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<docDscr>
  <citation>
    <titlStmt>
      <titl>Inflammatory Diseases in Paediatric Rheumatology</titl>
      <IDNo>FRESH-PEF60138-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)" role="">Pierre QUARTIER-DIT-MAIRE</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Inflammatory Diseases in Paediatric Rheumatology            </titl>
      <altTitl>
                    CEMARA                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60138-en            </IDNo>
      <IDNo agency="PEF">
                    60138                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60138                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Pierre QUARTIER-DIT-MAIRE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)">
        <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
        <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <producer role="sponsor">
                                            ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)" email="pierre.quartier@aphp.fr">
                    Pierre;QUARTIER-DIT-MAIRE
                                            <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="267500452" 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="">
                    adverse events</keyword>
      <keyword vocab="" vocabURI="">
                    life-threatening</keyword>
      <keyword vocab="" vocabURI="">
                    sequelae</keyword>
      <keyword vocab="" vocabURI="">
                    embryonic/foetal impairment</keyword>
      <keyword vocab="" vocabURI="">
                    neoplasia</keyword>
      <keyword vocab="" vocabURI="">
                    Health episodes</keyword>
      <keyword vocab="" vocabURI="">
                    death</keyword>
      <keyword vocab="" vocabURI="">
                    hospitalisation</keyword>
      <topcClas vocab="health theme">
                        Paediatrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D010372"/>
                                                </topcClas>
      <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">
                        Menopause                                            </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">General objective: To evaluate the risk of the occurrence of serious adverse events under or after exposure to prescribed biotherapy for rheumatoid arthritis. The selected population consists of a growing proportion of patients exposed to early introductory biotherapy from childhood (TNF-Alpha antagonists, IL-1, IL-6, anti-CD20, CTLA-4Ig etc.), sometimes in combination with immunosuppressants Secondary objectives: 1/ To simultaneously assess the risk of the occurrence of serious adverse events (SAE) in the absence of biotherapy for the entire paediatric rheumatology cohort. 2/ To assess the risk of SAEs in the presence or absence of biotherapy for main sub-cohorts: juvenile idiopathic arthritis, paediatric autoimmune diseases, systemic vasculitis and childhood collagen diseases including lupus. 3/ To describe progressive characteristics and treatment of these patients in more detail. 4/ To further basic, clinical and epidemiological studies by creating a biobank and connections with other cohorts and registries 5/ To promote the assessment of medical practices and the application of national protocol recommendations for diagnosis and care.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2007-01-01"/>
      <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">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002648"/>
                                                    </universe>
      <universe clusion="I">Patients included in the CEMARA database must have a diagnosis relevant to the label "juvenile arthritis" in the rare disease reference centre = inflammatory paediatric rheumatology diseases identified in the CEMARA thesaurus (and Orphanet thesauraus) belonging to one of the following 4 categories: juvenile idiopathic arthritis, other juvenile arthritis, paediatric autoinflammatory diseases, systemic diseases and paediatric vasculitis                    </universe>
      <dataKind>Clinical data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality</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>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <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>1068</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
      <complete>Data may be used by academic teams. Data may not be used by industrial teams</complete>
    </setAvail>
    <useStmt>
      <restrctn>Contractual access.</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
