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

NCT ID: NCT01695434

Last Updated: 2013-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-02-28

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Copaxone MRI

Patients with relapsing-remitting multiple sclerosis who take Copaxone will have a MRI.

MRI

Intervention Type: OTHER

All subjects will undergo a MRI.

Healthy Controls MRI

Subjects who are otherwise healthy, without neurological disorders, will have a MRI.

MRI

Intervention Type: OTHER

All subjects will undergo a MRI.

Interventions

MRI

All subjects will undergo a MRI.

Intervention Type: OTHER

Eligibility Criteria

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)

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Robert Zivadinov, MD, PhD

Director, Buffalo Neuroimaging Analysis Center, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Buffalo Neuroimaging Analysis Center

Buffalo, New York, United States

Countries

United States

Other Identifiers

GA-SWI 24

Identifier Type: -

Identifier Source: org_study_id