<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/NCT04434885</url>
  </required_header>
  <id_info>
    <org_study_id>AXIS</org_study_id>
    <nct_id>NCT04434885</nct_id>
  </id_info>
  <brief_title>Axial Involvement in Psoriatic Arthritis Cohort</brief_title>
  <acronym>AXIS</acronym>
  <official_title>Axial Involvement in Psoriatic Arthritis Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Assessment of Spondyloarthritis International Society (ASAS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Group for Research and Assessment of Psoriasis and Psoriatic Arthritis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</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>
      This is a multinational multicenter cross-sectional study in patients with a definite&#xD;
      diagnosis of PsA. The population of interest will consist of 400 adult patients diagnosed&#xD;
      with PsA and fulfilling the classification criteria for PsA and not receiving biological or&#xD;
      targeted synthetic disease modifying antirheumatic drugs (b or tsDMARDs). Participating&#xD;
      rheumatologists are encouraged to include consecutive PsA patients not treated with biologic&#xD;
      or a targeted synthetic disease-modifying antirheumatic drug because of their potential&#xD;
      impact on active inflammatory changes in the axial skeleton, which will be the focus of the&#xD;
      current study. Patients will be recruited prospectively in selected study centres and will&#xD;
      undergo study-related examinations including imaging of the axial skeleton (X-rays and&#xD;
      magnetic resonance imaging). Collected data will serve as a basis for the judgement on the&#xD;
      presence or absence of axial involvement by the local investigator and, independently, by the&#xD;
      central study committee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background. Involvement of the axial skeleton (of sacroiliac joints and / or spine) is one of&#xD;
      the frequent manifestations associated with psoriatic skin disease along with involvement of&#xD;
      peripheral musculoskeletal structures (peripheral arthritis, enthesitis, dactylitis), which&#xD;
      are usually referred to as psoriatic arthritis (PsA). Depending on the definition used, the&#xD;
      prevalence of axial disease varies from 25% to 70% of patients with PsA. There is an urgent&#xD;
      need for an evidence-based definition and a unified and widely accepted nomenclature for&#xD;
      axial involvement in PsA that would allow defining a homogeneous subgroup of patients in the&#xD;
      heterogeneous PsA population.&#xD;
&#xD;
      Aim and study objectives. To develop a data-driven definition of axial involvement in PsA&#xD;
      based on cross-sectional evaluation of patients with a diagnosis of PsA fulfilling the CASPAR&#xD;
      criteria. The study objectives are: to determine the prevalence of axial involvement in a&#xD;
      cohort of patients with PsA; to identify the frequency of imaging findings suggestive of&#xD;
      inflammatory involvement of axial skeleton in PsA; to identify factors (clinical, lab,&#xD;
      imaging) associated with the presence of axial involvement in PsA.&#xD;
&#xD;
      Study design and study population. This is a multinational multicenter cross-sectional study&#xD;
      in patients with a definite diagnosis of PsA. The population of interest will consist of 400&#xD;
      adult patients diagnosed with PsA and fulfilling the classification criteria for PsA and not&#xD;
      receiving biological or targeted synthetic disease-modifying antirheumatic drugs (b or&#xD;
      tsDMARDs). Participating rheumatologists are encouraged to include consecutive PsA patients&#xD;
      not treated with biologic or a targeted synthetic disease-modifying antirheumatic drug&#xD;
      because of their potential impact on active inflammatory changes in the axial skeleton, which&#xD;
      will be the focus of the current study. Patients will be recruited prospectively in selected&#xD;
      study centres and will undergo study-related examinations including imaging of the axial&#xD;
      skeleton (X-rays and magnetic resonance imaging). Collected data will serve as a basis for&#xD;
      the judgement on the presence or absence of axial involvement by the local investigator and,&#xD;
      independently, by the central study committee.&#xD;
&#xD;
      Analysis and study outcomes. The prevalence of axial involvement in a cohort of patients with&#xD;
      PsA according to the local and central assessment will be calculated in PsA patients&#xD;
      presenting with peripheral involvement (the primary analysis population) as well as in the&#xD;
      entire group. The prevalence of axial involvement as assessed by the local investigator in&#xD;
      PsA patients presenting with peripheral involvement will be the primary outcome of the study.&#xD;
      The agreement between local and central judgements will be analyzed. A sub-analysis of a&#xD;
      group presenting without peripheral involvement (i.e., pure axial disease) will be performed.&#xD;
      The frequency of imaging findings (on MRI and X-rays) suggestive of inflammatory involvement&#xD;
      of axial skeleton (sacroiliac joints and spine) in PsA according to the local and central&#xD;
      assessment will be calculated. The agreement between local and central judgements will be&#xD;
      analyzed. Parameters associated with the presence of axial involvement in PsA will be&#xD;
      explored as well. The diagnostic / classification value of each parameter will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The prevalence of axial involvement by local investigator</measure>
    <time_frame>Baseline</time_frame>
    <description>The frequency of axial involvement (global judgment) as assessed by the local investigator in PsA patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The frequency of axial involvement by the central committee</measure>
    <time_frame>Baseline</time_frame>
    <description>The frequency of axial involvement (global judgment) as assessed by the central clinical committee in PsA patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The frequency of imaging findings suggestive of axial involvement</measure>
    <time_frame>Baseline</time_frame>
    <description>The frequency of imaging findings (on MRI and X-rays) suggestive of inflammatory involvement of axial skeleton (sacroiliac joints and spine) in PsA according to the local and central assessment</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Psoriatic Arthritis</condition>
  <arm_group>
    <arm_group_label>Psoriatic arthritis</arm_group_label>
    <description>Patients diagnosed with PsA and fulfilling the classification criteria for PsA with symptom duration of up to 10 years and not receiving biological or targeted synthetic disease modifying antirheumatic drugs (b or tsDMARDs).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical and imaging examination of symptoms and signs suggestive of axial involvement</intervention_name>
    <description>Clinical and imaging examination including X-rays and magnetic resonance imaging of sacroiliac joints and spine</description>
    <arm_group_label>Psoriatic arthritis</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The population of interest will consist of consecutive adult patients diagnosed with PsA&#xD;
        and fulfilling the CASPAR (ClASsification criteria for Psoriatic ARthritis) classification&#xD;
        criteria for PsA with symptom duration of up to 10 years and not receiving biological or&#xD;
        targeted synthetic disease modifying antirheumatic drugs (b or tsDMARDs). Participating&#xD;
        rheumatologists are encouraged to include consecutive PsA patients not treated with&#xD;
        biologic or a targeted synthetic disease-modifying antirheumatic drug because of their&#xD;
        potential impact on active inflammatory changes in the axial skeleton, which will be the&#xD;
        focus of the current study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;=18 years.&#xD;
&#xD;
          -  Definite diagnosis of PsA.&#xD;
&#xD;
          -  Fulfilment of the CASPAR criteria for PsA.&#xD;
&#xD;
          -  Duration of PsA symptoms ≤10 years.&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to give informed consent or to comply with the protocol.&#xD;
&#xD;
          -  Current or past treatment with biologic or a targeted synthetic disease-modifying&#xD;
             antirheumatic drug (DMARDs).&#xD;
&#xD;
          -  Contraindications for MRI and/or plain X-ray examination of sacroiliac joints and&#xD;
             spine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Denis Poddubnyy, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dafna D. Gladman, MD, FRCPC</last_name>
    <role>Study Chair</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Denis Poddubnyy, MD</last_name>
    <phone>+4930450514582</phone>
    <email>denis.poddubnyy@charite.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dafna D. Gladman, MD, FRCPC</last_name>
    <phone>+14166035753</phone>
    <email>dafna.gladman@utoronto.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dafna D Gladman, MD, FRCPC</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denis Poddubnyy, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 21, 2022</last_update_submitted>
  <last_update_submitted_qc>June 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Denis Poddubnyy</investigator_full_name>
    <investigator_title>Professor of Rheumatology</investigator_title>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study data will be made available for subsequent analysis upon reasonable request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>After completion of the primary analysis</ipd_time_frame>
    <ipd_access_criteria>Submission of a research proposal and approval by the study chairs</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04434885
org study id: AXIS
nct id: NCT04434885
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multinational multicenter cross-sectional study in patients with a definite
      diagnosis of PsA. The population of interest will consist of 400 adult patients diagnosed
      with PsA and fulfilling the classification criteria for PsA and not receiving biological or
      targeted synthetic disease modifying antirheumatic drugs (b or tsDMARDs). Participating
      rheumatologists are encouraged to include consecutive PsA patients not treated with biologic
      or a targeted synthetic disease-modifying antirheumatic drug because of their potential
      impact on active inflammatory changes in the axial skeleton, which will be the focus of the
      current study. Patients will be recruited prospectively in selected study centres and will
      undergo study-related examinations including imaging of the axial skeleton (X-rays and
      magnetic resonance imaging). Collected data will serve as a basis for the judgement on the
      presence or absence of axial involvement by the local investigator and, independently, by the
      central study committee.
