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Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months (GAO)

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ClinicalTrials.gov Identifier: NCT02017808
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo

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.

Condition or disease
Multiple Sclerosis

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).


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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational, Single-blinded, Longitudinal Optical Coherence Tomography Study of Effect of Copaxone (Glatiramer Acetate) on Retinal Nerve Fiber Layer Thickness in Patients With Relapsing-remitting Multiple Sclerosis Over 24 Months
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Copaxone
Patients with multiple sclerosis who are currently prescribed glatiramer acitate (Copaxone)
OCT
Healthy controls



Primary Outcome Measures :
  1. Retinal health in multiple sclerosis patients prescribed copaxone [ Time Frame: 24 months ]
    Participants will have an OCT retinal health will be determined by degree of axonal loss.


Secondary Outcome Measures :
  1. Measuring disability progression [ Time Frame: 24 months ]
    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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with relapsing remitting multiple sclerosis Healthy controls without known neurological problems.
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017808


Locations
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United States, New York
Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States, 14203
Sponsors and Collaborators
University at Buffalo
Teva Pharmaceuticals USA
Investigators
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Principal Investigator: Robert Zivadinov, MD, PhD SUNY University at Buffalo

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Responsible Party: Robert Zivadinov, MD, PhD, Director, Buffalo Neuroimaging Analysis Center, Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT02017808     History of Changes
Other Study ID Numbers: GA-OCT
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Robert Zivadinov, MD, PhD, University at Buffalo:
OCT
Copaxone
Multiple sclerosis
relapsing-remitting

Additional relevant MeSH terms:
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Glatiramer Acetate
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents