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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993004
• Other study ID #: IRB0220060134
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: April 20, 2016
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Rutgers-RWJMS	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No