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

Multiple Sclerosis Clinical Trial

— GASWI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695434
• Other study ID #: GA-SWI 24
• Status: Completed
• Phase: N/A
• First received: September 26, 2012
• Last updated: March 21, 2013
• Start date: June 2012
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: HSIRB
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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-ß, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)

• MS patients having abnormal kidney function (creatinine clearance <59)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Other:
• MRI
All subjects will undergo a MRI.

Locations

Country	Name	City	State
United States	Buffalo Neuroimaging Analysis Center	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No