A Longitudinal Study of Effect of Copaxone in RRMS Over 24 Months

Study Overview
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Brief Summary
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To explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls.

Detailed Description
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This is a prospective, observational, single-blinded, longitudinal, 24-month MRI study of the evolution of iron deposits, as evidenced by SWI-filtered phase imaging, in RRMS patients treated with GA and in healthy controls.

Official Title
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A Prospective, Observational, Single-blinded, Longitudinal MRI Study of Effect of Glatiramer Acetate on Iron Deposition in Patients With Relapsing-remitting Multiple Sclerosis Over 24 Months

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005) Being on GA monotherapy (20mg/day sc) for at least 24 months prior to the 24-month MRI scan Having baseline clinical MRI scan that included SWI-filtered phase imaging in a 12-month window from the start day of the of the GA (MS patients) Having baseline clinical MRI scan that included SWI-filtered phase imaging (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 Pass MRI health screening MS patients passing contrast screening MS patients having normal kidney function (creatinine clearance >59) None of the exclusion criteria Exclusion Criteria: Patients who had a relapse within 30 days prior to MRI baseline scan date Patients who received steroid treatment within 30 days prior to the MRI baseline 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.) MS patients having abnormal kidney function (creatinine clearance <59)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Copaxone MRI<br>Patients with relapsing-remitting multiple sclerosis who take Copaxone will have a MRI. | Other: MRI<br>* All subjects will undergo a MRI.<br>|
| Healthy Controls MRI<br>Subjects who are otherwise healthy, without neurological disorders, will have a MRI. | Other: MRI<br>* All subjects will undergo a MRI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore whether treatment with GA may decrease iron deposition in subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months and compared to a reference population of healthy controls. | MRI collected from RRMS patients who have taken Copaxone for 24 months | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate whether treatment with GA may decrease accumulation of iron in lesions, as detected by SWI-filtered phase imaging, in patients with RRMS over 24 months. | Evaluate if Copaxone will decrease iron in lesions. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, Copaxone, healthy controls, MRI, glatiramer acetate