<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/NCT01676701</url>
  </required_header>
  <id_info>
    <org_study_id>14598</org_study_id>
    <secondary_id>H9B-MC-BCEF</secondary_id>
    <nct_id>NCT01676701</nct_id>
  </id_info>
  <brief_title>Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA)</brief_title>
  <official_title>Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the serum concentration of tabalumab after the&#xD;
      administration using either prefilled syringe or auto-injector after the initial loading dose&#xD;
      and after 12 weeks of treatment. Treatment period is followed by 40 weeks optional safety&#xD;
      extension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient efficacy observed in study BCDM(NCT01198002) and BCDV(NCT01202773)&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose</measure>
    <time_frame>Days 4, 7, 9, 11, and 14 after loading dose administered</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK: Area Under the Concentration Time Curve From Time 0 to 14 Days [AUC(0-14)]</measure>
    <time_frame>Days 4, 7, 9, 11, and 14 after loading dose administered</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set</measure>
    <time_frame>Baseline, Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ACR Response</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index</measure>
    <time_frame>Baseline, Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 12-Week Endpoint in Disease Activity Score Based on a 28-Joint Count and C-Reactive Protein (DAS28-CRP) Level</measure>
    <time_frame>Baseline, Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28)</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Developing Anti-Tabalumab Antibodies</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Operation Failures</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ)</measure>
    <time_frame>Baseline, Weeks 4 and 8</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Tabalumab Auto-Injector</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tabalumab 180 milligram (mg) loading dose administered using auto-injectors at Week 0 as 2 subcutaneous (SC) injections (90 mg each), followed by a 90 mg SC injection every 2 weeks (Q2W) up to Week 12.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tabalumab Prefilled Syringe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tabalumab 180 mg loading dose administered using prefilled syringes at Week 0 as 2 SC injections (90 mg each), followed by a 90 mg SC injection Q2W up to Week 12.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tabalumab Auto-Injector</intervention_name>
    <description>Administered SC by auto-injector</description>
    <arm_group_label>Tabalumab Auto-Injector</arm_group_label>
    <other_name>LY2127399</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tabalumab Prefilled Syringe</intervention_name>
    <description>Administered SC by prefilled syringe</description>
    <arm_group_label>Tabalumab Prefilled Syringe</arm_group_label>
    <other_name>LY2127399</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ambulatory males or females ≥18 years of age&#xD;
&#xD;
          -  Diagnosis of adult-onset RA&#xD;
&#xD;
          -  Active RA (at least 8/68 tender and at least 8/66 swollen joints)&#xD;
&#xD;
          -  Screening C-reactive protein (CRP) &gt;1.2 times the upper limit of normal (ULN) or a&#xD;
             screening erythrocyte sedimentation rate (ESR) &gt;28 millimeters per hour (mm/hr)&#xD;
&#xD;
          -  Documented history of, or current, positive rheumatoid factor (RF) and/or anti-cyclic&#xD;
             citrullinated peptide antibody (anti-CCP Ab) test&#xD;
&#xD;
          -  Regular use of methotrexate (MTX) for at least 12 weeks and stable dose (10 to 25&#xD;
             mg/week) for at least 8 weeks prior to baseline&#xD;
&#xD;
          -  American College of Rheumatology (ACR) functional class I, II, or III&#xD;
&#xD;
          -  Able and willing to inject tabalumab by themselves (or have an assistant who will&#xD;
             inject tabalumab) and able and willing to complete all study procedures&#xD;
&#xD;
          -  Able and willing to have blood drawn for pharmacokinetic (PK) sampling&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of oral corticosteroids at average daily doses of &gt;10 milligrams per day (mg/day)&#xD;
             of prednisone or its equivalent within 6 weeks prior to baseline&#xD;
&#xD;
          -  Injection of any parenteral (including intraarticular) corticosteroid within 6 weeks&#xD;
             of baseline&#xD;
&#xD;
          -  Have previously discontinued treatment with a biologic disease-modifying antirheumatic&#xD;
             drug (DMARD) or a novel drug that interrupts cytokine signaling [for example, Janus&#xD;
             kinase (JAK) inhibitors] due to insufficient efficacy&#xD;
&#xD;
          -  Participants who had discontinued biologic DMARDS for reasons other than efficacy will&#xD;
             not be excluded but must have done so prior to baseline&#xD;
&#xD;
          -  Participants who discontinued a JAK inhibitor for lack of efficacy&#xD;
&#xD;
          -  Participants who discontinued a JAK inhibitor for reasons other than efficacy will not&#xD;
             be excluded, but must have done so prior to baseline for 21 days&#xD;
&#xD;
          -  Previous severe reaction to any biologic therapy that, in the opinion of the&#xD;
             Investigator, would pose an unacceptable risk to the participant if participating in&#xD;
             the study&#xD;
&#xD;
          -  Have had an inadequate response to treatment with 3 or more of the following DMARDs&#xD;
             prescribed alone or in combination at approved doses for a minimum of 90 days:&#xD;
             leflunomide, azathioprine, cyclosporine, and/or sulfasalazine&#xD;
&#xD;
          -  Use of other DMARDs (for example, gold salts, cyclosporin, azathioprine, or any other&#xD;
             immunosuppressives) other than MTX, hydroxychloroquine, chloroquine, or sulfasalazine,&#xD;
             or the use of a JAK inhibitor in the 8 weeks prior to baseline&#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>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lewes</city>
        <state>Delaware</state>
        <zip>19958</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>DeBary</city>
        <state>Florida</state>
        <zip>32713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Prairie Village</city>
        <state>Kansas</state>
        <zip>66206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>68507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19152</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1015ABO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Córdoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Quilmes</city>
        <zip>B1878DVC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>San Juan</city>
        <zip>5400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tucuman</city>
        <zip>4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hostivice</city>
        <zip>253-01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Plzen-Bory</city>
        <zip>305 99</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Prague</city>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Uherske Hradiste</city>
        <zip>686 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Zlin</city>
        <zip>760 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bialystok</city>
        <zip>15-351</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Elblag</city>
        <zip>82300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lublin</city>
        <zip>20-607</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Poznan</city>
        <zip>60-218</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ponce</city>
        <zip>00716</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>San Juan</city>
        <zip>00918</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Santurce</city>
        <zip>00909</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Moscow</city>
        <zip>119435</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Saratov</city>
        <zip>410026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ulyanovsk</city>
        <zip>432063</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Czechia</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <results_first_submitted>March 24, 2018</results_first_submitted>
  <results_first_submitted_qc>March 24, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">April 26, 2018</results_first_posted>
  <disposition_first_submitted>January 7, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>January 7, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">February 6, 2014</disposition_first_posted>
  <last_update_submitted>March 24, 2018</last_update_submitted>
  <last_update_submitted_qc>March 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The study was to include a 12-week treatment period, optional 40-week safety extension, and post-treatment follow-up (at least 24 weeks). At the time of early study termination, all participants who had received tabalumab discontinued dosing and then completed the post-treatment follow-up period. No one entered the 40-week safety extension period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tabalumab Auto-Injector</title>
          <description>Tabalumab: Using auto-injectors, participants received a 180 milligram (mg) loading dose at Week 0 as 2 subcutaneous (SC) injections (90 mg each). Participants also received a 90 mg SC injection every 2 weeks (Q2W) until early study termination (up to Week 6).</description>
        </group>
        <group group_id="P2">
          <title>Tabalumab Prefilled Syringe</title>
          <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Post-Treatment Follow-Up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Tabalumab Auto-Injector</title>
          <description>Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
        </group>
        <group group_id="B2">
          <title>Tabalumab Prefilled Syringe</title>
          <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</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="4"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>43.3 to 65.4 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose</title>
        <time_frame>Days 4, 7, 9, 11, and 14 after loading dose administered</time_frame>
        <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>Tabalumab Auto-Injector</title>
            <description>Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
          <group group_id="O2">
            <title>Tabalumab Prefilled Syringe</title>
            <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose</title>
          <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PK: Area Under the Concentration Time Curve From Time 0 to 14 Days [AUC(0-14)]</title>
        <time_frame>Days 4, 7, 9, 11, and 14 after loading dose administered</time_frame>
        <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>Tabalumab Auto-Injector</title>
            <description>Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
          <group group_id="O2">
            <title>Tabalumab Prefilled Syringe</title>
            <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
        </group_list>
        <measure>
          <title>PK: Area Under the Concentration Time Curve From Time 0 to 14 Days [AUC(0-14)]</title>
          <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set</title>
        <time_frame>Baseline, Week 12</time_frame>
        <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>Tabalumab Auto-Injector</title>
            <description>Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
          <group group_id="O2">
            <title>Tabalumab Prefilled Syringe</title>
            <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set</title>
          <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving ACR Response</title>
        <time_frame>Week 12</time_frame>
        <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>Tabalumab Auto-Injector</title>
            <description>Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
          <group group_id="O2">
            <title>Tabalumab Prefilled Syringe</title>
            <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving ACR Response</title>
          <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index</title>
        <time_frame>Baseline, Week 12</time_frame>
        <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>Tabalumab Auto-Injector</title>
            <description>Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
          <group group_id="O2">
            <title>Tabalumab Prefilled Syringe</title>
            <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index</title>
          <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 12-Week Endpoint in Disease Activity Score Based on a 28-Joint Count and C-Reactive Protein (DAS28-CRP) Level</title>
        <time_frame>Baseline, Week 12</time_frame>
        <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>Tabalumab Auto-Injector</title>
