<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01695434</url>
  </required_header>
  <id_info>
    <org_study_id>GA-SWI 24</org_study_id>
    <nct_id>NCT01695434</nct_id>
  </id_info>
  <brief_title>A Longitudinal Study of Effect of Copaxone in RRMS Over 24 Months</brief_title>
  <acronym>GASWI</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University at Buffalo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in&#xD;
      subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24&#xD;
      months and compared to a reference population of healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, observational, single-blinded, longitudinal, 24-month MRI study of the&#xD;
      evolution of iron deposits, as evidenced by SWI-filtered phase imaging, in RRMS patients&#xD;
      treated with GA and in healthy controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <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.</measure>
    <time_frame>24 months</time_frame>
    <description>MRI collected from RRMS patients who have taken Copaxone for 24 months</description>
  </primary_outcome>
  <secondary_outcome>
    <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.</measure>
    <time_frame>24 months</time_frame>
    <description>Evaluate if Copaxone will decrease iron in lesions.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Copaxone MRI</arm_group_label>
    <description>Patients with relapsing-remitting multiple sclerosis who take Copaxone will have a MRI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls MRI</arm_group_label>
    <description>Subjects who are otherwise healthy, without neurological disorders, will have a MRI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>All subjects will undergo a MRI.</description>
    <arm_group_label>Copaxone MRI</arm_group_label>
    <arm_group_label>Healthy Controls MRI</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of&#xD;
        Neurology, State University at Buffalo, NY, USA who are also taking Copaxone as their&#xD;
        disease modifying therapy.&#xD;
&#xD;
        Healthy controls from the general population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MS patients diagnosed with clinically definite MS according to the McDonald criteria&#xD;
             (Polman et al., 2005)&#xD;
&#xD;
          -  Being on GA monotherapy (20mg/day sc) for at least 24 months prior to the 24-month MRI&#xD;
             scan&#xD;
&#xD;
          -  Having baseline clinical MRI scan that included SWI-filtered phase imaging in a&#xD;
             12-month window from the start day of the of the GA (MS patients)&#xD;
&#xD;
          -  Having baseline clinical MRI scan that included SWI-filtered phase imaging (healthy&#xD;
             controls)&#xD;
&#xD;
          -  MS patients having a RR disease course (Lublin and Reingold, 1996)&#xD;
&#xD;
          -  Age 18-65 (healthy controls will be matched to MS patients for age and sex)&#xD;
&#xD;
          -  Signed informed consent at the 24-month follow-up&#xD;
&#xD;
          -  Pass MRI health screening&#xD;
&#xD;
          -  MS patients passing contrast screening&#xD;
&#xD;
          -  MS patients having normal kidney function (creatinine clearance &gt;59)&#xD;
&#xD;
          -  None of the exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had a relapse within 30 days prior to MRI baseline scan date&#xD;
&#xD;
          -  Patients who received steroid treatment within 30 days prior to the MRI baseline scan&#xD;
             date&#xD;
&#xD;
          -  Women who are pregnant, lactating or of childbearing age who do not consent to&#xD;
             approved contraceptive use during the study&#xD;
&#xD;
          -  MS patients who used other imunomodulatory or immunosuppressant treatment other than&#xD;
             GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine,&#xD;
             fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept,&#xD;
             natalizumab, etc.)&#xD;
&#xD;
          -  MS patients having abnormal kidney function (creatinine clearance &lt;59)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Buffalo Neuroimaging Analysis Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>March 21, 2013</last_update_submitted>
  <last_update_submitted_qc>March 21, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University at Buffalo</investigator_affiliation>
    <investigator_full_name>Robert Zivadinov, MD, PhD</investigator_full_name>
    <investigator_title>Director, Buffalo Neuroimaging Analysis Center, Professor</investigator_title>
  </responsible_party>
  <keyword>multiple sclerosis</keyword>
  <keyword>MRI</keyword>
  <keyword>Copaxone</keyword>
  <keyword>healthy controls</keyword>
  <keyword>glatiramer acetate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01695434
org study id: GA-SWI 24
nct id: NCT01695434
lead sponsor: 
has dmc: No
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.
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.
observational model: Case-Control
time perspective: Prospective
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.
time frame: 24 months
description: MRI collected from RRMS patients who have taken Copaxone for 24 months
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.
time frame: 24 months
description: Evaluate if Copaxone will decrease iron in lesions.
arm group label: Copaxone MRI
description: Patients with relapsing-remitting multiple sclerosis who take Copaxone will have a MRI.
arm group label: Healthy Controls MRI
description: Subjects who are otherwise healthy, without neurological disorders, will have a MRI.
intervention type: Other
intervention name: MRI
description: All subjects will undergo a MRI.
arm group label: Copaxone MRI
arm group label: Healthy Controls MRI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University at Buffalo
investigator full name: Robert Zivadinov, MD, PhD
investigator title: Director, Buffalo Neuroimaging Analysis Center, Professor
mesh term: Multiple Sclerosis
mesh term: Sclerosis