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

A Prospective, Observational, Single-blinded, Longitudinal MRI Study of Effect of Glatiramer Acetate on Iron Deposition in Patients With Relapsing-remitting Multiple Sclerosis Over 24 Months

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: MRI

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Buffalo Neuroimaging Analysis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of Neurology, State University at Buffalo, NY, USA who are also taking Copaxone as their disease modifying therapy.

Healthy controls from the general population.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Copaxone MRI; Patients with relapsing-remitting multiple sclerosis who take Copaxone will have a MRI.	Other: MRI; All subjects will undergo a MRI.
Healthy Controls MRI; Subjects who are otherwise healthy, without neurological disorders, will have a MRI.	Other: MRI; All subjects will undergo a MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	MRI collected from RRMS patients who have taken Copaxone for 24 months	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Evaluate if Copaxone will decrease iron in lesions.	24 months

Collaborators and Investigators

• Sponsor: University at Buffalo

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: September 26, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): September 28, 2012

Study Record Updates

• Last Update Posted (Estimate): March 25, 2013
• Last Update Submitted That Met QC Criteria: March 21, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: MRI; multiple sclerosis; healthy controls; glatiramer acetate; Copaxone
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: GA-SWI 24