<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/NCT02258282</url>
  </required_header>
  <id_info>
    <org_study_id>YSP20140688</org_study_id>
    <nct_id>NCT02258282</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Etanercept in Patients With Psoriasis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chengdu PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate safety and efficacy of etanercept in patients with&#xD;
      psoriasis who had an unsatisfactory response to traditional DMARDs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline of Physician's Global Assessment (PGA) at 24 weeks</measure>
    <time_frame>At 0 week, 12 weeks, 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Body Surface Area (BSA)</measure>
    <time_frame>At 0 week, 12 weeks, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Psoriasis Area and Severity Index (PASI)</measure>
    <time_frame>At 0 week, 12 weeks, 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Etanercept</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients under the treatment of 50 mg Etanercept</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients under the treatment of traditional DMARDs</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etanercept</intervention_name>
    <arm_group_label>Etanercept</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  has plaque psoriasis and has shown an unsatisfactory response to traditional DMARDs&#xD;
&#xD;
          -  18 to 75 years old&#xD;
&#xD;
          -  has PGA of 3 or more at Day 0&#xD;
&#xD;
          -  has BSA of 3% or more at Day 0&#xD;
&#xD;
          -  has psoriasis severe enough to be eligible to systemic therapy&#xD;
&#xD;
          -  willing to use an effective method of contraception for at least 30 days before Day 0&#xD;
             and until at least 1 month after the last drug administration;&#xD;
&#xD;
          -  capable of giving informed consent&#xD;
&#xD;
          -  with normal or non clinically significant chest X-ray within 6 months prior to Day 0&#xD;
&#xD;
          -  with negative Purified Protein Derivative (PPD) or Quantiferon TB Gold test within 90&#xD;
             days prior to Day 0&#xD;
&#xD;
          -  female patients of childbearing potential have a negative serum pregnancy test&#xD;
&#xD;
          -  patient is able to start etanercept per the approved product monograph&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has used topical steroids, topical tar preparations, or other anti-psoriatic&#xD;
             preparations within the two weeks prior to Day 0 or during the study period&#xD;
&#xD;
          -  has presence of erythrodermic, pustular or guttate psoriasis&#xD;
&#xD;
          -  has had significant infections within the 30 days prior to Day 0&#xD;
&#xD;
          -  has received investigational drugs within the four weeks prior to screening or during&#xD;
             the study period&#xD;
&#xD;
          -  has been treated with systemic anti-psoriatic drugs such as steroids, retinoids,&#xD;
             cyclosporine, PUVA therapy or methotrexate within the four weeks prior to Day 0 or&#xD;
             during the study period&#xD;
&#xD;
          -  received systemic antibiotics within the four weeks prior to Day 0&#xD;
&#xD;
          -  has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks&#xD;
             prior to Day 0 or during the study period&#xD;
&#xD;
          -  has used infliximab within 14 days of Day 0 or during the study period&#xD;
&#xD;
          -  has used other biologic agents for the treatment of psoriasis besides etanercept 8&#xD;
             weeks prior to Day 0 or during the study period&#xD;
&#xD;
          -  has had an allergic reaction to infliximab&#xD;
&#xD;
          -  has an unstable or serious medical condition as defined by the investigator or&#xD;
             presence of any significant medical condition that might cause this study to be&#xD;
             detrimental to the patient&#xD;
&#xD;
          -  uncontrolled or severe comorbidities such as poorly controlled diabetes mellitus, NYHA&#xD;
             class III or IV heart failure, history of myocardial infarction or cerebrovascular&#xD;
             accident or transient ischemic attack within three months of screening visit; unstable&#xD;
             angina pectoris&#xD;
&#xD;
          -  uncontrolled hypertension, oxygen-dependent severe pulmonary disease&#xD;
&#xD;
          -  has a known sero-positivity for HIV virus or history of any other immunosuppressive&#xD;
             disease&#xD;
&#xD;
          -  has active or chronic Hepatitis B or C&#xD;
&#xD;
          -  has any mycobacterial disease, patient with a chest X-Ray suggestive of tuberculosis&#xD;
             or patient taking anti-tuberculosis medication&#xD;
&#xD;
          -  has a known hypersensitivity to etanercept or one of its components&#xD;
&#xD;
          -  has received a live attenuated vaccine within the 12 weeks prior to Day 0 or plans to&#xD;
             receive one during the study&#xD;
&#xD;
          -  current pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>General Hospital of Chengdu Military Area Command PLA</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610083</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>March 31, 2017</last_update_submitted>
  <last_update_submitted_qc>March 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chengdu PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Yang Min</investigator_full_name>
    <investigator_title>Ph.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etanercept</mesh_term>
  </intervention_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/NCT02258282
org study id: YSP20140688
nct id: NCT02258282
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate safety and efficacy of etanercept in patients with
      psoriasis who had an unsatisfactory response to traditional DMARDs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes from baseline of Physician's Global Assessment (PGA) at 24 weeks
time frame: At 0 week, 12 weeks, 24 weeks
measure: Mean Body Surface Area (BSA)
time frame: At 0 week, 12 weeks, 24 weeks
measure: Mean Psoriasis Area and Severity Index (PASI)
time frame: At 0 week, 12 weeks, 24 weeks
arm group label: Etanercept
arm group type: Experimental
description: Patients under the treatment of 50 mg Etanercept
arm group label: Control
arm group type: Sham Comparator
description: Patients under the treatment of traditional DMARDs
intervention type: Drug
intervention name: Etanercept
arm group label: Etanercept
intervention type: Drug
intervention name: Control
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chengdu PLA General Hospital
investigator full name: Yang Min
investigator title: Ph.D
mesh term: Psoriasis
mesh term: Etanercept