<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/NCT01688219</url>
  </required_header>
  <id_info>
    <org_study_id>45896566645469</org_study_id>
    <nct_id>NCT01688219</nct_id>
  </id_info>
  <brief_title>Immune Response in the SAPHO Syndrome</brief_title>
  <official_title>Immune Mechanisms During SAPHO Syndrome and Treatment by Etarnecept</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <brief_summary>
    <textblock>
      The aetiology of SAPHO syndrome seems to involve genetic, infectious and immunological&#xD;
      components. The investigators examined innate and adaptative immune responses in SAPHO&#xD;
      syndrome as compared with psoriatic arthritis and rheumatoid arthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2005</start_date>
  <completion_date type="Actual">May 2008</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>IL-8 production by PMN</measure>
    <time_frame>24 h</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>TNFalpha production by PMN</measure>
    <time_frame>24 h</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">39</enrollment>
  <condition>SAPHO Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        SAPHO syndrome patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of SAPHO syndrome&#xD;
&#xD;
          -  Must have bone lesions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infliximab treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilles Hayem, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Assitance Publique-Hopitaux Paris</affiliation>
  </overall_official>
  <verification_date>October 2007</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SAPHO syndrome</keyword>
  <keyword>Innate immunity</keyword>
  <keyword>TNF alpha</keyword>
  <keyword>Polymorphonuclear neutrophils</keyword>
  <keyword>Propionibacterium acnes</keyword>
  <keyword>Interleukin-8</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Hyperostosis Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT01688219
org study id: 45896566645469
nct id: NCT01688219
lead sponsor: 
The aetiology of SAPHO syndrome seems to involve genetic, infectious and immunological
      components. The investigators examined innate and adaptative immune responses in SAPHO
      syndrome as compared with psoriatic arthritis and rheumatoid arthritis.
observational model: Cohort
time perspective: Prospective
measure: IL-8 production by PMN
time frame: 24 h
measure: TNFalpha production by PMN
time frame: 24 h
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gilles Hayem, PhD
role: Study Director
affiliation: Assitance Publique-Hopitaux Paris
responsible party type: Sponsor
mesh term: Acquired Hyperostosis Syndrome
mesh term: Syndrome