Immune Regulation in Multiple Sclerosis: MicroRNA and Antigen-Presenting Cells

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01587690
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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 interferon-beta-treated patients with multiple sclerosis.

Detailed Description

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 interferon-beta-treated patients with multiple sclerosis. The expression of microRNA will be analysed in cell subsets separated from peripheral blood mononuclear cells.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 )

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative MicroRNA expression in B cells	one time (baseline)	Expression of multiple microRNA is being tested in B cells in three groups of subjects at one time point

Trial Locations

Locations (1)

Rutgers-RWJMS; 🇺🇸 New Brunswick, New Jersey, United States