<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/NCT03823924</url>
  </required_header>
  <id_info>
    <org_study_id>2017_39</org_study_id>
    <secondary_id>2018-A01552-53</secondary_id>
    <nct_id>NCT03823924</nct_id>
  </id_info>
  <brief_title>Changes in Body Composition Under Ustekinumab in PsA</brief_title>
  <acronym>STELARA-CC</acronym>
  <official_title>Body Composition and Bone Mineral Density in Patients With Psoriatic Arthritis and Changes After 6 Months of Treatment With Ustekinumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</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>
      There is not much body composition and bone mineral density data available for patients with&#xD;
      psoriatic arthritis (rheumatoid arthritis) compared to control subjects.&#xD;
&#xD;
      The evaluation of the total fat mass and in particular of its abdominal distribution&#xD;
      (visceral adiposity) is important because an excessive adiposity generates adverse effects on&#xD;
      the health (hypertension, dyslipidemia, cardiovascular risk and resistance to the insulin).&#xD;
&#xD;
      In addition, data on changes in body composition and bone mineral density were not available&#xD;
      under a new psA treatment, namely ustekinumab (anti-IL12 / 23 antibody).&#xD;
&#xD;
      It is proposed to conduct a pilot study to evaluate body composition, distribution (visceral&#xD;
      adiposity) and bone mineral density in patients with psoriatic arthritis (versus control&#xD;
      subjects) and their changes after 6 months of treatment with ustekinumab&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    logistic problems&#xD;
  </why_stopped>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">July 11, 2021</completion_date>
  <primary_completion_date type="Actual">July 11, 2021</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>Visceral adiposity (VAT)</measure>
    <time_frame>At baseline</time_frame>
    <description>Comparison at baseline of visceral adiposity (VAT) in cm² between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total lean mass</measure>
    <time_frame>At baseline</time_frame>
    <description>Comparison at baseline of total lean mass (TLM, kg), between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total fat mass</measure>
    <time_frame>At baseline</time_frame>
    <description>Comparison at baseline of total fat mass (TBF, %) between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone mineral density</measure>
    <time_frame>At baseline</time_frame>
    <description>Comparison at baseline of bone mineral density (BMD, g/cm²) between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total fat mass (TBF, %) under ustekinumab in PsA</measure>
    <time_frame>at baseline and at 6 months (± 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total lean mass (TLM, kg) under ustekinumab in PsA</measure>
    <time_frame>at baseline and at 6 months (± 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in visceral adiposity (cm²) under ustekinumab in PsA</measure>
    <time_frame>at baseline and at 6 months (± 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bone mineral density (BMD, g/cm²) under ustekinumab in PsA</measure>
    <time_frame>at baseline and at 6 months (± 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in makers of bone remodeling under ustekinumab in PsA</measure>
    <time_frame>at baseline and at 6 months (± 2 months)</time_frame>
    <description>C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in leptin under ustekinumab in PsA</measure>
    <time_frame>at baseline and at 6 months (± 2 months)</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3</enrollment>
  <condition>Psoriatic Arthritis</condition>
  <arm_group>
    <arm_group_label>Psoriatic arthritis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bone mineral density (BMD)</intervention_name>
    <description>The bone mineral density (BMD) performed by DXA, which will allow the analysis of bone density (mg / cm²) at the lumbar spine (BMD L1 to L4) and the total hip (non-dominant).&#xD;
This examination will also allow an analysis of the body composition at the same time (lean mass, fat mass and bone mass for the whole body).</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Psoriatic arthritis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with psoriatic arthritis and controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Psoriatic arthritis:&#xD;
&#xD;
               1. Men and women ≥ 18 years&#xD;
&#xD;
               2. Patients with PsA according to CASPAR criteria,&#xD;
&#xD;
               3. Patients who do not have yet started ustekinumab,&#xD;
&#xD;
               4. Patients who signed the informed consent.&#xD;
&#xD;
          -  Healthy volunteers:&#xD;
&#xD;
               1. Men and women ≥ 18 years&#xD;
&#xD;
               2. Patients who signed the informed consent.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  Items 1 to 10 are applicable to healthy volunteers and PsA&#xD;
&#xD;
               1. History of fragility fracture AND / OR T-score ≤-3 if ≥50 years AND / OR Z-score&#xD;
                  ≤-3 if &lt;50 years during the screening phase,&#xD;
&#xD;
               2. Corticosteroids ≥10 mg / day,&#xD;
&#xD;
               3. Diseases or treatments affecting bone metabolism (breast cancer with&#xD;
                  anti-aromatase, malabsorption, primary hyperparathyroidism, uncontrolled&#xD;
                  hyperthyroidism ...),&#xD;
&#xD;
               4. History of radiotherapy on the lumbar spine or hip,&#xD;
&#xD;
               5. Patients undergoing hormone replacement therapy (HRT) or patients already on&#xD;
                  anti-osteoporotic therapy (bisphosphonates, strontium ranelate, teriparatide or&#xD;
                  denosumab),&#xD;
&#xD;
               6. Chronic kidney disease with creatinine clearance (CKD-EPI) ≤ 30 ml / min,&#xD;
&#xD;
               7. Weight&gt; 160 kg,&#xD;
&#xD;
               8. Patients under restrictive diet or considering a diet of this type during the&#xD;
                  study period,&#xD;
&#xD;
               9. Patients who have an intense exercise program or plan to benefit from it during&#xD;
                  the study period,&#xD;
&#xD;
              10. Pregnant or lactating women or having a pregnancy project,&#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>Julien Paccou, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Roger Salengro, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>October 13, 2022</last_update_submitted>
  <last_update_submitted_qc>October 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriatic arthritis</keyword>
  <keyword>ustekinumab</keyword>
  <keyword>body composition</keyword>
  <keyword>bone mineral density</keyword>
  <keyword>adiposity</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/NCT03823924
org study id: 2017_39
secondary id: 2018-A01552-53
nct id: NCT03823924
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is not much body composition and bone mineral density data available for patients with
      psoriatic arthritis (rheumatoid arthritis) compared to control subjects.

      The evaluation of the total fat mass and in particular of its abdominal distribution
      (visceral adiposity) is important because an excessive adiposity generates adverse effects on
      the health (hypertension, dyslipidemia, cardiovascular risk and resistance to the insulin).

      In addition, data on changes in body composition and bone mineral density were not available
      under a new psA treatment, namely ustekinumab (anti-IL12 / 23 antibody).

      It is proposed to conduct a pilot study to evaluate body composition, distribution (visceral
      adiposity) and bone mineral density in patients with psoriatic arthritis (versus control
      subjects) and their changes after 6 months of treatment with ustekinumab
observational model: Case-Control
time perspective: Prospective
measure: Visceral adiposity (VAT)
time frame: At baseline
description: Comparison at baseline of visceral adiposity (VAT) in cm² between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²).
measure: Total lean mass
time frame: At baseline
description: Comparison at baseline of total lean mass (TLM, kg), between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²).
measure: Total fat mass
time frame: At baseline
description: Comparison at baseline of total fat mass (TBF, %) between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²).
measure: Bone mineral density
time frame: At baseline
description: Comparison at baseline of bone mineral density (BMD, g/cm²) between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²).
measure: Change in total fat mass (TBF, %) under ustekinumab in PsA
time frame: at baseline and at 6 months (± 2 months)
measure: Change in total lean mass (TLM, kg) under ustekinumab in PsA
time frame: at baseline and at 6 months (± 2 months)
measure: Change in visceral adiposity (cm²) under ustekinumab in PsA
time frame: at baseline and at 6 months (± 2 months)
measure: Change in bone mineral density (BMD, g/cm²) under ustekinumab in PsA
time frame: at baseline and at 6 months (± 2 months)
measure: Change in makers of bone remodeling under ustekinumab in PsA
time frame: at baseline and at 6 months (± 2 months)
description: C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP)
measure: Change in leptin under ustekinumab in PsA
time frame: at baseline and at 6 months (± 2 months)
arm group label: Psoriatic arthritis
arm group label: Healthy volunteers
intervention type: Procedure
intervention name: Bone mineral density (BMD)
description: The bone mineral density (BMD) performed by DXA, which will allow the analysis of bone density (mg / cm²) at the lumbar spine (BMD L1 to L4) and the total hip (non-dominant).
This examination will also allow an analysis of the body composition at the same time (lean mass, fat mass and bone mass for the whole body).
arm group label: Healthy volunteers
arm group label: Psoriatic arthritis
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: Julien Paccou, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic