<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/NCT01707186</url>
  </required_header>
  <id_info>
    <org_study_id>2010930</org_study_id>
    <nct_id>NCT01707186</nct_id>
  </id_info>
  <brief_title>Pictorial Representation of Illness and Self Measure</brief_title>
  <acronym>PRISM</acronym>
  <official_title>Pictorial Representation of Illness and Self Measure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UCB Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the&#xD;
      mid-1990s; the task was first developed as a simple measure of how a person was coping with&#xD;
      his or her experience of illness. This is an international, multicentre study to evaluate the&#xD;
      PRISM tool for the assessment of suffering in rheumatoid arthritis at different stages of the&#xD;
      illness and the effect of treatment intervention. There are 5 sites: Berlin, Oxford, Limoges,&#xD;
      Montreal and Queensland. The study will recruit 200 patients in total.&#xD;
&#xD;
      In addition to the procedures for the patient's routine clinical visit, the patients will be&#xD;
      invited to answer a series of questionnaires and donate 20ml blood sample. Patients will be&#xD;
      asked to attend 3 times over 24 weeks&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2012</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</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>PRISM/PRISM+</measure>
    <time_frame>30 September 2015</time_frame>
    <description>Questionnaires</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">220</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Group 1A</arm_group_label>
    <description>Early phase, requiring change in treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Established phase, stable treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2A</arm_group_label>
    <description>Established phase, requiring a change in treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Early phase, stable treatment</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with rheumatoid arthritis from hospital clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Male or Female, aged 18 years or above.&#xD;
&#xD;
          -  Written confirmed diagnosed of rheumatoid arthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of any of the following:&#xD;
&#xD;
          -  Multiple sclerosis&#xD;
&#xD;
          -  Motor neurone disease&#xD;
&#xD;
          -  Parkinson's disease&#xD;
&#xD;
          -  Alzheimer's disease&#xD;
&#xD;
          -  Depression or anxiety disorders as identified using the Patient depression screening&#xD;
             questions from the patient health questionnaire 9 (PHQ9).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Taylor, FRCP, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nuffield Orthopaedic Centre</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 7HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>April 29, 2019</last_update_submitted>
  <last_update_submitted_qc>April 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 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/NCT01707186
org study id: 2010930
nct id: NCT01707186
lead sponsor: 
collaborator: 
has dmc: No
PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the
      mid-1990s; the task was first developed as a simple measure of how a person was coping with
      his or her experience of illness. This is an international, multicentre study to evaluate the
      PRISM tool for the assessment of suffering in rheumatoid arthritis at different stages of the
      illness and the effect of treatment intervention. There are 5 sites: Berlin, Oxford, Limoges,
      Montreal and Queensland. The study will recruit 200 patients in total.

      In addition to the procedures for the patient's routine clinical visit, the patients will be
      invited to answer a series of questionnaires and donate 20ml blood sample. Patients will be
      asked to attend 3 times over 24 weeks
observational model: Cohort
time perspective: Prospective
measure: PRISM/PRISM+
time frame: 30 September 2015
description: Questionnaires
arm group label: Group 1A
description: Early phase, requiring change in treatment
arm group label: Group 2
description: Established phase, stable treatment
arm group label: Group 2A
description: Established phase, requiring a change in treatment
arm group label: Group 1
description: Early phase, stable treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Peter Taylor, FRCP, PhD
role: Principal Investigator
affiliation: University of Oxford
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid