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CompletedNCT01587690Updated Nov 20, 2013

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

An observational study in Multiple Sclerosis, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-20.

Sponsored by Rutgers, The State University of New Jersey · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
24
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Multiple Sclerosis
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 24 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

human subjects will be enrolled in New Brunswick, NJ

Inclusion criteria

  • 18-60 year-old healthy subjects or patients with RRMS/CIS

Exclusion criteria

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 )
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
24 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Healthy subjects

    Self-explanatory

  • 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

  • Treated Patients

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

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What researchers measure

Primary outcomes

  1. 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: one time (baseline)

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Study locations

1 site
  • Rutgers-RWJMS
    New Brunswick, New Jersey 08901, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01587690
Lead sponsor
Rutgers, The State University of New Jersey
Responsible party
Sponsor
First posted
Apr 30, 2012
Start date
Nov 2011
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Nov 20, 2013

Study contacts

Konstantin Balashov, MD, PhD
principal investigator · Rutgers-RWJMS

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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