A Longitudinal Study of Effect of Copaxone in RRMS Over 24 Months (NCT01695434) | Clinical Trial Compass
CompletedNot Applicable
A Longitudinal Study of Effect of Copaxone in RRMS Over 24 Months
United States60 participantsStarted 2012-06
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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…
What they're measuring
1
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.