<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/NCT01692912</url>
  </required_header>
  <id_info>
    <org_study_id>PRC-05-2011</org_study_id>
    <nct_id>NCT01692912</nct_id>
  </id_info>
  <brief_title>Psoriatic Arthritis Treat to Target vs. Usual Care</brief_title>
  <acronym>PRC-05-2011</acronym>
  <official_title>A Trial of Active Psoriatic Arthritis (PsA): Randomizing to Treat to a Target vs. Usual Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pope Research Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Pope Research Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Canadian Rheumatologists will be randomized to treat their participants with active Psoriatic&#xD;
      Arthritis to a target (disease activity score &lt;2.6), or as per their routine care. The aim of&#xD;
      this study is to determine whether treating to a target results in greater disease&#xD;
      improvement than treating patients using routine care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Canadian Rheumatologists will be randomized to treat their participants with active Psoriatic&#xD;
      Arthritis to a target (disease activity score &lt;2.6), or as per their routine care. The aim of&#xD;
      this study is to determine whether treating to a target results in greater disease&#xD;
      improvement than treating patients using routine care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no enrollment&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients achieving low DAS</measure>
    <time_frame>Month 9 Visit</time_frame>
    <description>The primary outcome measure will be the percentage of patients achieving low Disease Activity Score (DAS&lt;2.6) in each patient group (Intensive Care vs. Routine Care) at the end of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to achieving DAS28&lt;2.6</measure>
    <time_frame>Month 3 Visit, Month 6 Visit, and Month 9 Visit</time_frame>
    <description>Compares the effectiveness of Intensive Care and Routine Care groups, as measured by the time to achieving target of DAS28&lt;2.6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute change in DAS28</measure>
    <time_frame>Month 3 Visit, Month 6 Visit, Month 9 Visit</time_frame>
    <description>To compare the effectiveness of Intensive Care and Routine Care in improving the patient DAS28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients achieving ACR 20, 50, and 70</measure>
    <time_frame>Month 3 Visit, Month 6 Visit, Month 9 Visit</time_frame>
    <description>ACR 20/50/70 defined as:&#xD;
20%, 50%, or 70% reduction in tender joint count, and&#xD;
20%, 50%, or 70% reduction in swollen joint count, and&#xD;
a 20%, 50%, or 70% reduction in 3 of the following 5 measures:&#xD;
Patient and physician global assessments (VAS)&#xD;
Patient pain score (VAS)&#xD;
HAQ-DI&#xD;
ESR or CRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients achieving PsARC</measure>
    <time_frame>Month 3 Visit, Month 6 Visit, Month 9 Visit</time_frame>
    <description>PsARC defined as improvement in at least 2 of the 4 following measures, one of which must be joint swelling or tenderness, and no worsening in any of the 4 measures:&#xD;
MDGA (0-5 point scale): reduction by 1 point.&#xD;
PGA (0-5 point scale): reduction by 1 point.&#xD;
TJC (76 or 68): reduction by &gt;=30%.&#xD;
SJC (76 or 68): reduction by &gt;=30%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute change in HAQ-DI</measure>
    <time_frame>Month 3 Visit, Month 6 Visit, Month 9 Visit</time_frame>
    <description>HAQ-DI is a self-administered questionnaire using the patient's functional ability during the last week. It consists of 20 items converging to 8 scales measuring dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. The patients rate each activity as 0 = without any difficulty, 1 = some difficulty, 2 = much difficulty and 4 = unable. The final score ranges from 0 to 3 with higher scores indicating more disability.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Psoriatic Arthritis (PsA)</condition>
  <arm_group>
    <arm_group_label>Intensive Care (IC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rheumatologists treating to target of DAS28&lt;2.6</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine Care (RC)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants treated in the routine manner by their rheumatologist (not treated to the target of DAS28&lt;2.6)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intensive Care</intervention_name>
    <description>Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28&lt;2.6</description>
    <arm_group_label>Intensive Care (IC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Psoriatic Arthritis as diagnosed by a rheumatologist and meeting ACR classification&#xD;
             criteria for PsA or CASPAR criteria&#xD;
&#xD;
          -  The subject must provide written informed consent for participation in the study&#xD;
             before any study specific procedures are performed&#xD;
&#xD;
          -  Subject has 3 or more SJC on 28 joint count&#xD;
&#xD;
          -  Age &gt;=18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a history of being non-compliant&#xD;
&#xD;
          -  Serious concomitant illnesses that in the investigator's opinion negate ability to&#xD;
             optimally treat the patient&#xD;
&#xD;
          -  If treating with TNF inhibitor, positive PPD &gt; 5mm who have not received INH for&#xD;
             recommended course or untreated TB (ie CXR evidence of latent infection). Usual&#xD;
             screening is in place for standard of care.&#xD;
&#xD;
          -  Pregnancy, breast-feeding or considering pregnancy over the next 12 months&#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>Janet E. Pope, MD, MPH, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pope Research Corp., University of Western Ontario, St. Joseph's Health Care London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pope Research Corp., 68 Green Acres Drive</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6G 2S3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Arthritis Program Research Group</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthur Karasik</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M9C 5N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Rheumatologie de Montreal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 1S6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>April 5, 2017</last_update_submitted>
  <last_update_submitted_qc>April 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriatic Arthritis</keyword>
  <keyword>Randomized</keyword>
  <keyword>Single blind</keyword>
  <keyword>Treat to target</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</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/NCT01692912
org study id: PRC-05-2011
nct id: NCT01692912
lead sponsor: 
collaborator: 
has dmc: No
Canadian Rheumatologists will be randomized to treat their participants with active Psoriatic
      Arthritis to a target (disease activity score <2.6), or as per their routine care. The aim of
      this study is to determine whether treating to a target results in greater disease
      improvement than treating patients using routine care.
Canadian Rheumatologists will be randomized to treat their participants with active Psoriatic
      Arthritis to a target (disease activity score <2.6), or as per their routine care. The aim of
      this study is to determine whether treating to a target results in greater disease
      improvement than treating patients using routine care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Percentage of patients achieving low DAS
time frame: Month 9 Visit
description: The primary outcome measure will be the percentage of patients achieving low Disease Activity Score (DAS<2.6) in each patient group (Intensive Care vs. Routine Care) at the end of the study.
measure: Time to achieving DAS28<2.6
time frame: Month 3 Visit, Month 6 Visit, and Month 9 Visit
description: Compares the effectiveness of Intensive Care and Routine Care groups, as measured by the time to achieving target of DAS28<2.6
measure: Absolute change in DAS28
time frame: Month 3 Visit, Month 6 Visit, Month 9 Visit
description: To compare the effectiveness of Intensive Care and Routine Care in improving the patient DAS28.
measure: Percentage of Patients achieving ACR 20, 50, and 70
time frame: Month 3 Visit, Month 6 Visit, Month 9 Visit
description: ACR 20/50/70 defined as:
20%, 50%, or 70% reduction in tender joint count, and
20%, 50%, or 70% reduction in swollen joint count, and
a 20%, 50%, or 70% reduction in 3 of the following 5 measures:
Patient and physician global assessments (VAS)
Patient pain score (VAS)
HAQ-DI
ESR or CRP
measure: Percentage of patients achieving PsARC
time frame: Month 3 Visit, Month 6 Visit, Month 9 Visit
description: PsARC defined as improvement in at least 2 of the 4 following measures, one of which must be joint swelling or tenderness, and no worsening in any of the 4 measures:
MDGA (0-5 point scale): reduction by 1 point.
PGA (0-5 point scale): reduction by 1 point.
TJC (76 or 68): reduction by >=30%.
SJC (76 or 68): reduction by >=30%.
measure: Absolute change in HAQ-DI
time frame: Month 3 Visit, Month 6 Visit, Month 9 Visit
description: HAQ-DI is a self-administered questionnaire using the patient's functional ability during the last week. It consists of 20 items converging to 8 scales measuring dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. The patients rate each activity as 0 = without any difficulty, 1 = some difficulty, 2 = much difficulty and 4 = unable. The final score ranges from 0 to 3 with higher scores indicating more disability.
arm group label: Intensive Care (IC)
arm group type: Active Comparator
description: Rheumatologists treating to target of DAS28<2.6
arm group label: Routine Care (RC)
arm group type: No Intervention
description: Participants treated in the routine manner by their rheumatologist (not treated to the target of DAS28<2.6)
intervention type: Other
intervention name: Intensive Care
description: Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28<2.6
arm group label: Intensive Care (IC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janet E. Pope, MD, MPH, FRCPC
role: Principal Investigator
affiliation: Pope Research Corp., University of Western Ontario, St. Joseph's Health Care London
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic