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/NCT06002945</url>
    </required_header>
    <id_info>
      <org_study_id>2000026920</org_study_id>
      <secondary_id>1U54NS115054-01</secondary_id>
      <nct_id>NCT06002945</nct_id>
    </id_info>
    <brief_title>Exploring Outcomes and Characteristics of Myasthenia Gravis 2</brief_title>
    <acronym>EXPLORE-MG2</acronym>
    <official_title>Exploring Outcomes and Characteristics of Myasthenia Gravis 2</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Yale University</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this prospective observational study is to create a network repository of&#xD;
        clinical data and biological samples to help researchers learn more about myasthenia gravis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The EXPLORE-MG2 (EXPLoring Outcomes and chaRactEristics of Myasthenia Gravis 2) study is a&#xD;
        multi-center natural history study of myasthenia gravis (MG), a rare autoimmune disease&#xD;
        characterized by weakness of the voluntary muscles. MG has a prevalence of approximately&#xD;
        14-40 per 100,000 people in the United States. There is no cure for MG, however,&#xD;
        understanding the disease is crucial to pave the way for development of new therapies and a&#xD;
        deeper mechanistic understanding to improve patient outcomes. Thus, EXPLORE-MG2 aims to&#xD;
        accomplish comprehensive clinical phenotyping linked to bio-specimen collection in an effort&#xD;
        to better understand disease characteristics and identify treatment predictive and responsive&#xD;
        biomarkers. The primary purpose of this project is to create a network repository of data and&#xD;
        biological samples to help researchers learn more about myasthenia gravis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 12, 2021</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2026</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>The number of participants enrolled and serial blood reported at the conclusion of the enrollment period.</measure>
      <time_frame>5 years</time_frame>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Myasthenia Gravis</condition>
    <arm_group>
      <arm_group_label>Neurological Outpatients</arm_group_label>
      <description>Participants in this group will be recruited from the outpatient clinical population at MGNet participating sites. Treating physicians will make the initial determination of patients' potential eligibility to participate in the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Blood sample</intervention_name>
      <description>Each blood draw will involve removing approximately 75 mL (5 tablespoons) of blood</description>
      <arm_group_label>Neurological Outpatients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects will be 18 years of age or older with a clinical diagnosis of a Myasthenia Gravis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with MG based on clinical presentation and seropositivity for MG associated&#xD;
               autoantibodies (AChR binding, MuSK, or LRP4 antibodies), and/or a decremental response&#xD;
               on repetitive nerve stimulation, positive single fiber electromyography (EMG) or&#xD;
               positive edrophonium test. Signs and symptoms should not be better explained by&#xD;
               another disease process.&#xD;
  &#xD;
            -  A) Diagnosed with MG within 2 years of study enrollment and with adequate records to&#xD;
               document MG history (e.g., onset, MG meds) prior to enrollment at the discretion of&#xD;
               the investigator.&#xD;
  &#xD;
          or B) MuSK antibody, LRP4 antibody, or thymoma-associated MG at any point in the disease&#xD;
          course. Patients with a diagnosis of MG more than 2 years prior to the first study visit&#xD;
          who are expected to undergo a thymectomy may also be enrolled.&#xD;
  &#xD;
            -  Participant has the capacity to understand and sign a written informed consent form.&#xD;
  &#xD;
            -  Participant must be willing to complete the study and return for follow-up visits.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A history of chronic degenerative, psychiatric, or neurologic disorder other than MG&#xD;
               that can produce weakness or fatigue that would confound outcome measure assessments&#xD;
               or any disorder that interferes with participation in this protocol.&#xD;
  &#xD;
            -  Participant is unable or unwilling to comply with the study procedures.&#xD;
  &#xD;
            -  Treatment with any investigational agent within 4 weeks of the baseline visit or 5&#xD;
               half-lives of the investigational drug (whichever is longer).&#xD;
  &#xD;
                 1. Participation in other observational studies is not exclusionary&#xD;
  &#xD;
                 2. It is anticipated that some participants enrolled in EXPLORE-MG2 may be enrolled&#xD;
                    in future interventional trials while active in EXPLORE-MG2. This is acceptable.&#xD;
                    The exclusion only applies to starting EXPLORE-MG2 when participation in an&#xD;
                    interventional trial is imminent or active.&#xD;
  &#xD;
                 3. If an EXPLORE-MG2 participant is later enrolled in an interventional trial, it&#xD;
                    will be at the investigator's discretion whether to continue collecting&#xD;
                    biosamples while the patient is participating in the interventional trial.&#xD;
                    Collection of natural history data should continue.&#xD;
  &#xD;
            -  Known active malignancy at enrollment other than skin cancer, low grade prostate&#xD;
               cancer, or cervical cancer in situ. Thymoma is not included in this exclusion&#xD;
               criteria.&#xD;
  &#xD;
            -  Any other disease, metabolic dysfunction, physical examination finding, or clinical&#xD;
               laboratory finding giving reasonable suspicion of a disease or condition that&#xD;
               contraindicates or that may affect the interpretation of the results or render the&#xD;
               participant not an appropriate study participant.&#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>Richard Nowak, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Vern Juel, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alex Hammett</last_name>
      <phone>919-668-8432</phone>
      <email>alex.hammett@duke.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Helen Girma</last_name>
      <email>hgirma@mfa.gwu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of California-Irvine</name>
        <address>
          <city>Irvine</city>
          <state>California</state>
          <zip>92697</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ali Habib, MD</last_name>
      </contact>
      <investigator>
        <last_name>Ali Habib, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Cedars Sinai Medical Center</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90048</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Richard Lewis, MD</last_name>
      </contact>
      <investigator>
        <last_name>Richard Lewis, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Yale University</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06519</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bailey Sheldon</last_name>
        <phone>203-293-0370</phone>
        <email>bailey.munrosheldon@yale.edu</email>
      </contact>
      <contact_backup>
        <email>richard.nowak@yale.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Richard Nowak, MD, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>George Washington University</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20037</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Henry Kaminski, MD</last_name>
      </contact>
      <investigator>
        <last_name>Henry Kaminski, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Chicago</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60637</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Betty Soliven, MD</last_name>
      </contact>
      <investigator>
        <last_name>Betty Soliven, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Massachusetts General Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amanda Guidon, MD, MPH</last_name>
      </contact>
      <investigator>
        <last_name>Amanda Guidon, MD, MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of North Carolina</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Duke University Medical Center</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27710</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Vern Juel, MD</last_name>
      </contact>
      <investigator>
        <last_name>Vern Juel, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Wake Forest University</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27157</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rachana Mehta, MD</last_name>
      </contact>
      <investigator>
        <last_name>Rachana Mehta, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical University of South Carolina</name>
        <address>
          <city>Charleston</city>
          <state>South Carolina</state>
          <zip>29425</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Katherine Ruzhansky, MD</last_name>
      </contact>
      <investigator>
        <last_name>Katherine Ruzhansky, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Yale University</investigator_affiliation>
      <investigator_full_name>Richard Nowak</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Neuromuscular</keyword>
    <keyword>Autoimmune Diseases of the Nervous System</keyword>
    <keyword>Nervous System Diseases</keyword>
    <keyword>Muscle weakness</keyword>
    <keyword>Autoimmune Diseases</keyword>
    <keyword>Immune System Diseases</keyword>
    <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/NCT06002945
  org study id: 2000026920
  secondary id: 1U54NS115054-01
  nct id: NCT06002945
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective observational study is to create a network repository of
        clinical data and biological samples to help researchers learn more about myasthenia gravis.
  The EXPLORE-MG2 (EXPLoring Outcomes and chaRactEristics of Myasthenia Gravis 2) study is a
        multi-center natural history study of myasthenia gravis (MG), a rare autoimmune disease
        characterized by weakness of the voluntary muscles. MG has a prevalence of approximately
        14-40 per 100,000 people in the United States. There is no cure for MG, however,
        understanding the disease is crucial to pave the way for development of new therapies and a
        deeper mechanistic understanding to improve patient outcomes. Thus, EXPLORE-MG2 aims to
        accomplish comprehensive clinical phenotyping linked to bio-specimen collection in an effort
        to better understand disease characteristics and identify treatment predictive and responsive
        biomarkers. The primary purpose of this project is to create a network repository of data and
        biological samples to help researchers learn more about myasthenia gravis.
  observational model: Cohort
  time perspective: Prospective
  measure: The number of participants enrolled and serial blood reported at the conclusion of the enrollment period.
  time frame: 5 years
  arm group label: Neurological Outpatients
  description: Participants in this group will be recruited from the outpatient clinical population at MGNet participating sites. Treating physicians will make the initial determination of patients' potential eligibility to participate in the study.
  intervention type: Other
  intervention name: Blood sample
  description: Each blood draw will involve removing approximately 75 mL (5 tablespoons) of blood
  arm group label: Neurological Outpatients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Richard Nowak, MD
  role: Principal Investigator
  affiliation: Yale University
  last name: Vern Juel, MD
  role: Principal Investigator
  affiliation: Duke University
  last name: Alex Hammett
  phone: 919-668-8432
  email: alex.hammett@duke.edu
  last name: Helen Girma
  email: hgirma@mfa.gwu.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Yale University
  investigator full name: Richard Nowak
  investigator title: Principal Investigator
  mesh term: Myasthenia Gravis
  mesh term: Muscle Weakness
  sharing ipd: No