<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/NCT03023592</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH170115</org_study_id>
    <nct_id>NCT03023592</nct_id>
  </id_info>
  <brief_title>Study of Iguratimod in Sjögren's Syndrome</brief_title>
  <official_title>A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single-center, self-control, open-label study of efficacy and safety of Iguratimod in&#xD;
      patients with Sjögren's Syndrome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg&#xD;
      twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient&#xD;
      Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score,&#xD;
      unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline&#xD;
      and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's&#xD;
      Syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">April 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ESSDAI improvement</measure>
    <time_frame>week 24</time_frame>
    <description>The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ESSPRI improvement</measure>
    <time_frame>week 24</time_frame>
    <description>The change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at 24 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unstimulated salivary flow rate</measure>
    <time_frame>week 24</time_frame>
    <description>The change from baseline in unstimulated salivary flow rate at 24 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schimer's test</measure>
    <time_frame>week 24</time_frame>
    <description>The change from baseline in Schimer's test at 24 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>week 24</time_frame>
    <description>The change from baseline in SF-36 score at 24 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAQ</measure>
    <time_frame>week 24</time_frame>
    <description>The change from baseline in HAQ score at 24 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunoglobulins</measure>
    <time_frame>week 24</time_frame>
    <description>The change from baseline in IgG, IgM and IgA levels at 24 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rheumatoid Factors</measure>
    <time_frame>week 24</time_frame>
    <description>The change from baseline in titer of rheumatoid factors at 24 weeks.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Sjogren's Syndrome</condition>
  <arm_group>
    <arm_group_label>Iguratimod</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are treated with Iguratimod 25 mg Twice a day for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iguratimod</intervention_name>
    <description>Iguratimod 25 mg orally twice a day for 24 weeks</description>
    <arm_group_label>Iguratimod</arm_group_label>
    <other_name>T-614</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of Sjogren's syndrome according to the revised American-European Consensus&#xD;
             Group (AECG) criteria&#xD;
&#xD;
          -  Positive dry eyes and (or) dry mouth symptoms&#xD;
&#xD;
          -  Hyperglobulinemia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complicated with other systemic autoimmune diseases&#xD;
&#xD;
          -  Severe complications of Sjogren's syndrome&#xD;
&#xD;
          -  Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents&#xD;
             therapy within 3 months prior to the screening visit&#xD;
&#xD;
          -  Active infections or chronic infectious diseases&#xD;
&#xD;
          -  A history of malignancies&#xD;
&#xD;
          -  Pregnancy or breathfeeding&#xD;
&#xD;
          -  Inability to comply with the study protocol for any other reason&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan Zhao, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hua Chen, Dr.</last_name>
    <phone>86-10-69158797</phone>
    <email>chenhua@pumch.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hua Chen, Dr.</last_name>
      <phone>86-10-69158797</phone>
      <email>chenhua@pumch.cn</email>
    </contact>
    <investigator>
      <last_name>Yan Zhao, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 15, 2017</last_update_submitted>
  <last_update_submitted_qc>January 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sjogren's Syndrome</keyword>
  <keyword>Iguratimod</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sjogren's Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03023592
org study id: PUMCH170115
nct id: NCT03023592
lead sponsor: 
has dmc: Yes
A single-center, self-control, open-label study of efficacy and safety of Iguratimod in
      patients with Sjögren's Syndrome
In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg
      twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient
      Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score,
      unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline
      and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's
      Syndrome.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ESSDAI improvement
time frame: week 24
description: The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks.
measure: ESSPRI improvement
time frame: week 24
description: The change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at 24 weeks.
measure: Unstimulated salivary flow rate
time frame: week 24
description: The change from baseline in unstimulated salivary flow rate at 24 weeks.
measure: Schimer's test
time frame: week 24
description: The change from baseline in Schimer's test at 24 weeks.
measure: SF-36
time frame: week 24
description: The change from baseline in SF-36 score at 24 weeks.
measure: HAQ
time frame: week 24
description: The change from baseline in HAQ score at 24 weeks.
measure: Immunoglobulins
time frame: week 24
description: The change from baseline in IgG, IgM and IgA levels at 24 weeks.
measure: Rheumatoid Factors
time frame: week 24
description: The change from baseline in titer of rheumatoid factors at 24 weeks.
arm group label: Iguratimod
arm group type: Experimental
description: Patients are treated with Iguratimod 25 mg Twice a day for 24 weeks.
intervention type: Drug
intervention name: Iguratimod
description: Iguratimod 25 mg orally twice a day for 24 weeks
arm group label: Iguratimod
other name: T-614
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yan Zhao, Dr.
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Hua Chen, Dr.
phone: 86-10-69158797
email: chenhua@pumch.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Sjogren's Syndrome
mesh term: Syndrome
sharing ipd: No