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

This study is enrolling participants by invitation only.

First Received: December 16, 2008 Last Updated: January 7, 2009 History of Changes

Sponsors and Collaborators:	University of California, San Francisco National Multiple Sclerosis Society Teva Pharmaceutical Industries
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00819195

Purpose

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	Intervention
Multiple Sclerosis	Drug: Glatiramer acetate

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Copolymer 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment
Official Title:	Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Production of inflammatory cytokines by monocytes and naive T cells. [ Time Frame: 0, 1, 2, 4, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
RRMS: Experimental Relapsing-remitting multiple sclerosis patients who have not yet received glatiramer acetate (Copaxone) therapy	Drug: Glatiramer acetate 20 mg daily subcutaneous injection. Six-month duration.
HC: No Intervention Healthy control volunteers

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819195

Locations

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 Pharmaceutical Industries

Investigators

Principal Investigator:

Scott S. Zamvil, M.D. Ph.D.

UCSF Department of Neurology

More Information

Publications:

Weber MS, Prod'homme T, Youssef S, Dunn SE, Rundle CD, Lee L, Patarroyo JC, Stüve O, Sobel RA, Steinman L, Zamvil SS. Type II monocytes modulate T cell-mediated central nervous system autoimmune disease. Nat Med. 2007 Aug;13(8):935-43. Epub 2007 Aug 5.

Neuhaus O, Farina C, Wekerle H, Hohlfeld R. Mechanisms of action of glatiramer acetate in multiple sclerosis. Neurology. 2001 Mar 27;56(6):702-8. No abstract available.

Farina C, Weber MS, Meinl E, Wekerle H, Hohlfeld R. Glatiramer acetate in multiple sclerosis: update on potential mechanisms of action. Lancet Neurol. 2005 Sep;4(9):567-75. Review.

Kim HJ, Ifergan I, Antel JP, Seguin R, Duddy M, Lapierre Y, Jalili F, Bar-Or A. Type 2 monocyte and microglia differentiation mediated by glatiramer acetate therapy in patients with multiple sclerosis. J Immunol. 2004 Jun 1;172(11):7144-53.

Weber MS, Starck M, Wagenpfeil S, Meinl E, Hohlfeld R, Farina C. Multiple sclerosis: glatiramer acetate inhibits monocyte reactivity in vitro and in vivo. Brain. 2004 Jun;127(Pt 6):1370-8. Epub 2004 Apr 16.

Responsible Party:	University of California, San Francisco ( Scott S. Zamvil, M.D., Ph.D., Associate Professor )
Study ID Numbers:	H9992-31522
Study First Received:	December 16, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00819195 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

relapsing-remitting
multiple sclerosis
Copaxone
glatiramer acetate
MS

Study placed in the following topic categories:

Copolymer 1
Autoimmune Diseases
Multiple Sclerosis
Immunologic Factors
Demyelinating Diseases

Adjuvants, Immunologic
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Immunosuppressive Agents
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Nervous System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Sclerosis

Immunosuppressive Agents
Pharmacologic Actions
Copolymer 1
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 06, 2009