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

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00618267
First received: February 8, 2008
Last updated: March 4, 2010
Last verified: March 2010
  Purpose

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
Multiple Sclerosis

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618267

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

No publications provided

Responsible Party: Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT00618267     History of Changes
Other Study ID Numbers: 014-07-NAT, Biogen Idec 014-07-NAT
Study First Received: February 8, 2008
Last Updated: March 4, 2010
Health Authority: United States: Biogen Idec Data Monitoring Committee

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

ClinicalTrials.gov processed this record on July 26, 2014