<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/NCT03835624</url>
  </required_header>
  <id_info>
    <org_study_id>Benha University</org_study_id>
    <nct_id>NCT03835624</nct_id>
  </id_info>
  <brief_title>Interleukin 33 in Juvenile Idiopathic Arthritis Patients</brief_title>
  <official_title>Interleukin 33 in Juvenile Idiopathic Arthritis Patients :Relation to Disease State and Muscloskeletal Ultrasound Findings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Benha University</source>
  <brief_summary>
    <textblock>
      The aim of this study is to measure serum and synovial fluid levels of IL 33 and its relative&#xD;
      mRNA expression in peripheral blood mononuclear cells in juvenile idiopathic arthritis (JIA)&#xD;
      patients and to correlate it with the clinical and laboratory characteristics, disease&#xD;
      activity and musculoskeletal ultrasound findings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SUBJECTS AND METHODS&#xD;
&#xD;
      Subjects:This study will be a case-control study including sixty children with juvenile&#xD;
      idiopathic arthritis attending pediatric rheumatology clinic of Benha University Hospital and&#xD;
      Benha children hospital and thirty apparently healthy children as controls. They will be&#xD;
      classified into:&#xD;
&#xD;
        -  Group (I) study group:60 cases of children with juvenile idiopathic arthritis.&#xD;
&#xD;
        -  Group (II) Control group:60 of apparently healthy children matched for age and sex&#xD;
&#xD;
      A)Full history taking&#xD;
&#xD;
      B) Full clinical examination&#xD;
&#xD;
      C) Clinical assessment of disease activity&#xD;
&#xD;
      D) Laboratory Investigations:&#xD;
&#xD;
      All subjects will be investigated by&#xD;
&#xD;
        1. complete blood count.&#xD;
&#xD;
        2. Erythrocyte sedmentation rate.&#xD;
&#xD;
        3. C-reactive protein .&#xD;
&#xD;
        4. Liver enzymes: ALT and AST.&#xD;
&#xD;
        5. Rheumatoid factor.&#xD;
&#xD;
        6. Antinuclear antibody (ANA).&#xD;
&#xD;
        7. serum ferritin&#xD;
&#xD;
        8. serum and synovial fluid Interleukin 33 by ELISA and its relative expression in&#xD;
           peripheral blood mononuclear cells by PCR&#xD;
&#xD;
      E) Musculoskeletal Ultrasound examination&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">November 20, 2019</completion_date>
  <primary_completion_date type="Actual">November 20, 2019</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>27 active joints count</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>active arthritis, defined as joint swelling or limitation of movement accompanied by pain and tenderness, assessed in 27 joints</description>
  </primary_outcome>
  <primary_outcome>
    <measure>physician's global assessment of disease activity scale</measure>
    <time_frame>through study completion, an average of 4 months.</time_frame>
    <description>physician's global assessment of disease activity on a 0- 10 cm visual analogue scale (VAS). Higher value indicates worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>parent/patient global assessment of well-being scale</measure>
    <time_frame>through study completion, an average of 4 months.isit to measure IL33</time_frame>
    <description>parent/patient global assessment of well-being on a 0-10 cm visual analogue scale .Higher value indicates worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Erythrocyte sedimentation rate (ESR)</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>ESR measured in mm/1st hour by westergren method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27)</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>The JADAS-27 (range 0-57) was computed by summing the scores of four core-set criteria [3]: physician's global assessment of disease activity (PGA) on a 10 cm visual analogue scale (VAS); parent/patient global assessment of well-being on a 10 cm VAS [7]; active arthritis, defined as joint swelling or limitation of movement accompanied by pain and tenderness, assessed in 27 joints; and ESR (mm/h) normalized to a 0-10 scale, using the formula ESR - 20/10, whereby, before the calculation, ESR values &lt;20 mm/h were converted to 0 and ESR values &gt;120 mm/h were converted to 120. A higher JADAS-27 indicates higher disease activity and a lower JADAS-27 indicates lower disease activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C reactive protein (CRP)</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>CRP measured in mg/L using nephlometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum ferritin level</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>Serum ferritin level measured in ng/mL using elisa</description>
  </primary_outcome>
  <primary_outcome>
    <measure>grey scale 10 joint score</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>grey scale musculoskeletal ultrasound including 10-joints (bilateral knee, ankle, wrist, elbow and the 2nd metacarpophalangeal (MCP) joints)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>power Doppler 10 joint score</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>power Doppler musculoskeletal ultrasound including 10-joints (bilateral knee, ankle, wrist, elbow and the 2nd metacarpophalangeal (MCP) joints)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rheumatoid factor</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>rheumatoid factor measured in U/ml using latex agglutination test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>disease activity for systemic arthritis with active systemic features (and without active arthritis)</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>DISEASE ACTIVITY LEVELS (2 levels) Active fever AND physician global assessment of overall disease activity 7 of 10 Active fever AND systemic features of high disease activity (e.g., significant serositis) that result in physician global assessment of overall disease activity 7 of 10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Juvenile Arthritis Multidimensional Assessment Report</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>The JAMAR is a questionnaire includes the following 15 sections:&#xD;
