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

NCT00618267 | Completed DMC

• 2 other identifiers: 014-07-NATBiogen Idec 014-07-NAT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

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.

  1 blood draw

Secondary Outcomes (1)

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

  1 blood draw

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Multiple Sclerosis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead
• Elan Pharmaceuticals: collaborator

Study Sites (1)

Brigham and Women's Hospital - Partners MS Center

Brookline, Massachusetts, 02445, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

About 1 ½ teaspoons of blood will be drawn.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Samia J Khoury, MD

  Harvard Medical School, Brigham and Women's Hospital - Partners MS Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 20, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 5, 2010

Record last verified: 2010-03

Locations

US (1)