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