<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/NCT03810144</url>
  </required_header>
  <id_info>
    <org_study_id>128-CL-01</org_study_id>
    <nct_id>NCT03810144</nct_id>
  </id_info>
  <brief_title>Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test</brief_title>
  <acronym>CareFirst</acronym>
  <official_title>Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test on Clinical Outcomes and Pharmaceutical Utilization in Patients With Rheumatoid Arthritis: A Prospective, Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sequenom, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratory Corporation of America</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sequenom, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nine months multi-center prospective, randomized observational study, two arm trial to&#xD;
      evaluate the effect of MBDA score-guided care on disease activity and medical costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nine months multi-center prospective, randomized observational study, two arm trial to&#xD;
      evaluate the effect of MBDA score-guided care on disease activity and medical costs. To&#xD;
      investigate whether treatment decisions guided by MBDA scores result in reduced disease&#xD;
      activity and overall medical cost among patients with RA relative to usual care (UC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 22, 2018</start_date>
  <completion_date type="Actual">October 16, 2022</completion_date>
  <primary_completion_date type="Actual">August 16, 2022</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>Mean MBDA Score</measure>
    <time_frame>Baseline to 9 months</time_frame>
    <description>Change in disease activity from baseline to month 9 as measured by mean MBDA score.&#xD;
MBDA Score stands for the Vectra multi-biomarker disease activity (MBDA) blood test.&#xD;
Scale: Low (&gt;30); Moderate (30-44); High (&gt;44)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Overall Medical Costs</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>Changes in overall medical costs, RA-related medical costs, pharmacy costs, RA treatment medication costs, and biologic DMARD medication costs from baseline to one year, as defined in Appendix 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Utilization</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>Medical utilization metrics (admissions, readmissions, emergency room visits, physician visits, etc.).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients who Showed a Response to Medication</measure>
    <time_frame>Baseline to month 9</time_frame>
    <description>Proportion of patients who showed a response to medication, defined as a decrease in MBDA score of at least 8 from baseline to month 9.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacy Utilization</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>Pharmacy utilization metrics (days' supply, prescriptions, etc.).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Adherence</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>Treatment adherence metrics measured according to medical possession ratio and time to discontinuation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of Patients with Non-High MBDA Scores</measure>
    <time_frame>Baseline to month 9</time_frame>
    <description>Proportion of patients with non-high (≤44) MBDA scores from baseline to month 9.</description>
  </other_outcome>
  <other_outcome>
    <measure>Overall Medical Costs</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>Overall medical costs, pharmacy costs, RA treatment medication costs, and biologic DMARD medication costs (Appendix 2) from baseline to one year according to:&#xD;
Baseline MBDA score category (low &lt;30, moderate 30-44, high &gt;44).&#xD;
Whether treatment decisions were consistent with the MBDA score-based treatment guidance in Appendix 1 (guided treatment arm only).&#xD;
Whether MBDA score category changed from baseline to month 9.&#xD;
Whether biologic DMARD use was tapered.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">444</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Vectra Guided</arm_group_label>
    <description>For patients in the guided care arm, treating physicians will receive the Vectra MBDA Test score prior to the patient visit and will have a set of guidance for decision-making based on these scores. Treating physicians will be strongly encouraged to follow the guidance but will not be required to do so. For test results to be available at the time of each visit in the MBDA guided treatment arm, blood testing will be performed 7-10 days before the visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <description>For patients in the UC arm, treating physicians will not have access to MBDA scores until the end of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Vectra MBDA Test</intervention_name>
    <description>Vectra Guided versus Usual Care</description>
    <arm_group_label>Vectra Guided</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with RA who are currently taking one or more non-biologic DMARD and/or biologic&#xD;
        DMARD listed in Appendix 2.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to sign an informed consent form (ICF)&#xD;
&#xD;
          -  Age at least 18 years old at screening visit&#xD;
&#xD;
          -  Diagnosed with RA according to 1987 or 2010 criteria of the American College of&#xD;
             Rheumatology&#xD;
&#xD;
          -  Actively managed by a CareFirst health care practitioner&#xD;
&#xD;
          -  Currently taking one or more biologic and/or non-biologic DMARDs listed in Appendix 2&#xD;
&#xD;
          -  Currently has CareFirst medical coverage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  History of malignancy within the past 5 years or any evidence of persistent&#xD;
             malignancy, except fully excised basal cell or squamous cell carcinomas of the skin,&#xD;
             or cervical carcinoma in situ that has been treated or excised in a curative procedure&#xD;
&#xD;
          -  Current enrollment in another clinical trial&#xD;
&#xD;
          -  On non-biologic DMARD monotherapy or combination therapy with stable disease for ≥6&#xD;
             months&#xD;
&#xD;
          -  Any condition or circumstance that makes it likely the patient will not be able to&#xD;
             complete the 9-month trial&#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>Elena Hitraya, MD</last_name>
    <role>Study Director</role>
    <affiliation>Consultant</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Annapolis Rheumatology LLC</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lifebridge Sinai Hospital of Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Associates of Baltimore LLC</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21286</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nasseri Clinic of Arthritis &amp; Rheumatic Diseases, LLC.</name>
      <address>
        <city>Catonsville</city>
        <state>Maryland</state>
        <zip>21228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis Care Specialists of Maryland</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klein &amp; Associates</name>
      <address>
        <city>Cumberland</city>
        <state>Maryland</state>
        <zip>21502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid-Atlantic Rheumatology</name>
      <address>
        <city>Glen Burnie</city>
        <state>Maryland</state>
        <zip>21060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis &amp; Pain Associates of PG County</name>
      <address>
        <city>Greenbelt</city>
        <state>Maryland</state>
        <zip>20770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klein &amp; Associates</name>
      <address>
        <city>Hagerstown</city>
        <state>Maryland</state>
        <zip>21502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Shah Medical Group</name>
      <address>
        <city>Hollywood</city>
        <state>Maryland</state>
        <zip>20639</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Rheumatology and Bone Research</name>
      <address>
        <city>Wheaton</city>
        <state>Maryland</state>
        <zip>20902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2023</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/NCT03810144
org study id: 128-CL-01
nct id: NCT03810144
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nine months multi-center prospective, randomized observational study, two arm trial to
      evaluate the effect of MBDA score-guided care on disease activity and medical costs.
Nine months multi-center prospective, randomized observational study, two arm trial to
      evaluate the effect of MBDA score-guided care on disease activity and medical costs. To
      investigate whether treatment decisions guided by MBDA scores result in reduced disease
      activity and overall medical cost among patients with RA relative to usual care (UC).
observational model: Cohort
time perspective: Prospective
measure: Mean MBDA Score
time frame: Baseline to 9 months
description: Change in disease activity from baseline to month 9 as measured by mean MBDA score.
MBDA Score stands for the Vectra multi-biomarker disease activity (MBDA) blood test.
Scale: Low (>30); Moderate (30-44); High (>44)
measure: Changes in Overall Medical Costs
time frame: Baseline to 1 year
description: Changes in overall medical costs, RA-related medical costs, pharmacy costs, RA treatment medication costs, and biologic DMARD medication costs from baseline to one year, as defined in Appendix 2.
measure: Medical Utilization
time frame: Baseline to 1 year
description: Medical utilization metrics (admissions, readmissions, emergency room visits, physician visits, etc.).
measure: Proportion of Patients who Showed a Response to Medication
time frame: Baseline to month 9
description: Proportion of patients who showed a response to medication, defined as a decrease in MBDA score of at least 8 from baseline to month 9.
measure: Pharmacy Utilization
time frame: Baseline to 1 year
description: Pharmacy utilization metrics (days' supply, prescriptions, etc.).
measure: Treatment Adherence
time frame: Baseline to 1 year
description: Treatment adherence metrics measured according to medical possession ratio and time to discontinuation.
measure: Proportion of Patients with Non-High MBDA Scores
time frame: Baseline to month 9
description: Proportion of patients with non-high (≤44) MBDA scores from baseline to month 9.
measure: Overall Medical Costs
time frame: Baseline to 1 year
description: Overall medical costs, pharmacy costs, RA treatment medication costs, and biologic DMARD medication costs (Appendix 2) from baseline to one year according to:
Baseline MBDA score category (low <30, moderate 30-44, high >44).
Whether treatment decisions were consistent with the MBDA score-based treatment guidance in Appendix 1 (guided treatment arm only).
Whether MBDA score category changed from baseline to month 9.
Whether biologic DMARD use was tapered.
arm group label: Vectra Guided
description: For patients in the guided care arm, treating physicians will receive the Vectra MBDA Test score prior to the patient visit and will have a set of guidance for decision-making based on these scores. Treating physicians will be strongly encouraged to follow the guidance but will not be required to do so. For test results to be available at the time of each visit in the MBDA guided treatment arm, blood testing will be performed 7-10 days before the visit.
arm group label: Usual Care
description: For patients in the UC arm, treating physicians will not have access to MBDA scores until the end of the study.
intervention type: Genetic
intervention name: Vectra MBDA Test
description: Vectra Guided versus Usual Care
arm group label: Vectra Guided
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elena Hitraya, MD
role: Study Director
affiliation: Consultant
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid