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

NCT01695434 | Completed

• 1 other identifier: GA-SWI 24
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Copaxone MRI

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

Other: MRI

Healthy Controls MRI

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

Other: MRI

Interventions

MRI OTHER

All subjects will undergo a MRI.

Copaxone MRI; Healthy Controls MRI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University at Buffalo: lead

Study Sites (1)

Buffalo Neuroimaging Analysis Center

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Buffalo Neuroimaging Analysis Center, Professor

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: September 28, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 25, 2013

Record last verified: 2013-03

Locations

US (1)