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<docDscr>
  <citation>
    <titlStmt>
      <titl>Multicentric Cohort of Patients Receiving Systemic Treatment (Conventional or Biotherapy) for Moderate to Severe Cutaneous Psoriasis</titl>
      <IDNo>FRESH-PEF8863-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)" role="">SARRA POCHON</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Multicentric Cohort of Patients Receiving Systemic Treatment (Conventional or Biotherapy) for Moderate to Severe Cutaneous Psoriasis            </titl>
      <altTitl>
                    PSOBIOTEQ                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF8863-en            </IDNo>
      <IDNo agency="PEF">
                    8863                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF8863                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Olivier CHOSIDOW                                                                                                                            </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>
      <AuthEnty>
                    Florence TUBACH                                                                                                                            </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="The PSOBIOTEQ meets the objective of the European PSONET project to develop standardised procedures for the sharing and analysis of national data registers for the long-term monitoring of the efficacy and safety of systemic psoriasis treatment." type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            SOCIETE FRANÇAISE DE DERMATOLOGIE ET DE PATHOLOGIE SEXUELLEMENT TRANSMISSIBLE                    
                                    </producer>
      <producer role="sponsor">
                                            ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)                    
                                    </producer>
      <producer role="sponsor">
                                            MSD FRANCE                    
                                    </producer>
      <producer role="sponsor">
                                            PFIZER (FRANCE)                    
                                    </producer>
      <producer role="sponsor">
                                            JANSSEN CILAG (JANSSEN - JOHNSON &amp;amp; JOHNSON - JOHNSON &amp;amp; JOHNSON INNOVATIVE MEDICINE)                    
                                    </producer>
      <producer role="sponsor">
                                            ABBVIE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            ABBOTT FRANCE                    
                                    </fundAg>
      <fundAg>
                                            AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)                    
                                    </fundAg>
      <fundAg>
                                            ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)                    
                                    </fundAg>
      <fundAg>
                                            JANSSEN CILAG (JANSSEN - JOHNSON &amp;amp; JOHNSON - JOHNSON &amp;amp; JOHNSON INNOVATIVE MEDICINE)                    
                                    </fundAg>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
      <fundAg>
                                            MSD FRANCE                    
                                    </fundAg>
      <fundAg>
                                            PFIZER (FRANCE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)" email="olivier.chosidow@aphp.fr">
                    Olivier;CHOSIDOW
                                            <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
                                    </contact>
      <contact affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)" email="florence.tubach@aphp.fr">
                    Florence;TUBACH
                                            <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="267500452" 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="">
                    systemic conventional treatment</keyword>
      <keyword vocab="" vocabURI="">
                    methotrexate</keyword>
      <keyword vocab="" vocabURI="">
                    cyclosporine</keyword>
      <keyword vocab="" vocabURI="">
                    health safety</keyword>
      <keyword vocab="" vocabURI="">
                    real life</keyword>
      <keyword vocab="" vocabURI="">
                    skin cancer</keyword>
      <keyword vocab="" vocabURI="">
                    carcinoma</keyword>
      <keyword vocab="" vocabURI="">
                    usage</keyword>
      <keyword vocab="" vocabURI="">
                    biotherapy</keyword>
      <keyword vocab="" vocabURI="">
                    infliximab</keyword>
      <keyword vocab="" vocabURI="">
                    adalimumab</keyword>
      <keyword vocab="" vocabURI="">
                    etanercept</keyword>
      <keyword vocab="" vocabURI="">
                    ustekinumab</keyword>
      <keyword vocab="" vocabURI="">
                    pharmacoepidemiology</keyword>
      <keyword vocab="" vocabURI="">
                    exposure</keyword>
      <keyword vocab="" vocabURI="">
                    melanoma</keyword>
      <topcClas vocab="health theme">
                        Oncology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D008495"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Dermatology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/5375c411-6db9-40ed-a854-6554102a587b"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D003880"/>
                                                </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or conventional treatment) for moderate to severe cutaneous psoriasis. PSOBIOTEQ is the result of merging two studies that share the same study population but address different objectives: PSOBIO, developed by academic dermatologists and epidemiologists focusing on safety issues, and Pso-TEQ, developed by industrial teams at the request of the French Transparency Commission (Haute Autorité de Santé) that focuses on usage issues. The exposure of interest is the biological therapy exposure: Infliximab, Adalimumab, Etanercept and Ustekinumab. The general objective of PSOBIO is to assess the safety and efficacy of biotherapy in the treatment of cutaneous psoriasis "in real life" compared with conventional systemic therapy. However, Pso-TEQ has a descriptive objective concerning the usage methods of biological therapies "in real life" and the long-term benefits.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2012-01-01"/>
      <collDate event="end" date="2020-01-01"/>
      <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">Inclusion criteria: - Patients aged 18 or over; - Attending or hospitalised in services participating in the study; - Has been informed of the research objectives and outcome and has signed an informed consent form to participate; - Cutaneous psoriasis (clinical diagnosis); - Justifying the prescription of major systemic therapy (Methotrexate or Cyclosporine or biotherapy) and belongs to one of the following 3 groups: - Patients beginning biotherapy (Infliximab, Adalimumab, Etanercept, Ustekinumab and other biotherapy entering the market) AND who have not been previously exposed; - Patients beginning biotherapy AND who have been already exposed.                     </universe>
      <universe clusion="E">biotherapy) for at least 3 months (Methotrexate or Cyclosporine) AND for which no biotherapy treatment is planned within the next 6 months AND are naive to all biotherapy.criteria: - Patients for whom cutaneous psoriasis is not the main reason for systemic treatment (biotherapy or conventional treatment); treatment justified by psoriatic arthritis, concomitant Crohn's disease, etc. - Patients unable to comply with the cohort monitoring (unreachable by phone, unable to complete the self -administered questionnaire) or whose follow-up is expected to be difficult.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
      <dataKind>Behavioral data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>MeDRA</standardName>
        </standard>
      </standardsCompliance>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services
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>[1000-10000[ 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>2,636</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Data belongs to AP-HP and cannot be used or sent to a third party without prior consent. Access to data is by request to the Psobioteq project scientific committee; Access shall also be subject to a partnership contract signed between AP-HP and the legal representative of the requesting team specifying the terms and conditions of data provision. Every laboratory participating in the Psobioteq study will have access to data involving their product.</conditions>
    </useStmt>
    <notes>Psonet study variables (European study) will be sent to the European registry according to the terms outlined in a specific document.</notes>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
