<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/NCT03274141</url>
  </required_header>
  <id_info>
    <org_study_id>IM101-331</org_study_id>
    <nct_id>NCT03274141</nct_id>
  </id_info>
  <brief_title>Comparing the Effectiveness of a Treat-to-target (T2T) Disease Management Strategy vs. Routine Care (RC) in Adult Patients With Moderate to Severe Rheumatoid Arthritis (RA) Treated With Subcutaneous Abatacept (Orencia - SC)</brief_title>
  <acronym>ABC</acronym>
  <official_title>The Abatacept Best Care (ABC) Trial</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>
      This is a 12 month prospective, multicenter, post-marketing, observational study to compare&#xD;
      the effectiveness of a treat-to-target (T2T) disease management strategy vs. routine care&#xD;
      (RC) in adult patients with moderate to severe rheumatoid arthritis (RA) treated with&#xD;
      subcutaneous abatacept (Orencia - SC). Patients completing the study will be offered to&#xD;
      participate in a 12-month extension of their follow-up provided that this is in agreement&#xD;
      with the judgment of the treating physician.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2011</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of T2T patients achieving sustained CDAI LDA</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of RC patients achieving sustained CDAI LDA</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving SDAI remission</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Simplified Disease Activity Index (SDAI) remission is achieved when SDAI score is less than or equal to 3.3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time for patients to achieve SDAI remission</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Length of time from treatment initiation SDAI remission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving CDAI remission</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Clinical Disease Activity Index (CDAI) remission is achieved when CDAI score is less than or equal to 2.8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time for patients to achieve CDAI remission</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Length of time from treatment initiation CDAI remission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving DAS28-CRP LDA</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Disease Activity Score (DAS) Low Disease Activity (LDA) is achieved when DAS28-CRP score is less than 3.2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time for patients to achieve DAS28-CRP LDA</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Length of time from treatment initiation to a DAS28-CRP score of less than 3.2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving DAS28-CRP remission</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Disease Activity Score (DAS) remission is achieved when DAS28-CRP score is less than 2.6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time for patients to achieve DAS28-CRP remission</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Length of time from treatment initiation to a DAS28-CRP score of less than 2.6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving Boolean remission</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Boolean remission is defined as TJC28 ≤1 and SJC28 ≤1 and CRP ≤1 mg/dl and PtGA ≤1 (on a 0-10 scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time for patients to achieve Boolean remission</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Length of time from treatment initiation to Boolean remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving RAPID3 LDA</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Routine Assessment of Patient Index Data 3 (RAPID3) Low Disease Activity (LDA) is achieved when RAPID3 score is less than or equal to 6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time for patients to achieve RAPID3 LDA</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Length of time from treatment initiation to a RAPID3 score of less than or equal to 6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving RAPID3 remission</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Routine Assessment of Patient Index Data 3 (RAPID3) remission is achieved when RAPID3 score is less than or equal to 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time for patients to achieve RAPID3 remission</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Length of time from treatment initiation to a RAPID3 score of less than or equal to 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving MCID in HAQ-DI</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>minimal clinically important difference (MCID; Δ ≥ 0.22, ≥0.25, and ≥0.5) in Health Assessment Questionnaire Disability Index (HAQ-DI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time for patients to achieve MCID in HAQ-DI</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Length of time from treatment initiation to a Δ ≥ 0.22, ≥0.25, and ≥0.5 in HAQ-DI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving clinically meaningful improvement</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Number of patients achieving clinically meaningful improvement as measured by a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time for patients to achieve clinically meaningful improvement</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Length of time from treatment initiation to a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving patient expectations for treatment of their RA</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Assessed using simple Visual Analogue Scales (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in DAS28-CRP score</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>Measured by investigator assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in CDAI score</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>Measured by investigator assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in SDAI score</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>Measured by investigator assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in RAPID3 score</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>Measured by investigator assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Tender Joint Count of 28 joints (TJC28) score</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>Measured by patient assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Swollen Joint Count of 28 joints (SJC28) score</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>Measured by patient assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in HAQ-DI score</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>Measured by patient assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Work Productivity and Activity Impairment (WPAI) score</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>Measured by patient assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Patient Pain</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>Measured by patient assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Patient Fatigue</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>Measured by patient assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients continuing treatment</measure>
    <time_frame>At 12 months</time_frame>
    <description>Measured by investigator assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients continuing treatment</measure>
    <time_frame>At 24 months</time_frame>
    <description>Measured by investigator assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of changes to Rheumatoid Arthritis (RA) treatment</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Measured by investigator assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Measured by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent Adverse Events</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Measured by investigator assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to achieve sustained CDAI LDA</measure>
    <time_frame>Up to 12 Months</time_frame>
    <description>Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">281</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>T2T Patients</arm_group_label>
    <description>RA patients managed with a treat-to-target (T2T) strategy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RC Patients</arm_group_label>
    <description>RA patients managed with routine care(RC)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-Interventional</intervention_name>
    <description>Non-Interventional</description>
    <arm_group_label>RC Patients</arm_group_label>
    <arm_group_label>T2T Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with active RA defined as a CDAI &gt; 10 for whom the treating physician has&#xD;
        made the decision to initiate treatment with SC abatacept according to the approved&#xD;
        Canadian product monograph and regional reimbursement criteria will be potentially eligible&#xD;
        for inclusion in the study. The decision to treat the patient with SC abatacept must have&#xD;
        been reached prior to and independently of considering the patient for study enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older.&#xD;
&#xD;
          -  Active moderate to severe RA, defined as CDAI &gt; 10.&#xD;
&#xD;
          -  The treating physician has made the decision to initiate treatment with SC abatacept&#xD;
             in accordance with the Canadian product monograph.&#xD;
&#xD;
          -  Patient has provided a written informed consent and is able to complete the survey&#xD;
             requirements.&#xD;
&#xD;
          -  Patient fulfills the reimbursement criteria for treatment with SC abatacept under&#xD;
             provincial or private health insurance reimbursement coverage.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has received abatacept (SC or IV) prior to the enrolment visit.&#xD;
&#xD;
          -  Has failed more than one prior biologic DMARD therapy&#xD;
&#xD;
          -  Has a history of autoimmune disease or of any joint inflammatory disease other than RA&#xD;
             with the exception of concomitant secondary Sjogren's syndrome.&#xD;
&#xD;
          -  Is participating in an ongoing clinical trial and/or has received treatment with an&#xD;
             investigational agent within 4 weeks before starting treatment with SC abatacept.&#xD;
&#xD;
          -  Is participating in another industry-sponsored observational study.&#xD;
&#xD;
          -  Patients participating to non-industry related registries or other data collection&#xD;
             studies can be included&#xD;
&#xD;
          -  Presence of any condition that, in the opinion of the treating physician, prohibits&#xD;
             the patient from participating in the study or obscures the assessment of RA&#xD;
             treatment.&#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>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Westmount</city>
        <state>Quebec</state>
        <zip>H3Z 1R7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</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>
  <!-- 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/NCT03274141
org study id: IM101-331
nct id: NCT03274141
lead sponsor: 
has dmc: No
This is a 12 month prospective, multicenter, post-marketing, observational study to compare
      the effectiveness of a treat-to-target (T2T) disease management strategy vs. routine care
      (RC) in adult patients with moderate to severe rheumatoid arthritis (RA) treated with
      subcutaneous abatacept (Orencia - SC). Patients completing the study will be offered to
      participate in a 12-month extension of their follow-up provided that this is in agreement
      with the judgment of the treating physician.
observational model: Cohort
time perspective: Prospective
measure: Number of T2T patients achieving sustained CDAI LDA
time frame: Approximately 1 year
description: Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
measure: Number of RC patients achieving sustained CDAI LDA
time frame: Approximately 1 year
description: Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
measure: Number of patients achieving SDAI remission
time frame: Up to 24 months
description: Simplified Disease Activity Index (SDAI) remission is achieved when SDAI score is less than or equal to 3.3
measure: Mean time for patients to achieve SDAI remission
time frame: Up to 24 months
description: Length of time from treatment initiation SDAI remission
measure: Number of patients achieving CDAI remission
time frame: Up to 24 months
description: Clinical Disease Activity Index (CDAI) remission is achieved when CDAI score is less than or equal to 2.8
measure: Mean time for patients to achieve CDAI remission
time frame: Up to 24 months
description: Length of time from treatment initiation CDAI remission
measure: Number of patients achieving DAS28-CRP LDA
time frame: Up to 24 months
description: Disease Activity Score (DAS) Low Disease Activity (LDA) is achieved when DAS28-CRP score is less than 3.2
measure: Mean time for patients to achieve DAS28-CRP LDA
time frame: Up to 24 months
description: Length of time from treatment initiation to a DAS28-CRP score of less than 3.2
measure: Number of patients achieving DAS28-CRP remission
time frame: Up to 24 months
description: Disease Activity Score (DAS) remission is achieved when DAS28-CRP score is less than 2.6
measure: Mean time for patients to achieve DAS28-CRP remission
time frame: Up to 24 months
description: Length of time from treatment initiation to a DAS28-CRP score of less than 2.6
measure: Number of patients achieving Boolean remission
time frame: Up to 24 months
description: Boolean remission is defined as TJC28 ≤1 and SJC28 ≤1 and CRP ≤1 mg/dl and PtGA ≤1 (on a 0-10 scale)
measure: Mean time for patients to achieve Boolean remission
time frame: Up to 24 months
description: Length of time from treatment initiation to Boolean remission.
