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Completed

NCT Number: NCT00618267

ATP Expression in Lymphocytes of MS Patients by Means of "ImmuKnow®" Assay.

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital - Partners MS Center

Brookline, Massachusetts, 02445, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Secondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count.

    Time frame: 1 blood draw

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Collaborators

  • Elan Pharmaceuticals

Registry information

Official study title

Single Center, Pilot Study to Measure ATP Expression in Lymphocytes of MS Patients Undergoing Various Therapies by Means of Using the "ImmuKnow®" Test

Acronym: Cylex

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 20, 2008
Registry last updated
Mar 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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