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

April 20, 2016 updated by: Konstantin Balashov, Rutgers, The State University of New Jersey
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 Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers-RWJMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Control human subjects and patients with RRMS will be enrolled in New Brunswick, NJ

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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 Glatiramer acetate prior to enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative MicroRNA expression in B cells
Time Frame: 1 day
Expression of multiple microRNA is being tested in B cells in three groups of subjects at one time point
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Konstantin Balashov, MD, PhD, FAAN, Rutgers-RWJMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB0220060134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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