<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/NCT01694693</url>
  </required_header>
  <id_info>
    <org_study_id>IM101-364</org_study_id>
    <nct_id>NCT01694693</nct_id>
  </id_info>
  <brief_title>Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study</brief_title>
  <official_title>Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Database analysis:&#xD;
&#xD;
        -  To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA)&#xD;
&#xD;
        -  To describe joint population of Orencia&#xD;
&#xD;
        -  To assess the impact of the treatment on health status of the treated population as&#xD;
           assessed by morbid-mortality criteria&#xD;
&#xD;
        -  To describe therapeutic strategies and use of health services&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Observational Model: Historic cohort generated from Société Française de Rhumatologie's&#xD;
           (SFR) Orencia and Rheumatoid Arthritis (ORA) registry&#xD;
&#xD;
        -  Sampling Method: all physicians and sites taking in charge RA patients received an&#xD;
           invitation mailing to participate to ORA&#xD;
&#xD;
        -  Minimum Age: 18 years old at Orencia initiation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Business objectives have changed&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 31, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with first clinically significant Disease Activity Score (DAS) change</measure>
    <time_frame>Up to 5 Years</time_frame>
    <description>Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≥ 1.2&#xD;
DAS28 will be measured every 6 months during 5 years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with first response to treatment [according to definition of European League Against Rheumatism (EULAR) response criteria]</measure>
    <time_frame>Up to 5 Years</time_frame>
    <description>EULAR response will be measured every 6 months during 5 years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with first Low Disease Activity State (LDAS)</measure>
    <time_frame>Up to 5 Years</time_frame>
    <description>Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≤ 3.2&#xD;
DAS28 will be measured every 6 months during 5 years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with first Remission state</measure>
    <time_frame>Up to 5 Years</time_frame>
    <description>Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation &lt;2.6&#xD;
DAS28 will be measured every 6 months during 5 years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients disease progression with prior improvement</measure>
    <time_frame>Up to 5 Years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients disease progression with no prior improvement</measure>
    <time_frame>Up to 5 Years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with modification of Orencia administration condition</measure>
    <time_frame>Up to 5 Years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients discontinued and switched from Orencia</measure>
    <time_frame>Up to 5 Years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rate of any type of Adverse events related to Orencia</measure>
    <time_frame>Up to 5 Years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with specific predefined events</measure>
    <time_frame>Up to 5 Years</time_frame>
    <description>Predefined events are severe infection, thromboembolic events, cancer, lymphoma, other autoimmune disease, cutaneous disorder, significant or persistent disability, death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response over the time will be assessed over 5 years on EULAR response, LDAS</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>RA patients treated by Orencia</arm_group_label>
    <description>RA patients treated by Orencia according to usual practice from June 1st 2007</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Orencia</intervention_name>
    <description>No Intervention</description>
    <arm_group_label>RA patients treated by Orencia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients included in SFR's ORA Registry&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For more information regarding BMS clinical trial participation, please visit&#xD;
        www.BMSStudyConnect.com.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult outpatients, male or female aged ≥ 18 years old&#xD;
&#xD;
          -  Diagnosed with a rheumatoid arthritis according to ACR criteria&#xD;
&#xD;
          -  Treated with Orencia according to usual practice conditions from June 1st 2007&#xD;
&#xD;
          -  Agreeing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients treated by Orencia in the context of clinical trials&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>May 9, 2017</last_update_submitted>
  <last_update_submitted_qc>May 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abatacept</mesh_term>
  </intervention_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/NCT01694693
org study id: IM101-364
nct id: NCT01694693
lead sponsor: 
has dmc: No
Database analysis:

        -  To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA)

        -  To describe joint population of Orencia

        -  To assess the impact of the treatment on health status of the treated population as
           assessed by morbid-mortality criteria

        -  To describe therapeutic strategies and use of health services
-  Observational Model: Historic cohort generated from Société Française de Rhumatologie's
           (SFR) Orencia and Rheumatoid Arthritis (ORA) registry

        -  Sampling Method: all physicians and sites taking in charge RA patients received an
           invitation mailing to participate to ORA

        -  Minimum Age: 18 years old at Orencia initiation
observational model: Other
time perspective: Retrospective
measure: Number of patients with first clinically significant Disease Activity Score (DAS) change
time frame: Up to 5 Years
description: Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≥ 1.2
DAS28 will be measured every 6 months during 5 years
measure: Number of patients with first response to treatment [according to definition of European League Against Rheumatism (EULAR) response criteria]
time frame: Up to 5 Years
description: EULAR response will be measured every 6 months during 5 years
measure: Number of patients with first Low Disease Activity State (LDAS)
time frame: Up to 5 Years
description: Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≤ 3.2
DAS28 will be measured every 6 months during 5 years
measure: Number of patients with first Remission state
time frame: Up to 5 Years
description: Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation <2.6
DAS28 will be measured every 6 months during 5 years
measure: Number of patients disease progression with prior improvement
time frame: Up to 5 Years
measure: Number of patients disease progression with no prior improvement
time frame: Up to 5 Years
measure: Number of patients with modification of Orencia administration condition
time frame: Up to 5 Years
measure: Number of patients discontinued and switched from Orencia
time frame: Up to 5 Years
measure: Incidence rate of any type of Adverse events related to Orencia
time frame: Up to 5 Years
measure: Number of patients with specific predefined events
time frame: Up to 5 Years
description: Predefined events are severe infection, thromboembolic events, cancer, lymphoma, other autoimmune disease, cutaneous disorder, significant or persistent disability, death
measure: Response over the time will be assessed over 5 years on EULAR response, LDAS
time frame: Up to 5 years
arm group label: RA patients treated by Orencia
description: RA patients treated by Orencia according to usual practice from June 1st 2007
intervention type: Drug
intervention name: Orencia
description: No Intervention
arm group label: RA patients treated by Orencia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Abatacept