<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/NCT02205489</url>
  </required_header>
  <id_info>
    <org_study_id>LPS13650</org_study_id>
    <secondary_id>2014-000092-62</secondary_id>
    <secondary_id>U1111-1153-3922</secondary_id>
    <nct_id>NCT02205489</nct_id>
  </id_info>
  <brief_title>Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA</brief_title>
  <acronym>EMERALD</acronym>
  <official_title>Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To assess the distribution of IARs by severity grade when LEMTRADA is administered to RRMS&#xD;
      patients who will be medicated according to specified algorithm designed to manage infusion&#xD;
      associated reactions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total duration of participation in the study per patient is approximately 13.5 months.&#xD;
&#xD;
      After the end of the second course of LEMTRADA treatment, patients will be followed by their&#xD;
      physician in a regular healthcare setting until 48 months safety monitoring period is&#xD;
      completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC). An IAR is any adverse event occurring during or within 24 hours of LEMTRADA infusion.</measure>
    <time_frame>up to 30 days in the first treatment course and the second treatment course, respectively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of IARs</measure>
    <time_frame>up to 30 days in the first treatment course and the second treatment course, respectively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion and type of serious IARs</measure>
    <time_frame>up to 30 days in the first treatment course and the second treatment course, respectively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion by type (as defined by clinical symptoms)</measure>
    <time_frame>up to 30 days in the first treatment course and the second treatment course, respectively</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Relapsing-remitting Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>GZ402673 LEMTRADA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alemtuzumab GZ402673</intervention_name>
    <description>Pharmaceutical form:concentration for solution Route of administration: intravenous infusion</description>
    <arm_group_label>GZ402673 LEMTRADA</arm_group_label>
    <other_name>Lemtrada</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cetirizine</intervention_name>
    <description>Pharmaceutical form:tablet Route of administration: oral</description>
    <arm_group_label>GZ402673 LEMTRADA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ranitidine</intervention_name>
    <description>Pharmaceutical form:tablet Route of administration: oral</description>
    <arm_group_label>GZ402673 LEMTRADA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>methylprednisolone</intervention_name>
    <description>Pharmaceutical form:tablet Route of administration: oral</description>
    <arm_group_label>GZ402673 LEMTRADA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>methylprednisolone</intervention_name>
    <description>Pharmaceutical form:solution Route of administration: intravenous</description>
    <arm_group_label>GZ402673 LEMTRADA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aciclovir</intervention_name>
    <description>Pharmaceutical form:tablet Route of administration: oral</description>
    <arm_group_label>GZ402673 LEMTRADA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>esomeprazole</intervention_name>
    <description>Pharmaceutical form:tablet Route of administration: oral</description>
    <arm_group_label>GZ402673 LEMTRADA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ibuprofen</intervention_name>
    <description>Pharmaceutical form:tablet Route of administration: oral</description>
    <arm_group_label>GZ402673 LEMTRADA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paracetamol</intervention_name>
    <description>Pharmaceutical form:tablet Route of administration: oral</description>
    <arm_group_label>GZ402673 LEMTRADA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adult RRMS patients who will be initiating treatment with Lemtrada according to local&#xD;
             approved label.&#xD;
&#xD;
          -  Signed written informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Previously treated with LEMTRADA.&#xD;
&#xD;
          -  Contraindications to LEMTRADA according to the labeling in the country.&#xD;
&#xD;
          -  Any known contraindications to the symptomatic therapy used in the infusion management&#xD;
             guidance based on their local approved label.&#xD;
&#xD;
          -  Currently participating in another investigational interventional study.&#xD;
&#xD;
          -  Any technical/administrative reason that makes it impossible to enroll the patient in&#xD;
             the study.&#xD;
&#xD;
          -  Patient is the Investigator or any Sub-investigator, research assistant, pharmacist,&#xD;
             study coordinator, other staff or relative thereof directly involved in the conduct of&#xD;
             the protocol.&#xD;
&#xD;
          -  Patient who has withdrawn consent before enrollment (starting from signed informed&#xD;
             consent form).&#xD;
&#xD;
          -  Despite screening of the patient, enrolment is stopped at the study level.&#xD;
&#xD;
          -  Woman of childbearing potential not protected by highly-effective method(s) of birth&#xD;
             control (as defined in a local protocol amendment in case of specific local&#xD;
             requirement) and/or who are unwilling or unable to be tested for pregnancy.&#xD;
&#xD;
          -  Pregnancy (defined as positive beta human chorionic gonadotropin (β-HCG) blood test),&#xD;
             breast feeding.&#xD;
&#xD;
          -  Known infection with latent tuberculosis or active tuberculosis.&#xD;
&#xD;
          -  Known infection with Hepatitis B, Hepatitis C.&#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>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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 056002</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 056001</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250009</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250005</name>
      <address>
        <city>Lille Cedex</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250001</name>
      <address>
        <city>Lyon Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250006</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250010</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250007</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250008</name>
      <address>
        <city>PARIS Cedex 20</city>
        <zip>75970</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250004</name>
      <address>
        <city>RENNES Cedex 9</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250003</name>
      <address>
        <city>Strasbourg Cedex 2</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250002</name>
      <address>
        <city>Toulouse</city>
        <zip>31200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528001</name>
      <address>
        <city>Breda</city>
        <zip>4818CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528002</name>
      <address>
        <city>Rotterdam</city>
        <zip>3079DZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724001</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724005</name>
      <address>
        <city>Bilbao</city>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724002</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724006</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724003</name>
      <address>
        <city>Sevilla</city>
        <zip>41071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724004</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Netherlands</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>June 8, 2016</last_update_submitted>
  <last_update_submitted_qc>June 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 9, 2016</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>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cetirizine</mesh_term>
    <mesh_term>Acyclovir</mesh_term>
    <mesh_term>Ibuprofen</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Alemtuzumab</mesh_term>
    <mesh_term>Esomeprazole</mesh_term>
    <mesh_term>Ranitidine</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_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/NCT02205489
org study id: LPS13650
secondary id: 2014-000092-62
secondary id: U1111-1153-3922
nct id: NCT02205489
lead sponsor: 
has dmc: No
Primary Objective:

      To assess the distribution of IARs by severity grade when LEMTRADA is administered to RRMS
      patients who will be medicated according to specified algorithm designed to manage infusion
      associated reactions.
The total duration of participation in the study per patient is approximately 13.5 months.

      After the end of the second course of LEMTRADA treatment, patients will be followed by their
      physician in a regular healthcare setting until 48 months safety monitoring period is
      completed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC). An IAR is any adverse event occurring during or within 24 hours of LEMTRADA infusion.
time frame: up to 30 days in the first treatment course and the second treatment course, respectively
measure: Proportion of IARs
time frame: up to 30 days in the first treatment course and the second treatment course, respectively
measure: Proportion and type of serious IARs
time frame: up to 30 days in the first treatment course and the second treatment course, respectively
measure: Proportion by type (as defined by clinical symptoms)
time frame: up to 30 days in the first treatment course and the second treatment course, respectively
arm group label: GZ402673 LEMTRADA
arm group type: Experimental
description: First course: Intravenous infusion for 5 consecutive days. Second course (will occur 12 months after the first course of treatment): Intravenous infusion for 3 consecutive days.
intervention type: Drug
intervention name: Alemtuzumab GZ402673
description: Pharmaceutical form:concentration for solution Route of administration: intravenous infusion
arm group label: GZ402673 LEMTRADA
other name: Lemtrada
intervention type: Drug
intervention name: cetirizine
description: Pharmaceutical form:tablet Route of administration: oral
arm group label: GZ402673 LEMTRADA
intervention type: Drug
intervention name: ranitidine
description: Pharmaceutical form:tablet Route of administration: oral
arm group label: GZ402673 LEMTRADA
intervention type: Drug
intervention name: methylprednisolone
description: Pharmaceutical form:tablet Route of administration: oral
arm group label: GZ402673 LEMTRADA
intervention type: Drug
intervention name: methylprednisolone
description: Pharmaceutical form:solution Route of administration: intravenous
arm group label: GZ402673 LEMTRADA
intervention type: Drug
intervention name: aciclovir
description: Pharmaceutical form:tablet Route of administration: oral
arm group label: GZ402673 LEMTRADA
intervention type: Drug
intervention name: esomeprazole
description: Pharmaceutical form:tablet Route of administration: oral
arm group label: GZ402673 LEMTRADA
intervention type: Drug
intervention name: ibuprofen
description: Pharmaceutical form:tablet Route of administration: oral
arm group label: GZ402673 LEMTRADA
intervention type: Drug
intervention name: paracetamol
description: Pharmaceutical form:tablet Route of administration: oral
arm group label: GZ402673 LEMTRADA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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facility: 
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country: Belgium
country: France
country: Netherlands
country: Spain
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
mesh term: Cetirizine
mesh term: Acyclovir
mesh term: Ibuprofen
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Alemtuzumab
mesh term: Esomeprazole
mesh term: Ranitidine
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate