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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: MRI

• Registration Number: NCT01695434
• Lead Sponsor: University at Buffalo

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-09-26
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-09-28
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls MRI	MRI	Subjects who are otherwise healthy, without neurological disorders, will have a MRI.
Copaxone MRI	MRI	Patients with relapsing-remitting multiple sclerosis who take Copaxone will have a MRI.

Primary Outcome Measures

Name	Time	Method
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.	24 months	MRI collected from RRMS patients who have taken Copaxone for 24 months

Secondary Outcome Measures

Name	Time	Method
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.	24 months	Evaluate if Copaxone will decrease iron in lesions.

Trial Locations

Locations (1)

Buffalo Neuroimaging Analysis Center; 🇺🇸 Buffalo, New York, United States