<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/NCT03818958</url>
  </required_header>
  <id_info>
    <org_study_id>17-COLL-04</org_study_id>
    <nct_id>NCT03818958</nct_id>
  </id_info>
  <brief_title>Seric Calprotectine in Spondyloarthritis</brief_title>
  <acronym>Calprotect</acronym>
  <official_title>Study of the Interest of Serum Calprotectin Determination in the Diagnosis of Spondyloarthritis and to Diferenciate With Fibromyalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      To date, there are no biomarkers in spondyloarthritis that can differentiate between&#xD;
      spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker&#xD;
      that is increasingly used in inflammatory diseases of the digestive tract. A growing interest&#xD;
      in this biomarker is emerging in rheumatology, several publications have focused on its&#xD;
      interest in rheumatoid arthritis, highlighting an association between serum calprotectin&#xD;
      levels and disease activity. In spondyloarthritis, a few studies seem to show that it could&#xD;
      be a marker of disease activity. Although a 2012 study found no difference in serum&#xD;
      calprotectin levels between subjects with spondyloarthritis and controls. Still others have&#xD;
      shown that it could be a predictive factor of radiological evolution in the same disease key.&#xD;
      These data support, despite the questionable results of the Klingberg study, the value of&#xD;
      this dosage in spondyloarthritis. The objective of this work is to show that this assay could&#xD;
      be useful to differentiate spondyloarthritis from other pathologies with similar clinical&#xD;
      presentation such as fibromyalgia. Difficulties classically encountered in common practice in&#xD;
      rheumatology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">January 15, 2018</completion_date>
  <primary_completion_date type="Actual">January 15, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>calprotectine rate</measure>
    <time_frame>5 months</time_frame>
    <description>blood test</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Spondylarthritis</condition>
  <arm_group>
    <arm_group_label>active spondyloarthritis</arm_group_label>
    <description>subjects with active spondyloarthritis with a BASDAI greater than 4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>remission spondyloarthritis</arm_group_label>
    <description>subjects presenting with a remission spondyloarthritis defined by a BASDAI less than 4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls without spondyloarthritis</arm_group_label>
    <description>controls without spondyloarthritis or other chronic inflammatory rheumatism and without fibromyalgia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fibromyalgia</arm_group_label>
    <description>subjects with fibromyalgia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sampling</intervention_name>
    <description>blood sampling</description>
    <arm_group_label>active spondyloarthritis</arm_group_label>
    <arm_group_label>controls without spondyloarthritis</arm_group_label>
    <arm_group_label>fibromyalgia</arm_group_label>
    <arm_group_label>remission spondyloarthritis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary clinic care, rheumatology patients at the CHU de NICE&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients in the active line of the rheumatology department with one of the following&#xD;
             criteria:&#xD;
&#xD;
               -  active spondyloarthritis (BASDAI &gt;4),&#xD;
&#xD;
               -  or spondyloarthritis in low activity (BASDAI&lt;4),&#xD;
&#xD;
               -  or fibromyalgia without associated inflammatory rheumatism,&#xD;
&#xD;
               -  or healthy subjects (without inflammatory rheumatism and without fibromyalgia.&#xD;
&#xD;
          -  Patients who have not objected to the use of their samples&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patient&#xD;
&#xD;
          -  Subject not affiliated to the social security system&#xD;
&#xD;
          -  Subject deprived of liberty&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nice Hospital</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</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>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03818958
org study id: 17-COLL-04
nct id: NCT03818958
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To date, there are no biomarkers in spondyloarthritis that can differentiate between
      spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker
      that is increasingly used in inflammatory diseases of the digestive tract. A growing interest
      in this biomarker is emerging in rheumatology, several publications have focused on its
      interest in rheumatoid arthritis, highlighting an association between serum calprotectin
      levels and disease activity. In spondyloarthritis, a few studies seem to show that it could
      be a marker of disease activity. Although a 2012 study found no difference in serum
      calprotectin levels between subjects with spondyloarthritis and controls. Still others have
      shown that it could be a predictive factor of radiological evolution in the same disease key.
      These data support, despite the questionable results of the Klingberg study, the value of
      this dosage in spondyloarthritis. The objective of this work is to show that this assay could
      be useful to differentiate spondyloarthritis from other pathologies with similar clinical
      presentation such as fibromyalgia. Difficulties classically encountered in common practice in
      rheumatology.
observational model: Case-Control
time perspective: Cross-Sectional
measure: calprotectine rate
time frame: 5 months
description: blood test
arm group label: active spondyloarthritis
description: subjects with active spondyloarthritis with a BASDAI greater than 4
arm group label: remission spondyloarthritis
description: subjects presenting with a remission spondyloarthritis defined by a BASDAI less than 4
arm group label: controls without spondyloarthritis
description: controls without spondyloarthritis or other chronic inflammatory rheumatism and without fibromyalgia
arm group label: fibromyalgia
description: subjects with fibromyalgia
intervention type: Other
intervention name: blood sampling
description: blood sampling
arm group label: active spondyloarthritis
arm group label: controls without spondyloarthritis
arm group label: fibromyalgia
arm group label: remission spondyloarthritis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
sharing ipd: No