<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/NCT03823391</url>
  </required_header>
  <id_info>
    <org_study_id>M16-560</org_study_id>
    <secondary_id>2018-003053-21</secondary_id>
    <nct_id>NCT03823391</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)</brief_title>
  <official_title>A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants&#xD;
      with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX)&#xD;
      compared with adalimumab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consists of a 12-week double-blind active-controlled phase and a 12 week&#xD;
      double-blind extension period.&#xD;
&#xD;
      In the active-controlled period of the first 12 weeks of treatment, participants are&#xD;
      randomized to receive either ABBV-3373 100 mg intravenously (IV) every other week (EOW) or&#xD;
      adalimumab 80 mg subcutaneously (SC) EOW according to a 2:1 ratio.&#xD;
&#xD;
      At Week 12, the administration of ABBV-3373 was to stop to assess the durability of the&#xD;
      observed clinical effects up to 24 weeks. Participants randomized to ABBV-3373 were to&#xD;
      receive placebo injections, whereas participants randomized into the adalimumab arm were to&#xD;
      continue their 80 mg dosing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2019</start_date>
  <completion_date type="Actual">August 26, 2020</completion_date>
  <primary_completion_date type="Actual">April 8, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale [VAS] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Simplified Disease Activity Index (SDAI)</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal &lt; 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>The DAS28 (ESR) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:&#xD;
≥ 50% improvement in 68-tender joint count;&#xD;
≥ 50% improvement in 66-swollen joint count; and&#xD;
≥ 50% improvement in at least 3 of the 5 following parameters:&#xD;
Physician global assessment of disease activity&#xD;
Patient global assessment of disease activity&#xD;
Patient assessment of pain&#xD;
Health Assessment Questionnaire - Disability Index (HAQ-DI)&#xD;
High-sensitivity C-reactive protein (hsCRP).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Rheumatoid Arthritis (RA)</condition>
  <arm_group>
    <arm_group_label>ABBV-3373 Followed by Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adalimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered with placebo to ABBV-3373 by intravenous infusion and 80 mg adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive 80 mg adalimumab subcutaneously every other week until Week 22.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABBV-3373</intervention_name>
    <description>ABBV-3373 is administered as intravenous (IV) infusion</description>
    <arm_group_label>ABBV-3373 Followed by Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for ABBV-3373</intervention_name>
    <description>Placebo for ABBV-3373 is administered as IV infusion</description>
    <arm_group_label>Adalimumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adalimumab</intervention_name>
    <description>Adalimumab is administered as subcutaneous (SC) injection</description>
    <arm_group_label>Adalimumab</arm_group_label>
    <other_name>Humira</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for adalimumab</intervention_name>
    <description>Placebo for adalimumab is administered as subcutaneous (SC) injection</description>
    <arm_group_label>ABBV-3373 Followed by Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant has the clinical diagnosis of RA for &gt; 3 months based on the 1987 American&#xD;
             College of Rheumatology (ACR) classification criteria or 2010 ACR/European League&#xD;
             against Rheumatism (EULAR) criteria.&#xD;
&#xD;
          -  Participant meets the following disease activity criteria: &gt;= 4 swollen joints (based&#xD;
             on 28 joint count) and &gt;= 4 tender joints (based on 28 joint count) at Screening and&#xD;
             Baseline visits and disease activity score (28 joints) (DAS28) C-reactive protein&#xD;
             (CRP) &gt;= 3.2 at Screening.&#xD;
&#xD;
          -  Participant has an incomplete response to methotrexate. Participants must have been on&#xD;
             oral or parental MTX therapy &gt;= 3 months and on a stable prescription of 15 to 25&#xD;
             mg/week (or &gt;= 10 mg/week in participants intolerant of MTX at doses &gt;= 15 mg/week)&#xD;
             for &gt;= 4 weeks prior to the first dose of study drug. Participant must be expected to&#xD;
             be able to continue on stable dose of MTX for the duration of study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants previously exposed to adalimumab or other anti-tumor necrosis factor&#xD;
             (TNF) biologics.&#xD;
&#xD;
          -  Participants previously exposed to non-anti-TNF biologics or targeted synthetic&#xD;
             disease-modifying antirheumatic drugs (DMARDs) for RA, with exception of participants&#xD;
             exposed for less than 3 months and terminated not due to lack of efficacy or&#xD;
             intolerability.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rheum Assoc of North Alabama /ID# 213626</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Arthritis and Rheum Researc /ID# 208515</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.V. Mehta MD, Med Corporation /ID# 213068</name>
      <address>
        <city>Hemet</city>
        <state>California</state>
        <zip>92543</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robin K. Dore MD, Inc /ID# 213045</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Rheum &amp; Osteo Med Grp /ID# 213044</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Clinical Research /ID# 213973</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis Center, Inc. /ID# 213972</name>
      <address>
        <city>Palm Harbor</city>
        <state>Florida</state>