            <description>Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
          <group group_id="O2">
            <title>Tabalumab Prefilled Syringe</title>
            <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 12-Week Endpoint in Disease Activity Score Based on a 28-Joint Count and C-Reactive Protein (DAS28-CRP) Level</title>
          <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28)</title>
        <time_frame>Week 12</time_frame>
        <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>Tabalumab Auto-Injector</title>
            <description>Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
          <group group_id="O2">
            <title>Tabalumab Prefilled Syringe</title>
            <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28)</title>
          <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Developing Anti-Tabalumab Antibodies</title>
        <time_frame>Week 12</time_frame>
        <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>Tabalumab Auto-Injector</title>
            <description>Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
          <group group_id="O2">
            <title>Tabalumab Prefilled Syringe</title>
            <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Developing Anti-Tabalumab Antibodies</title>
          <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Operation Failures</title>
        <time_frame>Week 12</time_frame>
        <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>Tabalumab Auto-Injector</title>
            <description>Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
          <group group_id="O2">
            <title>Tabalumab Prefilled Syringe</title>
            <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Operation Failures</title>
          <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ)</title>
        <time_frame>Baseline, Weeks 4 and 8</time_frame>
        <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>Tabalumab Auto-Injector</title>
            <description>Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
          <group group_id="O2">
            <title>Tabalumab Prefilled Syringe</title>
            <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ)</title>
          <population>No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Week 12 or early termination (Treatment Period) and last dose up to 24 weeks post last dose (Post-Treatment Follow-Up Period)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tabalumab Auto-Injector (Treatment Period)</title>
          <description>Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
        </group>
        <group group_id="E2">
          <title>Tabalumab Auto-Injector (Post Treatment Follow-Up Period)</title>
          <description>No study drug was administered during the Post-Treatment Follow-Up Period for participants in the Tabalumab Auto-Injector treatment arm.</description>
        </group>
        <group group_id="E3">
          <title>Tabalumab Prefilled Syringe (Treatment Period)</title>
          <description>Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).</description>
        </group>
        <group group_id="E4">
          <title>Tabalumab Prefilled Syringe (Post Treatment Follow-Up Period)</title>
          <description>No study drug was administered during the Post-Treatment Follow-Up Period for participants in the Tabalumab Prefilled Syringe treatment arm.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (16.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastric Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to early termination of the trial, no participant had outcome measure data analyzed. Participants who received study treatment had disposition, demographic, and adverse event data reported.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT01676701
org study id: 14598
secondary id: H9B-MC-BCEF
nct id: NCT01676701
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the serum concentration of tabalumab after the
      administration using either prefilled syringe or auto-injector after the initial loading dose
      and after 12 weeks of treatment. Treatment period is followed by 40 weeks optional safety
      extension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose
time frame: Days 4, 7, 9, 11, and 14 after loading dose administered
measure: PK: Area Under the Concentration Time Curve From Time 0 to 14 Days [AUC(0-14)]
time frame: Days 4, 7, 9, 11, and 14 after loading dose administered
measure: Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set
time frame: Baseline, Week 12
measure: Percentage of Participants Achieving ACR Response
time frame: Week 12
measure: Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index
time frame: Baseline, Week 12
measure: Change From Baseline to 12-Week Endpoint in Disease Activity Score Based on a 28-Joint Count and C-Reactive Protein (DAS28-CRP) Level
time frame: Baseline, Week 12
measure: Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28)
time frame: Week 12
measure: Number of Participants Developing Anti-Tabalumab Antibodies
time frame: Week 12
measure: Number of Operation Failures
time frame: Week 12
measure: Change From Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ)
time frame: Baseline, Weeks 4 and 8
arm group label: Tabalumab Auto-Injector
arm group type: Experimental
description: Tabalumab 180 milligram (mg) loading dose administered using auto-injectors at Week 0 as 2 subcutaneous (SC) injections (90 mg each), followed by a 90 mg SC injection every 2 weeks (Q2W) up to Week 12.
arm group label: Tabalumab Prefilled Syringe
arm group type: Experimental
description: Tabalumab 180 mg loading dose administered using prefilled syringes at Week 0 as 2 SC injections (90 mg each), followed by a 90 mg SC injection Q2W up to Week 12.
intervention type: Drug
intervention name: Tabalumab Auto-Injector
description: Administered SC by auto-injector
arm group label: Tabalumab Auto-Injector
other name: LY2127399
intervention type: Drug
intervention name: Tabalumab Prefilled Syringe
description: Administered SC by prefilled syringe
arm group label: Tabalumab Prefilled Syringe
other name: LY2127399
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Argentina
country: Czechia
country: Poland
country: Puerto Rico
country: Russian Federation
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Antibodies, Monoclonal
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to early termination of the trial, no participant had outcome measure data analyzed. Participants who received study treatment had disposition, demographic, and adverse event data reported.
point of contact: 