<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF74116-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>Subcutaneous Tocilizumab in monotherapy or in combination with csDMARD in patients with moderate to severe active Rheumatoid Arthritis and followed by hospital and office-based rheumatologists: Non-interventional study to describe realworld drug retention rate of the biotherapy at 1 year</titl>
      <IDNo>FRESH-PEF74116-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="F. HOFFMANN-LA ROCHE AG" role="">Camille BACHOT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Subcutaneous Tocilizumab in monotherapy or in combination with csDMARD in patients with moderate to severe active Rheumatoid Arthritis and followed by hospital and office-based rheumatologists: Non-interventional study to describe realworld drug retention rate of the biotherapy at 1 year            </titl>
      <altTitl>
                    TANDEM                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF74116-en            </IDNo>
      <IDNo agency="PEF">
                    74116                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF74116                </IDNo>
      <IDNo agency="NCT">
                    NCT02608112                </IDNo>
    </titlStmt>
    <rspStmt>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            F. HOFFMANN-LA ROCHE AG                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="F. HOFFMANN-LA ROCHE AG" email="data_sharing.france@roche.com">
                    ;Medical data center
                                            <ExtLink title="ROR" URI="https://ror.org/01mqmer16" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="775752140" 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="">
                    Tocilizumab</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">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Primary objective : To assess the drug retention rate of TCZ sc at 12 months under real-world conditions in patients with moderate to severe active RA followed by hospital- and office-based rheumatologists Secondary objectives : - To assess the drug retention rate of TCZ sc at 6 and 18 months. - To compare the drug retention of TCZ sc in monotherapy and in combination with MTX or other csDMARD. - To describe steroid dosing after introduction of TCZ sc with a stratification on the use of MTX or other csDMARDs at 6, 12 and 18 months. - To assess adherence to TCZ sc using a French version of the Compliance Questionnaire for Rheumatology 5 (CQR5) and patient diary at 6, 12 and 18 months. - To evaluate the French version of the CQR5 by assessing the correlation with the data collected from the patient diary data. - To describe the modalities of use of TCZ sc. - To describe the management of RA and patients’ healthcare pathway between hospital- and office-based rheumatologists. - To describe the efficacy of TCZ sc under real-world conditions of use. - To describe the characteristics of patients treated with TCZ sc and the characteristics of the involved physicians. - To assess the tolerability profile of TCZ sc under real-world conditions of use. - To describe the quality of life (QoL) in patients receiving TCZ sc under real-world conditions of use.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2015-01-01"/>
      <collDate event="end" date="2018-01-01"/>
      <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 at least 18 years-old. - Patients with moderate to severe RA not previously treated with TCZ (iv or sc), for whom the rheumatologists have decided to initiate TCZ sc treatment as monotherapy or in combination with another csDMARD. - Patients who have been informed verbally and in writing about this study, who do not object to their data being electronically processed or subjected to data quality control and who have signed the consent form.                    </universe>
      <dataKind>Clinical data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>CDISC</standardName>
        </standard>
      </standardsCompliance>
      <otherQualityStatement>GCP/GVP</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <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>&lt; 500 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>286</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
