Immune Regulation in Multiple Sclerosis: The Effect of Glatiramer Acetate on MicroRNA Expression in Antigen-Presenting Cells
1 other identifier
observational
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 19, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 21, 2016
April 1, 2016
2.4 years
November 19, 2013
April 20, 2016
Conditions
Outcome Measures
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
1 day
Study Arms (3)
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
Eligibility Criteria
Control human subjects and patients with RRMS will be enrolled in New Brunswick, NJ
You may qualify if:
- year-old healthy subjects or patients with RRMS/CIS
You may not qualify if:
- 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
- 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)
- Pregnancy
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rutgers-RWJMS
New Brunswick, New Jersey, 08901, United States
Biospecimen
peripheral blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Konstantin Balashov, MD, PhD, FAAN
Rutgers-RWJMS
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 19, 2013
First Posted
November 25, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 21, 2016
Record last verified: 2016-04