Clinical trial NCT01695434: A Longitudinal Study of Effect of Copaxone in RRMS Over 24 Months
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
MRI
Copaxone
healthy controls
glatiramer acetate
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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)
* 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)

Primary outcomes:
measure: 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.
timeFrame: 24 months
Secondary outcomes:
measure: 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.
timeFrame: 24 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Buffalo Neuroimaging Analysis Center
state: New York
Study officials:
References: