<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/NCT03789292</url>
  </required_header>
  <id_info>
    <org_study_id>CT-P17 3.1</org_study_id>
    <secondary_id>2018-001690-25</secondary_id>
    <nct_id>NCT03789292</nct_id>
  </id_info>
  <brief_title>A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis</brief_title>
  <official_title>A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celltrion</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celltrion</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients&#xD;
      With Active Rheumatoid Arthritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal&#xD;
      antibody that is being developed as a similar biological medicinal product to Humira. The&#xD;
      purpose of this study is to demonstrate similar efficacy and safety of CT-P17 and Humira in&#xD;
      patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Actual">April 24, 2020</completion_date>
  <primary_completion_date type="Actual">October 8, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>American College of Rheumatology(ACR)20 Response Rate at Week 24.</measure>
    <time_frame>Week 24</time_frame>
    <description>ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ACR50 and ACR70 Response Rate at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACR20, ACR50, and ACR70 Response Rate up to Week 52</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)</measure>
    <time_frame>Week 24</time_frame>
    <description>The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:&#xD;
DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96&#xD;
Where:&#xD;
TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).&#xD;
DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:&#xD;
DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96&#xD;
Where:&#xD;
TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).&#xD;
DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">648</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>CT-P17 Subcutaneous(SC) (adalimumab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CT-P17 SC (adalimumab)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Humira SC (adalimumab)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Humira SC (adalimumab)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CT-P17 SC</intervention_name>
    <description>Subcutaneous injection of Adalimumab 40mg every two weeks</description>
    <arm_group_label>CT-P17 Subcutaneous(SC) (adalimumab)</arm_group_label>
    <arm_group_label>Humira SC (adalimumab)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Humira SC</intervention_name>
    <description>Subcutaneous injection of Adalimumab 40mg every two weeks</description>
    <arm_group_label>Humira SC (adalimumab)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is male or female aged 18 to 75 years old, both inclusive.&#xD;
&#xD;
          -  Patient has had a diagnosis of rheumatoid arthritis according to the 2010 American&#xD;
             College of Rheumatology(ACR)/EULAR classification criteria for at least 24 weeks prior&#xD;
             to the first administration of the study drug .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who has previously received investigational or licensed product; biologic or&#xD;
             targeted synthetic disease-modifying antirheumatic drugs for the treatment of&#xD;
             rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any&#xD;
             purposes.&#xD;
&#xD;
          -  Patient who has allergies to any of the excipients of study drug or any other murine&#xD;
             and human proteins, or patient with a hypersensitivity to immunoglobulin products.&#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>MinJi Ma</last_name>
    <role>Study Chair</role>
    <affiliation>Celltrion, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Multiprofile Transport Hospital Tsar Boris III</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <results_first_submitted>July 19, 2021</results_first_submitted>
  <results_first_submitted_qc>October 20, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 17, 2021</results_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Adalimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03789292/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03789292/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CT-P17 Subcutaneous(SC) (Adalimumab)</title>
          <description>Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.&#xD;
Treatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.</description>
        </group>
        <group group_id="P2">
          <title>EU-approved Humira SC (Adalimumab)</title>
          <description>Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.&#xD;
Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.</description>
        </group>
        <group group_id="P3">
          <title>Switched to CT-P17</title>
          <description>Treatment Period 1: N/A&#xD;
Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period I (Week 0 to Week 26)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="324"/>
                <participants group_id="P2" count="324"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="303"/>
                <participants group_id="P2" count="305"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Significant dose delay</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patient decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period II (Week 26 to Week 52)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="303"/>
                <participants group_id="P2" count="153">Patients who had administrated Humira SC during Treatment Period 1 has been devided into 2 groups - maintaining Humira SC and switched to CT-P17.</participants>
                <participants group_id="P3" count="152">Patients who had administrated Humira SC during Treatment Period 1 has been devided into 2 groups - maintaining Humira SC and switched to CT-P17.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="287"/>
                <participants group_id="P2" count="147"/>
                <participants group_id="P3" count="143"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Significant dose delay</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Could not visit the site due to COVID-19 pandemic</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CT-P17</title>
          <description>Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.</description>
        </group>
        <group group_id="B2">
          <title>EU-approved Humira</title>
          <description>Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="324"/>
            <count group_id="B2" value="324"/>
            <count group_id="B3" value="648"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="268"/>
                    <measurement group_id="B2" value="282"/>
                    <measurement group_id="B3" value="550"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.5" lower_limit="18" upper_limit="75"/>
                    <measurement group_id="B2" value="54.0" lower_limit="19" upper_limit="75"/>
                    <measurement group_id="B3" value="54.0" lower_limit="18" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="249"/>
                    <measurement group_id="B2" value="265"/>
                    <measurement group_id="B3" value="514"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="299"/>
                    <measurement group_id="B2" value="298"/>
                    <measurement group_id="B3" value="597"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lithuania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peru</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="231"/>
                    <measurement group_id="B2" value="231"/>
                    <measurement group_id="B3" value="462"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>American College of Rheumatology(ACR)20 Response Rate at Week 24.</title>
        <description>ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)</description>
        <time_frame>Week 24</time_frame>
        <population>Intent-to-Treat (ITT) population.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P17 Subcutaneous(SC) (Adalimumab)</title>
            <description>Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.&#xD;
Treatment Period 2: All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.</description>
          </group>
          <group group_id="O2">
            <title>EU-approved Humira SC (Adalimumab)</title>
            <description>Treatment Period 1: On Day 1 (Week 0), patients were randomly assigned to receive either CT-P17 or EU-approved Humira (40mg/0.4mL each) administered by subcutaneous (SC) injection via pre-filled syringe (PFS) every other week (EOW) in combination with methotrexate (MTX) and folic acid from Week 0 to Week 24.&#xD;
Treatment Period 2: Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>American College of Rheumatology(ACR)20 Response Rate at Week 24.</title>
          <description>ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)</description>
          <population>Intent-to-Treat (ITT) population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="324"/>
                <count group_id="O2" value="324"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="268"/>
                    <measurement group_id="O2" value="268"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ACR50 and ACR70 Response Rate at Week 24</title>
        <description>ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.</description>
        <time_frame>Week 24</time_frame>
        <population>Intent-to-Treat (ITT) population.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P17</title>
            <description>Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>EU-approved Humira</title>
            <description>Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>ACR50 and ACR70 Response Rate at Week 24</title>
          <description>ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.</description>
          <population>Intent-to-Treat (ITT) population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="324"/>
                <count group_id="O2" value="324"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ACR50 at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="195"/>
                    <measurement group_id="O2" value="206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70 at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132"/>
                    <measurement group_id="O2" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ACR20, ACR50, and ACR70 Response Rate up to Week 52</title>
        <description>ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>Intent-to-Treat (ITT) population.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P17 Maintenance</title>
            <description>All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.</description>
          </group>
          <group group_id="O2">
            <title>Humira Maintenance</title>
            <description>Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.</description>
          </group>
          <group group_id="O3">
            <title>Switched to CT-P17</title>
            <description>Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>ACR20, ACR50, and ACR70 Response Rate up to Week 52</title>
          <description>ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.</description>
          <population>Intent-to-Treat (ITT) population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="303"/>
                <count group_id="O2" value="153"/>
                <count group_id="O3" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ACR20 at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="244"/>
                    <measurement group_id="O2" value="119"/>
                    <measurement group_id="O3" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR50 at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="201"/>
                    <measurement group_id="O2" value="95"/>
                    <measurement group_id="O3" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70 at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                    <measurement group_id="O2" value="75"/>
                    <measurement group_id="O3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)</title>
        <description>The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:&#xD;
DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96&#xD;
Where:&#xD;
TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).&#xD;
DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.</description>
        <time_frame>Week 24</time_frame>
        <population>Intent-to-Treat (ITT) population.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P17</title>
            <description>Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.</description>
          </group>
          <group group_id="O2">
            <title>EU-approved Humira</title>
            <description>Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)</title>
          <description>The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:&#xD;
DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96&#xD;
Where:&#xD;
TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).&#xD;
DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.</description>
          <population>Intent-to-Treat (ITT) population.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="324"/>
                <count group_id="O2" value="324"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.738" spread="1.1911"/>
                    <measurement group_id="O2" value="-2.734" spread="1.2052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)</title>
        <description>The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:&#xD;
DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96&#xD;
Where:&#xD;
TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).&#xD;
DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>Intent-to-Treat (ITT) population.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P17 Maintenance</title>
            <description>All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.</description>
          </group>
          <group group_id="O2">
            <title>Humira Maintenance</title>
            <description>Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.</description>
          </group>
          <group group_id="O3">
            <title>Switched to CT-P17</title>
            <description>Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, in a ratio of 1:1 to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)</title>
          <description>The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:&#xD;
DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96&#xD;
Where:&#xD;
TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).&#xD;
DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.</description>
          <population>Intent-to-Treat (ITT) population.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="303"/>
                <count group_id="O2" value="153"/>
                <count group_id="O3" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.945" spread="1.1273"/>
                    <measurement group_id="O2" value="-3.074" spread="1.1926"/>
                    <measurement group_id="O3" value="-2.983" spread="1.2529"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were assessed from the date the patient signed the Informed Consent Form(ICF) until 4 weeks after the last study drug administration (up to 52 weeks).</time_frame>
      <desc>Treatment Period I: Week 0 to Week 26 pre-dose Treatment Period II: Week 26 to Week 52 end of study visit</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment 1: CT-P17</title>
          <description>Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.</description>
        </group>
        <group group_id="E2">
          <title>Treatment 1: EU-approved Humira</title>
          <description>Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.</description>
        </group>
        <group group_id="E3">
          <title>Treatment 2: CT-P17 Maintenance</title>
          <description>All patients who were initially randomly assigned to CT-P17 (40mg/0.4mL) at Day 1 (Week 0) continued their treatment with CT-P17 from Week 26 up to Week 48.</description>
        </group>
        <group group_id="E4">
          <title>Treatment 2: Humira Maintenance</title>
          <description>Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.</description>
        </group>
        <group group_id="E5">
          <title>Treatment 2: Switched to CT-P17</title>
          <description>Patients who were initially randomly assigned to EU-approved Humira were randomized again prior dosing at Week 26, to either continue EU-approved Humira or undergo transition to CT-P17 (40mg/0.4mL each) from Week 26 to Week 48.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Vitreous hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Nonalcoholic fatty liver disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Breast abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Chronic tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Gastroenteritis rotavirus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Extradural hematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Limb crushing injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Benign muscle neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amyotrophic lateral sclerosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Carotid artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Ischemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rheumatoid lung</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cataract operation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Polypectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="96" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="118" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="50" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="33" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Latent tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="324"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="324"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="303"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>JiWoong Lim</name_or_title>
      <organization>Celltrion Inc.</organization>
      <phone>032-850-5806</phone>
      <email>jiwoong.lim@celltrion.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03789292
org study id: CT-P17 3.1
secondary id: 2018-001690-25
nct id: NCT03789292
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients
      With Active Rheumatoid Arthritis
CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal
      antibody that is being developed as a similar biological medicinal product to Humira. The
      purpose of this study is to demonstrate similar efficacy and safety of CT-P17 and Humira in
      patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: American College of Rheumatology(ACR)20 Response Rate at Week 24.
time frame: Week 24
description: ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)
measure: ACR50 and ACR70 Response Rate at Week 24
time frame: Week 24
description: ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
measure: ACR20, ACR50, and ACR70 Response Rate up to Week 52
time frame: Up to Week 52
description: ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
measure: Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)
time frame: Week 24
description: The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:
DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96
Where:
TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).
DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.
measure: Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)
time frame: Up to Week 52
description: The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:
DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96
Where:
TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).
DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.
arm group label: CT-P17 Subcutaneous(SC) (adalimumab)
arm group type: Experimental
description: CT-P17 SC (adalimumab)
arm group label: Humira SC (adalimumab)
arm group type: Active Comparator
description: Humira SC (adalimumab)
intervention type: Biological
intervention name: CT-P17 SC
description: Subcutaneous injection of Adalimumab 40mg every two weeks
arm group label: CT-P17 Subcutaneous(SC) (adalimumab)
arm group label: Humira SC (adalimumab)
intervention type: Biological
intervention name: Humira SC
description: Subcutaneous injection of Adalimumab 40mg every two weeks
arm group label: Humira SC (adalimumab)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: MinJi Ma
role: Study Chair
affiliation: Celltrion, Inc.
facility: 
country: Bulgaria
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Adalimumab
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 