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

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ClinicalTrials.gov Identifier: NCT01993004
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Konstantin Balashov, 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 glatiramer acetate-treated patients with multiple sclerosis.

Condition or disease
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 glatiramer acetate-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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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Immune Regulation in Multiple Sclerosis: The Effect of Glatiramer Acetate on MicroRNA Expression in Antigen-Presenting Cells
Study Start Date : July 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
peripheral blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Control human subjects and patients with RRMS will be enrolled in New Brunswick, NJ
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993004


Locations
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United States, New Jersey
Rutgers-RWJMS
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Konstantin Balashov, MD, PhD, FAAN Rutgers-RWJMS

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Responsible Party: Konstantin Balashov, Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01993004     History of Changes
Other Study ID Numbers: IRB0220060134
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Glatiramer Acetate
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents