<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/NCT03833271</url>
  </required_header>
  <id_info>
    <org_study_id>MS Pecs-Paediatrics</org_study_id>
    <nct_id>NCT03833271</nct_id>
  </id_info>
  <brief_title>The Efficacy of Influenza Vaccine Program in Children With Juvenile Idiopathic Arthritis. A Single Centre Results From Hungary</brief_title>
  <official_title>The Investigation of Immune Function and the Effectiveness of Influenza Vaccine in Children With Juvenile Idiopathic Arthritis Compared to Healthy Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pecs</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pecs</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 aim of our study is to compare the immune function of patient treated with DMARD&#xD;
      (methotrexate), or tumor necrosis factor (TNF)-alpha inhibitor (adalimumab) to healthy&#xD;
      children. The study consists of three parts. In each part physical examination and routine&#xD;
      laboratory tests are done.&#xD;
&#xD;
      At the first examination flow cytometry analysis is performed, after that the participants&#xD;
      are immunized with influenza (3Fluart) vaccine. At part two and three further flow cytometry&#xD;
      is carried out and seroconversion is measured.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 28, 2018</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparing the healthy population and the JIA participants treated with DMARD (MTX) or TNF-alpha inhibitor (adalimumab)</measure>
    <time_frame>12-14 weeks</time_frame>
    <description>Analysing T and B cells (%, /microL) by flow cytometry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immune response to influenza vaccine, the rate of seroconversion</measure>
    <time_frame>12-14 weeks</time_frame>
    <description>Measuring seroconversion after influenza vaccine (IU)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <arm_group>
    <arm_group_label>TNF-alpha inhibitor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Methotrexate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza vaccine, Immune function</intervention_name>
    <description>Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.</description>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Methotrexate</arm_group_label>
    <arm_group_label>TNF-alpha inhibitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  JIA (oligoarticular, polyarticular) treated with MTX or MTX/adalimumab&#xD;
&#xD;
          -  Healthy controls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with infection&#xD;
&#xD;
          -  Children with active JIA disease&#xD;
&#xD;
          -  JIA other than oligoarticular, polyarticular type&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pécs, Medical School, Department of Paediatrics</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pecs</investigator_affiliation>
    <investigator_full_name>Nagy Arnold</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_browse>
  <!-- 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/NCT03833271
org study id: MS Pecs-Paediatrics
nct id: NCT03833271
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of our study is to compare the immune function of patient treated with DMARD
      (methotrexate), or tumor necrosis factor (TNF)-alpha inhibitor (adalimumab) to healthy
      children. The study consists of three parts. In each part physical examination and routine
      laboratory tests are done.

      At the first examination flow cytometry analysis is performed, after that the participants
      are immunized with influenza (3Fluart) vaccine. At part two and three further flow cytometry
      is carried out and seroconversion is measured.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Comparing the healthy population and the JIA participants treated with DMARD (MTX) or TNF-alpha inhibitor (adalimumab)
time frame: 12-14 weeks
description: Analysing T and B cells (%, /microL) by flow cytometry.
measure: Immune response to influenza vaccine, the rate of seroconversion
time frame: 12-14 weeks
description: Measuring seroconversion after influenza vaccine (IU)
arm group label: TNF-alpha inhibitor
arm group type: Active Comparator
arm group label: Methotrexate
arm group type: Active Comparator
arm group label: Healthy
arm group type: Active Comparator
intervention type: Biological
intervention name: Influenza vaccine, Immune function
description: Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.
arm group label: Healthy
arm group label: Methotrexate
arm group label: TNF-alpha inhibitor
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Hungary
responsible party type: Principal Investigator
investigator affiliation: University of Pecs
investigator full name: Nagy Arnold
investigator title: Principal Investigator
mesh term: Arthritis
mesh term: Arthritis, Juvenile