<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/NCT03817983</url>
  </required_header>
  <id_info>
    <org_study_id>A094864</org_study_id>
    <nct_id>NCT03817983</nct_id>
  </id_info>
  <brief_title>MRE as a Screening Tool for axSpA in IBD</brief_title>
  <acronym>ProSpA-CD</acronym>
  <official_title>Magnetic Resonance Enterography as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease: A Prospective Single-center Cross-sectional Observational Study Using MRE Screening Followed by Clinical Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cambridge University Hospitals NHS Foundation Trust</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 study aims to assess the effectiveness (specificity and sensitivity) of using magnetic&#xD;
      resonance enterography (MRE) as a screening tool for axial spondyloarthritis (axSpA) in&#xD;
      patients with Crohns disease. Patients with evidence of axSpA on MRE imaging will be assessed&#xD;
      clinically for axSpA (including a dedicated axial magnetic resonance imaging scan of the&#xD;
      spine and sacroiliac joints) and will be compared to a group of age and sex-matched control&#xD;
      participants with Crohn's disease but with no evidence of axSpA on MRE imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spondyloarthritis (SpA) is a term that encompasses psoriatic arthritis with axial disease,&#xD;
      ankylosing spondylitis and non-radiological axial spondyloarthritis. The prevalence of SpA in&#xD;
      the general population is estimated to be between 0.01%-2.5%. SpA patients have a high burden&#xD;
      of inflammatory bowel disease (IBD), which primarily includes Crohn's disease (CD) and&#xD;
      Ulcerative colitis (UC), with an estimated prevalence of 10%-12%. However, few studies have&#xD;
      investigated the converse; the presence of IBD cases with undiagnosed SpA. Untreated SpA may&#xD;
      lead to a significant impact on general health and quality of life; therefore early diagnosis&#xD;
      and treatment is crucial. Most CD patients will have had a MRE assessment for their CD, which&#xD;
      also captures the axial skeleton and can therefore be used to screen for evidence of axial&#xD;
      SpA (axSpA). In this study, MRE images from consenting CD subjects will be reviewed for&#xD;
      evidence of axSpA. CD patients with evidence of axSpA will then be reviewed in a rheumatology&#xD;
      clinic to assess more specifically for SpA. This will include completion of patient reported&#xD;
      outcome measures, clinical examination, routine blood tests, HLA-B27 genotyping and a&#xD;
      dedicated axial magnetic resonance imaging (MRI) scan. The patients will also be consented to&#xD;
      participate in the second part of the study which will be to compare these 'cases'&#xD;
      statistically to a 'control' group of age- and sex-matched CD subjects without MRE evidence&#xD;
      of axSpA.&#xD;
&#xD;
      This study aims to: (i) determine the validity, sensitivity and specificity of MRE as a&#xD;
      screening tool for axSpA in CD patients using dedicated axial MRI scans with clinical&#xD;
      assessment as the gold standard; (ii) devise an algorithm of clinical indices that can be&#xD;
      used as a screening tool for axSpA in CD cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Actual">August 8, 2020</completion_date>
  <primary_completion_date type="Actual">August 8, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The sensitivity and specificity of MRE as a screening tool for axial spondyloarthritis in Crohn's disease</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the 2009 ASAS criteria for axial Spondyloarthritis.</measure>
    <time_frame>12 months</time_frame>
    <description>ASAS (Assessment of Spondyloarthritis International Society)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the modified New York criteria for Ankylosing spondylitis</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the CASPAR criteria for psoriatic arthritis</measure>
    <time_frame>12 months</time_frame>
    <description>CASPAR (Classification Criteria for Psoriatic Arthritis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of these patients (expressed as a percentage) proceeding to non-pharmacological and pharmacological treatment of their axial Spondyloarthritis, as a surrogate measure of change in clinical care as a result of MRE screening.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The predictive value of specific extra-articular features with a diagnosis of axial spondyloarthritis in Crohn's disease</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The predictive value of a particular site of Crohn's disease (colon, ileum etc) with a diagnosis of axial spondyloarthritis in Crohn's disease</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">261</enrollment>
  <condition>Axial Spondyloarthritis</condition>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>MRE review for axSpA</arm_group_label>
    <description>Review of MRE scan for evidence of axSpA in Crohn's disease patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRE review for axSpA</intervention_name>
    <description>Screening for evidence of axSpA on the MRE scan of patients with Crohn's disease followed by clinical and MRI assessment</description>
    <arm_group_label>MRE review for axSpA</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      All subjects (cases and controls) will be asked to consent to provide research samples,&#xD;
      including whole blood and stool, for storage and future analysis (serum for biomarker&#xD;
      analysis, plasma for proteomic analysis, DNA for genotyping, and stool for microbiome&#xD;
      analysis).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Crohn's disease (aged more than 18 years) who have had a MRE scan performed&#xD;
        between January 1st 2015 and January 1st 2019&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who are willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          2. Male and female subjects aged 18 years or above.&#xD;
&#xD;
          3. Diagnosed by the gastroenterology team with Crohn's disease.&#xD;
&#xD;
          4. MRE imaging since 2015 for their Crohn's disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Subjects unwilling or unable to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deepak R Jadon, MBBCh PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CUH NHSFT</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rheumatology Research Unit</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cambridge University Hospitals NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Jobie Evans</investigator_full_name>
    <investigator_title>Dr Jobie Evans (MD Student)</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Axial Spondyloarthritis</mesh_term>
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 23, 2022</submitted>
    <returned>May 31, 2023</returned>
    <submitted>August 25, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03817983
org study id: A094864
nct id: NCT03817983
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to assess the effectiveness (specificity and sensitivity) of using magnetic
      resonance enterography (MRE) as a screening tool for axial spondyloarthritis (axSpA) in
      patients with Crohns disease. Patients with evidence of axSpA on MRE imaging will be assessed
      clinically for axSpA (including a dedicated axial magnetic resonance imaging scan of the
      spine and sacroiliac joints) and will be compared to a group of age and sex-matched control
      participants with Crohn's disease but with no evidence of axSpA on MRE imaging.
Spondyloarthritis (SpA) is a term that encompasses psoriatic arthritis with axial disease,
      ankylosing spondylitis and non-radiological axial spondyloarthritis. The prevalence of SpA in
      the general population is estimated to be between 0.01%-2.5%. SpA patients have a high burden
      of inflammatory bowel disease (IBD), which primarily includes Crohn's disease (CD) and
      Ulcerative colitis (UC), with an estimated prevalence of 10%-12%. However, few studies have
      investigated the converse; the presence of IBD cases with undiagnosed SpA. Untreated SpA may
      lead to a significant impact on general health and quality of life; therefore early diagnosis
      and treatment is crucial. Most CD patients will have had a MRE assessment for their CD, which
      also captures the axial skeleton and can therefore be used to screen for evidence of axial
      SpA (axSpA). In this study, MRE images from consenting CD subjects will be reviewed for
      evidence of axSpA. CD patients with evidence of axSpA will then be reviewed in a rheumatology
      clinic to assess more specifically for SpA. This will include completion of patient reported
      outcome measures, clinical examination, routine blood tests, HLA-B27 genotyping and a
      dedicated axial magnetic resonance imaging (MRI) scan. The patients will also be consented to
      participate in the second part of the study which will be to compare these 'cases'
      statistically to a 'control' group of age- and sex-matched CD subjects without MRE evidence
      of axSpA.

      This study aims to: (i) determine the validity, sensitivity and specificity of MRE as a
      screening tool for axSpA in CD patients using dedicated axial MRI scans with clinical
      assessment as the gold standard; (ii) devise an algorithm of clinical indices that can be
      used as a screening tool for axSpA in CD cases.
observational model: Case-Control
time perspective: Prospective
measure: The sensitivity and specificity of MRE as a screening tool for axial spondyloarthritis in Crohn's disease
time frame: 12 months
measure: The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the 2009 ASAS criteria for axial Spondyloarthritis.
time frame: 12 months
description: ASAS (Assessment of Spondyloarthritis International Society)
measure: The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the modified New York criteria for Ankylosing spondylitis
time frame: 12 months
measure: The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the CASPAR criteria for psoriatic arthritis
time frame: 12 months
description: CASPAR (Classification Criteria for Psoriatic Arthritis)
measure: The proportion of these patients (expressed as a percentage) proceeding to non-pharmacological and pharmacological treatment of their axial Spondyloarthritis, as a surrogate measure of change in clinical care as a result of MRE screening.
time frame: 12 months
measure: The predictive value of specific extra-articular features with a diagnosis of axial spondyloarthritis in Crohn's disease
time frame: 12 months
measure: The predictive value of a particular site of Crohn's disease (colon, ileum etc) with a diagnosis of axial spondyloarthritis in Crohn's disease
time frame: 12 months
arm group label: MRE review for axSpA
description: Review of MRE scan for evidence of axSpA in Crohn's disease patients
intervention type: Diagnostic Test
intervention name: MRE review for axSpA
description: Screening for evidence of axSpA on the MRE scan of patients with Crohn's disease followed by clinical and MRI assessment
arm group label: MRE review for axSpA
All subjects (cases and controls) will be asked to consent to provide research samples,
      including whole blood and stool, for storage and future analysis (serum for biomarker
      analysis, plasma for proteomic analysis, DNA for genotyping, and stool for microbiome
      analysis).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Deepak R Jadon, MBBCh PhD
role: Principal Investigator
affiliation: CUH NHSFT
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Cambridge University Hospitals NHS Foundation Trust
investigator full name: Jobie Evans
investigator title: Dr Jobie Evans (MD Student)
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Axial Spondyloarthritis
mesh term: Crohn Disease
sharing ipd: Undecided
submitted: July 23, 2022
returned: May 31, 2023
submitted: August 25, 2023