Studying the Effects of Copaxone on Retinal Health Using... | NCT02017808

Studies
Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months

NCT02017808

Sponsor

University at Buffalo

Status

Completed

Last Update Posted

Dec 3, 2014Estimated

Enrollment

100Actual

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

Dec 2014

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

Feb 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 4, 2013

First Submission Date that Met QC Criteria

Dec 20, 2013

First Posted Date

Dec 23, 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

Dec 1, 2014

Last Update Posted Date

Dec 3, 2014Estimated

Name	Class
Teva Pharmaceuticals USA	INDUSTRY

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

This is a prospective, observational, single-blinded, longitudinal, 24-month OCT study of the evolution of axonal loss, as evidenced by loss of RNFLT and TMV, in RRMS patients treated with GA and in healthy controls.

Detailed Description

The primary aim of this study is to explore whether treatment with Copaxone may decrease accumulation of axonal loss, as measured by retinal nerve fiber layer thickness (RNFLT) on optical coherence tomography (OCT) in patients with RRMS over 24 months and compared to a reference population of healthy controls.

The secondary objective of this study is to investigate the effect of GA on total macular volume (TMV) on OCT in patients with RRMS over 24 months. We will also explore how the 24-month changes of RNFLT and TMV on OCT relate to progression of disability, as measured by Expanded Disability Status Scale (EDSS).

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

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Copaxone		Patients with multiple sclerosis who are currently prescribed glatiramer acitate (Copaxone)
OCT		Healthy controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retinal health in multiple sclerosis patients prescribed copaxone	Participants will have an OCT retinal health will be determined by degree of axonal loss.	24 months

Secondary Outcomes

Measure	Description	Time Frame
Measuring disability progression	Investigating the effect of copaxone on total macular volume on OCT in patients with RRMS. Exploring progression of disability as measured by Expanded Disability Status Scale (EDSS).	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)
Starting GA monotherapy (20mg/day sc) at the time of the OCT scan
Having baseline clinical OCT scan that included RNFLT and TMV assessment at the start of the GA
Having baseline clinical OCT scan that included RNFLT and TMV assessment (healthy controls)
MS patients having a RR disease course (Lublin and Reingold, 1996)
Age 18-65 (healthy controls will be matched to MS patients for age and sex)
Signed informed consent at the 24-month follow-up
None of the exclusion criteria

Exclusion Criteria:

Patients who had a relapse within 30 days prior to OCT scan date
Patients who received steroid treatment within 30 days prior to OCT scan date
Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with relapsing remitting multiple sclerosis Healthy controls without known neurological problems.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Robert Zivadinov, MD, PhD	SUNY University at Buffalo	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Buffalo Neuroimaging Analysis Center		Buffalo	New York	14203	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

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