Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis
- Registration Number
- NCT00819195
- Lead Sponsor
- University of California, San Francisco
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description RRMS Glatiramer acetate Relapsing-remitting multiple sclerosis patients who have not yet received glatiramer acetate (Copaxone) therapy recommended as part of clinical care
- Primary Outcome Measures
Name Time Method Production of inflammatory cytokines by monocytes and naive T cells. 0, 1, 2, 4, 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCSF Multiple Sclerosis Center
🇺🇸San Francisco, California, United States