<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/NCT03284970</url>
  </required_header>
  <id_info>
    <org_study_id>MS200136_0077</org_study_id>
    <nct_id>NCT03284970</nct_id>
  </id_info>
  <brief_title>Retrospective Study to Determine Effect of Rebif and Tecfidera on Infections and Lymphocytes</brief_title>
  <official_title>Effect of Interferon Beta-1a SC 44 µg Three Times Weekly (Tiw) (Rebif) and Dimethyl Fumarate (DMF, Tecfidera) on Infections and Lymphocytes in Patients 50 Years or Older From a Single Center Chart Review</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EMD Serono Research &amp; Development Institute, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck KGaA, Darmstadt, Germany</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>EMD Serono</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be a single center, retrospective, pilot study to determine the effect of&#xD;
      Rebif (interferon beta-1a) and Tecfidera (dimethyl fumarate) on infections on total&#xD;
      lymphocyte counts, grade of lymphopenia, Cluster of Differentiation 4 (CD4) and Cluster of&#xD;
      Differentiation 8 (CD8) counts and ratios in subjects aged 50 years and above with&#xD;
      Relapsing-Remitting Multiple Sclerosis (RRMS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">May 11, 2018</completion_date>
  <primary_completion_date type="Actual">May 11, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects With One or More Infections</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With One or More Serious Infections</measure>
    <time_frame>Baseline, 6 Months, 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With One or More Opportunistic Infections</measure>
    <time_frame>Baseline, 6 Months, 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Infections per Subject</measure>
    <time_frame>Baseline, 6 Months, 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Serious Infections per Subject</measure>
    <time_frame>Baseline, 6 Months, 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Opportunistic Infections per Subject</measure>
    <time_frame>Baseline, 6 Months, 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Lymphocyte Levels</measure>
    <time_frame>Baseline, 6 Months, 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Lymphopenia Grades I, II, III and IV</measure>
    <time_frame>Baseline, 6 Months, 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Counts</measure>
    <time_frame>Baseline, 6 Months, 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Ratio</measure>
    <time_frame>Baseline, 6 Months, 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline, 6 Months, 12 Months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">34</enrollment>
  <condition>Relapsing-Remitting Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Rebif (interferon beta 1a)</arm_group_label>
    <description>This study will retrospectively collect the data from the subjects who had been treated with Rebif subcutaneously (SC) at a dose of 44 micro-grams three times a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tecfidera (dimethyl fumarate)</arm_group_label>
    <description>This study will retrospectively collect the data from the subjects who had been treated with Tecfidera.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include subjects aged 50 years or older with relapsing RRMS, identified from&#xD;
        a feasibility assessment conducted at a single center in United States, who were treated&#xD;
        with either interferon beta-1a SC 44 micro-gram or dimethyl fumarate between January 1,&#xD;
        2015 to December 31, 2015.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  RRMS subjects who have been treated with interferon beta 1a SC 44 micro-gram thrice a&#xD;
             week and dimethyl fumarate in inpatient or outpatient settings during the period from&#xD;
             January 1, 2015 to December 31, 2015.&#xD;
&#xD;
          -  Subjects with at least one year of laboratory values post-index date to analyze&#xD;
             lymphocyte counts, and CD4 and CD8 counts. The date of first blood draw for laboratory&#xD;
             tests after January 1, 2015 will be defined as the subject's index date.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Subjects who have been on treatment for less than 1 year after their index date.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Responsible</last_name>
    <role>Study Director</role>
    <affiliation>EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neurology Center of New England</name>
      <address>
        <city>Foxboro</city>
        <state>Massachusetts</state>
        <zip>02035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>August 3, 2018</last_update_submitted>
  <last_update_submitted_qc>August 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Interferon beta-1a</keyword>
  <keyword>Dimethyl fumarate</keyword>
  <keyword>Rebif</keyword>
  <keyword>Tecfidera</keyword>
  <keyword>Relapsing-Remitting Multiple Sclerosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</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/NCT03284970
org study id: MS200136_0077
nct id: NCT03284970
lead sponsor: 
collaborator: 
has dmc: No
This study will be a single center, retrospective, pilot study to determine the effect of
      Rebif (interferon beta-1a) and Tecfidera (dimethyl fumarate) on infections on total
      lymphocyte counts, grade of lymphopenia, Cluster of Differentiation 4 (CD4) and Cluster of
      Differentiation 8 (CD8) counts and ratios in subjects aged 50 years and above with
      Relapsing-Remitting Multiple Sclerosis (RRMS).
observational model: Cohort
time perspective: Retrospective
measure: Percentage of Subjects With One or More Infections
time frame: Up to 12 months
measure: Percentage of Subjects With One or More Serious Infections
time frame: Baseline, 6 Months, 12 Months
measure: Percentage of Subjects With One or More Opportunistic Infections
time frame: Baseline, 6 Months, 12 Months
measure: Number of Infections per Subject
time frame: Baseline, 6 Months, 12 Months
measure: Number of Serious Infections per Subject
time frame: Baseline, 6 Months, 12 Months
measure: Number of Opportunistic Infections per Subject
time frame: Baseline, 6 Months, 12 Months
measure: Total Lymphocyte Levels
time frame: Baseline, 6 Months, 12 Months
measure: Percentage of Subjects With Lymphopenia Grades I, II, III and IV
time frame: Baseline, 6 Months, 12 Months
measure: Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Counts
time frame: Baseline, 6 Months, 12 Months
measure: Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Ratio
time frame: Baseline, 6 Months, 12 Months
measure: Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline, 6 Months, 12 Months
arm group label: Rebif (interferon beta 1a)
description: This study will retrospectively collect the data from the subjects who had been treated with Rebif subcutaneously (SC) at a dose of 44 micro-grams three times a week.
arm group label: Tecfidera (dimethyl fumarate)
description: This study will retrospectively collect the data from the subjects who had been treated with Tecfidera.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Responsible
role: Study Director
affiliation: EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis