<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/NCT01709760</url>
  </required_header>
  <id_info>
    <org_study_id>TSHEN1101</org_study_id>
    <nct_id>NCT01709760</nct_id>
  </id_info>
  <brief_title>A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RA</brief_title>
  <acronym>ENIA11</acronym>
  <official_title>A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mycenax Biotech Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mycenax Biotech Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre,&#xD;
      Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with&#xD;
      Methotrexate versus Methotrexate Alone in Patients with Rheumatoid Arthritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of the study are to evaluate the efficacy and safety of ENIA11 in combination&#xD;
      with methotrexate versus methotrexate alone in patients with rheumatoid arthritis.&#xD;
&#xD;
      This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study to&#xD;
      evaluate the efficacy and safety of ENIA11 in combination with methotrexate versus&#xD;
      methotrexate alone in patients with rheumatoid arthritis.&#xD;
&#xD;
      Subject participation duration: A total of 28 weeks, including: 2 weeks of screening, 24&#xD;
      weeks of treatment and 2 weeks of follow-up&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Phase 3</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>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ACR20 responder at last treatment visit</measure>
    <time_frame>Week 24</time_frame>
    <description>The primary efficacy endpoint is defined as ACR20 responder at last treatment visit (Week 24).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>methotrexate &amp; ENIA11</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ENIA11 25 mg, sc twice weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>methotrexate &amp; Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo, sc twice weekly</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>Methotrexate 15-25 mg/week</description>
    <arm_group_label>methotrexate &amp; ENIA11</arm_group_label>
    <arm_group_label>methotrexate &amp; Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ENIA11</intervention_name>
    <description>ENIA11 25 mg, sc twice weekly</description>
    <arm_group_label>methotrexate &amp; ENIA11</arm_group_label>
    <other_name>TuNEX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo, sc twice weekly</description>
    <arm_group_label>methotrexate &amp; Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients aged ≥ 20 years old;&#xD;
&#xD;
          2. Patient meet ACR criteria for rheumatoid arthritis over 6 month duration;&#xD;
&#xD;
          3. Patient with active disease at the time of screening as defined by six or more swollen&#xD;
             joints and six or more tender joints;&#xD;
&#xD;
          4. Presence of at least one of the following criteria:&#xD;
&#xD;
               -  Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h,&#xD;
&#xD;
               -  C-Reactive Protein (CRP) ≥ 10 mg/L,&#xD;
&#xD;
          5. RA functional class I, II, or III;&#xD;
&#xD;
          6. Patients have been treated on methotrexate for at least 3 month, and maintained at&#xD;
             stable dose of 15-25 mg/week for at least 8 weeks; MTX low dose as 10 mg per week is&#xD;
             allowed for patients who had a documented history of constitutional symptoms at higher&#xD;
             doses.&#xD;
&#xD;
          7. Patient is willing and able to comply with study procedures and sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active autoimmune disease (other than RA) requiring immunosuppressive therapy;&#xD;
&#xD;
          2. In the opinion of the investigator, the patient shows persistent signs of&#xD;
             immunosuppression;&#xD;
&#xD;
          3. Known hypersensitivity to etanercept or ENIA11 or any of its components;&#xD;
&#xD;
          4. Previous unsuccessful treatment with etanercept, anti-TNF monoclonal antibodies or a&#xD;
             soluble TNF receptor (e.g., infliximab);&#xD;
&#xD;
          5. Suspected or diagnosed pulmonary tuberculosis, or other chronic or current infectious&#xD;
             disease at discretion of investigator;&#xD;
&#xD;
          6. Patients who have a history or evidence of a medical condition that would expose them&#xD;
             to an undue risk of a significant adverse event during the course of the trial,&#xD;
             including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine,&#xD;
             immune, neurological, hematological, gastrointestinal or psychiatric disease as&#xD;
             determined by the clinical judgment of the investigator;&#xD;
&#xD;
          7. Patients with any of the following laboratory abnormalities: ALT/AST &gt; 3 times ULN,&#xD;
             creatinine &gt; 2 mg/dl, WBC &lt; 3,000/mm3, Hgb &lt; 8.5 g/dL, platelet count &lt; 100,000/mm3;&#xD;
&#xD;
          8. Patients have received live attenuated vaccination program within 3 months or BCG&#xD;
             vaccine within 12 months prior enrollment;&#xD;
&#xD;
          9. Female patient of childbearing potential who:&#xD;
&#xD;
               -  is lactating; or&#xD;
&#xD;
               -  has positive urine pregnancy test at Visit 1; or&#xD;
&#xD;
               -  refuse to adopt reliable method of contraception during the study;&#xD;
&#xD;
         10. Diagnosis of primary fibromyalgia or other joint inflammatory disease including but&#xD;
             not limited to gout, reactive arthritis, psoriatic arthritis, seronegative&#xD;
             spondyloarthropathy, Lyme disease;&#xD;
&#xD;
         11. Known or suspected positive serology for human immunodeficiency, hepatitis B or C&#xD;
             virus;&#xD;
&#xD;
         12. Patient has received any investigational agent within 28 days or 5 half-lives,&#xD;
             whichever is longer, prior to the first dose of investigational product;&#xD;
&#xD;
         13. Patient has history of substance abuse, drug addiction or alcoholism;&#xD;
&#xD;
         14. Patient who have had participated in prior phase I/II clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joung-Liang Lan, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>China Medical University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chung-Ming Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>China Medical University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Der-Yuan Chen, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taichung Veterans General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ling-Ying Lu, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaohsiung Veterans General Hospital.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ning-Sheng Lai, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Buddhist Tzu Chi General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tien-Tsai Cheng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gregory J Tsay, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chung Shan Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ying-Ming Chiu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhua Christian Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Changhua Christian Hospital</name>
      <address>
        <city>Changhua</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buddhist Tzu Chi General Hospital</name>
      <address>
        <city>Chiayi City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chung Shan Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei City Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>April 13, 2018</last_update_submitted>
  <last_update_submitted_qc>April 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ENIA11</keyword>
  <keyword>MTX</keyword>
  <keyword>RA</keyword>
  <keyword>TNF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methotrexate</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/NCT01709760
org study id: TSHEN1101
nct id: NCT01709760
lead sponsor: 
has dmc: Yes
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre,
      Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with
      Methotrexate versus Methotrexate Alone in Patients with Rheumatoid Arthritis
The objectives of the study are to evaluate the efficacy and safety of ENIA11 in combination
      with methotrexate versus methotrexate alone in patients with rheumatoid arthritis.

      This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study to
      evaluate the efficacy and safety of ENIA11 in combination with methotrexate versus
      methotrexate alone in patients with rheumatoid arthritis.

      Subject participation duration: A total of 28 weeks, including: 2 weeks of screening, 24
      weeks of treatment and 2 weeks of follow-up
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
measure: ACR20 responder at last treatment visit
time frame: Week 24
description: The primary efficacy endpoint is defined as ACR20 responder at last treatment visit (Week 24).
arm group label: methotrexate & ENIA11
arm group type: Experimental
description: ENIA11 25 mg, sc twice weekly
arm group label: methotrexate & Placebo
arm group type: Active Comparator
description: Placebo, sc twice weekly
intervention type: Drug
intervention name: Methotrexate
description: Methotrexate 15-25 mg/week
arm group label: methotrexate & ENIA11
arm group label: methotrexate & Placebo
intervention type: Drug
intervention name: ENIA11
description: ENIA11 25 mg, sc twice weekly
arm group label: methotrexate & ENIA11
other name: TuNEX
intervention type: Drug
intervention name: Placebo
description: Placebo, sc twice weekly
arm group label: methotrexate & Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Joung-Liang Lan, PHD
role: Principal Investigator
affiliation: China Medical University Hospital
last name: Chung-Ming Huang, MD
role: Principal Investigator
affiliation: China Medical University Hospital
last name: Der-Yuan Chen, PHD
role: Principal Investigator
affiliation: Taichung Veterans General Hospital
last name: Ling-Ying Lu, PHD
role: Principal Investigator
affiliation: Kaohsiung Veterans General Hospital.
last name: Ning-Sheng Lai, PHD
role: Principal Investigator
affiliation: Buddhist Tzu Chi General Hospital
last name: Tien-Tsai Cheng, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
last name: Gregory J Tsay, PHD
role: Principal Investigator
affiliation: Chung Shan Medical University
last name: Ying-Ming Chiu, MD
role: Principal Investigator
affiliation: Changhua Christian Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Methotrexate