Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis
NCT ID: NCT00819195
Last Updated: 2013-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
17 participants
OBSERVATIONAL
2008-12-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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RRMS
Relapsing-remitting multiple sclerosis patients who have not yet received glatiramer acetate (Copaxone) therapy recommended as part of clinical care
Glatiramer acetate
20 mg daily subcutaneous injection. Six-month duration.
HC
Healthy control volunteers
No interventions assigned to this group
Interventions
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Glatiramer acetate
20 mg daily subcutaneous injection. Six-month duration.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 other immunomodulatory therapies (e.g. imuran, mycophenolate or methotrexate)
* Primary-progressive (PP) and secondary-progressive (SP) multiple sclerosis
* Pregnancy
18 Years
55 Years
ALL
Yes
Sponsors
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National Multiple Sclerosis Society
OTHER
Teva Neuroscience, Inc.
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Scott S. Zamvil, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
UCSF Department of Neurology
Locations
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UCSF Multiple Sclerosis Center
San Francisco, California, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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10-03877
Identifier Type: -
Identifier Source: org_study_id