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Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis

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: NCT00819195
Recruitment Status : Completed
First Posted : January 8, 2009
Last Update Posted : October 8, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether glatiramer acetate (Copaxone) will induce anti-inflammatory type II monocyte development during treatment of MS, and if these antigen presenting cells (APC) will promote Th2 and Treg differentiation of naïve T cells.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Glatiramer acetate

Study Design

Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis
Study Start Date : December 2008
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Relapsing-remitting multiple sclerosis patients who have not yet received glatiramer acetate (Copaxone) therapy recommended as part of clinical care
Drug: Glatiramer acetate
20 mg daily subcutaneous injection. Six-month duration.
Other Name: Copaxone
Healthy control volunteers

Outcome Measures

Primary Outcome Measures :
  1. Production of inflammatory cytokines by monocytes and naive T cells. [ Time Frame: 0, 1, 2, 4, 6 months ]

Biospecimen Retention:   Samples Without DNA
Peripheral blood mononuclear cells (PBMC) Serum RNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Relapsing-remitting multiple sclerosis patients at the UCSF Multiple Sclerosis Center.

Inclusion Criteria:

  • Relapsing-remitting (RR) MS patients (McDonald criteria)
  • Ages 18-55
  • Males and females
  • EDSS score ≤5
  • No prior treatment with Copaxone
  • Prior treatment with corticosteroids or interferon-beta (-1a or -1b) is acceptable, provided there is a washout period of at least one month

Exclusion Criteria:

  • Treatment with Tysabri, Novantrone or cyclophosphamide
  • Treatment with other immunomodulatory therapies (e.g. imuran, mycophenolate or methotrexate)
  • Primary-progressive (PP) and secondary-progressive (SP) multiple sclerosis
  • Pregnancy
Contacts and Locations

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): NCT00819195

United States, California
UCSF Multiple Sclerosis Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Multiple Sclerosis Society
Teva Neuroscience, Inc.
Principal Investigator: Scott S. Zamvil, M.D. Ph.D. UCSF Department of Neurology
More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00819195     History of Changes
Other Study ID Numbers: 10-03877
First Posted: January 8, 2009    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013

Keywords provided by University of California, San Francisco:
multiple sclerosis
glatiramer acetate

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Glatiramer Acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents