A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis

Sponsor

John F. Foley, MD (Other)

Overall Status

Completed

CT.gov ID

NCT01737372

Collaborator

Genzyme, a Sanofi Company (Industry)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will look at the blood and cerebrospinal fluid of consented participants who either have early stage multiple sclerosis (clinically isolated syndrome) or who have later stage (secondary progressive multiple sclerosis), or participants who do not have any neurological or autoimmune illness. Biomarkers and microRNA will be assessed for group differences.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Secondary Progressive Multiple Sclerosis Clinically Isolated Syndrome

Detailed Description

Multiple Sclerosis is a chronic autoimmune disorder of the central nervous system. While there are current immunomodulatory therapies that have been shown to be efficacious in the early stages of MS, these therapies are less potent in the later phases of MS. We can look at magnetic resonance imaging with gadolinium to measure active disease but it does not detect axonal degeneration. Therefore, there is a need to identify other biomarkers that may be used to diagnose MS and predict disease progression. Biomarkers found in the cerebrospinal fluid (CSF) are in closer proximity to the inflammatory lesion sites and are more sensitive.

This pilot study seeks to characterize differences in microRNA profiles and cell products in the early and later stages of MS, with the hope that that microRNA profiles could then be correlated to clinical and CSF inflammation indexes. CSF will be obtained from 45 participants.

Study Design

Study Type:

Observational

Actual Enrollment :

49 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Secondary Progressive MS (SPMS) Secondary Progressive MS participants
Clinically Isolated Syndrome (CIS) Clinically isolated syndrome participants
Healthy participants No immunological or neurological illnesses.

Outcome Measures

Primary Outcome Measures

To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis. [baseline]

Secondary Outcome Measures

Correlate microRNA profiles with clinical and CSF inflammation indexes [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

able to understand and agree to informed consent;
male or female patients 18-68 years of age
no disease modifying therapy 60 days prior to Baseline
EDSS score of less than or equal to 3.0 if a CIS patient; or less than or equal to 7.5 if SPMS patient
Labs within normal range no greater than 2 times the ULN or at the discretion of the PI
weight 46 kilograms to 127 kilograms inclusive
no active systemic infection
not currently pregnant or breast feeding
no history of corticosteroid treatment or relapse within 60 days prior to Baseline.

Exclusion Criteria:

not able to understand informed consent
if any of the inclusion criteria is not met
HIV infection, or current active Hepatitis B or C infection, positive HCVAb or HBsAG or HBcAB
positive pregnancy test
patient withdraws consent
Coumadin use within 60 days prior to Baseline