<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/NCT03250169</url>
  </required_header>
  <id_info>
    <org_study_id>011717</org_study_id>
    <nct_id>NCT03250169</nct_id>
  </id_info>
  <brief_title>Neurofilaments for NEDA Assessing in MS</brief_title>
  <official_title>Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen Mary University of London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      Goal is to evaluate the achievement of biological NEDA as demonstrated by a drop in&#xD;
      neurofilament levels in MS patients commencing Alemtuzumab therapy as part of their MS&#xD;
      management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary&#xD;
&#xD;
        1. To evaluate the achievement of NEDA using blood and CSF neurofilaments in Alemtuzumab&#xD;
           treated patients.&#xD;
&#xD;
           Secondary&#xD;
&#xD;
        2. To assess prognosis at the end of the study based on neurofilament status.&#xD;
&#xD;
        3. To correlate neurofilament levels with clinical and MRI markers of disease activity.&#xD;
&#xD;
        4. To evaluate the effect of Alemtuzumab on the profile of other CSF, blood, urine, faeces&#xD;
           biomarkers of inflammation, neurodegeneration, neuronal sprouting and synaptogenesis,&#xD;
           treatment activity and metabolic activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Under recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">January 28, 2022</completion_date>
  <primary_completion_date type="Actual">January 28, 2022</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>Blood and CSF neurofilaments in Alemtuzumab patients over 24months</measure>
    <time_frame>2 years</time_frame>
    <description>Neurofilaments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall clinical response based on neurofilament response</measure>
    <time_frame>2 years</time_frame>
    <description>neurofilaments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurofilament status and association with clinical and MRI markers of disease activity.</measure>
    <time_frame>2 years</time_frame>
    <description>Correlation index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longitudinal assessment of other biomarkers of inflammation &amp; plasticity</measure>
    <time_frame>2 years</time_frame>
    <description>Correlation index</description>
  </secondary_outcome>
  <enrollment type="Actual">21</enrollment>
  <condition>Multiple Sclerosis</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alemtuzumab</intervention_name>
    <description>Licensed dose</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Relapsing-remitting MS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).&#xD;
&#xD;
          2. Age 18-55 years.&#xD;
&#xD;
          3. EDSS score between 0-5.5.&#xD;
&#xD;
          4. Commencing Alemtuzumab therapy at Neurology Infusion and Planned Investigation Unit,&#xD;
             The Royal London Hospital, Ward 11D&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A diagnosis of Secondary Progressive MS (SPMS) or other forms of progressive MS.&#xD;
&#xD;
          2. Those unable to comply with study requirement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Queen Mary University of London</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>E1 2AT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>February 9, 2022</last_update_submitted>
  <last_update_submitted_qc>February 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 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>No</sharing_ipd>
  </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/NCT03250169
org study id: 011717
nct id: NCT03250169
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Goal is to evaluate the achievement of biological NEDA as demonstrated by a drop in
      neurofilament levels in MS patients commencing Alemtuzumab therapy as part of their MS
      management.
Primary

        1. To evaluate the achievement of NEDA using blood and CSF neurofilaments in Alemtuzumab
           treated patients.

           Secondary

        2. To assess prognosis at the end of the study based on neurofilament status.

        3. To correlate neurofilament levels with clinical and MRI markers of disease activity.

        4. To evaluate the effect of Alemtuzumab on the profile of other CSF, blood, urine, faeces
           biomarkers of inflammation, neurodegeneration, neuronal sprouting and synaptogenesis,
           treatment activity and metabolic activity.
observational model: Cohort
time perspective: Prospective
measure: Blood and CSF neurofilaments in Alemtuzumab patients over 24months
time frame: 2 years
description: Neurofilaments
measure: Overall clinical response based on neurofilament response
time frame: 2 years
description: neurofilaments
measure: Neurofilament status and association with clinical and MRI markers of disease activity.
time frame: 2 years
description: Correlation index
measure: Longitudinal assessment of other biomarkers of inflammation & plasticity
time frame: 2 years
description: Correlation index
intervention type: Drug
intervention name: Alemtuzumab
description: Licensed dose
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Alemtuzumab
sharing ipd: No