Immune Regulation in Multiple Sclerosis: The Effect of Glatiramer Acetate on MicroRNA Expression in Antigen-Presenting Cells

N/ACompletedNCT01993004

Rutgers, The State University of New Jersey24 enrolled

Overview

MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in many human diseases. The purpose of this pilot study is to determine if microRNA expression is changed in untreated and glatiramer acetate-treated patients with multiple sclerosis.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Sclerosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 18-60 year-old healthy subjects or patients with RRMS/CIS Exclusion Criteria: 1. Any treatment with steroids in the last 30 days prior to the blood draw or any immunosuppressive or Disease-modifying treatment (DMT) other than Glatiramer Acetate in the last 90 days 2. Presence of other disorders that may be associated with immune-deficient or autoimmune process (e.g., HIV, lymphoma, lupus) or demyelinating disease other than MS (e.g., Lyme, B12 deficiency) 3. Pregnancy 4. Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting (Expanded Disability Status Scale (EDSS) score greater than 5.5)

Locations (1)

Rutgers-RWJMS

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

Relative MicroRNA expression in B cells

Expression of multiple microRNA is being tested in B cells in three groups of subjects at one time point

Time frame: 1 day

Data from ClinicalTrials.gov

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