<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/NCT04474912</url>
  </required_header>
  <id_info>
    <org_study_id>6293-22-7-2020</org_study_id>
    <nct_id>NCT04474912</nct_id>
  </id_info>
  <brief_title>Serum IL-17 Correlated With Inflammatory Changes in Osteoarthritis and Rheumatoid Arthritis</brief_title>
  <official_title>Serum IL-17 Correlated With Inflammatory Changes But Not With Bony Changes in Both Hand Osteoarthritis and Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The total number of the included subjects was 120 in 3 equal groups (RA, OA and control). All&#xD;
      subject was subjected to serum IL17 level measurement. MSK US (of both wrists, MCPs, PIPs and&#xD;
      DIPs) was done to all patients in RA and OA groups. Disease activity was measured by disease&#xD;
      activity score (DAS28) for RA patients. Visual analogue scale for pain (VAS) was obtained&#xD;
      from patients in RA and OA groups. Functional assessment was done using health assessment&#xD;
      questionnaire (HAQ) for RA patients and the Australian/Canadian (AUSCAN) Osteoarthritis Hand&#xD;
      Index for OA patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">November 29, 2020</completion_date>
  <primary_completion_date type="Actual">November 29, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical disease activity in Rheumatoid Arthritis (RA) and hand Osteoarthritis (OA) patients</measure>
    <time_frame>12 months</time_frame>
    <description>During the whole course of the study, disease activity of the patients was measured by disease activity score (DAS28) for RA patients. Visual analogue scale for pain (VAS) was obtained from patients in RA and OA groups. Functional assessment was done using health assessment questionnaire (HAQ) for RA patients and the Australian/Canadian (AUSCAN) Osteoarthritis Hand Index for OA patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IL-17 serum levels in RA and OA patients</measure>
    <time_frame>2 weeks</time_frame>
    <description>IL-17 will be measured by enzyme linked immunosorbent assay from collected serum samples from the study participants</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Radiologic bony changes in RA and OA patients</measure>
    <time_frame>12 months</time_frame>
    <description>During the whole course of the study period, recruited participants undergone musculoskeletal (MSK) ultrasound to assess the bony changes.</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Rheumatoid Arthritis (RA) and Osteoarthritis (OA)</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Healthy volunteers with no symptoms or signs of rheumatoid arthritis or osteoarthritis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rheumatoid arthritis group</arm_group_label>
    <description>Rheumatoid arthritis (RA) patients fulfilled 2010 American college of rheumatology (ACR) classification criteria. A patient is considered having definite RA if he/she scores at least 6 points in the established classification system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Osteoarthritis group</arm_group_label>
    <description>Osteoarthritis (OA) patients fulfilled 1990 ACR criteria for the classification and reporting of osteoarthritis of the hand. A patient is considered having hand OA if he /she Hand pain, aching, or stiffness plus 3 or 4 of hard tissue enlargement of 2 or more of 10 selected joints or hard tissue enlargement of 2 or more DIP joints or fewer than 3 swollen MCP joints, or deformity of at least 1 of 10 selected joints which are are the second and third distal interphalangeal (DIP), the second and third proximal interphalangeal, and the first carpometacarpal joints of both hands</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study participants will be recruited from attendants to Rheumatology and Rehabilitation&#xD;
        outpatient clinic at Zagazig University Hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A patient is considered having definite RA if he/she scores at least 6 points in the&#xD;
             established classification system&#xD;
&#xD;
          -  A patient is considered having Hand OA if he /she Hand pain, aching, or stiffness plus&#xD;
             3 or 4 of hard tissue enlargement of 2 or more of 10 selected joints or hard tissue&#xD;
             enlargement of 2 or more DIP joints or fewer than 3 swollen MCP joints, or deformity&#xD;
             of at least 1 of 10 selected joints which are are the second and third distal&#xD;
             interphalangeal (DIP), the second and third proximal interphalangeal, and the first&#xD;
             carpometacarpal joints of both hands&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any subject with liver diseases, coronary artery diseases, kidney diseases or other&#xD;
             inflammatory conditions was excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zagazig University Faculty of Medicine</name>
      <address>
        <city>Zagazig</city>
        <state>Sharqia</state>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>January 20, 2021</last_update_submitted>
  <last_update_submitted_qc>January 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Noha M Hammad, MD</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT04474912
org study id: 6293-22-7-2020
nct id: NCT04474912
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The total number of the included subjects was 120 in 3 equal groups (RA, OA and control). All
      subject was subjected to serum IL17 level measurement. MSK US (of both wrists, MCPs, PIPs and
      DIPs) was done to all patients in RA and OA groups. Disease activity was measured by disease
      activity score (DAS28) for RA patients. Visual analogue scale for pain (VAS) was obtained
      from patients in RA and OA groups. Functional assessment was done using health assessment
      questionnaire (HAQ) for RA patients and the Australian/Canadian (AUSCAN) Osteoarthritis Hand
      Index for OA patients
observational model: Case-Control
time perspective: Retrospective
measure: Clinical disease activity in Rheumatoid Arthritis (RA) and hand Osteoarthritis (OA) patients
time frame: 12 months
description: During the whole course of the study, disease activity of the patients was measured by disease activity score (DAS28) for RA patients. Visual analogue scale for pain (VAS) was obtained from patients in RA and OA groups. Functional assessment was done using health assessment questionnaire (HAQ) for RA patients and the Australian/Canadian (AUSCAN) Osteoarthritis Hand Index for OA patients.
measure: IL-17 serum levels in RA and OA patients
time frame: 2 weeks
description: IL-17 will be measured by enzyme linked immunosorbent assay from collected serum samples from the study participants
measure: Radiologic bony changes in RA and OA patients
time frame: 12 months
description: During the whole course of the study period, recruited participants undergone musculoskeletal (MSK) ultrasound to assess the bony changes.
arm group label: Control group
description: Healthy volunteers with no symptoms or signs of rheumatoid arthritis or osteoarthritis
arm group label: Rheumatoid arthritis group
description: Rheumatoid arthritis (RA) patients fulfilled 2010 American college of rheumatology (ACR) classification criteria. A patient is considered having definite RA if he/she scores at least 6 points in the established classification system
arm group label: Osteoarthritis group
description: Osteoarthritis (OA) patients fulfilled 1990 ACR criteria for the classification and reporting of osteoarthritis of the hand. A patient is considered having hand OA if he /she Hand pain, aching, or stiffness plus 3 or 4 of hard tissue enlargement of 2 or more of 10 selected joints or hard tissue enlargement of 2 or more DIP joints or fewer than 3 swollen MCP joints, or deformity of at least 1 of 10 selected joints which are are the second and third distal interphalangeal (DIP), the second and third proximal interphalangeal, and the first carpometacarpal joints of both hands
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Noha M Hammad, MD
investigator title: Principal investigator
mesh term: Arthritis
mesh term: Osteoarthritis
mesh term: Arthritis, Rheumatoid