Assessment of physical function (PF) using 15-items with score 0-45. Higher scores indicating higher degree of disability 2. 21-numbered circle Visual Analogue Scale (VAS) for pain 3. Assessment of the presence of joint pain or swelling.4.Assessment of morning stiffness 5. extra-articular symptoms (fever and rash) 6.disease activity on a 21-circle VAS. 7.disease status. 8. course. 9.medications . 10. side effects. 11.difficulties with medication 12. school/university/work problems. 13. HRQoL 14.patient's overall well-being on a 21-numbered circle VAS. 15. satisfaction with outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>disease activity for systemic arthritis with active arthritis (and without active systemic features)</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>Low disease activity (must satisfy all) 4 or fewer active joints, ESR or CRP level normal PGA of disease activity less than4 of, 10 PAGA of well-being 2 of 10 Moderate disease activity (does not satisfy criteria for low or high disease activity) High disease activity (must satisfy at least 3) 8 or more active joints,ESR or CRP level greater than twice upper limit of normal, PGA of disease activity 7 of 10, PAGA of well-being 5 of 10</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <arm_group>
    <arm_group_label>juvenile idiopathic arthritis</arm_group_label>
    <description>about 60 cases of children with juvenile idiopathic arthritis diagnosed according to ILAR classification criteria of juvenile idiopathic arthritis will be recruited from pediatric rheumatology clinic of Benha university hospital serum interleukin 33 and its relative expression in peripheral blood mononuclear cells (PBMNCs) will be measured in their blood samples also IL-33 will be measured in synovial fluid samples</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>about 60 apparently healthy children with comparable age and sex to the patients.&#xD;
serum interleukin 33 and its relative expression in PBMNCs will be measured in their bloodsamples.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>interleukin 33</intervention_name>
    <description>serum and synovial fluid samples will be obtained from patients and serum samples from controls to measure interleukin 33 and its relative mRNA expression in peripheral blood mononuclear cells by PCR</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>juvenile idiopathic arthritis</arm_group_label>
    <other_name>IL-33</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples from Juvenile idiopathic arthritis patients and healthy controls and synovial&#xD;
      fluid samples from Juvenile idiopathic arthritis patients&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study will be a case-control study including sixty children with juvenile idiopathic&#xD;
        arthritis attending pediatric rheumatology clinic of Benha University Hospital and and 60&#xD;
        apparently healthy children as controls.&#xD;
&#xD;
        They will be classified into:&#xD;
&#xD;
          -  Group (I) study group:60 cases of children with juvenile idiopathic arthritis.&#xD;
&#xD;
          -  Group (II) Control group:60 of apparently healthy children matched for age and sex.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children less than 16 years old diagnosed according to ILAR classification criteria of&#xD;
             juvenile idiopathic arthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1-Exclusion other causes of arthritis in children as:&#xD;
&#xD;
               1. Other autoimmune diseases Vasculitis- SLE- Rheumatic fever- Dermatomyositis-&#xD;
                  Polymyositis- Enteropathic arthritis- Behcet disease- Sjogren-Scleroderma- Mixed&#xD;
                  connective diseases&#xD;
&#xD;
               2. Infectious disease or septic arthritis.&#xD;
&#xD;
               3. Metabolic diseases.&#xD;
&#xD;
               4. Endocrine diseases.&#xD;
&#xD;
               5. Neuropathic diseases.&#xD;
&#xD;
               6. Heritable bone disease.&#xD;
&#xD;
               7. Neoplastic diseases including leukemia.&#xD;
&#xD;
               8. Sarcoidosis.&#xD;
&#xD;
               9. Familial Mediterranean fever. 2-Exclusion of children with diseases that affect&#xD;
                  serum level of IL 33 as:&#xD;
&#xD;
               1. Inflammatory diseases of airway e.g asthma&#xD;
&#xD;
               2. Inflammatory bowel disease&#xD;
&#xD;
               3. Systemic lupus erythmatosus&#xD;
&#xD;
               4. Inflammatory skin disease e.g :atopic dermatitis&#xD;
&#xD;
               5. Cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Waleed Hassan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Benha university- Qaluibya- Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Benha University Hospital</name>
      <address>
        <city>Banhā</city>
        <state>Qalubiya</state>
        <zip>13518</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>December 8, 2019</last_update_submitted>
  <last_update_submitted_qc>December 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>Waleed Ahmed Salaheldeen Hassan</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Juvenile Idiopathic Arthritis</keyword>
  <keyword>Interleukin 33</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>


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/NCT03835624
org study id: Benha University
nct id: NCT03835624
lead sponsor: 
The aim of this study is to measure serum and synovial fluid levels of IL 33 and its relative
      mRNA expression in peripheral blood mononuclear cells in juvenile idiopathic arthritis (JIA)
      patients and to correlate it with the clinical and laboratory characteristics, disease
      activity and musculoskeletal ultrasound findings.
SUBJECTS AND METHODS

      Subjects:This study will be a case-control study including sixty children with juvenile
      idiopathic arthritis attending pediatric rheumatology clinic of Benha University Hospital and
      Benha children hospital and thirty apparently healthy children as controls. They will be
      classified into:

        -  Group (I) study group:60 cases of children with juvenile idiopathic arthritis.

        -  Group (II) Control group:60 of apparently healthy children matched for age and sex

      A)Full history taking

      B) Full clinical examination

      C) Clinical assessment of disease activity

      D) Laboratory Investigations:

      All subjects will be investigated by

        1. complete blood count.

        2. Erythrocyte sedmentation rate.

        3. C-reactive protein .

        4. Liver enzymes: ALT and AST.

        5. Rheumatoid factor.

        6. Antinuclear antibody (ANA).

        7. serum ferritin

        8. serum and synovial fluid Interleukin 33 by ELISA and its relative expression in
           peripheral blood mononuclear cells by PCR

      E) Musculoskeletal Ultrasound examination
observational model: Case-Control
time perspective: Prospective
measure: 27 active joints count
time frame: through study completion, an average of 4 months
description: active arthritis, defined as joint swelling or limitation of movement accompanied by pain and tenderness, assessed in 27 joints
measure: physician's global assessment of disease activity scale
time frame: through study completion, an average of 4 months.
description: physician's global assessment of disease activity on a 0- 10 cm visual analogue scale (VAS). Higher value indicates worse outcome
measure: parent/patient global assessment of well-being scale
time frame: through study completion, an average of 4 months.isit to measure IL33
description: parent/patient global assessment of well-being on a 0-10 cm visual analogue scale .Higher value indicates worse outcome
measure: Erythrocyte sedimentation rate (ESR)
time frame: through study completion, an average of 4 months
description: ESR measured in mm/1st hour by westergren method
measure: The 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27)
time frame: through study completion, an average of 4 months
description: The JADAS-27 (range 0-57) was computed by summing the scores of four core-set criteria [3]: physician's global assessment of disease activity (PGA) on a 10 cm visual analogue scale (VAS); parent/patient global assessment of well-being on a 10 cm VAS [7]; active arthritis, defined as joint swelling or limitation of movement accompanied by pain and tenderness, assessed in 27 joints; and ESR (mm/h) normalized to a 0-10 scale, using the formula ESR - 20/10, whereby, before the calculation, ESR values <20 mm/h were converted to 0 and ESR values >120 mm/h were converted to 120. A higher JADAS-27 indicates higher disease activity and a lower JADAS-27 indicates lower disease activity
measure: C reactive protein (CRP)
time frame: through study completion, an average of 4 months
description: CRP measured in mg/L using nephlometry
measure: Serum ferritin level
time frame: through study completion, an average of 4 months
description: Serum ferritin level measured in ng/mL using elisa
measure: grey scale 10 joint score
time frame: through study completion, an average of 4 months
description: grey scale musculoskeletal ultrasound including 10-joints (bilateral knee, ankle, wrist, elbow and the 2nd metacarpophalangeal (MCP) joints)
measure: power Doppler 10 joint score
time frame: through study completion, an average of 4 months
description: power Doppler musculoskeletal ultrasound including 10-joints (bilateral knee, ankle, wrist, elbow and the 2nd metacarpophalangeal (MCP) joints)
measure: rheumatoid factor
time frame: through study completion, an average of 4 months
description: rheumatoid factor measured in U/ml using latex agglutination test
measure: disease activity for systemic arthritis with active systemic features (and without active arthritis)
time frame: through study completion, an average of 4 months
description: DISEASE ACTIVITY LEVELS (2 levels) Active fever AND physician global assessment of overall disease activity 7 of 10 Active fever AND systemic features of high disease activity (e.g., significant serositis) that result in physician global assessment of overall disease activity 7 of 10
measure: The Juvenile Arthritis Multidimensional Assessment Report
time frame: through study completion, an average of 4 months
description: The JAMAR is a questionnaire includes the following 15 sections:
Assessment of physical function (PF) using 15-items with score 0-45. Higher scores indicating higher degree of disability 2. 21-numbered circle Visual Analogue Scale (VAS) for pain 3. Assessment of the presence of joint pain or swelling.4.Assessment of morning stiffness 5. extra-articular symptoms (fever and rash) 6.disease activity on a 21-circle VAS. 7.disease status. 8. course. 9.medications . 10. side effects. 11.difficulties with medication 12. school/university/work problems. 13. HRQoL 14.patient's overall well-being on a 21-numbered circle VAS. 15. satisfaction with outcome.
measure: disease activity for systemic arthritis with active arthritis (and without active systemic features)
time frame: through study completion, an average of 4 months
description: Low disease activity (must satisfy all) 4 or fewer active joints, ESR or CRP level normal PGA of disease activity less than4 of, 10 PAGA of well-being 2 of 10 Moderate disease activity (does not satisfy criteria for low or high disease activity) High disease activity (must satisfy at least 3) 8 or more active joints,ESR or CRP level greater than twice upper limit of normal, PGA of disease activity 7 of 10, PAGA of well-being 5 of 10
arm group label: juvenile idiopathic arthritis
description: about 60 cases of children with juvenile idiopathic arthritis diagnosed according to ILAR classification criteria of juvenile idiopathic arthritis will be recruited from pediatric rheumatology clinic of Benha university hospital serum interleukin 33 and its relative expression in peripheral blood mononuclear cells (PBMNCs) will be measured in their blood samples also IL-33 will be measured in synovial fluid samples
arm group label: control group
description: about 60 apparently healthy children with comparable age and sex to the patients.
serum interleukin 33 and its relative expression in PBMNCs will be measured in their bloodsamples.
intervention type: Diagnostic Test
intervention name: interleukin 33
description: serum and synovial fluid samples will be obtained from patients and serum samples from controls to measure interleukin 33 and its relative mRNA expression in peripheral blood mononuclear cells by PCR
arm group label: control group
arm group label: juvenile idiopathic arthritis
other name: IL-33
blood samples from Juvenile idiopathic arthritis patients and healthy controls and synovial
      fluid samples from Juvenile idiopathic arthritis patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Waleed Hassan, MD
role: Principal Investigator
affiliation: Benha university- Qaluibya- Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: Waleed Ahmed Salaheldeen Hassan
investigator title: Assistant professor
mesh term: Arthritis
mesh term: Arthritis, Juvenile