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/NCT06006832</url>
    </required_header>
    <id_info>
      <org_study_id>K2009</org_study_id>
      <nct_id>NCT06006832</nct_id>
    </id_info>
    <brief_title>A Prospective Cohort Study of Myasthenia Gravis in China</brief_title>
    <official_title>Clinical Characteristics, Prognosis and Biomarkers of Myasthenia Gravis: a Prospective Cohort Study in China</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this prospective cohort study is to investigate long-term therapeutic strategies&#xD;
        for myasthenia gravis (MG) and identify potential biomarkers. The main questions it aims to&#xD;
        answer are:&#xD;
  &#xD;
          1. Whether low-dose oral steroids may lead to a reduction in the recurrence rate among&#xD;
             patients with MG.&#xD;
  &#xD;
          2. To identify potential biomarkers that can predict disease progression and prognosis.&#xD;
  &#xD;
        This study recruits well-controlled patients with MG. Based on patient preferences and&#xD;
        considerations such as coexisting conditions (e.g., uncontrolled hypertension, diabetes,&#xD;
        severe osteoporosis, obesity), the participants will be non-randomly divided into two groups:&#xD;
        a maintenance steroid therapy group and a withdrawal group (withdraw all immunosuppresants).&#xD;
        Subsequently, these groups of patients will undergo long-term follow-up assessments.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2026</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>Relapse of myasthenia gravis</measure>
      <time_frame>Within two years after recruitment</time_frame>
      <description>One of the following three is met: (1) MGFA Postintervention Status: failure to maintain MMS (minimal manifestations status) or better. (2) Myasthenia gravis activities of daily living (MG-ADL) score ≥ 3; (3) Re-administration of cholinesterase inhibitors was required after achieving Complete Stable Remission (CSR) on the MGFA Postintervention Status.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time of relapse</measure>
      <time_frame>Within two years after recruitment</time_frame>
      <description>The time between recruitment and relapse of MG.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of MG assessment scales at relapse</measure>
      <time_frame>Within two years after recruitment</time_frame>
      <description>Change of MG assessment scales at relapse, including MGFA PIS (Postintervention Status), MG-ADL (myasthenia gravis activities of daily living), QMG (Quantitative Myasthenia gravis) and MGC (Myasthenia gravis composite).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events of steroids</measure>
      <time_frame>Within two years after recruitment</time_frame>
      <description>Using CTCAE (Common Terminology Criteria for Adverse Events) to assess Adverse events.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">202</enrollment>
    <condition>Myasthenia Gravis</condition>
    <arm_group>
      <arm_group_label>maintenance steroid therapy group</arm_group_label>
      <description>Maintaining low-dose oral steroids</description>
    </arm_group>
    <arm_group>
      <arm_group_label>immunosuppresants withdrawal group</arm_group_label>
      <description>Withdraw all immunosuppresants</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Steroid Drug</intervention_name>
      <description>Maintaining low-dose oral steroids</description>
      <arm_group_label>maintenance steroid therapy group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Withdraw all immunosuppresants</intervention_name>
      <description>Withdraw all immunosuppresants</description>
      <arm_group_label>immunosuppresants withdrawal group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Whole blood of each participant at each visit.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with myasthenia gravis who can completed long-term follow-up at PUMCH.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1: Attended the outpatient department of neurology of PUMCH from 9/30/2022 to&#xD;
               9/30/2024.&#xD;
  &#xD;
            -  2: Diagnosed as myasthenia gravis.&#xD;
  &#xD;
            -  3: Follow-up time at PUMCH&gt;6 months.&#xD;
  &#xD;
            -  4: The patient understood and signed the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1: Comorbidities with other conditions that cause skeletal muscle weakness make the&#xD;
               clinical symptoms difficult to assess&#xD;
  &#xD;
            -  2: Records related to comorbidities and medications were not available at baseline and&#xD;
               during follow-up.&#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>Yuzhou Guan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yuzhou Guan</last_name>
      <phone>8610-69155817</phone>
      <email>guanyz001@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bin Peng</last_name>
        <phone>8610-69155817</phone>
        <email>pumchkyc@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</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>Myasthenia Gravis</mesh_term>
      <mesh_term>Muscle Weakness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06006832
  org study id: K2009
  nct id: NCT06006832
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective cohort study is to investigate long-term therapeutic strategies
        for myasthenia gravis (MG) and identify potential biomarkers. The main questions it aims to
        answer are:
  
          1. Whether low-dose oral steroids may lead to a reduction in the recurrence rate among
             patients with MG.
  
          2. To identify potential biomarkers that can predict disease progression and prognosis.
  
        This study recruits well-controlled patients with MG. Based on patient preferences and
        considerations such as coexisting conditions (e.g., uncontrolled hypertension, diabetes,
        severe osteoporosis, obesity), the participants will be non-randomly divided into two groups:
        a maintenance steroid therapy group and a withdrawal group (withdraw all immunosuppresants).
        Subsequently, these groups of patients will undergo long-term follow-up assessments.
  observational model: Cohort
  time perspective: Prospective
  measure: Relapse of myasthenia gravis
  time frame: Within two years after recruitment
  description: One of the following three is met: (1) MGFA Postintervention Status: failure to maintain MMS (minimal manifestations status) or better. (2) Myasthenia gravis activities of daily living (MG-ADL) score ≥ 3; (3) Re-administration of cholinesterase inhibitors was required after achieving Complete Stable Remission (CSR) on the MGFA Postintervention Status.
  measure: Time of relapse
  time frame: Within two years after recruitment
  description: The time between recruitment and relapse of MG.
  measure: Change of MG assessment scales at relapse
  time frame: Within two years after recruitment
  description: Change of MG assessment scales at relapse, including MGFA PIS (Postintervention Status), MG-ADL (myasthenia gravis activities of daily living), QMG (Quantitative Myasthenia gravis) and MGC (Myasthenia gravis composite).
  measure: Adverse events of steroids
  time frame: Within two years after recruitment
  description: Using CTCAE (Common Terminology Criteria for Adverse Events) to assess Adverse events.
  arm group label: maintenance steroid therapy group
  description: Maintaining low-dose oral steroids
  arm group label: immunosuppresants withdrawal group
  description: Withdraw all immunosuppresants
  intervention type: Drug
  intervention name: Steroid Drug
  description: Maintaining low-dose oral steroids
  arm group label: maintenance steroid therapy group
  intervention type: Other
  intervention name: Withdraw all immunosuppresants
  description: Withdraw all immunosuppresants
  arm group label: immunosuppresants withdrawal group
  Whole blood of each participant at each visit.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yuzhou Guan
  role: Principal Investigator
  affiliation: Peking Union Medical College Hospital
  last name: Yuzhou Guan
  phone: 8610-69155817
  email: guanyz001@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Myasthenia Gravis
  mesh term: Muscle Weakness
  sharing ipd: No