<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01692899</url>
  </required_header>
  <id_info>
    <org_study_id>NRB1800007</org_study_id>
    <secondary_id>B1801356</secondary_id>
    <nct_id>NCT01692899</nct_id>
  </id_info>
  <brief_title>Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice</brief_title>
  <acronym>MAINTAIN</acronym>
  <official_title>Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>scientific steering committee of KOL in rheumatology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy&#xD;
      in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated&#xD;
      factors, and retention rates of possible second-line tumor necrosis factor α inhibitors&#xD;
      (TNFi).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this retrolective, multicentric study, medical charts of RA patients starting TNFi between&#xD;
      March 2005 and April 2009 were reviewed, with follow-up between 2 and 6 years. The retention&#xD;
      rate was estimated using the Kaplan-Meier method. Comparison between TNFi was done after&#xD;
      adjustment using a Cox model. Factors associated with better retention were identified by&#xD;
      multivariate analysis. Medical charts of all patients with RA starting a first TNFα inhibitor&#xD;
      therapy between March 1, 2005 (start of commercialization of adalimumab in France) and April&#xD;
      30, 2009 (allowing at least 2 years of follow-up) were systematically reviewed in detail by 2&#xD;
      rheumatologist investigators&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compare retention rates of adalimumab, etanercept and infliximab administered as first-line biologic therapy in RA</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare retention rates of TNFα inhibitor monoclonal antibodies (adalimumab and infliximab) and the soluble receptor (etanercept)</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Causes of discontinuing these treatments</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the factors associated with better retention of the first TNFα inhibitors</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare retention rates of possible second-line TNFα inhibitors</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">780</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Etanercept</arm_group_label>
    <description>Etanercept: administered as first line biotherapy in RA during the period of the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adalimumab</arm_group_label>
    <description>Adalimumab: administered as first line biotherpy in RA during the period of the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infliximab</arm_group_label>
    <description>Infliximab: administered as first line biotherpy in RA during the period of the study</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        RA defined by the 1987 ACR criteria [18]; first TNFα inhibitor prescribed in the previously&#xD;
        mentioned period; TNFα inhibitor prescribed as first-line biotherapy; and patients had&#xD;
        undergone at least one evaluation in the center after treatment initiation. Patients were&#xD;
        excluded if: they had previously received another biotherapy; the TNFα inhibitor was&#xD;
        prescribed in an RCT; or they refused to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  RA defined by the 1987 ACR criteria [18]&#xD;
&#xD;
          -  first TNFα inhibitor prescribed in the previously mentioned period&#xD;
&#xD;
          -  TNFα inhibitor prescribed as first-line biotherapy&#xD;
&#xD;
          -  undergone at least one evaluation in the center after treatment initiation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previously received another biotherapy&#xD;
&#xD;
          -  TNFα inhibitor was prescribed in an RCT&#xD;
&#xD;
          -  refused to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=NRB1800007&amp;StudyName=Retention%20Rates%20of%20Adalimumab%2C%20Etanercept%20and%20Infliximab%20as%20First%20and%20Second-Line%20Biotherapy%20in%20Patients%20with%20Rheumatoid%20Arthritis%20in%20</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>September 24, 2012</last_update_submitted>
  <last_update_submitted_qc>September 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Retention Rates</keyword>
  <keyword>of Adalimumab</keyword>
  <keyword>Etanercept and Infliximab</keyword>
  <keyword>as First and Second-Line Biotherapy</keyword>
  <keyword>in Patients with Rheumatoid Arthritis</keyword>
  <keyword>in Daily Practice.</keyword>
  <keyword>TNF inhibitors</keyword>
  <keyword>biotherapy</keyword>
  <keyword>retrospective study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01692899
org study id: NRB1800007
secondary id: B1801356
nct id: NCT01692899
lead sponsor: 
collaborator: 
has dmc: No
To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy
      in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated
      factors, and retention rates of possible second-line tumor necrosis factor α inhibitors
      (TNFi).
In this retrolective, multicentric study, medical charts of RA patients starting TNFi between
      March 2005 and April 2009 were reviewed, with follow-up between 2 and 6 years. The retention
      rate was estimated using the Kaplan-Meier method. Comparison between TNFi was done after
      adjustment using a Cox model. Factors associated with better retention were identified by
      multivariate analysis. Medical charts of all patients with RA starting a first TNFα inhibitor
      therapy between March 1, 2005 (start of commercialization of adalimumab in France) and April
      30, 2009 (allowing at least 2 years of follow-up) were systematically reviewed in detail by 2
      rheumatologist investigators
time perspective: Retrospective
measure: Compare retention rates of adalimumab, etanercept and infliximab administered as first-line biologic therapy in RA
time frame: 2 years
measure: Compare retention rates of TNFα inhibitor monoclonal antibodies (adalimumab and infliximab) and the soluble receptor (etanercept)
time frame: 4 years
measure: Causes of discontinuing these treatments
time frame: 4 years
measure: Determine the factors associated with better retention of the first TNFα inhibitors
time frame: 4 years
measure: Compare retention rates of possible second-line TNFα inhibitors
time frame: 4 years
arm group label: Etanercept
description: Etanercept: administered as first line biotherapy in RA during the period of the study
arm group label: Adalimumab
description: Adalimumab: administered as first line biotherpy in RA during the period of the study
arm group label: Infliximab
description: Infliximab: administered as first line biotherpy in RA during the period of the study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=NRB1800007&StudyName=Retention%20Rates%20of%20Adalimumab%2C%20Etanercept%20and%20Infliximab%20as%20First%20and%20Second-Line%20Biotherapy%20in%20Patients%20with%20Rheumatoid%20Arthritis%20in%20
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid