<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/NCT02260791</url>
  </required_header>
  <id_info>
    <org_study_id>FKB327-002</org_study_id>
    <nct_id>NCT02260791</nct_id>
  </id_info>
  <brief_title>A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients</brief_title>
  <acronym>ARABESC</acronym>
  <official_title>A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujifilm Kyowa Kirin Biologics Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujifilm Kyowa Kirin Biologics Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison&#xD;
      to Humira® in rheumatoid arthritis patients who have inadequate disease control on&#xD;
      methotrexate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>American College of Rheumatology (ACR) 20 Response Rate</measure>
    <time_frame>Week 24</time_frame>
    <description>The primary efficacy endpoint was the ACR20 response rate at Week 24.&#xD;
An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.&#xD;
Acute phase reactant (CRP)&#xD;
Patient global assessment of disease activity&#xD;
Physician global assessment of disease activity&#xD;
Patient pain scale&#xD;
Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score</measure>
    <time_frame>Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24</time_frame>
    <description>The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACR20 Response Rates Over Time</measure>
    <time_frame>Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24</time_frame>
    <description>An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.&#xD;
Acute phase reactant (CRP)&#xD;
Patient global assessment of disease activity&#xD;
Physician global assessment of disease activity&#xD;
Patient pain scale&#xD;
Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACR50 Response Rates Over Time</measure>
    <time_frame>Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24</time_frame>
    <description>An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.&#xD;
Acute phase reactant (CRP)&#xD;
Patient global assessment of disease activity&#xD;
Physician global assessment of disease activity&#xD;
Patient pain scale&#xD;
Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACR70 Response Rates Over Time</measure>
    <time_frame>Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24</time_frame>
    <description>An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.&#xD;
Acute phase reactant (CRP)&#xD;
Patient global assessment of disease activity&#xD;
Physician global assessment of disease activity&#xD;
Patient pain scale&#xD;
Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swollen Joint Count</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tender Joint Count</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Serum C-Reactive Protein (CRP) Concentration</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Assessment of Disease Activity</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Assessment of Disease Activity</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Assessment of Pain</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured (&quot;No pain&quot; at 0 and &quot;Intolerable pain&quot; at 100). Patient's assessment of pain is a value of the individual ACR core set variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Questionnaire Disability Index (HAQ-DI)</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DAS28-CRP Score Over Time</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)</measure>
    <time_frame>Baseline, Week 12 and Week 24</time_frame>
    <description>The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of Patients Developing Anti-drug Antibodies (ADAs)</measure>
    <time_frame>Baseline and last sampling day</time_frame>
    <description>Blood samples for the assessment of ADA activity were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12, and 24.</description>
  </other_outcome>
  <other_outcome>
    <measure>Trough Adalimumab Concentration</measure>
    <time_frame>Week 2, Week 4, Week 12, Week 20, and Week 24</time_frame>
    <description>Blood samples for the quantification of adalimumab concentration in serum were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12 and 20, and Week 24. Samples were taken prior to dosing (trough samples).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">728</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <arm_group>
    <arm_group_label>FKB327</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Humira®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FKB327</intervention_name>
    <description>Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.</description>
    <arm_group_label>FKB327</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Humira®</intervention_name>
    <description>Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.</description>
    <arm_group_label>Humira®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female aged 18 years or over&#xD;
&#xD;
          2. Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months&#xD;
&#xD;
          3. Patient has active RA&#xD;
&#xD;
          4. Patient has taken a stable dose of methotrexate for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has been previously treated with adalimumab&#xD;
&#xD;
          2. Patient has been previously treated or has ongoing treatment with prohibited&#xD;
             medications&#xD;
&#xD;
          3. Patient has been immunised with a live or attenuated vaccine in past 4 weeks&#xD;
&#xD;
          4. Patient has positive result for HIV, HBV, HCV or TB infection&#xD;
&#xD;
        Other Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Josephine Glover, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Coephycient Pharmaceutical Consultancy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Palm Desert</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mesquite</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St. Catherines</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Trois-Rivieres</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Osorno</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Puerto Varas</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site G</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site M</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Temuco</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brno</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hlucin</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site U</name>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Uherske Hradiste</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zlin</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aachen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hildesheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ratingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site B</name>
      <address>
        <city>Arequipa</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site M</name>
      <address>
