<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/NCT04468165</url>
  </required_header>
  <id_info>
    <org_study_id>HIK-DMF-2020-01</org_study_id>
    <nct_id>NCT04468165</nct_id>
  </id_info>
  <brief_title>Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region</brief_title>
  <official_title>Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hikma Pharmaceuticals LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hikma Pharmaceuticals LLC</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this observational study is to evaluate the effectiveness, safety and health&#xD;
      related quality of life of Generic DMF (Sclera® or Marovarex ®, Hikma) in patients undergoing&#xD;
      routine clinical care for RRMS in MENA Region&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational, multi-center, prospective, cohort study, where no visits or&#xD;
      intervention(s) additional to the daily practice will be performed. In the study sites,&#xD;
      patients undergoing routine clinical care for RRMS and initiated treatment with Generic DMF&#xD;
      (Sclera® or Marovarex ®, Hikma) in accordance with the approved SPC will be followed up and&#xD;
      assessed for a total of 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 23, 2021</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoint of the study is ARR (Annualized Relapse Rate) at 12 month.</measure>
    <time_frame>12 Months</time_frame>
    <description>Relapses will be identified and recorded by Site investigators. A relapse is defined as any new or historical neurological symptom, not associated with fever or infection, lasting for at least 24 h and accompanied by new neurological signs. New or recurrent neurologic symptoms that occurred &lt;30 days after the onset of a relapse as defined earlier were considered part of the same relapse.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) (including laboratory abnormalities)</measure>
    <time_frame>up to 12 months from Initiation of Hikma DMF</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation will be assessed</measure>
    <time_frame>up to 12 months from Initiation of Hikma DMF</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients experiencing a relapse over the 12 months period from Initiation of Hikma DMF</measure>
    <time_frame>up to 12 months from Initiation of Hikma DMF</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Relapse</measure>
    <time_frame>up to 12 months from Initiation of Hikma DMF</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with disability progression as measured by the EDSS over time</measure>
    <time_frame>up to 12 months from Initiation of Hikma DMF</time_frame>
    <description>Disability worsening is defined as 1.5-point increase (if baseline EDSS score was 0), 1.0-point increase (if baseline EDSS score was &lt; 5.5) or 0.5- point increase (if baseline EDSS score was ≥ 5.5) confirmed at least 6 months apart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Multiple Sclerosis Impact Scale-29 Items (MSIS-29) scores over time</measure>
    <time_frame>up to 12 months from Initiation of Hikma DMF</time_frame>
    <description>The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">155</enrollment>
  <condition>Relapsing Remitting Multiple Sclerosis</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dimethyl Fumarate (DMF)</intervention_name>
    <description>Gastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate</description>
    <other_name>Sclera ®, Hikma</other_name>
    <other_name>Marovarex ®, Hikma</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be recruited from different sites in Jordan, Lebanon, Algeria, Egypt and KSA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who initiate treatment with Hikma Generic DMF at baseline in accordance with&#xD;
             the approved Summary of Product Characteristics&#xD;
&#xD;
          2. Age ≥ 18 years&#xD;
&#xD;
          3. Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria who&#xD;
             are :&#xD;
&#xD;
               1. Newly diagnosed who had no prior DMT, or&#xD;
&#xD;
               2. Switched patients who had ≥1 prior DMTs, other than DMF&#xD;
&#xD;
          4. Patients who agree to participate in the study and provide a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with previous exposure to DMF other than (Sclera® or Marovarex ®-Hikma),&#xD;
             Fumaderm (fumaric acid esters), or compounded fumarates.&#xD;
&#xD;
          2. Patients participating in other clinical studies&#xD;
&#xD;
          3. Patients who meet any of the contraindications to the administration of the Study drug&#xD;
             according to the approved Summary of Product Characteristics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>CHU Frantz FANON</name>
      <address>
        <city>Blida</city>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nedir Mohamed Hospital</name>
      <address>
        <city>Tizi Ouzou</city>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New University Hospital</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Demerdash hospital (Ain Shams University)</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Clinic</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Abdullah University Hospital (KAUH)</name>
      <address>
        <city>Ar Ramtha</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Algeria</country>
    <country>Egypt</country>
    <country>Jordan</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dimethyl Fumarate</keyword>
  <keyword>Generic Dimethyl Fumarate</keyword>
  <keyword>Delayed-Release Dimethyl Fumarate</keyword>
  <keyword>Disease Modifying Treatments</keyword>
  <keyword>Nervous System</keyword>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Relapsing-Remitting Multiple Sclerosis</keyword>
  <keyword>Cohort Study</keyword>
  <keyword>Observational Study</keyword>
  <keyword>Effectiveness</keyword>
  <keyword>Safety</keyword>
  <keyword>Health Related Quality of life</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dimethyl Fumarate</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/NCT04468165
org study id: HIK-DMF-2020-01
nct id: NCT04468165
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this observational study is to evaluate the effectiveness, safety and health
      related quality of life of Generic DMF (Sclera® or Marovarex ®, Hikma) in patients undergoing
      routine clinical care for RRMS in MENA Region
This is an observational, multi-center, prospective, cohort study, where no visits or
      intervention(s) additional to the daily practice will be performed. In the study sites,
      patients undergoing routine clinical care for RRMS and initiated treatment with Generic DMF
      (Sclera® or Marovarex ®, Hikma) in accordance with the approved SPC will be followed up and
      assessed for a total of 12 months.
observational model: Cohort
time perspective: Prospective
measure: The primary endpoint of the study is ARR (Annualized Relapse Rate) at 12 month.
time frame: 12 Months
description: Relapses will be identified and recorded by Site investigators. A relapse is defined as any new or historical neurological symptom, not associated with fever or infection, lasting for at least 24 h and accompanied by new neurological signs. New or recurrent neurologic symptoms that occurred <30 days after the onset of a relapse as defined earlier were considered part of the same relapse.
measure: Proportion of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) (including laboratory abnormalities)
time frame: up to 12 months from Initiation of Hikma DMF
measure: Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation will be assessed
time frame: up to 12 months from Initiation of Hikma DMF
measure: Proportion of patients experiencing a relapse over the 12 months period from Initiation of Hikma DMF
time frame: up to 12 months from Initiation of Hikma DMF
measure: Time to First Relapse
time frame: up to 12 months from Initiation of Hikma DMF
measure: Proportion of patients with disability progression as measured by the EDSS over time
time frame: up to 12 months from Initiation of Hikma DMF
description: Disability worsening is defined as 1.5-point increase (if baseline EDSS score was 0), 1.0-point increase (if baseline EDSS score was < 5.5) or 0.5- point increase (if baseline EDSS score was ≥ 5.5) confirmed at least 6 months apart
measure: Change in Multiple Sclerosis Impact Scale-29 Items (MSIS-29) scores over time
time frame: up to 12 months from Initiation of Hikma DMF
description: The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items.
intervention type: Drug
intervention name: Dimethyl Fumarate (DMF)
description: Gastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate
other name: Sclera ®, Hikma
other name: Marovarex ®, Hikma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Algeria
country: Egypt
country: Jordan
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
mesh term: Dimethyl Fumarate