<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/NCT03774914</url>
  </required_header>
  <id_info>
    <org_study_id>OBS13436</org_study_id>
    <secondary_id>EU PAS - cat 3</secondary_id>
    <nct_id>NCT03774914</nct_id>
  </id_info>
  <brief_title>LEMTRADA Pregnancy Registry in Multiple Sclerosis</brief_title>
  <official_title>International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genzyme, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      The primary goal of this registry is to assess the risk of spontaneous abortion in&#xD;
      prospective enrolled women exposed to LEMTRADA for multiple sclerosis.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      The secondary goals of this registry is to assess maternal, fetal and infant outcome in women&#xD;
      with multiple sclerosis, exposed to LEMTRADA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From enrollment during pregnancy up to 1 year after delivery for infant follow-up (maximum&#xD;
      approximatively 20 months)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The sponsor stopped the study due to low recruitment with no safety concerns&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Actual">November 22, 2021</completion_date>
  <primary_completion_date type="Actual">November 22, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>20 Months</target_duration>
  <primary_outcome>
    <measure>Spontaneous abortions (≤20 weeks gestation)</measure>
    <time_frame>32 weeks gestation</time_frame>
    <description>Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major congenital malformations</measure>
    <time_frame>From birth to 1 year after delivery</time_frame>
    <description>Numbers and rates of major congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minor congenital malformations</measure>
    <time_frame>From birth to 1 year after delivery</time_frame>
    <description>Numbers and rates of minor congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stillbirth (any non-deliberate foetal death at &gt;20 weeks gestation)</measure>
    <time_frame>26-32 weeks' gestation to within 6 weeks after the end of the pregnancy</time_frame>
    <description>Numbers and rates of stillbirth, on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Full-term live birth i.e. infants born maturely (≥37 gestation weeks)</measure>
    <time_frame>Within 6 weeks after the end of the pregnancy</time_frame>
    <description>Numbers and rates of full-term live birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm birth i.e. infants born prematurely i.e., live-born infant i.e., (pre-term &lt;37 weeks)</measure>
    <time_frame>26-32 weeks' gestation to within 6 weeks after the end of the pregnancy</time_frame>
    <description>Numbers and rates of pre-term birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elective terminations i.e. any induced or voluntary fetal loss</measure>
    <time_frame>16-20 weeks' gestation</time_frame>
    <description>Numbers and rates of elective terminations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Small for gestational age at birth i.e. birth size (weight, length, or head circumference) ≤10th percentile for gender and gestational age</measure>
    <time_frame>Within 6 weeks after the end of the pregnancy</time_frame>
    <description>Numbers and rates of small for gestational age on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any other adverse pregnancy outcomes</measure>
    <time_frame>Baseline to week 40</time_frame>
    <description>Numbers of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant postnatal growth (up to the first year of life)</measure>
    <time_frame>1 year after delivery</time_frame>
    <description>Numbers and rates of infants with postnatal size (weight, length or head circumference) less than or equal to the 10th percentile for sex and age using National Center for Health Statistics (NCHS) pediatric growth curves, and adjusted postnatal age for premature infants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant development impairment (up to the first year of life)</measure>
    <time_frame>1 year after delivery</time_frame>
    <description>Numbers and rates of infants with development impairment</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Lemtrada</arm_group_label>
    <description>Pregnant women exposed to LEMTRADA which is administered by IV infusion for 5 consecutive days, then for 3 consecutive days, 12 months after the first/previous treatment course</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alemtuzumab (GZ402673)</intervention_name>
    <description>Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion</description>
    <arm_group_label>Lemtrada</arm_group_label>
    <other_name>Lemtrada</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women with Multiple Sclerosis who were or became pregnant within the period of time between&#xD;
        the first infusion of a course of treatment with LEMTRADA to 4 months after their last&#xD;
        infusion for that course.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Women with Multiple Sclerosis who were or became pregnant within the period of time&#xD;
             between the first infusion of a course of treatment with LEMTRADA to 4 months after&#xD;
             their last infusion for that course.&#xD;
&#xD;
          -  Women able and willing to provide informed consent for study participation and the&#xD;
             requirement of the study. Informed consent will be obtained at the time of enrollment&#xD;
             in accordance with local regulatory requirements.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - Previous enrollment in this study for a previous pregnancy.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number :840999</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>00000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :036001</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :040-001</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :56</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :124999</name>
      <address>
        <city>Canada</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :208001</name>
      <address>
        <city>Aarhus C</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :276001</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :380001</name>
      <address>
        <city>Gallarate (VA)</city>
        <zip>21013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :528999</name>
      <address>
        <city>Netherlands</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :724999</name>
      <address>
        <city>Spain</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :752001</name>
      <address>
        <city>Göteborg</city>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :756001</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :826-001</name>
      <address>
        <city>Salford</city>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 21, 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alemtuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <!-- 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/NCT03774914
org study id: OBS13436
secondary id: EU PAS - cat 3
nct id: NCT03774914
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Primary Objective:

