<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/NCT01673633</url>
  </required_header>
  <id_info>
    <org_study_id>Sacroiliitis in SSc</org_study_id>
    <secondary_id>05/01/2012-4/21</secondary_id>
    <nct_id>NCT01673633</nct_id>
  </id_info>
  <brief_title>Sacroiliitis in Systemic Sclerosis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cukurova University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cukurova University</source>
  <brief_summary>
    <textblock>
      One of the major problems of systemic sclerosis (SSc) patients is suggested to be articular&#xD;
      involvement. Mostly involved joints in SSc were reported as wrist,&#xD;
      carpometacarpal-interphalangeal, foot, knee, hip and shoulder however there have been little&#xD;
      knowledge on sacroiliac joint. Here the investigators plan a study on the involvement of this&#xD;
      joint in SSc.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_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>The frequency of sacroiliitis in systemic sclerosis</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">175</enrollment>
  <condition>Systemic Sclerosis</condition>
  <condition>Sacroiliitis</condition>
  <condition>Inflammatory Back Pain</condition>
  <arm_group>
    <arm_group_label>SSc</arm_group_label>
    <description>Sacroiliitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rheumatoid arthritis</arm_group_label>
    <description>Sacroiliitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>Sacroiliitis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive systemic sclerosis and rheumatoid arthritis patients and healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed as systemic sclerosis and rheumatoid arthritis and healthy&#xD;
             volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not giving informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 27, 2012</last_update_submitted>
  <last_update_submitted_qc>August 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cukurova University</investigator_affiliation>
    <investigator_full_name>Didem Arslan Tas</investigator_full_name>
    <investigator_title>Internist and rheumatologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sacroiliitis</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Sclerosis</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/NCT01673633
org study id: Sacroiliitis in SSc
secondary id: 05/01/2012-4/21
nct id: NCT01673633
lead sponsor: 
One of the major problems of systemic sclerosis (SSc) patients is suggested to be articular
      involvement. Mostly involved joints in SSc were reported as wrist,
      carpometacarpal-interphalangeal, foot, knee, hip and shoulder however there have been little
      knowledge on sacroiliac joint. Here the investigators plan a study on the involvement of this
      joint in SSc.
observational model: Case-Control
time perspective: Prospective
measure: The frequency of sacroiliitis in systemic sclerosis
time frame: One year
arm group label: SSc
description: Sacroiliitis
arm group label: Rheumatoid arthritis
description: Sacroiliitis
arm group label: Healthy controls
description: Sacroiliitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cukurova University
investigator full name: Didem Arslan Tas
investigator title: Internist and rheumatologist
mesh term: Sacroiliitis
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Sclerosis