<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF73342-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>Study of the conditions of use of golimumab and its impact, in current practice, in patients with chronic inflammatory rheumatism.</titl>
      <IDNo>FRESH-PEF73342-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="MSD FRANCE" role="">Laurie LEVY-BACHELOT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Study of the conditions of use of golimumab and its impact, in current practice, in patients with chronic inflammatory rheumatism.            </titl>
      <altTitl>
                    GO-PRACTICE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73342-en            </IDNo>
      <IDNo agency="PEF">
                    73342                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73342                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Najat GOUYETTE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="MSD FRANCE">
        <ExtLink title="ROR" URI="https://ror.org/00kt5kp12" role="organisation id"/>
        <ExtLink title="SIREN" URI="417890589" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Laurie LEVY-BACHELOT                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="MSD FRANCE">
        <ExtLink title="ROR" URI="https://ror.org/00kt5kp12" role="organisation id"/>
        <ExtLink title="SIREN" URI="417890589" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            MSD FRANCE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            MSD FRANCE                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="MSD FRANCE" email="laurie.levy-bachelot@msd.com">
                    Laurie;LEVY-BACHELOT
                                            <ExtLink title="ROR" URI="https://ror.org/00kt5kp12" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="417890589" 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>
      <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>
    </subject>
    <abstract contentType="purpose">To evaluate the maintenance of golimumab therapy 24 months after initial prescription in adult patients with chronic inflammatory rheumatism in clinical practice in France The primary endpoint is the total percentage of patients who maintained treatment with golimumab two years after the initial prescription.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date=""/>
      <collDate event="end" date=""/>
      <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:  1. Patients aged 18 years or older.  2. Patients who gave oral consent to participate after receiving oral and written information about the study.  3. Patients with a diagnosis of chronic inflammatory rheumatism.  4. Patients with an initial hospital prescription of golimumab but not yet having initiated treatment with golimumab.  5. Patients able to understand and complete the self-evaluation questionnaires                       </universe>
      <universe clusion="E">1. Patients previously treated with golimumab and discontinuing treatment prior to inclusion.2. Patients who participated in previous golimumab trials3. Patients who had already begun treatment with golimumab prior to inclusion and were receiving treatment at the time of inclusion.4. Patients with pathologies or conditions that, according to the investigator, would limit the patient's ability to participate fully in the study or to meet all the requirements of the study;                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners</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>
      <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>750 included</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access not yet planned</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
