<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/NCT03769558</url>
  </required_header>
  <id_info>
    <org_study_id>IM101-643</org_study_id>
    <nct_id>NCT03769558</nct_id>
  </id_info>
  <brief_title>A Study of Juvenile Idiopathic Arthritis Patients Given Abatacept and the Number of Infections or Malignancies That Occur</brief_title>
  <official_title>Supplemental Data for the Juvenile Idiopathic Arthritis FDA Written Request</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will determine the incidences of infections and malignancies among JIA patients&#xD;
      treated with abatacept&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2016</start_date>
  <completion_date type="Actual">September 30, 2016</completion_date>
  <primary_completion_date type="Actual">September 30, 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of infections</measure>
    <time_frame>110 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of malignancies</measure>
    <time_frame>110 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">264</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <arm_group>
    <arm_group_label>JIA patients prescribed abatacept</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-Interventional</intervention_name>
    <description>Non-Interventional</description>
    <arm_group_label>JIA patients prescribed abatacept</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include all patients with JIA who are treated with abatacept&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Two diagnoses of JIA (ICD-9 code 714.3x) within 90 days&#xD;
&#xD;
          -  Age less than 18 years at the time of second of the two diagnoses&#xD;
&#xD;
          -  Index date is the date of initiating treatment with abatacept&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Greater than or equal to 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Princeton</city>
        <state>New Jersey</state>
        <zip>08540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</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>March 2020</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</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, Juvenile</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/NCT03769558
org study id: IM101-643
nct id: NCT03769558
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will determine the incidences of infections and malignancies among JIA patients
      treated with abatacept
observational model: Cohort
time perspective: Retrospective
measure: Incidence of infections
time frame: 110 months
measure: Incidence of malignancies
time frame: 110 months
arm group label: JIA patients prescribed abatacept
intervention type: Other
intervention name: Non-Interventional
description: Non-Interventional
arm group label: JIA patients prescribed abatacept
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 12 Months
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
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, Juvenile