        <zip>34684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>W. Broward Rheum Assoc Inc. /ID# 211017</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BayCare Medical Group, Inc. /ID# 213935</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614-7101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Arthritis Researc /ID# 213043</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRN Professional Research Network of Kansas, LLC /ID# 213046</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinvest Research LLC /ID# 215451</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65810-2607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Early Phase Research Unit (DCRI) /ID# 213212</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paramount Medical Research Con /ID# 209042</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>STAT Research, Inc. /ID# 213933</name>
      <address>
        <city>Vandalia</city>
        <state>Ohio</state>
        <zip>45377-9464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Tennessee Research Inst /ID# 208838</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PCCR Solution /ID# 215457</name>
      <address>
        <city>Colleyville</city>
        <state>Texas</state>
        <zip>76034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Universal Research Association /ID# 209167</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75024-5283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Research Organisation GmbH /ID# 210216</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 210055</name>
      <address>
        <city>Miskolc</city>
        <state>Borsod-Abauj-Zemplen</state>
        <zip>3529</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DRC Gyogyszervizsgalo Kozpont Kft. /ID# 210159</name>
      <address>
        <city>Balatonfüred</city>
        <state>Veszprem</state>
        <zip>8230</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Budai Irgalmasrendi Korhaz /ID# 208877</name>
      <address>
        <city>Budapest</city>
        <zip>1023</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont /ID# 210164</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus /ID# 212747</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center /ID# 211339</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5239424</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Medical center Amsterdam /ID# 209303</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SANUS Szpital Specjalistyczny /ID# 209022</name>
      <address>
        <city>Stalowa Wola</city>
        <zip>37-450</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reumatika - Centrum Reumatologii NZOZ /ID# 209220</name>
      <address>
        <city>Warsaw</city>
        <zip>02-691</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GCM Medical Group, PSC /ID# 208154</name>
      <address>
        <city>San Juan</city>
        <zip>00909</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mindful Medical Research /ID# 208403</name>
      <address>
        <city>San Juan</city>
        <zip>00918-3756</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <results_first_submitted>June 29, 2021</results_first_submitted>
  <results_first_submitted_qc>June 29, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 19, 2021</results_first_posted>
  <disposition_first_submitted>March 23, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>March 23, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 26, 2021</disposition_first_posted>
  <last_update_submitted>June 29, 2021</last_update_submitted>
  <last_update_submitted_qc>June 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid Arthritis (RA)</keyword>
  <keyword>ABBV-3373</keyword>
  <keyword>Adalimumab</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.</ipd_access_criteria>
    <ipd_url>https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03823391/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03823391/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) were enrolled at 14 sites in the United States and Puerto Rico, Poland, Hungary, and Israel.</recruitment_details>
      <pre_assignment_details>Participants were randomly assigned in a 2:1 ratio to either ABBV-3373 or adalimumab. Randomization was stratified by current use of systemic glucocorticoid (≤ 7.5 mg/d prednisone equivalent) for treatment of RA at Baseline (yes/no) and prior exposure to non-anti-tumor necrosis factor (TNF) biologics or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for less than 3 months and terminated not due to lack of efficacy or intolerance (yes/no).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Adalimumab</title>
          <description>Participants were administered placebo to ABBV-3373 by intravenous (IV) infusion and 80 mg adalimumab by subcutaneous injection every other week (EOW) for 12 weeks. After 12 weeks, participants received 80 mg adalimumab subcutaneously EOW until Week 22.</description>
        </group>
        <group group_id="P2">
          <title>ABBV-3373 Followed by Placebo</title>
          <description>Participants were administered 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants received placebo to adalimumab EOW until Week 22.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1: Week 1 to Week 12</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2: Weeks 12 to Week 24</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Full Analysis Set (FAS) includes all randomized participants who received at least 1 dose of the study drugs.</population>
      <group_list>
        <group group_id="B1">
          <title>Adalimumab</title>
          <description>Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks. After 12 weeks, participants received 80 mg adalimumab subcutaneously EOW until Week 22.</description>
        </group>
        <group group_id="B2">
          <title>ABBV-3373 Followed by Placebo</title>
          <description>Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks. After 12 weeks, participants received placebo to adalimumab EOW until Week 22.</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="17"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.0" spread="10.21"/>
                    <measurement group_id="B2" value="52.8" spread="13.14"/>
                    <measurement group_id="B3" value="53.2" spread="12.08"/>
                  </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>
              <category_list>
                <category>
                  <title>&lt; 40 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40 to 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_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="14"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </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="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="37"/>
                  </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/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of RA Symptoms</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.9" spread="3.22"/>
                    <measurement group_id="B2" value="8.0" spread="8.73"/>
                    <measurement group_id="B3" value="7.2" spread="7.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of RA Diagnosis</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.5" spread="3.09"/>
                    <measurement group_id="B2" value="5.0" spread="6.02"/>
                    <measurement group_id="B3" value="4.5" spread="5.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Use of Systemic Glucocorticoids</title>
          <description>Randomization was stratified by current use of systemic glucocorticoid (≤ 7.5 mg/day prednisone equivalent) for treatment of rheumatoid arthritis at Baseline).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Exposure to Non-anti-TNF or Targeted Synthetic DMARDs</title>
          <description>Randomization was stratified by prior exposure to non-anti-TNF biologics or targeted synthetic DMARDs (&lt; 3 months and terminated not due to lack of efficacy or intolerance).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</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>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease Activity Score 28 C-reactive protein (DAS28[CRP])</title>
          <description>The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP) (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.6" spread="0.71"/>
                    <measurement group_id="B2" value="5.6" spread="0.92"/>
                    <measurement group_id="B3" value="5.6" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])</title>
        <description>The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale [VAS] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Participants in the full analysis set with non-missing Baseline and at least one post-baseline value are included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>ABBV-3373</title>
            <description>Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])</title>
          <description>The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale [VAS] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.</description>
          <population>Participants in the full analysis set with non-missing Baseline and at least one post-baseline value are included in the analyses.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.51" spread="0.293"/>
                    <measurement group_id="O2" value="-2.65" spread="0.215"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Two primary comparisons were performed between ABBV-3373 and adalimumab. The first was the comparison of ABBV-3373 to historical adalimumab reference value -2.13 based on a meta-analysis consisting of 242 subjects from 3 historical adalimumab studies in which the success criterion was 2-sided P value ≤ 0.1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.022</p_value>
            <method>Mixed-effect model repeated measurement</method>
            <method_desc>Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.</method_desc>
            <param_type>Least Squares (LS) Mean Difference</param_type>
            <param_value>-0.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.215</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.89</ci_lower_limit>
            <ci_upper_limit>-0.15</ci_upper_limit>
            <estimate_desc>Between groups difference was a single-arm comparison of LS mean of ABBV-3373 estimated from the MMRM model above minus the historical mean of adalimumab (-2.13).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The second comparison was ABBV-3373 to adalimumab with combined in-trial and borrowed historical adalimumab data using a Bayesian historical borrowing approach in which the success criterion was posterior probability of ABBV-3373 being better than adalimumab &gt; 95%. When borrowing 30 historical adalimumab subjects, the combined least squares mean change from Baseline was -2.29.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.899</p_value>
            <p_value_desc>Posterior probability</p_value_desc>
            <method>Historical data borrowing</method>
            <method_desc>Based on posterior distribution of means for each group, the probability of Treatment mean - Control mean &lt; 0 given the observed data was calculated.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The mean difference in change from Baseline in DAS28 (CRP) at Week 12 between ABBV-3373 and adalimumab was also estimated only based on in-study data.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.683</p_value>
            <method>Mixed Effect Model Repeated Measurement</method>
            <method_desc>Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.353</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.74</ci_lower_limit>
            <ci_upper_limit>0.45</ci_upper_limit>
            <estimate_desc>Treatment difference = ABBV-3373 - Adalimumab</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)</title>
        <description>The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Participants in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>ABBV-3373</title>
            <description>Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)</title>
          <description>The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.</description>
          <population>Participants in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analyses.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.30" spread="2.656"/>