measure: Number of patients achieving RAPID3 LDA
time frame: Up to 24 months
description: Routine Assessment of Patient Index Data 3 (RAPID3) Low Disease Activity (LDA) is achieved when RAPID3 score is less than or equal to 6.
measure: Mean time for patients to achieve RAPID3 LDA
time frame: Up to 24 months
description: Length of time from treatment initiation to a RAPID3 score of less than or equal to 6
measure: Number of patients achieving RAPID3 remission
time frame: Up to 24 months
description: Routine Assessment of Patient Index Data 3 (RAPID3) remission is achieved when RAPID3 score is less than or equal to 3.
measure: Mean time for patients to achieve RAPID3 remission
time frame: Up to 24 months
description: Length of time from treatment initiation to a RAPID3 score of less than or equal to 3
measure: Number of patients achieving MCID in HAQ-DI
time frame: Up to 24 months
description: minimal clinically important difference (MCID; Δ ≥ 0.22, ≥0.25, and ≥0.5) in Health Assessment Questionnaire Disability Index (HAQ-DI)
measure: Mean time for patients to achieve MCID in HAQ-DI
time frame: Up to 24 months
description: Length of time from treatment initiation to a Δ ≥ 0.22, ≥0.25, and ≥0.5 in HAQ-DI
measure: Number of patients achieving clinically meaningful improvement
time frame: Up to 24 months
description: Number of patients achieving clinically meaningful improvement as measured by a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
measure: Mean time for patients to achieve clinically meaningful improvement
time frame: Up to 24 months
description: Length of time from treatment initiation to a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
measure: Number of patients achieving patient expectations for treatment of their RA
time frame: Up to 24 months
description: Assessed using simple Visual Analogue Scales (VAS)
measure: Change from baseline in DAS28-CRP score
time frame: Baseline up to 24 months
description: Measured by investigator assessment
measure: Change from baseline in CDAI score
time frame: Baseline up to 24 months
description: Measured by investigator assessment
measure: Change from baseline in SDAI score
time frame: Baseline up to 24 months
description: Measured by investigator assessment
measure: Change from baseline in RAPID3 score
time frame: Baseline up to 24 months
description: Measured by investigator assessment
measure: Change from baseline in Tender Joint Count of 28 joints (TJC28) score
time frame: Baseline up to 24 months
description: Measured by patient assessment
measure: Change from baseline in Swollen Joint Count of 28 joints (SJC28) score
time frame: Baseline up to 24 months
description: Measured by patient assessment
measure: Change from baseline in HAQ-DI score
time frame: Baseline up to 24 months
description: Measured by patient assessment
measure: Change from baseline in Work Productivity and Activity Impairment (WPAI) score
time frame: Baseline up to 24 months
description: Measured by patient assessment
measure: Change from baseline in Patient Pain
time frame: Baseline up to 24 months
description: Measured by patient assessment
measure: Change from baseline in Patient Fatigue
time frame: Baseline up to 24 months
description: Measured by patient assessment
measure: Number of patients continuing treatment
time frame: At 12 months
description: Measured by investigator assessment
measure: Number of patients continuing treatment
time frame: At 24 months
description: Measured by investigator assessment
measure: Number of changes to Rheumatoid Arthritis (RA) treatment
time frame: Up to 24 months
description: Measured by investigator assessment
measure: Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment
time frame: Up to 12 months
description: Measured by questionnaire
measure: Incidence of treatment-emergent Adverse Events
time frame: Up to 24 months
description: Measured by investigator assessment
measure: Time to achieve sustained CDAI LDA
time frame: Up to 12 Months
description: Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)
arm group label: T2T Patients
description: RA patients managed with a treat-to-target (T2T) strategy
arm group label: RC Patients
description: RA patients managed with routine care(RC)
intervention type: Other
intervention name: Non-Interventional
description: Non-Interventional
arm group label: RC Patients
arm group label: T2T Patients
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
facility: 
country: Canada
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid