<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/NCT04447937</url>
  </required_header>
  <id_info>
    <org_study_id>NPI-110</org_study_id>
    <nct_id>NCT04447937</nct_id>
  </id_info>
  <brief_title>Immunodeficiency in MS</brief_title>
  <official_title>Analysis of Medical Therapy and History as Risks of Immunodeficiency in Multiple Sclerosis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advanced Neurosciences Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novel Pharmaceutics Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Advanced Neurosciences Institute</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this study is to identify if there is a relationship between multiple&#xD;
      sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in&#xD;
      subjects living with MS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to identify if there is a relationship between multiple&#xD;
      sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in&#xD;
      subjects living with MS. By understanding this relationship future studies can be designed to&#xD;
      create a model of immunosenescence in multiple sclerosis, which could help healthcare&#xD;
      providers to predict and assess health risks. Preventative strategies can then be tested to&#xD;
      look for ways to prevent these immune-related risks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 29, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Immunoglobulin Levels</measure>
    <time_frame>1 year</time_frame>
    <description>IgG, IgA, IgM</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infections</measure>
    <time_frame>1 year</time_frame>
    <description>Serious and non-serious</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune-mediated conditions</measure>
    <time_frame>1 year</time_frame>
    <description>Serious and non-serious</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Malignant and pre-malignant conditions</measure>
    <time_frame>1 year</time_frame>
    <description>Serious and non-serious</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Multiple Sclerosis</condition>
  <condition>Hypogammaglobulinemia</condition>
  <condition>Immunodeficiency</condition>
  <condition>Infection, Bacterial</condition>
  <arm_group>
    <arm_group_label>Multiple Sclerosis and Related Diseases</arm_group_label>
    <description>Individuals with one or more immunoglobulin level results and medical histories available for data collection will be included. Subjects will be 18 years of age or older at the time of data collection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Interventions</intervention_name>
    <description>There are no interventions associated with the study.</description>
    <arm_group_label>Multiple Sclerosis and Related Diseases</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospective data from 1500 patients with immune-mediated CNS disease is expected to be&#xD;
        used from the electronic medical record eClinicalWorks and other electronic and paper&#xD;
        archives of Advanced Neurosciences Institute.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  One or more immunoglobulin level results and medical history available&#xD;
&#xD;
          -  18 years of age or older at the time of data collection&#xD;
&#xD;
          -  Patients with first symptom MS or other isolated demyelinating syndromes,&#xD;
             neuromyelitis optica, or rheumatic-associated CNS inflammation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No evidence of CNS autoimmune disease&#xD;
&#xD;
          -  Less than 18 years of age at the time of data abstraction&#xD;
&#xD;
          -  Undergoing plasma exchange at the time of any lab tests drawn&#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>Samuel F Hunter, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Advanced Neurosciences Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samuel F Hunter, MD, PhD</last_name>
    <phone>6157915470</phone>
    <email>sfhunter@neurosci.us</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julia G Dickenson, BS, BA</last_name>
    <phone>6157915470</phone>
    <email>jgdickenson@neurosci.us</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Advanced Neurosciences Institute</name>
      <address>
        <city>Franklin</city>
        <state>Tennessee</state>
        <zip>37064</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Samuel F Hunter, MD, PhD</last_name>
      <phone>615-791-5470</phone>
      <email>sfhunter@neurosci.us</email>
    </contact>
    <contact_backup>
      <last_name>Amy L Dix, MPAS, PA-C</last_name>
      <phone>(913)-660-4751</phone>
      <email>aldix@neurosci.us</email>
    </contact_backup>
    <investigator>
      <last_name>Julia G Dickenson, BS, BA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</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>Bacterial Infections</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Agammaglobulinemia</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Publications and findings from research</ipd_description>
  </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/NCT04447937
org study id: NPI-110
nct id: NCT04447937
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to identify if there is a relationship between multiple
      sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in
      subjects living with MS.
The purpose of this study is to identify if there is a relationship between multiple
      sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in
      subjects living with MS. By understanding this relationship future studies can be designed to
      create a model of immunosenescence in multiple sclerosis, which could help healthcare
      providers to predict and assess health risks. Preventative strategies can then be tested to
      look for ways to prevent these immune-related risks.
observational model: Cohort
time perspective: Retrospective
measure: Immunoglobulin Levels
time frame: 1 year
description: IgG, IgA, IgM
measure: Infections
time frame: 1 year
description: Serious and non-serious
measure: Immune-mediated conditions
time frame: 1 year
description: Serious and non-serious
measure: Malignant and pre-malignant conditions
time frame: 1 year
description: Serious and non-serious
arm group label: Multiple Sclerosis and Related Diseases
description: Individuals with one or more immunoglobulin level results and medical histories available for data collection will be included. Subjects will be 18 years of age or older at the time of data collection.
intervention type: Other
intervention name: No Interventions
description: There are no interventions associated with the study.
arm group label: Multiple Sclerosis and Related Diseases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samuel F Hunter, MD, PhD
role: Principal Investigator
affiliation: Advanced Neurosciences Institute
last name: Samuel F Hunter, MD, PhD
phone: 6157915470
email: sfhunter@neurosci.us
last name: Julia G Dickenson, BS, BA
phone: 6157915470
email: jgdickenson@neurosci.us
facility: 
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Bacterial Infections
mesh term: Multiple Sclerosis
mesh term: Agammaglobulinemia
mesh term: Immunologic Deficiency Syndromes
mesh term: Sclerosis
sharing ipd: No
ipd description: Publications and findings from research