<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/NCT02985424</url>
  </required_header>
  <id_info>
    <org_study_id>S-20160098</org_study_id>
    <secondary_id>16/40522</secondary_id>
    <nct_id>NCT02985424</nct_id>
  </id_info>
  <brief_title>Polymyalgia Rheumatica and Giant Cell Arteritis</brief_title>
  <official_title>Polymyalgia Rheumatica and Giant Cell Arteritis - Three Challenges - Consequences of the Vasculitis Process, Osteoporosis and Malignancy: A Prospective Cohort Study Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Svendborg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Svendborg Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose&#xD;
      Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern&#xD;
      of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica&#xD;
      (PMR)/Giant Cell Arteritis (GCA) .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA) are common inflammatory&#xD;
      conditions. The diagnosis of PMR/GCA poses many challenges since there are no specific&#xD;
      diagnostic tests. Recent literature emphasizes the ability of 18F-Fluorodeoxyglucose Positron&#xD;
      Emission Tomography/Computed Tomography (18F-FDG PET/CT) to assess global disease activity&#xD;
      and/or inflammation burden. 18F-FDG PET/CT may lead to make diagnosis at an earlier stage&#xD;
      than conventional imaging and assess response to therapy. With respect to the management of&#xD;
      PMR/GCA, there are three significant areas of concern as follows: Vasculitis process/vascular&#xD;
      stiffness, malignancy and osteoporosis.&#xD;
&#xD;
      Methods and Analysis:&#xD;
&#xD;
      Patients: All patients with the suspicion of PMR/GCR will be offered to participate in the&#xD;
      study. The current protocol consists of 4 separate studies including: I) The association of&#xD;
      clinical picture of PMR/GCA with PET detected vasculitis II) Evaluating validity of 18F-FDG&#xD;
      PET/CT scan for diagnosis of PMR/GCA compared to temporal artery biopsy III) Incidence of new&#xD;
      diagnosed malignancies in patients with PMR/GCA, or PMR like syndrome with the aim of PET/CT&#xD;
      scan and Chest X ray/Abdominal ultrasound IV) Impact of disease process as well as steroid&#xD;
      treatment on bone mineral density, body composition and vasculitis/vascular stiffness in&#xD;
      PMR/GCA patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 2017</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2018</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>Cumulated prednisolone dose within the first year after treatment initiation in patients with and without vasculitis in the large vessels</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient reported global visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)</measure>
    <time_frame>One year</time_frame>
    <description>Patient global assessment of disease severity as measured on a visual analogue scale (VAS) that ranges from 0 to 100, in patients with vasculitis in the large vessels detected by PET scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician reported visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)</measure>
    <time_frame>One year</time_frame>
    <description>Physician assessment of disease severity as measured on a visual analogue scale (VAS) that ranges from 0 to 100 in patients with vasculitis in the large vessels detected by PET scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported pain in patients with vasculitis in the large vessels (positive PET)</measure>
    <time_frame>One year</time_frame>
    <description>Patient assessment of pain intensity as measured on a visual analogue scale (VAS) that ranges from 0 to 100, in patients with vasculitis in the large vessels detected by PET scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morning stiffness (minute) in patients with vasculitis in the large vessels (positive PET)</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry results in patients with vasculitis in the large vessels (positive PET)</measure>
    <time_frame>One year</time_frame>
    <description>ESR, CRP and fibrinogen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of relapses in patients with vasculitis in the large vessels (positive PET)</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of PET positivity (vasculitis in the large vessels as well as findings compatible with PMR) in patients with temporal artery biopsy positive.</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of PET negativity (no signs of vasculitis in the large vessels) in patients with temporal artery biopsy negative.</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of malignancies in the included patients detected by the aim of 18F-FDG PET/CT scan.</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of malignancies in the included patients detected by the aim of Chest X Ray plus abdominal Ultrasound.