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<docDscr>
  <citation>
    <titlStmt>
      <titl>Observational Cohort on Rheumatology Practices and Uses</titl>
      <IDNo>FRESH-PEF60035-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="chu" role="">Francis GUILLEMIN</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Observational Cohort on Rheumatology Practices and Uses            </titl>
      <altTitl>
                    CORPUS                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60035-en            </IDNo>
      <IDNo agency="PEF">
                    60035                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60035                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Francis GUILLEMIN                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="chu">
        <ExtLink title="ROR" URI="https://ror.org/016ncsr12" role="organisation id"/>
        <ExtLink title="SIREN" URI="200042166" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            ABBOTT FRANCE                    
                                    </fundAg>
      <fundAg>
                                            MERCK SANTE                    
                                    </fundAg>
      <fundAg>
                                            PFIZER (FRANCE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="chu" email="francis.guillemin@univ-lorraine.fr">
                    Francis;GUILLEMIN
                                            <ExtLink title="ROR" URI="https://ror.org/016ncsr12" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="200042166" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Quality of life</keyword>
      <keyword vocab="" vocabURI="">
                    health</keyword>
      <keyword vocab="" vocabURI="">
                    healthcare usage</keyword>
      <keyword vocab="" vocabURI="">
                    resumption of activity</keyword>
      <keyword vocab="" vocabURI="">
                    biotherapy treatment</keyword>
      <keyword vocab="" vocabURI="">
                    side effects</keyword>
      <keyword vocab="" vocabURI="">
                    switch</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 spondyloarthritis                                            </topcClas>
      <topcClas vocab="cim-11">
                        Juvenile idiopathic arthritis                                            </topcClas>
    </subject>
    <abstract contentType="purpose">General objective: to determine the impact of basic prescribed treatment with or without prescribed biotherapy, focussing on the impact of changes in biotherapy over time. Epidemiological recording of the occurrence of adverse events in the long term. Secondary objective: To investigate the role of biotherapy in patient treatment by determining its position in prescribed treatment order during therapeutic sequences.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2007-01-01"/>
      <collDate event="end" date="2012-01-01"/>
      <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 level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">All patients that have never received biotherapy and are monitored in one of the participating centres: - patients with active rheumatoid arthritis (with or without prescription), DAS28 score greater than 3.2 regardless of disease onset age, with hand and feet x-rays in the last 3 months - active idiopathic juvenile arthritis (JIA) (with or without prescription), following methrexate intolerance or failure, x-ray in the last 3 months - active (with or without prescription) spondyloarthritis (SPA) (ankylosing or psoriatic arthritis) regardless of disease onset age, pelvic and spinal x-ray in the last 3 months, or of hands and feet according to peripheral or axial form                    </universe>
      <dataKind>Clinical data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <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>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>640 (407 PAR, 192 SPA, 41 AJI)</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Metadata-only access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
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