<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/NCT03003572</url>
  </required_header>
  <id_info>
    <org_study_id>1608171</org_study_id>
    <secondary_id>ANSM</secondary_id>
    <nct_id>NCT03003572</nct_id>
  </id_info>
  <brief_title>Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity</brief_title>
  <acronym>I GET DRY</acronym>
  <official_title>Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to&#xD;
      life-threatening conditions and is always responsible for a decreased quality of life. Its&#xD;
      evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be&#xD;
      carried out routinely is major in patients' follow-up. Because of the existence of&#xD;
      autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for&#xD;
      anti-Ro/SSA antibodies in inducing interferon alpha (IFNα) signaling and the specific&#xD;
      pharmacologic properties of IgE, anti-Ro/SSA IgE should be an interesting biomarker to&#xD;
      determine pSS's activity. The aim of the study is to evaluate whether the proportion of&#xD;
      anti-Ro/SSA IgE positive patients is higher in patients with active disease (i.e. Eular&#xD;
      Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or&#xD;
      already known diagnosis) will be included, Anti-Ro/SSA IgE titers will be determined, the&#xD;
      disease's features will be collected (including Eular Sjögren Syndrome Disease Activity&#xD;
      Index/Eular Sjogren's Syndrome Patient Reported Index).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 27, 2018</start_date>
  <completion_date type="Anticipated">June 2027</completion_date>
  <primary_completion_date type="Anticipated">June 2027</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of anti-Ro/SSA IgE positive patients</measure>
    <time_frame>Day 1</time_frame>
    <description>Comparison of proportion of anti-Ro/SSA IgE positive patients between patients with active pSS and patient without active pSS anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).&#xD;
Active pSS is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI) ≥ 5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between anti-Ro/SSA IgE titers and pSS's activity.</measure>
    <time_frame>Day 1</time_frame>
    <description>pSS's activity is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI).&#xD;
Anti-Ro/SSA IgE titers is measured by serial dilutions of the serum. Anti-Ro/SSA IgE titers is the last dilution whose absorbance (in optical density) is higher than positivity threshold.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between anti-Ro/SSA IgE positive patients and the symptomatology level</measure>
    <time_frame>Day 1</time_frame>
    <description>Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).&#xD;
The symptomatology level is measured by the Score Eular Sjogren's Syndrome Patient Reported Index (ESSPRI).&#xD;
If ESSPRI≥5: symptomatology whose intensity felt by the patient is not acceptable.&#xD;
If ESSPRI&lt;5: symptomatology whose intensity felt by the patient is acceptable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between anti-Ro/SSA IgE positive patients and onset of lymphoma</measure>
    <time_frame>5 years</time_frame>
    <description>Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).&#xD;
There is a medical monitoring every years by medical record and/or by phone know that a development of lymphoma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between anti-Ro/SSA IgE positive patients and interferon alpha signature</measure>
    <time_frame>Day 1</time_frame>
    <description>Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).&#xD;
Interferon alpha signature level is measured by real-time Polymerase Chain Reaction (PCR). They calculate the average of delta cycle threshold in messenger ribonucleic acid (mRNA) of regulate gene by interferon alpha.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison between anti-Ro/SSA IgE positive patients and clinical and biologic characteristics</measure>
    <time_frame>Day 1</time_frame>
    <description>Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).&#xD;
Composite outcome of clinical and biologic characteristics is describe below.&#xD;
Clinical characteristics: type of affected organs, lymphoma medical history, allergic disorders, scores Eular Sjögren Syndrome Disease Activity Index (ESSDAI), Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) and analogue visual scale disease patient and doctor, saliva flow and Schirmer test.&#xD;
Biologic characteristics: anti-Ro/SSA IgE titers, rheumatoid factor titers and number of totals lymphocytes and T cluster of differentiation 4 (CD4) lymphocytes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison between anti-La/SSB IgE positive patients and clinical and biologic characteristics</measure>
    <time_frame>Day 1</time_frame>
    <description>Anti-La/SSB IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).&#xD;
Composite outcome of clinical and biologic characteristics is describe below.&#xD;
Clinical characteristics: type of affected organs, lymphoma medical history, allergic disorders, scores Eular Sjögren Syndrome Disease Activity Index (ESSDAI), Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) and analogue visual scale disease patient and doctor, saliva flow and Schirmer test.&#xD;
Biologic characteristics: anti-La/SSB IgE titers, rheumatoid factor titers and number of totals lymphocytes and T CD4 lymphocytes.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">185</enrollment>
  <condition>Primary Sjögren's Syndrome</condition>
  <arm_group>
    <arm_group_label>patients with primary Sjögren's syndrome</arm_group_label>
    <description>Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA) in patients with primary Sjögren's syndrome according to the American-European Consensus Criteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood samples</intervention_name>
    <description>Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA).</description>
    <arm_group_label>patients with primary Sjögren's syndrome</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with primary Sjögren's syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary Sjögren's syndrome according to the American-European Consensus Criteria)&#xD;
&#xD;
          -  Informed and having signed the study consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary Sjögren's syndrome&#xD;
&#xD;
          -  Other systemic autoimmune disease (e.g. rheumatoid arthritis, AntiNeutrophil&#xD;
             Antibodies (ANCA) -associated vasculitis, mixed connective tissue disease…)&#xD;
&#xD;
          -  Incapacity or refusal to sign the informed consent form&#xD;
&#xD;
          -  Incapacity or refusal to perform the follow-up examinations required by the study&#xD;
&#xD;
          -  Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, Tumor&#xD;
             Necrosis Factor (TNF) antagonists or interferon during the 6 months prior to the&#xD;
             inclusion&#xD;
&#xD;
          -  Has any current signs or symptoms of active infection&#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>Pascal CATHEBRAS, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pascal CATHEBRAS, MD PhD</last_name>
    <phone>(0)477828342</phone>
    <phone_ext>+33</phone_ext>
    <email>pascal.cathebras@chu-st-etienne.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Florence RANCON, CRA</last_name>
    <phone>(0)477120284</phone>
    <phone_ext>+33</phone_ext>
    <email>florence.rancon@chu-st-etienne.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CH Pierre Oudot</name>
      <address>
        <city>Bourgoin-Jallieu</city>
        <zip>38300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marielle ROUX, MD</last_name>
    </contact>
    <investigator>
      <last_name>Marielle ROUX, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Estaing - Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc RUIVARD, MD PhD</last_name>
    </contact>
    <investigator>
      <last_name>Marc RUIVARD, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Virginie RIEU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vincent GROBOST, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble Alpes</name>
      <address>
        <city>Grenoble</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurence BOULLET, MD PhD</last_name>
    </contact>
    <investigator>
      <last_name>Laurence BOUILLET, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Françoise SARROT-REYNAULD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alban DEROUX, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexis BOCQUET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aurélie MADELON, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal SEVE, MD</last_name>
    </contact>
    <investigator>
      <last_name>Pascal SEVE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yvan JAMILLOUX, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mathieu GERFAUD-VALENTIN, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Claire BERNARD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mathilde FRANÇOIS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Lyon Sud</name>
      <address>
        <city>Lyon</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Christophe LEGA, MD</last_name>
    </contact>
    <investigator>
      <last_name>Jean-Christophe LEGA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Quitterie REYNAUD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Isabelle DURIEU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sabine MAINBOURG, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Edouard Herriot - CHU Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Arnaud HOT, MD PhD</last_name>
    </contact>
    <investigator>
      <last_name>Arnaud HOT, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cécile-Audrey DUREL, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Reims</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Amélie SERVATTAZ, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chu Saint-Etienne</name>
      <address>
        <city>Saint Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal CATHEBRAS, MD PhD</last_name>
    </contact>
    <investigator>
      <last_name>Pascal CATHEBRAS, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Isabelle GUICHARD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Baptiste GAULTIER, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne-Emmanuelle DEPINCE-BERGER, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thierry THOMAS, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hubert MAROTTE, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Héloïse MUNOZ-PONS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martin KILLIAN, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Béatrice PALLOT-PRADES, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Karima BOUSSOUALIM, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mijola LAMBERT, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sjögren's syndrome</keyword>
  <keyword>Immunoglobulin E</keyword>
  <keyword>Anti-Ro/SSA</keyword>
  <keyword>Autoimmune disease</keyword>
  <keyword>Biomarker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sjogren's Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03003572
org study id: 1608171
secondary id: ANSM
nct id: NCT03003572
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to
      life-threatening conditions and is always responsible for a decreased quality of life. Its
      evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be
      carried out routinely is major in patients' follow-up. Because of the existence of
      autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for
      anti-Ro/SSA antibodies in inducing interferon alpha (IFNα) signaling and the specific
      pharmacologic properties of IgE, anti-Ro/SSA IgE should be an interesting biomarker to
      determine pSS's activity. The aim of the study is to evaluate whether the proportion of
      anti-Ro/SSA IgE positive patients is higher in patients with active disease (i.e. Eular
      Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or
      already known diagnosis) will be included, Anti-Ro/SSA IgE titers will be determined, the
      disease's features will be collected (including Eular Sjögren Syndrome Disease Activity
      Index/Eular Sjogren's Syndrome Patient Reported Index).
observational model: Cohort
time perspective: Prospective
measure: Proportion of anti-Ro/SSA IgE positive patients
time frame: Day 1
description: Comparison of proportion of anti-Ro/SSA IgE positive patients between patients with active pSS and patient without active pSS anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).
Active pSS is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI) ≥ 5
measure: Correlation between anti-Ro/SSA IgE titers and pSS's activity.
time frame: Day 1
description: pSS's activity is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI).
Anti-Ro/SSA IgE titers is measured by serial dilutions of the serum. Anti-Ro/SSA IgE titers is the last dilution whose absorbance (in optical density) is higher than positivity threshold.
measure: Correlation between anti-Ro/SSA IgE positive patients and the symptomatology level
time frame: Day 1
description: Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).
The symptomatology level is measured by the Score Eular Sjogren's Syndrome Patient Reported Index (ESSPRI).
If ESSPRI≥5: symptomatology whose intensity felt by the patient is not acceptable.
If ESSPRI<5: symptomatology whose intensity felt by the patient is acceptable.
measure: Correlation between anti-Ro/SSA IgE positive patients and onset of lymphoma
time frame: 5 years
description: Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).
There is a medical monitoring every years by medical record and/or by phone know that a development of lymphoma.
measure: Correlation between anti-Ro/SSA IgE positive patients and interferon alpha signature
time frame: Day 1
description: Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).
Interferon alpha signature level is measured by real-time Polymerase Chain Reaction (PCR). They calculate the average of delta cycle threshold in messenger ribonucleic acid (mRNA) of regulate gene by interferon alpha.
measure: Comparison between anti-Ro/SSA IgE positive patients and clinical and biologic characteristics
time frame: Day 1
description: Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).
Composite outcome of clinical and biologic characteristics is describe below.
Clinical characteristics: type of affected organs, lymphoma medical history, allergic disorders, scores Eular Sjögren Syndrome Disease Activity Index (ESSDAI), Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) and analogue visual scale disease patient and doctor, saliva flow and Schirmer test.
Biologic characteristics: anti-Ro/SSA IgE titers, rheumatoid factor titers and number of totals lymphocytes and T cluster of differentiation 4 (CD4) lymphocytes.
measure: Comparison between anti-La/SSB IgE positive patients and clinical and biologic characteristics
time frame: Day 1
description: Anti-La/SSB IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA).
Composite outcome of clinical and biologic characteristics is describe below.
Clinical characteristics: type of affected organs, lymphoma medical history, allergic disorders, scores Eular Sjögren Syndrome Disease Activity Index (ESSDAI), Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) and analogue visual scale disease patient and doctor, saliva flow and Schirmer test.
Biologic characteristics: anti-La/SSB IgE titers, rheumatoid factor titers and number of totals lymphocytes and T CD4 lymphocytes.
arm group label: patients with primary Sjögren's syndrome
description: Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA) in patients with primary Sjögren's syndrome according to the American-European Consensus Criteria.
intervention type: Other
intervention name: Blood samples
description: Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA).
arm group label: patients with primary Sjögren's syndrome
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pascal CATHEBRAS, MD PhD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
last name: Pascal CATHEBRAS, MD PhD
phone: (0)477828342
phone ext: +33
email: pascal.cathebras@chu-st-etienne.fr
last name: Florence RANCON, CRA
phone: (0)477120284
phone ext: +33
email: florence.rancon@chu-st-etienne.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Sjogren's Syndrome
mesh term: Syndrome
sharing ipd: No