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

NCT ID: NCT01587690

Last Updated: 2013-11-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy subjects

Self-explanatory

No interventions assigned to this group

Untreated patients

Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are not on any disease-modifying treatment approved for MS

No interventions assigned to this group

Treated Patients

Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who were prescribed Interferon-beta-1a prior to enrollment

No interventions assigned to this group

Eligibility Criteria

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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 )
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Konstantin Balashov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers-RWJMS

Locations

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Rutgers-RWJMS

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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US-AVX-10-10077

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0220060134

Identifier Type: -

Identifier Source: org_study_id