        <city>Arequipa</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site CA</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site CH</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site PA</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site PE</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site S</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site D</name>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site R</name>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gdynia</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site KL</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site KR</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site P</name>
      <address>
        <city>Poznan</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site RH</name>
      <address>
        <city>Poznan</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Torun</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oradea</city>
        <state>Bihor</state>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Braila</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brasov</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site C</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site R</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site T</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Constanta</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Galati</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sfântu Gheorghe</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ufa</city>
        <state>Bashkortostan Republic</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Petrozavodsk</city>
        <state>Karelia Republic</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kazan</city>
        <state>Tatarstan Republic</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site D</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site SM</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site ST</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nizhny Novgorod</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Penza</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Perm</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ryazan</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site B</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site Z</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saratov</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Smolensk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vladimir</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site E</name>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site S</name>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>La Coruna</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bilbao</city>
        <state>Vizcaya</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site A</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site G</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Malaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chernivtsi</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site A</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site B</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site P</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lutsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site C</name>
      <address>
        <city>Lviv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site N</name>
      <address>
        <city>Lviv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poltava</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ternopil</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Uzhgorod</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site G</name>
      <address>
        <city>Vinnytsia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site Sh</name>
      <address>
        <city>Vinnytsia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site St</name>
      <address>
        <city>Vinnytsia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Serbia</country>
  </removed_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <results_first_submitted>July 5, 2017</results_first_submitted>
  <results_first_submitted_qc>August 23, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 20, 2017</results_first_posted>
  <last_update_submitted>October 23, 2017</last_update_submitted>
  <last_update_submitted_qc>October 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid</keyword>
  <keyword>Arthritis</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>Adalimumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were enrolled in 109 sites in 12 countries in 3 geographical regions: North America, Europe and Rest of World. The first participant enrolled on 05 January 2015 and the last participant completed on 12 July 2016.</recruitment_details>
      <pre_assignment_details>Screening details:&#xD;
Patients were randomised in a 1:1 ratio to receive either FKB327 40 mg eow or Humira 40 mg eow using the following stratification factors: prior biological treatment for Rheumatoid Arthritis (RA) (yes/no) and Screening disease activity (DAS28-CRP ≤5.1/&gt;5.1).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>FKB327</title>
          <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Humira®</title>
          <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="366"/>
                <participants group_id="P2" count="362"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="333"/>
                <participants group_id="P2" count="328"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen failure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Analysis Set was defined as the set of patients who received at least 1 dose of randomised treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>FKB327</title>
          <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Humira®</title>
          <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</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="366"/>
            <count group_id="B2" value="362"/>
            <count group_id="B3" value="728"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" lower_limit="18" upper_limit="85"/>
                    <measurement group_id="B2" value="53.6" lower_limit="21" upper_limit="93"/>
                    <measurement group_id="B3" value="53.3" lower_limit="18" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 18 and 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="302"/>
                    <measurement group_id="B2" value="299"/>
                    <measurement group_id="B3" value="601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="127"/>
                  </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="281"/>
                    <measurement group_id="B2" value="284"/>
                    <measurement group_id="B3" value="565"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="311"/>
                    <measurement group_id="B2" value="308"/>
                    <measurement group_id="B3" value="619"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czech Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peru</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="109"/>
                  </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</title>
        <description>The primary efficacy endpoint was the ACR20 response rate at Week 24.&#xD;
An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.&#xD;
Acute phase reactant (CRP)&#xD;
Patient global assessment of disease activity&#xD;
Physician global assessment of disease activity&#xD;
Patient pain scale&#xD;
Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])</description>
        <time_frame>Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>American College of Rheumatology (ACR) 20 Response Rate</title>
          <description>The primary efficacy endpoint was the ACR20 response rate at Week 24.&#xD;
An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.&#xD;
Acute phase reactant (CRP)&#xD;
Patient global assessment of disease activity&#xD;
Physician global assessment of disease activity&#xD;
Patient pain scale&#xD;
Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.5" lower_limit="67.5" upper_limit="77.0"/>
                    <measurement group_id="O2" value="74.3" lower_limit="69.4" upper_limit="78.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The difference and its 90% Confidence Interval (CI) for primary endpoint between FKB327 and Humira were estimated. If the 90% CI fell entirely between pre-specified equivalence margin (-12% to +15%), then FKB327 was considered equivalent to Humira.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>-12% to +15% equivalence margin using 90% CI around the difference in ACR20 response rate</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.3</ci_lower_limit>
            <ci_upper_limit>3.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score</title>
        <description>The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.</description>
        <time_frame>Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score</title>
          <description>The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</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="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="362"/>
                    <count group_id="O2" value="358"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.05" spread="0.913"/>
                    <measurement group_id="O2" value="6.06" spread="0.852"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="361"/>
                    <count group_id="O2" value="351"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.92" spread="1.070"/>
                    <measurement group_id="O2" value="4.86" spread="1.203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="357"/>
                    <count group_id="O2" value="348"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.44" spread="1.317"/>
                    <measurement group_id="O2" value="4.43" spread="1.383"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="348"/>
                    <count group_id="O2" value="345"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="1.295"/>
                    <measurement group_id="O2" value="4.09" spread="1.397"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="351"/>
                    <count group_id="O2" value="340"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.81" spread="1.320"/>
                    <measurement group_id="O2" value="3.85" spread="1.339"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="350"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.68" spread="1.304"/>
                    <measurement group_id="O2" value="3.67" spread="1.419"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="344"/>
                    <count group_id="O2" value="336"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.58" spread="1.329"/>
                    <measurement group_id="O2" value="3.57" spread="1.388"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="340"/>
                    <count group_id="O2" value="339"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.47" spread="1.298"/>
                    <measurement group_id="O2" value="3.47" spread="1.336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The secondary hypothesis involved equivalence of the difference between FKB327 and Humira in DAS28-CRP at Week 24. Based on the repeated measures analysis model, the difference and its 95% CI in the least-squares means (LSMs) for DAS28-CRP at Week 24 between FKB327 and Humira were estimated. If the 95% CI fell entirely between the pre-specified margin (+/- 0.6), then FKB327 was considered equivalent to Humira.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>If the 2-sided 95% CI for the difference in DAS28-CRP at Week 24 between FKB327 and Humira fell entirely between -0.6 and +0.6 then FKB327 was considered equivalent to Humira.</non_inferiority_desc>
            <param_type>Difference in least square mean</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.16</ci_lower_limit>
            <ci_upper_limit>0.18</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ACR20 Response Rates Over Time</title>
        <description>An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.&#xD;
Acute phase reactant (CRP)&#xD;
Patient global assessment of disease activity&#xD;
Physician global assessment of disease activity&#xD;
Patient pain scale&#xD;
Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])</description>
        <time_frame>Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment.Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>ACR20 Response Rates Over Time</title>
          <description>An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.&#xD;
Acute phase reactant (CRP)&#xD;
Patient global assessment of disease activity&#xD;
Physician global assessment of disease activity&#xD;
Patient pain scale&#xD;
Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment.Patients were analysed according to the randomised treatment in the primary analysis.</population>
          <units>percentage of responders</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="362"/>
                    <count group_id="O2" value="352"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.3" lower_limit="32.3" upper_limit="42.5"/>
                    <measurement group_id="O2" value="31" lower_limit="26.2" upper_limit="36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="359"/>
                    <count group_id="O2" value="349"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51" lower_limit="45.7" upper_limit="56.3"/>
                    <measurement group_id="O2" value="52.4" lower_limit="47.1" upper_limit="57.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="353"/>
                    <count group_id="O2" value="347"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.6" lower_limit="59.4" upper_limit="69.6"/>
                    <measurement group_id="O2" value="67.7" lower_limit="62.5" upper_limit="72.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="351"/>
                    <count group_id="O2" value="342"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.2" lower_limit="64.1" upper_limit="74"/>
                    <measurement group_id="O2" value="72.2" lower_limit="67.2" upper_limit="76.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="350"/>
                    <count group_id="O2" value="342"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.6" lower_limit="69.7" upper_limit="79.1"/>
                    <measurement group_id="O2" value="74.9" lower_limit="69.9" upper_limit="79.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="345"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" lower_limit="73.2" upper_limit="82.2"/>
                    <measurement group_id="O2" value="77.8" lower_limit="73" upper_limit="82.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="341"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.1" lower_limit="72.3" upper_limit="81.5"/>
                    <measurement group_id="O2" value="79.3" lower_limit="74.6" upper_limit="83.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ACR50 Response Rates Over Time</title>
        <description>An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.&#xD;
Acute phase reactant (CRP)&#xD;
Patient global assessment of disease activity&#xD;
Physician global assessment of disease activity&#xD;
Patient pain scale&#xD;
Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])</description>
        <time_frame>Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>ACR50 Response Rates Over Time</title>
          <description>An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.&#xD;
Acute phase reactant (CRP)&#xD;
Patient global assessment of disease activity&#xD;
Physician global assessment of disease activity&#xD;
Patient pain scale&#xD;
Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
          <units>percentage of responders</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="362"/>
                    <count group_id="O2" value="352"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="3" upper_limit="7.7"/>
                    <measurement group_id="O2" value="8.8" lower_limit="6.1" upper_limit="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="359"/>
                    <count group_id="O2" value="349"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3" lower_limit="13.5" upper_limit="21.6"/>
                    <measurement group_id="O2" value="17.8" lower_limit="13.9" upper_limit="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="353"/>
                    <count group_id="O2" value="346"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.9" lower_limit="24.2" upper_limit="33.9"/>
                    <measurement group_id="O2" value="30.9" lower_limit="26.1" upper_limit="36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="351"/>
                    <count group_id="O2" value="342"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.6" lower_limit="32.5" upper_limit="42.9"/>
                    <measurement group_id="O2" value="35.1" lower_limit="30" upper_limit="40.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="350"/>
                    <count group_id="O2" value="342"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.4" lower_limit="34.3" upper_limit="44.8"/>
                    <measurement group_id="O2" value="44.7" lower_limit="39.4" upper_limit="50.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="345"/>
                    <count group_id="O2" value="339"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.5" lower_limit="40.2" upper_limit="50.9"/>
                    <measurement group_id="O2" value="46" lower_limit="40.6" upper_limit="51.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="341"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" lower_limit="43.6" upper_limit="54.4"/>
                    <measurement group_id="O2" value="49.4" lower_limit="44" upper_limit="54.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ACR70 Response Rates Over Time</title>
        <description>An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.&#xD;
Acute phase reactant (CRP)&#xD;
Patient global assessment of disease activity&#xD;
Physician global assessment of disease activity&#xD;
Patient pain scale&#xD;
Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])</description>
        <time_frame>Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>ACR70 Response Rates Over Time</title>
          <description>An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.&#xD;
Acute phase reactant (CRP)&#xD;
Patient global assessment of disease activity&#xD;
Physician global assessment of disease activity&#xD;
Patient pain scale&#xD;
Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
          <units>percentage of responders</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="362"/>
                    <count group_id="O2" value="352"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0" upper_limit="1.5"/>
                    <measurement group_id="O2" value="2.3" lower_limit="1" upper_limit="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="359"/>
                    <count group_id="O2" value="349"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="2.6" upper_limit="7.1"/>
                    <measurement group_id="O2" value="6.9" lower_limit="4.5" upper_limit="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="353"/>
                    <count group_id="O2" value="347"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" lower_limit="8.2" upper_limit="15.1"/>
                    <measurement group_id="O2" value="10.7" lower_limit="7.6" upper_limit="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="351"/>
                    <count group_id="O2" value="342"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="11.8" upper_limit="19.6"/>
                    <measurement group_id="O2" value="13.2" lower_limit="9.8" upper_limit="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="350"/>
                    <count group_id="O2" value="342"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" lower_limit="13.6" upper_limit="21.8"/>
                    <measurement group_id="O2" value="19" lower_limit="15" upper_limit="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="345"/>
                    <count group_id="O2" value="339"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" lower_limit="16.7" upper_limit="25.5"/>
                    <measurement group_id="O2" value="23.6" lower_limit="19.2" upper_limit="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="342"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3" lower_limit="17.1" upper_limit="26.1"/>
                    <measurement group_id="O2" value="25.1" lower_limit="20.6" upper_limit="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Swollen Joint Count</title>
        <description>Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Swollen Joint Count</title>
          <description>Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables.</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
