 1 blood draw
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1 blood draw
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Secondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count.
Zeitfenster: 1 blood draw
|
1 blood draw
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Samia J Khoury, MD, Harvard Medical School, Brigham and Women's Hospital - Partners MS Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 014-07-NAT
- Biogen Idec 014-07-NAT
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