Background. Involvement of the axial skeleton (of sacroiliac joints and / or spine) is one of
      the frequent manifestations associated with psoriatic skin disease along with involvement of
      peripheral musculoskeletal structures (peripheral arthritis, enthesitis, dactylitis), which
      are usually referred to as psoriatic arthritis (PsA). Depending on the definition used, the
      prevalence of axial disease varies from 25% to 70% of patients with PsA. There is an urgent
      need for an evidence-based definition and a unified and widely accepted nomenclature for
      axial involvement in PsA that would allow defining a homogeneous subgroup of patients in the
      heterogeneous PsA population.

      Aim and study objectives. To develop a data-driven definition of axial involvement in PsA
      based on cross-sectional evaluation of patients with a diagnosis of PsA fulfilling the CASPAR
      criteria. The study objectives are: to determine the prevalence of axial involvement in a
      cohort of patients with PsA; to identify the frequency of imaging findings suggestive of
      inflammatory involvement of axial skeleton in PsA; to identify factors (clinical, lab,
      imaging) associated with the presence of axial involvement in PsA.

      Study design and study population. This is a multinational multicenter cross-sectional study
      in patients with a definite diagnosis of PsA. The population of interest will consist of 400
      adult patients diagnosed with PsA and fulfilling the classification criteria for PsA and not
      receiving biological or targeted synthetic disease-modifying antirheumatic drugs (b or
      tsDMARDs). Participating rheumatologists are encouraged to include consecutive PsA patients
      not treated with biologic or a targeted synthetic disease-modifying antirheumatic drug
      because of their potential impact on active inflammatory changes in the axial skeleton, which
      will be the focus of the current study. Patients will be recruited prospectively in selected
      study centres and will undergo study-related examinations including imaging of the axial
      skeleton (X-rays and magnetic resonance imaging). Collected data will serve as a basis for
      the judgement on the presence or absence of axial involvement by the local investigator and,
      independently, by the central study committee.

      Analysis and study outcomes. The prevalence of axial involvement in a cohort of patients with
      PsA according to the local and central assessment will be calculated in PsA patients
      presenting with peripheral involvement (the primary analysis population) as well as in the
      entire group. The prevalence of axial involvement as assessed by the local investigator in
      PsA patients presenting with peripheral involvement will be the primary outcome of the study.
      The agreement between local and central judgements will be analyzed. A sub-analysis of a
      group presenting without peripheral involvement (i.e., pure axial disease) will be performed.
      The frequency of imaging findings (on MRI and X-rays) suggestive of inflammatory involvement
      of axial skeleton (sacroiliac joints and spine) in PsA according to the local and central
      assessment will be calculated. The agreement between local and central judgements will be
      analyzed. Parameters associated with the presence of axial involvement in PsA will be
      explored as well. The diagnostic / classification value of each parameter will be evaluated.
observational model: Cohort
time perspective: Cross-Sectional
measure: The prevalence of axial involvement by local investigator
time frame: Baseline
description: The frequency of axial involvement (global judgment) as assessed by the local investigator in PsA patients
measure: The frequency of axial involvement by the central committee
time frame: Baseline
description: The frequency of axial involvement (global judgment) as assessed by the central clinical committee in PsA patients
measure: The frequency of imaging findings suggestive of axial involvement
time frame: Baseline
description: The frequency of imaging findings (on MRI and X-rays) suggestive of inflammatory involvement of axial skeleton (sacroiliac joints and spine) in PsA according to the local and central assessment
arm group label: Psoriatic arthritis
description: Patients diagnosed with PsA and fulfilling the classification criteria for PsA with symptom duration of up to 10 years and not receiving biological or targeted synthetic disease modifying antirheumatic drugs (b or tsDMARDs).
intervention type: Other
intervention name: Clinical and imaging examination of symptoms and signs suggestive of axial involvement
description: Clinical and imaging examination including X-rays and magnetic resonance imaging of sacroiliac joints and spine
arm group label: Psoriatic arthritis
Whole blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Denis Poddubnyy, MD
role: Study Chair
affiliation: Charite University, Berlin, Germany
last name: Dafna D. Gladman, MD, FRCPC
role: Study Chair
affiliation: University of Toronto
last name: Denis Poddubnyy, MD
phone: +4930450514582
email: denis.poddubnyy@charite.de
last name: Dafna D. Gladman, MD, FRCPC
phone: +14166035753
email: dafna.gladman@utoronto.ca
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Canada
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Denis Poddubnyy
investigator title: Professor of Rheumatology
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
sharing ipd: Yes
ipd description: Study data will be made available for subsequent analysis upon reasonable request
ipd info type: Study Protocol
ipd time frame: After completion of the primary analysis
ipd access criteria: Submission of a research proposal and approval by the study chairs