          <units>Count / Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3" spread="9.1"/>
                    <measurement group_id="O2" value="16" spread="8.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="6.04"/>
                    <measurement group_id="O2" value="3.5" spread="5.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tender Joint Count</title>
        <description>Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Tender Joint Count</title>
          <description>Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables.</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
          <units>Count / Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2" spread="14.49"/>
                    <measurement group_id="O2" value="25.9" spread="14.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" spread="10.56"/>
                    <measurement group_id="O2" value="8.1" spread="9.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of Serum C-Reactive Protein (CRP) Concentration</title>
        <description>Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Serum C-Reactive Protein (CRP) Concentration</title>
          <description>Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation.</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.12" spread="26.746"/>
                    <measurement group_id="O2" value="26.73" spread="28.534"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.98" spread="16.819"/>
                    <measurement group_id="O2" value="11.78" spread="18.528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Assessment of Disease Activity</title>
        <description>Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Assessment of Disease Activity</title>
          <description>Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</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="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68" spread="17.98"/>
                    <measurement group_id="O2" value="68.2" spread="18.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.2" spread="24.04"/>
                    <measurement group_id="O2" value="33.2" spread="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physician Assessment of Disease Activity</title>
        <description>Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Assessment of Disease Activity</title>
          <description>Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</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="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.4" spread="14.58"/>
                    <measurement group_id="O2" value="66.2" spread="15.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.5" spread="17.29"/>
                    <measurement group_id="O2" value="21.5" spread="16.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient's Assessment of Pain</title>
        <description>An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured (&quot;No pain&quot; at 0 and &quot;Intolerable pain&quot; at 100). Patient's assessment of pain is a value of the individual ACR core set variables.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient's Assessment of Pain</title>
          <description>An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured (&quot;No pain&quot; at 0 and &quot;Intolerable pain&quot; at 100). Patient's assessment of pain is a value of the individual ACR core set variables.</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</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="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.8" spread="18.71"/>
                    <measurement group_id="O2" value="67.7" spread="18.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.7" spread="23.86"/>
                    <measurement group_id="O2" value="33.6" spread="23.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Assessment Questionnaire Disability Index (HAQ-DI)</title>
        <description>The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Assessment Questionnaire Disability Index (HAQ-DI)</title>
          <description>The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables.</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</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="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.78" spread="0.544"/>
                    <measurement group_id="O2" value="1.8" spread="0.538"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" spread="0.696"/>
                    <measurement group_id="O2" value="1.26" spread="0.719"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DAS28-CRP Score Over Time</title>
        <description>The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DAS28-CRP Score Over Time</title>
          <description>The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</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="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="362"/>
                    <count group_id="O2" value="358"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.05" spread="0.913"/>
                    <measurement group_id="O2" value="6.06" spread="0.852"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="340"/>
                    <count group_id="O2" value="339"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.47" spread="1.298"/>
                    <measurement group_id="O2" value="3.47" spread="1.336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)</title>
        <description>The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.</description>
        <time_frame>Baseline, Week 12 and Week 24</time_frame>
        <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)</title>
          <description>The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.</description>
          <population>The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.</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="363"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="361"/>
                    <count group_id="O2" value="355"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.52" spread="0.941"/>
                    <measurement group_id="O2" value="6.56" spread="0.902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="349"/>
                    <count group_id="O2" value="340"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.24" spread="1.382"/>
                    <measurement group_id="O2" value="4.24" spread="1.353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="342"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.82" spread="1.384"/>
                    <measurement group_id="O2" value="3.85" spread="1.371"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Patients Developing Anti-drug Antibodies (ADAs)</title>
        <description>Blood samples for the assessment of ADA activity were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12, and 24.</description>
        <time_frame>Baseline and last sampling day</time_frame>
