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<docDscr>
  <citation>
    <titlStmt>
      <titl>Assessment and Follow-Up of Early Undifferentiated Rheumatoid Arthritis</titl>
      <IDNo>FRESH-PEF6711-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="SOCIETE FRAN&#xC7;AISE DE RHUMATOLOGIE" role="">Bernard COMBE</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Assessment and Follow-Up of Early Undifferentiated Rheumatoid Arthritis            </titl>
      <altTitl>
                    ESPOIR                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF6711-en            </IDNo>
      <IDNo agency="PEF">
                    6711                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF6711                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Bernard COMBE                                                                                </AuthEnty>
      <AuthEnty affiliation="SOCIETE FRAN&#xC7;AISE DE RHUMATOLOGIE">
        <ExtLink title="ROR" URI="https://ror.org/04g47ec58" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            SOCIETE FRANÇAISE DE RHUMATOLOGIE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            SOCIETE FRANÇAISE DE RHUMATOLOGIE                    
                                    </fundAg>
      <fundAg>
                                            ABBVIE                    
                                    </fundAg>
      <fundAg>
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </fundAg>
      <fundAg>
                                            LILLY FRANCE                    
                                    </fundAg>
      <fundAg>
                                            PFIZER (FRANCE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="SOCIETE FRAN&#xC7;AISE DE RHUMATOLOGIE" email="b-combe@chu-montpellier.fr">
                    Bernard;COMBE
                                            <ExtLink title="ROR" URI="https://ror.org/04g47ec58" role="organisation id"/>
                                    </contact>
      <contact affiliation="UNIVERSITE DE MONTPELLIER" email="nathalie.rincheval@inserm.fr">
                    Nathalie;RINCHEVAL
                                            <ExtLink title="ROR" URI="https://ror.org/051escj72" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130029796" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    rheumatoid arthritis</keyword>
      <keyword vocab="" vocabURI="">
                    Cohort</keyword>
      <topcClas vocab="health theme">
                        Rheumatology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D012219"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Inflammatory arthropathies                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Addiction                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants: Employment                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">To form a multicentric French cohort for early arthritis (less than 6 months duration) in order to establish a database for diagnostic, prognostic, medico-economic and pathogenetic studies.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2002-01-01"/>
      <collDate event="end" date="2025-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe clusion="I">Men or women - between 18 and 70 years old - affiliated with a social security scheme - who have at least 2 forms of arthritis for less than 6 weeks/months - who have not received any corticosteroids within the last 6 months (except for treatments lasting less than 2 weeks and infiltration if over 4 weeks before inclusion; except for oral steroid therapy over a period less than 2 weeks, averaging less than 20mg/day, concluded at least 15 days prior to inclusion)                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health care consumption and services
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
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        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[500-1000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>813</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Project data following call for proposals (twice per year) addressed to the Chairman of the Scientific Council and reviewed by two specialists. Final approval is given by the Scientific Council. Specific data are transferred after signing an agreement. A list of publications and works is available on the website.</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
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