Immune Regulation in Multiple Sclerosis: The Effect of Gl... | NCT01993004

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

NCT01993004

Sponsor

Rutgers, The State University of New Jersey

Status

Completed

Last Update Posted

Apr 21, 2016Estimated

Enrollment

24Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Nov 19, 2013

First Submission Date that Met QC Criteria

Nov 22, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2016

Last Update Posted Date

Apr 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Konstantin Balashov, Associate Professor, Rutgers, The State University of New JerseyPrincipal Investigator

Lead Sponsor

Rutgers, The State University of New JerseyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-60 year-old healthy subjects or patients with RRMS/CIS

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Control human subjects and patients with RRMS will be enrolled in New Brunswick, NJ

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Konstantin Balashov, MD, PhD, FAAN	Rutgers-RWJMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rutgers-RWJMS		New Brunswick	New Jersey	08901	United States

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided