xml: <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/NCT06007456</url>
    </required_header>
    <id_info>
      <org_study_id>RC 23/22</org_study_id>
      <nct_id>NCT06007456</nct_id>
    </id_info>
    <brief_title>Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis</brief_title>
    <official_title>Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis and Outcomes Evaluation During Transition to Adult Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IRCCS Burlo Garofolo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>IRCCS Burlo Garofolo</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>
        Juvenile Idiopathic Arthritis (JIA), the most common rheumatologic chronic disease in&#xD;
        children, is defined as arthritis persisting for at least 6 weeks with no known cause in a&#xD;
        patient under the age of 16. The term JIA is an umbrella that includes very different&#xD;
        diseases. The current International League of Associations for Rheumatology (ILAR)&#xD;
        classification divides JIA patients into 7 categories based on number of involved joints and&#xD;
        time of involvement, presence of systemic symptoms, psoriatic findings and spondyloarthritis.&#xD;
        This classification groups together patients with different disease and divides patients with&#xD;
        the same disease. In the first case, unifying distinct diseases could lead to&#xD;
        undifferentiated therapeutic choices, moving away from the modern concept of therapeutic&#xD;
        personalization. In the second case, similarities between paediatric and adult arthritis&#xD;
        could not be found. This involves both a loss of collaboration with the adult rheumatologist&#xD;
        and the difficulty in accessing possibly effective therapies approved only for adult&#xD;
        arthritis.&#xD;
  &#xD;
        In clinical practice, it is increasingly evident that the number of affected joints and the&#xD;
        speed of joint involvement are not useful criteria for defining the type and severity of&#xD;
        disease. Joint counts lead to underestimate the importance of joint distribution in the&#xD;
        identification of distinct forms of arthritis. A recent study found that patterns of joint&#xD;
        involvement represent prognostic features, so grouping patients by joint pattern and degree&#xD;
        of localization may help clinicians tailor treatments based on predicted disease&#xD;
        trajectories. Another important point to differentiate some forms of arthritis is the&#xD;
        presence of enthesitis and tenosynovitis. Sometimes tendon inflammation can be not clinically&#xD;
        evident, so ultrasound evaluation is useful to detect it. Musculoskeletal ultrasound (MSUS)&#xD;
        has been used worldwide by adult rheumatologist, but it is beginning a useful tool also in&#xD;
        patients with JIA. Recent studies underline the important role of MSUS findings to assess&#xD;
        disease activity and assist disease classification. In recent years, the need has emerged to&#xD;
        replace the ILAR criteria with a new nomenclature based on the disease biology. This approach&#xD;
        could help clinicians to choose a personalized therapeutic strategy for patients with&#xD;
        arthritis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 10, 2022</start_date>
    <completion_date type="Anticipated">March 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">March 15, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate disease activity by the Juvenile Arthritis Disease score during the transition to adult care</measure>
      <time_frame>Between 14-17 years of age</time_frame>
      <description>The Juvenile Arthritis Disease score (JADAS) includes 4 measures: physician's global assessment of disease activity, measured on a 0-10 visual analog scale (VAS) (0=no activity-10=maximum activity); parent global assessment of well-being, measured on a 0-10 VAS (0=very well-10=very poor); the erythrocyte sedimentation rate, normalized to a 0 to 10 scale; and a count of joints with active disease. The final score is calculated as the sum of the scores of these four components (higher scores indicate higher disease activity).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To evaluate disease activity by the Health Assessment Questionnaire - Disability Index during the transition to adult care</measure>
      <time_frame>Between 14-17 years of age</time_frame>
      <description>The Health Assessment Questionnaire - Disability Index (HAQ-DI) includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities, with 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To assess joint damage by radiological examination during the transition to adult care</measure>
      <time_frame>Between 14-17 years of age</time_frame>
      <description>Radiographs will be performed to assess the presence of joint damage</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To evaluate non-inflammatory pain by the widespread pain index scale during transition to adult care</measure>
      <time_frame>Between 14-17 years of age</time_frame>
      <description>Pain will be evaluated through the widespread pain index (WPI) scale that assesses the presence of pain in 19 designated body locations over the past 7 days. Each location is equal to a score of 1. The WPI indicates the total number of areas that are painful, giving a maximum value of 19. WPI score can range from 0 to 19.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Juvenile Idiopathic Arthritis</condition>
    <arm_group>
      <arm_group_label>Patients at onset of juvenile arthritis</arm_group_label>
      <description>New diagnosis of JIA</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients with juvenile arthritis in follow up</arm_group_label>
      <description>Subjects with JIA already followed at Rheumatologic Service</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects with JIA during the transition to adult care&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects under the age of 18 years&#xD;
  &#xD;
            -  Arthritis persisting for at least 6 weeks with no known cause&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No consent from the patients' guardians&#xD;
  &#xD;
            -  Patients with Systemic onset Juvenile Idiopathic Arthritis&#xD;
  &#xD;
            -  Patients who developed arthritis on a pre-existing inflammatory disorder such as&#xD;
               Inflammatory Bowel Disease, and had received previous treatments&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Serena Pastore, MD</last_name>
      <role>Study Director</role>
      <affiliation>IRCCS materno infantile Burlo Garofolo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Serena Pastore, MD</last_name>
      <phone>+390403785477</phone>
      <email>serena.pastore@burlo.trieste.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>IRCCS Burlo Garofolo</name>
        <address>
          <city>Trieste</city>
          <zip>34137</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Serena Pastore, MD</last_name>
        <phone>+390403785477</phone>
        <email>serena.pastore@burlo.trieste.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>JIA</keyword>
    <keyword>classification</keyword>
    <keyword>transition of care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
      <mesh_term>Arthritis, Juvenile</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007456
  org study id: RC 23/22
  nct id: NCT06007456
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Juvenile Idiopathic Arthritis (JIA), the most common rheumatologic chronic disease in
        children, is defined as arthritis persisting for at least 6 weeks with no known cause in a
        patient under the age of 16. The term JIA is an umbrella that includes very different
        diseases. The current International League of Associations for Rheumatology (ILAR)
        classification divides JIA patients into 7 categories based on number of involved joints and
        time of involvement, presence of systemic symptoms, psoriatic findings and spondyloarthritis.
        This classification groups together patients with different disease and divides patients with
        the same disease. In the first case, unifying distinct diseases could lead to
        undifferentiated therapeutic choices, moving away from the modern concept of therapeutic
        personalization. In the second case, similarities between paediatric and adult arthritis
        could not be found. This involves both a loss of collaboration with the adult rheumatologist
        and the difficulty in accessing possibly effective therapies approved only for adult
        arthritis.
  
        In clinical practice, it is increasingly evident that the number of affected joints and the
        speed of joint involvement are not useful criteria for defining the type and severity of
        disease. Joint counts lead to underestimate the importance of joint distribution in the
        identification of distinct forms of arthritis. A recent study found that patterns of joint
        involvement represent prognostic features, so grouping patients by joint pattern and degree
        of localization may help clinicians tailor treatments based on predicted disease
        trajectories. Another important point to differentiate some forms of arthritis is the
        presence of enthesitis and tenosynovitis. Sometimes tendon inflammation can be not clinically
        evident, so ultrasound evaluation is useful to detect it. Musculoskeletal ultrasound (MSUS)
        has been used worldwide by adult rheumatologist, but it is beginning a useful tool also in
        patients with JIA. Recent studies underline the important role of MSUS findings to assess
        disease activity and assist disease classification. In recent years, the need has emerged to
        replace the ILAR criteria with a new nomenclature based on the disease biology. This approach
        could help clinicians to choose a personalized therapeutic strategy for patients with
        arthritis.
  observational model: Other
  time perspective: Prospective
  measure: To evaluate disease activity by the Juvenile Arthritis Disease score during the transition to adult care
  time frame: Between 14-17 years of age
  description: The Juvenile Arthritis Disease score (JADAS) includes 4 measures: physician's global assessment of disease activity, measured on a 0-10 visual analog scale (VAS) (0=no activity-10=maximum activity); parent global assessment of well-being, measured on a 0-10 VAS (0=very well-10=very poor); the erythrocyte sedimentation rate, normalized to a 0 to 10 scale; and a count of joints with active disease. The final score is calculated as the sum of the scores of these four components (higher scores indicate higher disease activity).
  measure: To evaluate disease activity by the Health Assessment Questionnaire - Disability Index during the transition to adult care
  time frame: Between 14-17 years of age
  description: The Health Assessment Questionnaire - Disability Index (HAQ-DI) includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities, with 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8.
  measure: To assess joint damage by radiological examination during the transition to adult care
  time frame: Between 14-17 years of age
  description: Radiographs will be performed to assess the presence of joint damage
  measure: To evaluate non-inflammatory pain by the widespread pain index scale during transition to adult care
  time frame: Between 14-17 years of age
  description: Pain will be evaluated through the widespread pain index (WPI) scale that assesses the presence of pain in 19 designated body locations over the past 7 days. Each location is equal to a score of 1. The WPI indicates the total number of areas that are painful, giving a maximum value of 19. WPI score can range from 0 to 19.
  arm group label: Patients at onset of juvenile arthritis
  description: New diagnosis of JIA
  arm group label: Patients with juvenile arthritis in follow up
  description: Subjects with JIA already followed at Rheumatologic Service
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 18 Years
  healthy volunteers: No
  last name: Serena Pastore, MD
  role: Study Director
  affiliation: IRCCS materno infantile Burlo Garofolo
  last name: Serena Pastore, MD
  phone: +390403785477
  email: serena.pastore@burlo.trieste.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Arthritis
  mesh term: Arthritis, Juvenile