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

NCT ID: NCT01737372

Last Updated: 2016-11-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2016-10-31

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.

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.

Conditions

Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Clinically Isolated Syndrome

Keywords

Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Clinically Isolated Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Secondary Progressive MS (SPMS)

Secondary Progressive MS participants

No interventions assigned to this group

Clinically Isolated Syndrome (CIS)

Clinically isolated syndrome participants

No interventions assigned to this group

Healthy participants

No immunological or neurological illnesses.

No interventions assigned to this group

Eligibility Criteria

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.

• 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

Exclusion Criteria

• not able to understand informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

John F. Foley, MD

OTHER

Sponsor Role: lead

Responsible Party

John F. Foley, MD

President and Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John F Foley, MD

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain MS Research Group, LLC

Locations

Rocky Mountain MS Clinic

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

003-001-GEN

Identifier Type: -

Identifier Source: org_study_id