xml: <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/NCT05966467</url>
    </required_header>
    <id_info>
      <org_study_id>D9282C00003</org_study_id>
      <nct_id>NCT05966467</nct_id>
    </id_info>
    <brief_title>Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies</brief_title>
    <official_title>A Long-Term, Prospective, Observational, Registry of Patients With Anti-Aquaporin 4 Antibody-Positive (AQP4+) Neuromyelitis Optica Spectrum Disorder (NMOSD) Treated With Alexion Complement Component 5 (C5) Inhibitor Therapies (ALXN-C5IT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexion</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexion</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD&#xD;
        that is designed to collect data on clinical outcomes and safety in patients prescribed&#xD;
        Alexion C5 inhibitor therapies (C5IT). The registry will also collect data on patient&#xD;
        reported outcomes (PROs), quality of life (QoL), and targeted AQP4+ NMOSD therapies used to&#xD;
        provide evidence on the real-world impact of ALXN-C5IT on patients with AQP4+ NMOSD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        At the time of enrollment in the Registry, participant records will be queried for&#xD;
        retrospective information about the participant's medical history and AQP4+ NMOSD treatment&#xD;
        history for the time period beginning 1 year prior to ALXN-C5IT initiation through Registry&#xD;
        enrollment. The duration of data collection for the Registry will be approximately 5 years&#xD;
        from the day the last participant is enrolled.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2029</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>5 Years</target_duration>
    <primary_outcome>
      <measure>Annualized Relapse Rate (ARR)</measure>
      <time_frame>Up to approximately 5 years</time_frame>
      <description>The ARR is defined as the total number of relapses divided by the total number of participant-years.</description>
    </primary_outcome>
    <enrollment type="Anticipated">122</enrollment>
    <condition>Neuromyelitis Optica Spectrum Disorder</condition>
    <condition>NMOSD</condition>
    <condition>AQP4+ NMOSD</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Participants with a diagnosis of AQP4+ NMOSD who are being treated with ALXN-C5IT at the&#xD;
          time of enrollment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant is ≥ 18 years of age at the time of enrollment in the Registry.&#xD;
  &#xD;
            -  Participant must have a confirmed diagnosis of AQP4+ NMOSD.&#xD;
  &#xD;
            -  At the time of enrollment in the Registry, participants must be receiving treatment&#xD;
               with ALXN-C5IT for the purpose of chronic relapse prevention in a manner consistent&#xD;
               with the local label. Specifically, they should have received at least 1 dose of&#xD;
               eculizumab within 4 weeks prior to enrollment or at least 1 dose of ravulizumab within&#xD;
               12 weeks prior to enrollment.&#xD;
  &#xD;
            -  Participants must have both the following historical data available to be enrolled in&#xD;
               the Registry: ALXN-C5IT dosing information since initiation and number and types of&#xD;
               relapses from 1 year prior to ALXN-C5IT initiation through Registry enrollment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants currently enrolled in an interventional clinical study for the treatment&#xD;
               of AQP4+ NMOSD in which the intervention is a drug.&#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_contact>
      <last_name>AstraZeneca Clinical Study Information Center</last_name>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Neuromyelitis Optica Spectrum Disorder</keyword>
    <keyword>NMOSD</keyword>
    <keyword>C5 Inhibitor Therapies</keyword>
    <keyword>AQP4+ NMOSD</keyword>
    <keyword>Patient Registry</keyword>
    <keyword>Alexion C5IT</keyword>
    <keyword>Soliris</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neuromyelitis Optica</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966467
  org study id: D9282C00003
  nct id: NCT05966467
  lead sponsor: 
  has dmc: No
  Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD
        that is designed to collect data on clinical outcomes and safety in patients prescribed
        Alexion C5 inhibitor therapies (C5IT). The registry will also collect data on patient
        reported outcomes (PROs), quality of life (QoL), and targeted AQP4+ NMOSD therapies used to
        provide evidence on the real-world impact of ALXN-C5IT on patients with AQP4+ NMOSD.
  At the time of enrollment in the Registry, participant records will be queried for
        retrospective information about the participant's medical history and AQP4+ NMOSD treatment
        history for the time period beginning 1 year prior to ALXN-C5IT initiation through Registry
        enrollment. The duration of data collection for the Registry will be approximately 5 years
        from the day the last participant is enrolled.
  observational model: Cohort
  time perspective: Prospective
  measure: Annualized Relapse Rate (ARR)
  time frame: Up to approximately 5 years
  description: The ARR is defined as the total number of relapses divided by the total number of participant-years.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: AstraZeneca Clinical Study Information Center
  phone: 1-877-240-9479
  email: information.center@astrazeneca.com
  responsible party type: Sponsor
  mesh term: Neuromyelitis Optica
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)