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

University at Buffalo

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Other: MRI

Study type

Observational

Funder types

Other

Identifiers

NCT01695434

GA-SWI 24

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)