<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/NCT03832374</url>
  </required_header>
  <id_info>
    <org_study_id>15/E/27</org_study_id>
    <nct_id>NCT03832374</nct_id>
  </id_info>
  <brief_title>Association Between Subtypes of Anti Citrullinated Peptide Antibodies and Lung Damage in Rheumatoid Arthritis</brief_title>
  <acronym>ACPPPA</acronym>
  <official_title>Study of the Association Between Subtypes of Anti Citrullinated Peptide Antibodies and Lung Damage in Rheumatoid Arthritis in the West Indies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Center of Martinique</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>
      Rheumatoid arthritis is a genuine systemic disease associated with diffuse interstitial&#xD;
      pneumopathy and bronchial disorders. According to the literature review, the prevalence of&#xD;
      PID on thoracic CT scan is one-third of patients. Diffuse interstitial pneumopathy is&#xD;
      responsible for a significant morbidity and mortality, is currently under-diagnosed and its&#xD;
      treatment is poorly codified. The lung seems to have a central role in the genesis of&#xD;
      rheumatoid arthritis. It also appears that some subtypes of anti citrullinated peptide&#xD;
      antibodies are preferentially present in the lungs.&#xD;
&#xD;
      The hypothesis behind our project is that one or more subtypes of anti citrullinated peptide&#xD;
      antibodies with a preferential tropism for the lung would attack the parenchyma and pulmonary&#xD;
      airways.&#xD;
&#xD;
      Currently, there are no data on interstitial pneumopathy in black and Afro-Caribbean subjects&#xD;
      with rheumatoid arthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2016</start_date>
  <completion_date type="Actual">March 2022</completion_date>
  <primary_completion_date type="Actual">March 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of the positivity of the anti citrullinated peptide antibodies and subtype</measure>
    <time_frame>three years</time_frame>
    <description>Presence of one or more subtypes of anti citrullinated peptide antibodies in the serum of patients with interstitial pneumopathy associated with rheumatoid arthritis who would be absent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Genetic analysis of the main mutations</measure>
    <time_frame>three years</time_frame>
    <description>Presence of mutation TERT, RTEL1, PARN et SFTPC</description>
  </secondary_outcome>
  <enrollment type="Actual">77</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Descriptive</intervention_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with rheumatoid arthritis with diffuse insterstitial lung disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with rheumatoid arthritis ACR/EULAR 2010&#xD;
&#xD;
          -  Patient with a higher age or equal to 18&#xD;
&#xD;
          -  Patient receiving social security&#xD;
&#xD;
          -  Patient giving his free and informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with overlap syndrome with another autoimmune disease&#xD;
&#xD;
          -  Patients with known severe cardiopulmonary pathology&#xD;
&#xD;
          -  Woman who is pregnant and breast feeding&#xD;
&#xD;
          -  Patient with language difficulties or understanding&#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>BLETTERY Marie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Martinique</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Martinique</name>
      <address>
        <city>Fort-de-France</city>
        <zip>97261</zip>
        <country>Martinique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Martinique</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>October 29, 2018</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>March 8, 2022</last_update_submitted>
  <last_update_submitted_qc>March 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2022</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>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03832374
org study id: 15/E/27
nct id: NCT03832374
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rheumatoid arthritis is a genuine systemic disease associated with diffuse interstitial
      pneumopathy and bronchial disorders. According to the literature review, the prevalence of
      PID on thoracic CT scan is one-third of patients. Diffuse interstitial pneumopathy is
      responsible for a significant morbidity and mortality, is currently under-diagnosed and its
      treatment is poorly codified. The lung seems to have a central role in the genesis of
      rheumatoid arthritis. It also appears that some subtypes of anti citrullinated peptide
      antibodies are preferentially present in the lungs.

      The hypothesis behind our project is that one or more subtypes of anti citrullinated peptide
      antibodies with a preferential tropism for the lung would attack the parenchyma and pulmonary
      airways.

      Currently, there are no data on interstitial pneumopathy in black and Afro-Caribbean subjects
      with rheumatoid arthritis.
observational model: Other
time perspective: Prospective
measure: Frequency of the positivity of the anti citrullinated peptide antibodies and subtype
time frame: three years
description: Presence of one or more subtypes of anti citrullinated peptide antibodies in the serum of patients with interstitial pneumopathy associated with rheumatoid arthritis who would be absent
measure: Genetic analysis of the main mutations
time frame: three years
description: Presence of mutation TERT, RTEL1, PARN et SFTPC
intervention type: Other
intervention name: Descriptive
plasma, urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: BLETTERY Marie, MD
role: Principal Investigator
affiliation: CHU de Martinique
facility: 
country: Martinique
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: Undecided