</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on Aortic Pulse Wave Velocity (PWV)</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on upper limb PWV</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on Aortic augmentation index</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on Body Mass Index</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on T score</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on Z score</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on Lean Body Mass</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on Fat Mass</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on Bone Mineral Density</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on Bone Mineral Content</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on Fat Free Mass</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on Fat Free Mass Index</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of disease process and steroid treatment on Fat Mass Index</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Polymyalgia Rheumatica</condition>
  <condition>Giant Cell Arteritis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>18F-FDG PET/CT</intervention_name>
    <description>18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All new patients with clinical suspicion of PMR/GCA.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least five (A-E) components of the PMR diagnostic criteria, including:&#xD;
&#xD;
               -  A. Age ≥50 years,&#xD;
&#xD;
               -  B. Bilateral shoulder or hip pain,&#xD;
&#xD;
               -  C. Morning stiffness lasting &gt;45 min,&#xD;
&#xD;
               -  D. Elevated erythrocyte sedimentation rate (ESR),&#xD;
&#xD;
               -  E. Elevated C-reactive protein (CRP),&#xD;
&#xD;
               -  F. Disease duration &gt;2weeks, should be met to suspect PMR.&#xD;
&#xD;
          -  For GCA following criteria's must be seen: Age &gt; 50 years, ESR/CRP &gt; 50, as well as at&#xD;
             least two symptoms related to vasculitis (scalp tenderness, vision disturbances,&#xD;
             headache (new or changed), jaw claudication, tenderness of the temporal arteria) if&#xD;
             patients do not simultaneously have PMR. If the patient is suspected for PMR, one&#xD;
             cranial symptom is enough to suspect GCA.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Inability to communicate in Danish&#xD;
&#xD;
          -  Infections or malignancy when prednisolone is permanently unsuitable&#xD;
&#xD;
          -  Contraindication to imaging studies (allergy to contrast materials, reduced kidney&#xD;
             function, pregnancy and Blood Sugar (BS) &gt;8 mmol/l after 6 hours fasting)&#xD;
&#xD;
          -  Initiation of steroid treatment before the PET scan&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Inger Marie Jensen Hansen, Phd, DMSci</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Rheumatology, Odense University Hospital, Svendborg Hospital, Svendborg, Denmark.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amir Emamifar, MD</last_name>
    <phone>+45 71399718</phone>
    <email>amir.emamifar@rsyd.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Inger Marie Jensen Hansen, PhD, DMSci</last_name>
    <phone>+45 63202506</phone>
    <email>inger.marie.jensen.hansen@rsyd.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Rheumatology, Odense University Hospital, Svendborg Hospital</name>
      <address>
        <city>Svendborg</city>
        <zip>5700</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <contact>
      <last_name>Inger Marie Jensen Hansen, PhD, DMSci</last_name>
      <phone>+45 63202506</phone>
      <email>inger.marie.jensen.hansen@rsyd.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>April 24, 2017</last_update_submitted>
  <last_update_submitted_qc>April 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Svendborg Hospital</investigator_affiliation>
    <investigator_full_name>Amir Emamifar</investigator_full_name>
    <investigator_title>Doctor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polymyalgia Rheumatica</mesh_term>
    <mesh_term>Giant Cell Arteritis</mesh_term>
    <mesh_term>Arteritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02985424
org study id: S-20160098
secondary id: 16/40522
nct id: NCT02985424
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose
      Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern
      of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica
      (PMR)/Giant Cell Arteritis (GCA) .
Introduction:

      Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA) are common inflammatory
      conditions. The diagnosis of PMR/GCA poses many challenges since there are no specific
      diagnostic tests. Recent literature emphasizes the ability of 18F-Fluorodeoxyglucose Positron
      Emission Tomography/Computed Tomography (18F-FDG PET/CT) to assess global disease activity
      and/or inflammation burden. 18F-FDG PET/CT may lead to make diagnosis at an earlier stage
      than conventional imaging and assess response to therapy. With respect to the management of
      PMR/GCA, there are three significant areas of concern as follows: Vasculitis process/vascular
      stiffness, malignancy and osteoporosis.

      Methods and Analysis:

      Patients: All patients with the suspicion of PMR/GCR will be offered to participate in the
      study. The current protocol consists of 4 separate studies including: I) The association of
      clinical picture of PMR/GCA with PET detected vasculitis II) Evaluating validity of 18F-FDG
      PET/CT scan for diagnosis of PMR/GCA compared to temporal artery biopsy III) Incidence of new
      diagnosed malignancies in patients with PMR/GCA, or PMR like syndrome with the aim of PET/CT
      scan and Chest X ray/Abdominal ultrasound IV) Impact of disease process as well as steroid
      treatment on bone mineral density, body composition and vasculitis/vascular stiffness in
      PMR/GCA patients.
observational model: Cohort
time perspective: Prospective
measure: Cumulated prednisolone dose within the first year after treatment initiation in patients with and without vasculitis in the large vessels
time frame: One year
measure: Patient reported global visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)
time frame: One year
description: Patient global assessment of disease severity as measured on a visual analogue scale (VAS) that ranges from 0 to 100, in patients with vasculitis in the large vessels detected by PET scan
measure: Physician reported visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)
time frame: One year
description: Physician assessment of disease severity as measured on a visual analogue scale (VAS) that ranges from 0 to 100 in patients with vasculitis in the large vessels detected by PET scan.
measure: Patient reported pain in patients with vasculitis in the large vessels (positive PET)
time frame: One year
description: Patient assessment of pain intensity as measured on a visual analogue scale (VAS) that ranges from 0 to 100, in patients with vasculitis in the large vessels detected by PET scan
measure: Morning stiffness (minute) in patients with vasculitis in the large vessels (positive PET)
time frame: One year
measure: Biochemistry results in patients with vasculitis in the large vessels (positive PET)
time frame: One year
description: ESR, CRP and fibrinogen
measure: Number of relapses in patients with vasculitis in the large vessels (positive PET)
time frame: One year
measure: Proportion of PET positivity (vasculitis in the large vessels as well as findings compatible with PMR) in patients with temporal artery biopsy positive.
time frame: One year
measure: Proportion of PET negativity (no signs of vasculitis in the large vessels) in patients with temporal artery biopsy negative.
time frame: One year
measure: Incidence of malignancies in the included patients detected by the aim of 18F-FDG PET/CT scan.
time frame: One year
measure: Incidence of malignancies in the included patients detected by the aim of Chest X Ray plus abdominal Ultrasound.
time frame: One year
measure: Impact of disease process and steroid treatment on Aortic Pulse Wave Velocity (PWV)
time frame: One year
measure: Impact of disease process and steroid treatment on upper limb PWV
time frame: One year
measure: Impact of disease process and steroid treatment on Aortic augmentation index
time frame: One year
measure: Impact of disease process and steroid treatment on Body Mass Index
time frame: One year
measure: Impact of disease process and steroid treatment on T score
time frame: One year
measure: Impact of disease process and steroid treatment on Z score
time frame: One year
measure: Impact of disease process and steroid treatment on Lean Body Mass
time frame: One year
measure: Impact of disease process and steroid treatment on Fat Mass
time frame: One year
measure: Impact of disease process and steroid treatment on Bone Mineral Density
time frame: One year
measure: Impact of disease process and steroid treatment on Bone Mineral Content
time frame: One year
measure: Impact of disease process and steroid treatment on Fat Free Mass
time frame: One year
measure: Impact of disease process and steroid treatment on Fat Free Mass Index
time frame: One year
measure: Impact of disease process and steroid treatment on Fat Mass Index
time frame: One year
intervention type: Other
intervention name: 18F-FDG PET/CT
description: 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Inger Marie Jensen Hansen, Phd, DMSci
role: Study Chair
affiliation: Department of Rheumatology, Odense University Hospital, Svendborg Hospital, Svendborg, Denmark.
last name: Amir Emamifar, MD
phone: +45 71399718
email: amir.emamifar@rsyd.dk
last name: Inger Marie Jensen Hansen, PhD, DMSci
phone: +45 63202506
email: inger.marie.jensen.hansen@rsyd.dk
facility: 
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Svendborg Hospital
investigator full name: Amir Emamifar
investigator title: Doctor of Medicine
mesh term: Polymyalgia Rheumatica
mesh term: Giant Cell Arteritis
mesh term: Arteritis
mesh term: Fluorodeoxyglucose F18
sharing ipd: No