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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Brookline, Massachusetts, Estados Unidos, 02445
- Brigham and Women's Hospital - Partners MS Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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.
Periodo de tiempo: 1 blood draw
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1 blood draw
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Secondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count.
Periodo de tiempo: 1 blood draw
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1 blood draw
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Samia J Khoury, MD, Harvard Medical School, Brigham and Women's Hospital - Partners MS Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 014-07-NAT
- Biogen Idec 014-07-NAT
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