ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 427 for:    biogen | biogen

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00618267
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : March 5, 2010
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen

Brief Summary:

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.


Condition or disease
Multiple Sclerosis

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 100 participants
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
Study Start Date : March 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  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 Outcome Measures :
  1. Secondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count. [ Time Frame: 1 blood draw ]

Biospecimen Retention:   Samples Without DNA
About 1 ½ teaspoons of blood will be drawn.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Multiple Sclerosis
Criteria

Inclusion Criteria:

  1. Patients must be taking 1 of the following medications for 3 months or more: Cytoxan, Cellcept, Novantrone Betaseron, Rebif, Avonex or Copaxone.
  2. Patients must be able to provide written informed consent.

Exclusion Criteria:

  1. Patients on combination of multiple medications.
  2. Restricted treatment whereby no use in 50 days prior to enrollment visit is permitted: systemic steroids.
  3. With educational completion below 8th grade school equivalent or non-fluent in English.
  4. Any other reason, in the opinion of both the Investigator and/or Sponsor, the patient is determined not suitable for study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618267


Locations
United States, Massachusetts
Brigham and Women's Hospital - Partners MS Center
Brookline, Massachusetts, United States, 02445
Sponsors and Collaborators
Biogen
Elan Pharmaceuticals
Investigators
Principal Investigator: Samia J Khoury, MD Harvard Medical School, Brigham and Women's Hospital - Partners MS Center

Responsible Party: Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT00618267     History of Changes
Other Study ID Numbers: 014-07-NAT
Biogen Idec 014-07-NAT
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: March 5, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases