<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/NCT01689532</url>
  </required_header>
  <id_info>
    <org_study_id>CR100876</org_study_id>
    <secondary_id>CNTO136ARA3001</secondary_id>
    <nct_id>NCT01689532</nct_id>
  </id_info>
  <brief_title>A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine</brief_title>
  <official_title>A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously as Monotherapy, in Japanese Subjects With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutical K.K.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Janssen Pharmaceutical K.K.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single&#xD;
      therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA) who&#xD;
      have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized (patients will be assigned to treatment by chance), double-blind (study&#xD;
      personnel and patients will not know what treatments are being given), multicenter study. The&#xD;
      expected duration of the study is 68 weeks. This will include 52 weeks of treatment with&#xD;
      study agent with dosing every 2 weeks and 16 weeks of safety follow-up after the last dose.&#xD;
      Disease-modifying antirheumatic drugs (DMARDs), including MTX and SSZ, are not permitted from&#xD;
      4 weeks before the first dosing with study agent until Week 24. The use of DMARDs is&#xD;
      discouraged at or any time after Week 24; however, patients who have less than 20%&#xD;
      improvement from baseline in both swollen and tender joint counts at Week 24 will be allowed&#xD;
      to take DMARDs. At or any time after Week 16, the initiation and/or adjustment of oral&#xD;
      corticosteroids will be allowed for patients who have less than 20% improvement from baseline&#xD;
      in both swollen and tender joint counts at Week 16.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAE)</measure>
    <time_frame>Baseline upto Week 68</time_frame>
    <description>A TEAE was defined as an event that occurred in the treatment period during which it emerged (that is [i.e.] started or worsened in severity, relation, or other attribute), and even if the event continued to be present.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response</measure>
    <time_frame>At Weeks 16 and 24</time_frame>
    <description>The ACR 20 Response is defined as greater than or equal to (&gt;=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response</measure>
    <time_frame>At Weeks 16 and 24</time_frame>
    <description>The ACR 50 Response is defined as &gt;=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response</measure>
    <time_frame>At Weeks 16 and 24</time_frame>
    <description>The ACR 70 Response is defined as &gt;=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response</measure>
    <time_frame>At Weeks 16 and 24</time_frame>
    <description>The ACR 90 Response is defined as &gt;=90 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=90 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24</measure>
    <time_frame>Baseline, Weeks 16 and 24</time_frame>
    <description>Sixty six (66) joints were assessed for swelling by investigator to determine the number of joints that were considered swollen. A negative change from baseline in swollen joint count indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24</measure>
    <time_frame>Baseline, Weeks 16 and 24</time_frame>
    <description>Sixty eight (68) joints were assessed for tenderness to determine the number of joints that were considered tender. A negative change from baseline in the tender joint count indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24</measure>
    <time_frame>Baseline, Weeks 16 and 24</time_frame>
    <description>Participants assessed their average pain during the past week on a visual analogue scale (VAS). The scale ranged from 0 (no pain) to 10 (the worst possible pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24</measure>
    <time_frame>Baseline, Weeks 16 and 24</time_frame>
    <description>Participants rated their disease activity using the Visual Analog Scale (VAS) on a scale of 0 (very well) to 10 (very poor).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24</measure>
    <time_frame>Baseline, Weeks 16 and 24</time_frame>
    <description>Physician's Global Assessment of Disease Activity was assessed using the VAS on a scale of 0 (no arthritis activity) to 10 (extremely active arthritis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24</measure>
    <time_frame>Baseline, Weeks 16 and 24</time_frame>
    <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Here, 'n' signifies those participants who were evaluable for the specific timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24</measure>
    <time_frame>Baseline, Weeks 16 and 24</time_frame>
    <description>Serum CRP is a marker of systemic inflammation. A negative percent change from baseline in CRP represents improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Major Clinical Response at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>Major clinical response is achieving ACR 70 for 6 continuous months. The ACR 70 Response is defined as &gt;=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS, (The scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP. Achievement of major clinical response reflects an enhanced level of therapeutic efficacy and sustained reduction of signs and symptoms of rheumatoid arthritis (RA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24</measure>
    <time_frame>At Weeks 16 and 24</time_frame>
    <description>The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Good responders: improvement from baseline greater than (&gt;) 1.2 with DAS28 less than or equal to (&lt;=) 3.2; moderate responders: improvement from baseline &gt;1.2 with DAS28 &gt;3.2 to &lt;=5.1 or improvement from baseline &gt;0.6 to &lt;=1.2 with DAS28 &lt;=5.1; non-responders: improvement from baseline &lt;=0.6 or improvement from baseline &gt;0.6 and &lt;=1.2 with DAS28 &gt;5.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving DAS28 (CRP) Remission at Week 24</measure>
    <time_frame>At Week 24</time_frame>
    <description>The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (&lt;) 2.6 at any study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24</measure>
    <time_frame>Baseline, Weeks 16 and 24</time_frame>
    <description>The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52</measure>
    <time_frame>At Weeks 16, 24 and 52</time_frame>
    <description>The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity on VAS, physician's global assessments of disease activity on VAS, and CRP. SDAI-based ACR/EULAR remission is defined as a SDAI value of &lt;=3.3 at the visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52</measure>
    <time_frame>At Weeks 16, 24 and 52</time_frame>
    <description>The Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) &lt;=1; swollen joint count (66 joints) &lt;=1; CRP &lt;=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) &lt;=1 on a 0 to 10 scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24</measure>
    <time_frame>Baseline, Weeks 16 and 24</time_frame>
    <description>The CDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score range is 0-76. Score interpretation: Remission &lt;=2.8; Low Disease Activity CDAI &gt; 2.8 and &lt;=10; Moderate Disease Activity CDAI &gt;10 and &lt;=22; High Disease Activity CDAI &gt; 22.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24</measure>
    <time_frame>Baseline, Weeks 16 and 24</time_frame>
    <description>The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. The total score range is 0-86. Score interpretation: Remission SDAI &lt;=3.3; Low Disease Activity SDAI &gt;3.3 and &lt;=11; Moderate Disease Activity SDAI &gt;11 and &lt;=26; High Disease Activity SDAI &gt;26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24</measure>
    <time_frame>Baseline, at Week 16 and 24</time_frame>
    <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24</measure>
    <time_frame>At Weeks 16 and 24</time_frame>
    <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI response was defined as change of &gt; -0.22 from baseline in HAQ-DI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Maintaining HAQ-DI Response</measure>
    <time_frame>Baseline upto Week 52</time_frame>
    <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI responders who maintain a change from baseline of &gt; -0.22 in HAQ-DI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52</measure>
    <time_frame>Baseline, Weeks 24 and 52</time_frame>
    <description>HAQ-DI consisted of 20-question in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. AUC of change from baseline in HAQ-DI score is the AUC of change from baseline in HAQ-DI score versus the time. AUC was calculated based on the measurement (i.e., observed HAQ-DI score change from baseline) at scheduled visits using the trapezoidal rule. Functional status was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24</measure>
    <time_frame>Baseline, Weeks 16 and 24</time_frame>
    <description>Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). Negative values for this outcome measure represent improvement, i.e. shortening of duration of morning stiffness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52</measure>
    <time_frame>Baseline, Weeks 16, 24 and 52</time_frame>
    <description>The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52</measure>
    <time_frame>Baseline, Weeks 16, 24 and 52</time_frame>
    <description>The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52</measure>
    <time_frame>Baseline, Weeks 16, 24 and 52</time_frame>
    <description>The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52</measure>
    <time_frame>Baseline, Weeks 16, 24 and 52</time_frame>
    <description>Change from Baseline to end point in Euro Quality of life (Qol)-5 Dimension Questionnaire (EQ-5D). A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating &quot;full health&quot; and 0 representing dead.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <arm_group>
    <arm_group_label>Sirukumab 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sirukumab 50 mg and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sirukumab 100 mg</intervention_name>
    <description>Sirukumab 100 mg subcutaneous (SC) injection, at Weeks 0, 2, and every 2 weeks through Week 52.</description>
    <arm_group_label>Sirukumab 100 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sirukumab 50 mg</intervention_name>
    <description>Sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52.</description>
    <arm_group_label>Sirukumab 50 mg and Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Between sirukumab injections, placebo SC at Weeks 2, 6, and every 4 weeks through Week 52.</description>
    <arm_group_label>Sirukumab 50 mg and Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be a Japanese man or woman with a diagnosis of rheumatoid arthritis (RA), according to&#xD;
             the revised 1987 criteria of the American Rheumatism Association, for at least 3&#xD;
             months before screening&#xD;
&#xD;
          -  Has moderately to severely active RA with at least 6 of 68 tender joints and 6 of 66&#xD;
             swollen joints, at screening and at baseline&#xD;
&#xD;
          -  Has been unresponsive to adequate treatment with methotrexate (MTX), sulfasalazine&#xD;
             (SSZ), or combination of MTX or SSZ with other disease-modifying antirheumatic drugs&#xD;
             (DMARDs) at screening due to lack of benefit after at least 12 weeks of marketed dose&#xD;
             of MTX or SSZ, as assessed by the treating physician. Documented lack of benefit may&#xD;
             include inadequate improvement in joint counts, physical function, or overall disease&#xD;
             activity&#xD;
&#xD;
          -  If using oral corticosteroids, must be on a stable dose equivalent to &lt;=10 mg/day of&#xD;
             prednisolone for at least 2 weeks prior to first dosing with study agent. If currently&#xD;
             not using corticosteroids, the patient must not have received oral corticosteroids (by&#xD;
             mouth) for at least 2 weeks prior to first dosing with study agent&#xD;
&#xD;
          -  If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics (pain&#xD;
             relievers) for RA, must be on a stable dose for at least 2 weeks prior to first dosing&#xD;
             with study agent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a history of intolerance to at least 2 or inadequate response to at least one&#xD;
             anti-tumor necrosis factor-alpha (anti-TNF-alpha) agent after 3 months of therapy; has&#xD;
             received anti-TNF-alpha (eg, infliximab, golimumab, adalimumab, or etanercept) within&#xD;
             3 months of first study agent dosing&#xD;
&#xD;
          -  Has a history of intolerance to tocilizumab that precluded further treatment with it,&#xD;
             or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy; has&#xD;
             used B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent&#xD;
             dosing or has evidence during screening of abnormally low B-cell level caused by&#xD;
             previous B-cell depletion therapy; has used any other biologic therapy for the&#xD;
             treatment of RA within 3 months of first study agent dosing; has a history of&#xD;
             sirukumab use&#xD;
&#xD;
          -  Has received intra-articular (IA), intramuscular (IM), or intravenous (IV)&#xD;
             corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks&#xD;
             prior to first study agent dosing&#xD;
&#xD;
          -  Has received leflunomide within 24 months before first study agent dosing and has not&#xD;
             undergone a drug elimination procedure, unless the M1 metabolite is measured and is&#xD;
             undetectable. Drug elimination procedure must be completed prior to obtaining informed&#xD;
             consent&#xD;
&#xD;
          -  Has a history of cyclophosphamide or cytotoxic agent use; has received cyclosporine A,&#xD;
             azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or&#xD;
             D-penicillamine within 4 weeks of first study agent dosing; has received an&#xD;
             investigational drug (including investigational vaccines) or used an investigational&#xD;
             medical device within 3 months or 5 half-lives, whichever is longer, before first&#xD;
             study agent dosing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Pharmaceutical K.K., Japan Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutical K.K.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Asahikawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hitachinaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kirishima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kitakyushu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kobe</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Matsumoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miyagi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sendai</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yokohama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <results_first_submitted>July 8, 2016</results_first_submitted>
  <results_first_submitted_qc>September 6, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 27, 2016</results_first_posted>
  <disposition_first_submitted>February 16, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>February 16, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 15, 2016</disposition_first_posted>
  <last_update_submitted>September 6, 2016</last_update_submitted>
  <last_update_submitted_qc>September 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine</keyword>
  <keyword>Sirukumab</keyword>
  <keyword>Human Anti-IL-6 Monoclonal Antibody</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>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of the 180 participants who signed informed consent of this study, 122 participants (61 participants in each treatment group) were randomized and treated during the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sirukumab 50 Milligram (mg)</title>
          <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
        </group>
        <group group_id="P2">
          <title>Sirukumab 100 mg</title>
          <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </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="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline population included all randomized participants who received study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Sirukumab 50 Milligram (mg)</title>
          <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
        </group>
        <group group_id="B2">
          <title>Sirukumab 100 mg</title>
          <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</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="61"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="122"/>
          </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="55.4" spread="10.7"/>
                    <measurement group_id="B2" value="54.7" spread="12.16"/>
                    <measurement group_id="B3" value="55.1" spread="11.41"/>
                  </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="47"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>JAPAN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAE)</title>
        <description>A TEAE was defined as an event that occurred in the treatment period during which it emerged (that is [i.e.] started or worsened in severity, relation, or other attribute), and even if the event continued to be present.</description>
        <time_frame>Baseline upto Week 68</time_frame>
        <population>Safety analyses set included all participants who received at least 1 (partial or complete) dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAE)</title>
          <description>A TEAE was defined as an event that occurred in the treatment period during which it emerged (that is [i.e.] started or worsened in severity, relation, or other attribute), and even if the event continued to be present.</description>
          <population>Safety analyses set included all participants who received at least 1 (partial or complete) dose of the study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response</title>
        <description>The ACR 20 Response is defined as greater than or equal to (&gt;=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).</description>
        <time_frame>At Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response</title>
          <description>The ACR 20 Response is defined as greater than or equal to (&gt;=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.0"/>
                    <measurement group_id="O2" value="72.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.8"/>
                    <measurement group_id="O2" value="82.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response</title>
        <description>The ACR 50 Response is defined as &gt;=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.</description>
        <time_frame>At Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response</title>
          <description>The ACR 50 Response is defined as &gt;=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.5"/>
                    <measurement group_id="O2" value="57.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.2"/>
                    <measurement group_id="O2" value="63.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response</title>
        <description>The ACR 70 Response is defined as &gt;=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.</description>
        <time_frame>At Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response</title>
          <description>The ACR 70 Response is defined as &gt;=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2"/>
                    <measurement group_id="O2" value="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6"/>
                    <measurement group_id="O2" value="36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response</title>
        <description>The ACR 90 Response is defined as &gt;=90 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=90 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.</description>
        <time_frame>At Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response</title>
          <description>The ACR 90 Response is defined as &gt;=90 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=90 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2"/>
                    <measurement group_id="O2" value="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6"/>
                    <measurement group_id="O2" value="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24</title>
        <description>Sixty six (66) joints were assessed for swelling by investigator to determine the number of joints that were considered swollen. A negative change from baseline in swollen joint count indicates improvement.</description>
        <time_frame>Baseline, Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24</title>
          <description>Sixty six (66) joints were assessed for swelling by investigator to determine the number of joints that were considered swollen. A negative change from baseline in swollen joint count indicates improvement.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-65.66" spread="40.201"/>
                    <measurement group_id="O2" value="-73.84" spread="31.162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-71.16" spread="38.343"/>
                    <measurement group_id="O2" value="-75.82" spread="30.860"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24</title>
        <description>Sixty eight (68) joints were assessed for tenderness to determine the number of joints that were considered tender. A negative change from baseline in the tender joint count indicates improvement.</description>
        <time_frame>Baseline, Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24</title>
          <description>Sixty eight (68) joints were assessed for tenderness to determine the number of joints that were considered tender. A negative change from baseline in the tender joint count indicates improvement.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-63.95" spread="41.738"/>
                    <measurement group_id="O2" value="-65.58" spread="41.898"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-65.58" spread="41.933"/>
                    <measurement group_id="O2" value="-67.34" spread="42.145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24</title>
        <description>Participants assessed their average pain during the past week on a visual analogue scale (VAS). The scale ranged from 0 (no pain) to 10 (the worst possible pain).</description>
        <time_frame>Baseline, Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24</title>
          <description>Participants assessed their average pain during the past week on a visual analogue scale (VAS). The scale ranged from 0 (no pain) to 10 (the worst possible pain).</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.44" spread="39.043"/>
                    <measurement group_id="O2" value="-52.94" spread="44.384"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-52.45" spread="38.266"/>
                    <measurement group_id="O2" value="-57.56" spread="49.725"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24</title>
        <description>Participants rated their disease activity using the Visual Analog Scale (VAS) on a scale of 0 (very well) to 10 (very poor).</description>
        <time_frame>Baseline, Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24</title>
          <description>Participants rated their disease activity using the Visual Analog Scale (VAS) on a scale of 0 (very well) to 10 (very poor).</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-50.64" spread="48.679"/>
                    <measurement group_id="O2" value="-53.15" spread="38.925"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-51.55" spread="50.569"/>
                    <measurement group_id="O2" value="-56.94" spread="42.208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24</title>
        <description>Physician's Global Assessment of Disease Activity was assessed using the VAS on a scale of 0 (no arthritis activity) to 10 (extremely active arthritis).</description>
        <time_frame>Baseline, Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24</title>
          <description>Physician's Global Assessment of Disease Activity was assessed using the VAS on a scale of 0 (no arthritis activity) to 10 (extremely active arthritis).</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-65.28" spread="27.268"/>
                    <measurement group_id="O2" value="-66.17" spread="28.774"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-67.54" spread="25.521"/>
                    <measurement group_id="O2" value="-68.44" spread="27.161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24</title>
        <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Here, 'n' signifies those participants who were evaluable for the specific timepoint.</description>
        <time_frame>Baseline, Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24</title>
          <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Here, 'n' signifies those participants who were evaluable for the specific timepoint.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 16 (n= 59, 58)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-38.90" spread="53.204"/>
                    <measurement group_id="O2" value="-46.18" spread="48.572"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (n= 59, 58)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.25" spread="52.741"/>
                    <measurement group_id="O2" value="-48.98" spread="44.917"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24</title>
        <description>Serum CRP is a marker of systemic inflammation. A negative percent change from baseline in CRP represents improvement.</description>
        <time_frame>Baseline, Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24</title>
          <description>Serum CRP is a marker of systemic inflammation. A negative percent change from baseline in CRP represents improvement.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-98.60" spread="2.026"/>
                    <measurement group_id="O2" value="-98.97" spread="1.637"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-98.64" spread="2.148"/>
                    <measurement group_id="O2" value="-98.99" spread="1.251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Major Clinical Response at Week 52</title>
        <description>Major clinical response is achieving ACR 70 for 6 continuous months. The ACR 70 Response is defined as &gt;=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS, (The scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP. Achievement of major clinical response reflects an enhanced level of therapeutic efficacy and sustained reduction of signs and symptoms of rheumatoid arthritis (RA).</description>
        <time_frame>Week 52</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Major Clinical Response at Week 52</title>
          <description>Major clinical response is achieving ACR 70 for 6 continuous months. The ACR 70 Response is defined as &gt;=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and &gt;=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS, (The scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP. Achievement of major clinical response reflects an enhanced level of therapeutic efficacy and sustained reduction of signs and symptoms of rheumatoid arthritis (RA).</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1"/>
                    <measurement group_id="O2" value="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24</title>
        <description>The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Good responders: improvement from baseline greater than (&gt;) 1.2 with DAS28 less than or equal to (&lt;=) 3.2; moderate responders: improvement from baseline &gt;1.2 with DAS28 &gt;3.2 to &lt;=5.1 or improvement from baseline &gt;0.6 to &lt;=1.2 with DAS28 &lt;=5.1; non-responders: improvement from baseline &lt;=0.6 or improvement from baseline &gt;0.6 and &lt;=1.2 with DAS28 &gt;5.1.</description>
        <time_frame>At Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24</title>
          <description>The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Good responders: improvement from baseline greater than (&gt;) 1.2 with DAS28 less than or equal to (&lt;=) 3.2; moderate responders: improvement from baseline &gt;1.2 with DAS28 &gt;3.2 to &lt;=5.1 or improvement from baseline &gt;0.6 to &lt;=1.2 with DAS28 &lt;=5.1; non-responders: improvement from baseline &lt;=0.6 or improvement from baseline &gt;0.6 and &lt;=1.2 with DAS28 &gt;5.1.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.2"/>
                    <measurement group_id="O2" value="96.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.5"/>
                    <measurement group_id="O2" value="96.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving DAS28 (CRP) Remission at Week 24</title>
        <description>The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (&lt;) 2.6 at any study visit.</description>
        <time_frame>At Week 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving DAS28 (CRP) Remission at Week 24</title>
          <description>The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (&lt;) 2.6 at any study visit.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.2"/>
                    <measurement group_id="O2" value="59.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24</title>
        <description>The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.</description>
        <time_frame>Baseline, Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24</title>
          <description>The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.566" spread="0.8088"/>
                    <measurement group_id="O2" value="5.805" spread="1.0553"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.858" spread="1.1867"/>
                    <measurement group_id="O2" value="-3.069" spread="1.1483"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.949" spread="1.2445"/>
                    <measurement group_id="O2" value="-3.185" spread="1.1552"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52</title>
        <description>The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity on VAS, physician's global assessments of disease activity on VAS, and CRP. SDAI-based ACR/EULAR remission is defined as a SDAI value of &lt;=3.3 at the visit.</description>
        <time_frame>At Weeks 16, 24 and 52</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52</title>
          <description>The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity on VAS, physician's global assessments of disease activity on VAS, and CRP. SDAI-based ACR/EULAR remission is defined as a SDAI value of &lt;=3.3 at the visit.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.8"/>
                    <measurement group_id="O2" value="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.4"/>
                    <measurement group_id="O2" value="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.0"/>
                    <measurement group_id="O2" value="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52</title>
        <description>The Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) &lt;=1; swollen joint count (66 joints) &lt;=1; CRP &lt;=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) &lt;=1 on a 0 to 10 scale.</description>
        <time_frame>At Weeks 16, 24 and 52</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52</title>
          <description>The Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) &lt;=1; swollen joint count (66 joints) &lt;=1; CRP &lt;=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) &lt;=1 on a 0 to 10 scale.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9"/>
                    <measurement group_id="O2" value="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8"/>
                    <measurement group_id="O2" value="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2"/>
                    <measurement group_id="O2" value="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24</title>
        <description>The CDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score range is 0-76. Score interpretation: Remission &lt;=2.8; Low Disease Activity CDAI &gt; 2.8 and &lt;=10; Moderate Disease Activity CDAI &gt;10 and &lt;=22; High Disease Activity CDAI &gt; 22.</description>
        <time_frame>Baseline, Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24</title>
          <description>The CDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score range is 0-76. Score interpretation: Remission &lt;=2.8; Low Disease Activity CDAI &gt; 2.8 and &lt;=10; Moderate Disease Activity CDAI &gt;10 and &lt;=22; High Disease Activity CDAI &gt; 22.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.36" spread="9.454"/>
                    <measurement group_id="O2" value="35.69" spread="13.923"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.43" spread="12.138"/>
                    <measurement group_id="O2" value="-22.69" spread="13.231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.27" spread="12.207"/>
                    <measurement group_id="O2" value="-23.86" spread="13.487"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24</title>
        <description>The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. The total score range is 0-86. Score interpretation: Remission SDAI &lt;=3.3; Low Disease Activity SDAI &gt;3.3 and &lt;=11; Moderate Disease Activity SDAI &gt;11 and &lt;=26; High Disease Activity SDAI &gt;26.</description>
        <time_frame>Baseline, Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24</title>
          <description>The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. The total score range is 0-86. Score interpretation: Remission SDAI &lt;=3.3; Low Disease Activity SDAI &gt;3.3 and &lt;=11; Moderate Disease Activity SDAI &gt;11 and &lt;=26; High Disease Activity SDAI &gt;26.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.318" spread="9.6078"/>
                    <measurement group_id="O2" value="38.911" spread="14.7996"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.365" spread="12.4411"/>
                    <measurement group_id="O2" value="-25.896" spread="13.9910"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.206" spread="12.6842"/>
                    <measurement group_id="O2" value="-27.064" spread="14.2368"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24</title>
        <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.</description>
        <time_frame>Baseline, at Week 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24</title>
          <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3484" spread="0.65396"/>
                    <measurement group_id="O2" value="1.1721" spread="0.64111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5676" spread="0.53695"/>
                    <measurement group_id="O2" value="-0.4980" spread="0.61343"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5738" spread="0.54600"/>
                    <measurement group_id="O2" value="-0.5697" spread="0.56758"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24</title>
        <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI response was defined as change of &gt; -0.22 from baseline in HAQ-DI score.</description>
        <time_frame>At Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24</title>
          <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI response was defined as change of &gt; -0.22 from baseline in HAQ-DI score.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.4"/>
                    <measurement group_id="O2" value="67.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.8"/>
                    <measurement group_id="O2" value="70.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Maintaining HAQ-DI Response</title>
        <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI responders who maintain a change from baseline of &gt; -0.22 in HAQ-DI score.</description>
        <time_frame>Baseline upto Week 52</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Maintaining HAQ-DI Response</title>
          <description>The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI responders who maintain a change from baseline of &gt; -0.22 in HAQ-DI score.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.5"/>
                    <measurement group_id="O2" value="65.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52</title>
        <description>HAQ-DI consisted of 20-question in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. AUC of change from baseline in HAQ-DI score is the AUC of change from baseline in HAQ-DI score versus the time. AUC was calculated based on the measurement (i.e., observed HAQ-DI score change from baseline) at scheduled visits using the trapezoidal rule. Functional status was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time.</description>
        <time_frame>Baseline, Weeks 24 and 52</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52</title>
