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

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)