<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/NCT03028480</url>
  </required_header>
  <id_info>
    <org_study_id>204524</org_study_id>
    <nct_id>NCT03028480</nct_id>
  </id_info>
  <brief_title>Long Term Special Drug Use Investigation of Mepolizumab</brief_title>
  <official_title>Nucala® Subcutaneous Injection Special Drug Use Investigation (Long-Term)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a special drug use investigation program of NUCALA (a brand name for&#xD;
      Mepolizumab) administered subcutaneously (SC). In this study the information regarding the&#xD;
      safety and effectiveness of long term use of NUCALA after subcutaneous injection will be&#xD;
      collected from Asthma subjects in daily clinical practice. The observation period per subject&#xD;
      will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2&#xD;
      years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline&#xD;
      [GSK] group of companies&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 11, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects whose data enetered on Electronic data capture (EDC) system</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>This includes the number of enrolled subjects whose data is entered in the EDC system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adverse drug reaction</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>It will be calculated as the number of subjects having adverse drug reaction by total number of subjects on NUCALA treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects showing Response to the treatment</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Response rate will be calculated as number of subjects showing response to the NUCALA treatment by total number of subjects on treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects excluded from analysis due to exacerbation of asthma</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Exacerbation of asthma includes, hospitalization, emergency room visit and usage of systemic steroids</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects having adverse drug reactions (ADR)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>ADR is defined as , a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects require priority investigation matter</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Priority investigation matters include, Hypersensitivity reaction including anaphylaxis, infections, malignant tumour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response rate assessed by global assessment of effectiveness</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>The response rate is the proportion of subjects assessed as &quot;effective&quot; based on the course of subjective symptoms, and course of clinical symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of exacerbation of asthma</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Frequency will be analyzed 52 weeks prior to the initiation of NUCALA treatment. Exacerbation of asthma includes, hospitalization, emergency room visit and usage of systemic steroids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total score of Asthma Control Test (ACT)</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Information on ACT will be recorded by subjects before the initiation of the therapy and at Week 12, Week 24 and Week 52 after administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects having normal Peak Expiratory Flow (PEF) score</measure>
    <time_frame>Up to Week 54</time_frame>
    <description>PEF is the Respiratory Function Test. It will be measured (at morning or evening) at the nearest time point of 1 week before and after the initiation of NUCALA treatment</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Subjects with Bronchial asthma</arm_group_label>
    <description>Subjects with a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications will be enrolled</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NUCALA Injection</intervention_name>
    <description>Single dose of NUCALA SC will be administered. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.</description>
    <arm_group_label>Subjects with Bronchial asthma</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a&#xD;
        refractory asthma whose symptoms are inadequately controlled despite receiving standard&#xD;
        asthma medications)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a&#xD;
             refractory asthma whose symptoms are inadequately controlled despite receiving&#xD;
             standard asthma medications)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>October 27, 2021</last_update_submitted>
  <last_update_submitted_qc>October 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exacerbation</keyword>
  <keyword>Mepolizumab</keyword>
  <keyword>NUCALA</keyword>
  <!-- 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/NCT03028480
org study id: 204524
nct id: NCT03028480
lead sponsor: 
has dmc: No
This study is a special drug use investigation program of NUCALA (a brand name for
      Mepolizumab) administered subcutaneously (SC). In this study the information regarding the
      safety and effectiveness of long term use of NUCALA after subcutaneous injection will be
      collected from Asthma subjects in daily clinical practice. The observation period per subject
      will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2
      years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline
      [GSK] group of companies
observational model: Case-Only
time perspective: Prospective
measure: Number of subjects whose data enetered on Electronic data capture (EDC) system
time frame: Up to 3 years
description: This includes the number of enrolled subjects whose data is entered in the EDC system.
measure: Incidence of adverse drug reaction
time frame: Up to 3 years
description: It will be calculated as the number of subjects having adverse drug reaction by total number of subjects on NUCALA treatment
measure: Number of subjects showing Response to the treatment
time frame: Up to Week 52
description: Response rate will be calculated as number of subjects showing response to the NUCALA treatment by total number of subjects on treatment
measure: Number of subjects excluded from analysis due to exacerbation of asthma
time frame: Up to Week 52
description: Exacerbation of asthma includes, hospitalization, emergency room visit and usage of systemic steroids
measure: Number of subjects having adverse drug reactions (ADR)
time frame: Up to 3 years
description: ADR is defined as , a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.
measure: Number of subjects require priority investigation matter
time frame: Up to 3 years
description: Priority investigation matters include, Hypersensitivity reaction including anaphylaxis, infections, malignant tumour
measure: Response rate assessed by global assessment of effectiveness
time frame: Up to Week 52
description: The response rate is the proportion of subjects assessed as "effective" based on the course of subjective symptoms, and course of clinical symptoms
measure: Frequency of exacerbation of asthma
time frame: Up to Week 52
description: Frequency will be analyzed 52 weeks prior to the initiation of NUCALA treatment. Exacerbation of asthma includes, hospitalization, emergency room visit and usage of systemic steroids
measure: Total score of Asthma Control Test (ACT)
time frame: Up to Week 52
description: Information on ACT will be recorded by subjects before the initiation of the therapy and at Week 12, Week 24 and Week 52 after administration.
measure: Number of subjects having normal Peak Expiratory Flow (PEF) score
time frame: Up to Week 54
description: PEF is the Respiratory Function Test. It will be measured (at morning or evening) at the nearest time point of 1 week before and after the initiation of NUCALA treatment
arm group label: Subjects with Bronchial asthma
description: Subjects with a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications will be enrolled
intervention type: Drug
intervention name: NUCALA Injection
description: Single dose of NUCALA SC will be administered. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.
arm group label: Subjects with Bronchial asthma
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
responsible party type: Sponsor