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

NCT00819195 | Completed

• 1 other identifier: 10-03877
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

relapsing-remitting; multiple sclerosis; Copaxone; glatiramer acetate; MS

Outcome Measures

Primary Outcomes (1)

• Production of inflammatory cytokines by monocytes and naive T cells.

  0, 1, 2, 4, 6 months

Study Arms (2)

RRMS

Relapsing-remitting multiple sclerosis patients who have not yet received glatiramer acetate (Copaxone) therapy recommended as part of clinical care

Drug: Glatiramer acetate

HC

Healthy control volunteers

Interventions

Glatiramer acetate DRUG

20 mg daily subcutaneous injection. Six-month duration.

Also known as: Copaxone

RRMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Relapsing-remitting multiple sclerosis patients at the UCSF Multiple Sclerosis Center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Multiple Sclerosis Society: collaborator
• Teva Neuroscience, Inc.: collaborator

Study Sites (1)

UCSF Multiple Sclerosis Center

San Francisco, California, 94143, United States

Location

Related Publications (5)

• Weber MS, Prod'homme T, Youssef S, Dunn SE, Rundle CD, Lee L, Patarroyo JC, Stuve 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. doi: 10.1038/nm1620. Epub 2007 Aug 5.

  PMID: 17676050 BACKGROUND

• 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. doi: 10.1212/wnl.56.6.702. No abstract available.

  PMID: 11288751 BACKGROUND

• 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. doi: 10.1016/S1474-4422(05)70167-8.

  PMID: 16109363 BACKGROUND

• 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. doi: 10.4049/jimmunol.172.11.7144.

  PMID: 15153538 BACKGROUND

• 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. doi: 10.1093/brain/awh163. Epub 2004 Apr 16.

  PMID: 15090474 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood mononuclear cells (PBMC) Serum RNA

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Scott S. Zamvil, M.D. Ph.D.

  UCSF Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: January 8, 2009
• Study Start: December 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

US (1)