        <population>The Safety Analysis Set was defined as the set of patients who received at least 1 dose of randomised treatment. The Safety Analysis Set was used for all safety analyses. Patient safety data were analysed according to treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Developing Anti-drug Antibodies (ADAs)</title>
          <description>Blood samples for the assessment of ADA activity were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12, and 24.</description>
          <population>The Safety Analysis Set was defined as the set of patients who received at least 1 dose of randomised treatment. The Safety Analysis Set was used for all safety analyses. Patient safety data were analysed according to treatment actually received.</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="366"/>
                <count group_id="O2" value="362"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Positive)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                    <measurement group_id="O2" value="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Negative)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.4"/>
                    <measurement group_id="O2" value="94.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Missing)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                    <measurement group_id="O2" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last sampling day (Positive)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.7"/>
                    <measurement group_id="O2" value="59.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last sampling day (Negative)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.3"/>
                    <measurement group_id="O2" value="40.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Trough Adalimumab Concentration</title>
        <description>Blood samples for the quantification of adalimumab concentration in serum were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12 and 20, and Week 24. Samples were taken prior to dosing (trough samples).</description>
        <time_frame>Week 2, Week 4, Week 12, Week 20, and Week 24</time_frame>
        <population>The Pharmacokinetic Analysis Set (PKAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and had at least 1 serum adalimumab concentration result after receiving randomised treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FKB327</title>
            <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Humira®</title>
            <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Trough Adalimumab Concentration</title>
          <description>Blood samples for the quantification of adalimumab concentration in serum were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12 and 20, and Week 24. Samples were taken prior to dosing (trough samples).</description>
          <population>The Pharmacokinetic Analysis Set (PKAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and had at least 1 serum adalimumab concentration result after receiving randomised treatment.</population>
          <units>ng/mL</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="364"/>
                <count group_id="O2" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2434.6" lower_limit="2321.4" upper_limit="2553.2"/>
                    <measurement group_id="O2" value="2089.1" lower_limit="1990.9" upper_limit="2192.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3450.6" lower_limit="3223.2" upper_limit="3694.1"/>
                    <measurement group_id="O2" value="2932.1" lower_limit="2737" upper_limit="3141.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4316.3" lower_limit="3919.6" upper_limit="4753.2"/>
                    <measurement group_id="O2" value="3851.5" lower_limit="3493.9" upper_limit="4245.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4369.8" lower_limit="3892.3" upper_limit="4905.9"/>
                    <measurement group_id="O2" value="3873" lower_limit="3445.9" upper_limit="4353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4126" lower_limit="3645.1" upper_limit="4670.4"/>
                    <measurement group_id="O2" value="3758.2" lower_limit="3316.8" upper_limit="4258.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.</time_frame>
      <desc>Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.</desc>
      <group_list>
        <group group_id="E1">
          <title>FKB327</title>
          <description>Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Humira®</title>
          <description>Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Non-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="1" subjects_at_risk="366"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="366"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Amyloidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Disseminated tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Cervicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Latent tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Osteomyelitis chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Traumatic fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Lung infiltration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Lichen sclerosus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="366"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="362"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="366"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Non-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="26" subjects_at_risk="366"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="362"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="26" subjects_affected="26" subjects_at_risk="366"/>
                <counts group_id="E2" events="29" subjects_affected="29" subjects_at_risk="362"/>
              </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>Investigator and Sponsor will discuss the preparation of a manuscript for publication in a peer reviewed journal or an abstract for presentation. Either party may undertake the task but both must agree to the strategy before work is started. Each party will allow the other 30 days to comment before any results are submitted for publication or presentation. Authorship should reflect work done by the Investigators and Sponsor, in accordance with recognised principles of scientific collaboration.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Information</name_or_title>
      <organization>Fujifilm Kyowa Kirin Biologics Co., Ltd., EU Branch</organization>
      <phone>+44 1896 668 173</phone>
      <email>Clinical-Trials@fk-b.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/NCT02260791
org study id: FKB327-002
nct id: NCT02260791
lead sponsor: 
has dmc: No
The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison
      to Humira® in rheumatoid arthritis patients who have inadequate disease control on
      methotrexate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: American College of Rheumatology (ACR) 20 Response Rate
time frame: Week 24
description: The primary efficacy endpoint was the ACR20 response rate at Week 24.
An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.
Acute phase reactant (CRP)
Patient global assessment of disease activity
Physician global assessment of disease activity
Patient pain scale
Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])
measure: Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
description: The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
measure: ACR20 Response Rates Over Time
time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
description: An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.
Acute phase reactant (CRP)
Patient global assessment of disease activity
Physician global assessment of disease activity
Patient pain scale
Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])
measure: ACR50 Response Rates Over Time
time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
description: An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.
Acute phase reactant (CRP)
Patient global assessment of disease activity
Physician global assessment of disease activity
Patient pain scale
Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])
measure: ACR70 Response Rates Over Time
time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
description: An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.
Acute phase reactant (CRP)
Patient global assessment of disease activity
Physician global assessment of disease activity
Patient pain scale
Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])
measure: Swollen Joint Count
time frame: Baseline and Week 24
description: Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables.
measure: Tender Joint Count
time frame: Baseline and Week 24
description: Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables.
measure: Analysis of Serum C-Reactive Protein (CRP) Concentration
time frame: Baseline and Week 24
description: Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation.
measure: Patient Assessment of Disease Activity
time frame: Baseline and Week 24
description: Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.
measure: Physician Assessment of Disease Activity
time frame: Baseline and Week 24
description: Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.
measure: Patient's Assessment of Pain
time frame: Baseline and Week 24
description: An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured ("No pain" at 0 and "Intolerable pain" at 100). Patient's assessment of pain is a value of the individual ACR core set variables.
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
time frame: Baseline and Week 24
description: The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables.
measure: DAS28-CRP Score Over Time
time frame: Baseline and Week 24
description: The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
measure: DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)
time frame: Baseline, Week 12 and Week 24
description: The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
measure: Percentage of Patients Developing Anti-drug Antibodies (ADAs)
time frame: Baseline and last sampling day
description: Blood samples for the assessment of ADA activity were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12, and 24.
measure: Trough Adalimumab Concentration
time frame: Week 2, Week 4, Week 12, Week 20, and Week 24
description: Blood samples for the quantification of adalimumab concentration in serum were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12 and 20, and Week 24. Samples were taken prior to dosing (trough samples).
arm group label: FKB327
arm group type: Experimental
description: Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
arm group label: Humira®
arm group type: Active Comparator
description: Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
intervention type: Drug
intervention name: FKB327
description: Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
arm group label: FKB327
intervention type: Drug
intervention name: Humira®
description: Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
arm group label: Humira®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Josephine Glover, MD
role: Principal Investigator
affiliation: Coephycient Pharmaceutical Consultancy
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Bulgaria
country: Canada
country: Chile
country: Czechia
country: Germany
country: Peru
country: Poland
country: Romania
country: Russian Federation
country: Spain
country: Ukraine
country: United States
country: Czech Republic
country: Serbia
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Adalimumab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 