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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819195
• Other study ID #: 10-03877
• Status: Completed
• Phase: N/A
• First received: December 16, 2008
• Last updated: October 4, 2013
• Start date: December 2008
• Est. completion date: September 2012

Study information

• Verified date: October 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Glatiramer acetate
20 mg daily subcutaneous injection. Six-month duration.

Locations

Country	Name	City	State
United States	UCSF Multiple Sclerosis Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Multiple Sclerosis Society, Teva Neuroscience, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Production of inflammatory cytokines by monocytes and naive T cells.		0, 1, 2, 4, 6 months	No