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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01587690
First received: April 26, 2012
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Immune Regulation in Multiple Sclerosis: MicroRNA and Antigen-Presenting Cells

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Relative MicroRNA expression in B cells [ Time Frame: one time (baseline) ] [ Designated as safety issue: No ]
    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


Enrollment: 24
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

human subjects 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 )
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01587690

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

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01587690     History of Changes
Other Study ID Numbers: 0220060134, US-AVX-10-10077
Study First Received: April 26, 2012
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014