      The primary goal of this registry is to assess the risk of spontaneous abortion in
      prospective enrolled women exposed to LEMTRADA for multiple sclerosis.

      Secondary Objective:

      The secondary goals of this registry is to assess maternal, fetal and infant outcome in women
      with multiple sclerosis, exposed to LEMTRADA.
From enrollment during pregnancy up to 1 year after delivery for infant follow-up (maximum
      approximatively 20 months)
observational model: Cohort
time perspective: Prospective
measure: Spontaneous abortions (≤20 weeks gestation)
time frame: 32 weeks gestation
description: Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
measure: Major congenital malformations
time frame: From birth to 1 year after delivery
description: Numbers and rates of major congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
measure: Minor congenital malformations
time frame: From birth to 1 year after delivery
description: Numbers and rates of minor congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
measure: Stillbirth (any non-deliberate foetal death at >20 weeks gestation)
time frame: 26-32 weeks' gestation to within 6 weeks after the end of the pregnancy
description: Numbers and rates of stillbirth, on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
measure: Full-term live birth i.e. infants born maturely (≥37 gestation weeks)
time frame: Within 6 weeks after the end of the pregnancy
description: Numbers and rates of full-term live birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
measure: Preterm birth i.e. infants born prematurely i.e., live-born infant i.e., (pre-term <37 weeks)
time frame: 26-32 weeks' gestation to within 6 weeks after the end of the pregnancy
description: Numbers and rates of pre-term birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
measure: Elective terminations i.e. any induced or voluntary fetal loss
time frame: 16-20 weeks' gestation
description: Numbers and rates of elective terminations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
measure: Small for gestational age at birth i.e. birth size (weight, length, or head circumference) ≤10th percentile for gender and gestational age
time frame: Within 6 weeks after the end of the pregnancy
description: Numbers and rates of small for gestational age on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
measure: Any other adverse pregnancy outcomes
time frame: Baseline to week 40
description: Numbers of adverse events
measure: Infant postnatal growth (up to the first year of life)
time frame: 1 year after delivery
description: Numbers and rates of infants with postnatal size (weight, length or head circumference) less than or equal to the 10th percentile for sex and age using National Center for Health Statistics (NCHS) pediatric growth curves, and adjusted postnatal age for premature infants.
measure: Infant development impairment (up to the first year of life)
time frame: 1 year after delivery
description: Numbers and rates of infants with development impairment
arm group label: Lemtrada
description: Pregnant women exposed to LEMTRADA which is administered by IV infusion for 5 consecutive days, then for 3 consecutive days, 12 months after the first/previous treatment course
intervention type: Drug
intervention name: Alemtuzumab (GZ402673)
description: Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion
arm group label: Lemtrada
other name: Lemtrada
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Austria
country: Belgium
country: Canada
country: Denmark
country: Germany
country: Italy
country: Netherlands
country: Spain
country: Sweden
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Alemtuzumab
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org