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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01695434

Acronym

GASWI

Enrollment

Registered

2012-09-28

Start date

2012-06-30

Completion date

2013-02-28

Last updated

2013-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, MRI, Copaxone, healthy controls, glatiramer acetate

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.

Interventions

OTHERMRI

All subjects will undergo a MRI.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026