                    <measurement group_id="O2" value="-27.99" spread="1.955"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.601</p_value>
            <method>Mixed Effect Model Repeated Measurement</method>
            <method_desc>Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.69</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.207</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.08</ci_lower_limit>
            <ci_upper_limit>3.70</ci_upper_limit>
            <estimate_desc>Treatment difference = ABBV-3373 - Adalimumab</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Simplified Disease Activity Index (SDAI)</title>
        <description>The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal &lt; 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Participants in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>ABBV-3373</title>
            <description>Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Simplified Disease Activity Index (SDAI)</title>
          <description>The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal &lt; 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.</description>
          <population>Participants in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analyses.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.42" spread="2.659"/>
                    <measurement group_id="O2" value="-28.50" spread="1.961"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.737</p_value>
            <method>Mixed Effect Model Repeated Measurement</method>
            <method_desc>Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.205</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.47</ci_lower_limit>
            <ci_upper_limit>4.30</ci_upper_limit>
            <estimate_desc>Treatment difference = ABBV-3373 - Adalimumab</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])</title>
        <description>The DAS28 (ESR) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Participants in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>ABBV-3373</title>
            <description>Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])</title>
          <description>The DAS28 (ESR) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity.</description>
          <population>Participants in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analyses.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.55" spread="0.344"/>
                    <measurement group_id="O2" value="-2.76" spread="0.254"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.612</p_value>
            <method>Mixed Effect Model Repeated Measurement</method>
            <method_desc>Analysis included treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.418</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.92</ci_lower_limit>
            <ci_upper_limit>0.49</ci_upper_limit>
            <estimate_desc>Treatment difference = ABBV-3373 - Adalimumab</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12</title>
        <description>The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity.</description>
        <time_frame>Week 12</time_frame>
        <population>Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>ABBV-3373</title>
            <description>Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12</title>
          <description>The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity.</description>
          <population>Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.8" lower_limit="39.2" upper_limit="78.5"/>
                    <measurement group_id="O2" value="54.8" lower_limit="40.1" upper_limit="69.5"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.877</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel test adjusted for stratification factors.</method_desc>
            <param_type>Response Rate Difference</param_type>
            <param_value>-4.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-28.5</ci_lower_limit>
            <ci_upper_limit>20.5</ci_upper_limit>
            <estimate_desc>Response rate difference = ABBV-3373 - Adalimumab</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12</title>
        <description>Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:&#xD;
≥ 50% improvement in 68-tender joint count;&#xD;
≥ 50% improvement in 66-swollen joint count; and&#xD;
≥ 50% improvement in at least 3 of the 5 following parameters:&#xD;
Physician global assessment of disease activity&#xD;
Patient global assessment of disease activity&#xD;
Patient assessment of pain&#xD;
Health Assessment Questionnaire - Disability Index (HAQ-DI)&#xD;
High-sensitivity C-reactive protein (hsCRP).</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Adalimumab</title>
            <description>Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>ABBV-3373</title>
            <description>Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12</title>
          <description>Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:&#xD;
≥ 50% improvement in 68-tender joint count;&#xD;
≥ 50% improvement in 66-swollen joint count; and&#xD;
≥ 50% improvement in at least 3 of the 5 following parameters:&#xD;
Physician global assessment of disease activity&#xD;
Patient global assessment of disease activity&#xD;
Patient assessment of pain&#xD;
Health Assessment Questionnaire - Disability Index (HAQ-DI)&#xD;
High-sensitivity C-reactive protein (hsCRP).</description>
          <population>Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.7" lower_limit="45.6" upper_limit="83.8"/>
                    <measurement group_id="O2" value="51.6" lower_limit="36.8" upper_limit="66.4"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.426</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel test adjusting for stratification factors.</method_desc>
            <param_type>Response Rate Difference</param_type>
            <param_value>-13.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.2</ci_lower_limit>
            <ci_upper_limit>11.0</ci_upper_limit>
            <estimate_desc>Response rate difference = ABBV-3373 - Adalimumab</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Period 1: ABBV-3373</title>
          <description>Participants received 100 mg ABBV-3373 by intravenous infusion EOW and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Period 1: Adalimumab</title>
          <description>Participants received 80 mg adalimumab by subcutaneous injection EOW and placebo to ABBV-3373 by intravenous infusion EOW for 12 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Period 2: ABBV-3773 / Placebo</title>
          <description>Participants received placebo to adalimumab by subcutaneous injection EOW from Week 12 to Week 24.</description>
        </group>
        <group group_id="E4">
          <title>Period 2: Adalimumab / Adalimumab</title>
          <description>Participants continued to receive 80 mg adalimumab by subcutaneous injection EOW from Week 12 to Week 24.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>NON-CARDIAC CHEST PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAPHYLACTIC SHOCK</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BREAST ABSCESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</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="4" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>LEUKOPENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>PERIORBITAL SWELLING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL DISCOMFORT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>MOUTH SWELLING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>INFUSION SITE BRUISING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>INJECTION SITE PRURITUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>DRUG HYPERSENSITIVITY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>TYPE I HYPERSENSITIVITY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS VIRAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>ORAL HERPES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>BLOOD PRESSURE INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>LIVER FUNCTION TEST ABNORMAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>MYCOPLASMA TEST POSITIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>OSTEOARTHRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>RHEUMATOID ARTHRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>HYPOAESTHESIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>SCIATICA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>BRONCHIAL HYPERREACTIVITY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>OROPHARYNGEAL PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.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/NCT03823391
org study id: M16-560
secondary id: 2018-003053-21
nct id: NCT03823391
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants
      with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX)
      compared with adalimumab.
This study consists of a 12-week double-blind active-controlled phase and a 12 week
      double-blind extension period.

      In the active-controlled period of the first 12 weeks of treatment, participants are
      randomized to receive either ABBV-3373 100 mg intravenously (IV) every other week (EOW) or
      adalimumab 80 mg subcutaneously (SC) EOW according to a 2:1 ratio.

      At Week 12, the administration of ABBV-3373 was to stop to assess the durability of the
      observed clinical effects up to 24 weeks. Participants randomized to ABBV-3373 were to
      receive placebo injections, whereas participants randomized into the adalimumab arm were to
      continue their 80 mg dosing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])
time frame: Baseline and Week 12
description: The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale [VAS] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
measure: Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)
time frame: Baseline and Week 12
description: The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
measure: Change From Baseline in Simplified Disease Activity Index (SDAI)
time frame: Baseline and Week 12
description: The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal < 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
measure: Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])
time frame: Baseline and Week 12
description: The DAS28 (ESR) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity.
measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12
time frame: Week 12
description: The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity.
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
time frame: Baseline and Week 12
description: Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
≥ 50% improvement in 68-tender joint count;
≥ 50% improvement in 66-swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
arm group label: ABBV-3373 Followed by Placebo
arm group type: Experimental
description: Participants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22.
arm group label: Adalimumab
arm group type: Experimental
description: Participants will be administered with placebo to ABBV-3373 by intravenous infusion and 80 mg adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive 80 mg adalimumab subcutaneously every other week until Week 22.
intervention type: Drug
intervention name: ABBV-3373
description: ABBV-3373 is administered as intravenous (IV) infusion
arm group label: ABBV-3373 Followed by Placebo
intervention type: Drug
intervention name: Placebo for ABBV-3373
description: Placebo for ABBV-3373 is administered as IV infusion
arm group label: Adalimumab
intervention type: Drug
intervention name: Adalimumab
description: Adalimumab is administered as subcutaneous (SC) injection
arm group label: Adalimumab
other name: Humira
intervention type: Drug
intervention name: Placebo for adalimumab
description: Placebo for adalimumab is administered as subcutaneous (SC) injection
arm group label: ABBV-3373 Followed by Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
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country: Germany
country: Hungary
country: Israel
country: Netherlands
country: Poland
country: Puerto Rico
country: United States
url: http://www.rxabbvie.com
description: Related Info
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Adalimumab
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
ipd url: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 