          <description>HAQ-DI consisted of 20-question in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. AUC of change from baseline in HAQ-DI score is the AUC of change from baseline in HAQ-DI score versus the time. AUC was calculated based on the measurement (i.e., observed HAQ-DI score change from baseline) at scheduled visits using the trapezoidal rule. Functional status was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>units on a scale*week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 Through Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-74.0645" spread="78.34712"/>
                    <measurement group_id="O2" value="-69.2439" spread="75.85153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0 Through Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-189.2531" spread="178.07291"/>
                    <measurement group_id="O2" value="-187.4068" spread="191.77329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24</title>
        <description>Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). Negative values for this outcome measure represent improvement, i.e. shortening of duration of morning stiffness.</description>
        <time_frame>Baseline, Weeks 16 and 24</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24</title>
          <description>Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). Negative values for this outcome measure represent improvement, i.e. shortening of duration of morning stiffness.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-103.8" spread="268.32"/>
                    <measurement group_id="O2" value="-160.4" spread="374.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-77.6" spread="334.00"/>
                    <measurement group_id="O2" value="-169.4" spread="374.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52</title>
        <description>The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.</description>
        <time_frame>Baseline, Weeks 16, 24 and 52</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52</title>
          <description>The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Mental Component Score [MCS])</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.49" spread="9.577"/>
                    <measurement group_id="O2" value="46.55" spread="11.332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16 (MCS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.38" spread="9.655"/>
                    <measurement group_id="O2" value="6.46" spread="9.183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (MCS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.82" spread="10.376"/>
                    <measurement group_id="O2" value="6.81" spread="9.273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 52 (MCS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.74" spread="9.681"/>
                    <measurement group_id="O2" value="6.27" spread="9.915"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52</title>
        <description>The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.</description>
        <time_frame>Baseline, Weeks 16, 24 and 52</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52</title>
          <description>The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Physical Component Score [PCS])</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.12" spread="15.315"/>
                    <measurement group_id="O2" value="24.10" spread="15.642"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16 (PCS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.12" spread="14.349"/>
                    <measurement group_id="O2" value="12.48" spread="15.886"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (PCS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.45" spread="15.979"/>
                    <measurement group_id="O2" value="14.72" spread="15.290"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 52 (PCS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.67" spread="15.754"/>
                    <measurement group_id="O2" value="14.30" spread="15.395"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52</title>
        <description>The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant.</description>
        <time_frame>Baseline, Weeks 16, 24 and 52</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52</title>
          <description>The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.20" spread="26.145"/>
                    <measurement group_id="O2" value="25.93" spread="27.371"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.46" spread="26.562"/>
                    <measurement group_id="O2" value="28.85" spread="28.397"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.54" spread="26.972"/>
                    <measurement group_id="O2" value="31.50" spread="29.666"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52</title>
        <description>Change from Baseline to end point in Euro Quality of life (Qol)-5 Dimension Questionnaire (EQ-5D). A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating &quot;full health&quot; and 0 representing dead.</description>
        <time_frame>Baseline, Weeks 16, 24 and 52</time_frame>
        <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sirukumab 50 Milligram (mg)</title>
            <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Sirukumab 100 mg</title>
            <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52</title>
          <description>Change from Baseline to end point in Euro Quality of life (Qol)-5 Dimension Questionnaire (EQ-5D). A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating &quot;full health&quot; and 0 representing dead.</description>
          <population>All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.173"/>
                    <measurement group_id="O2" value="0.18" spread="0.177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.169"/>
                    <measurement group_id="O2" value="0.19" spread="0.172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.164"/>
                    <measurement group_id="O2" value="0.19" spread="0.166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Week 68</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sirukumab 50 Milligram (mg)</title>
          <description>Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.</description>
        </group>
        <group group_id="E2">
          <title>Sirukumab 100 mg</title>
          <description>Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 17.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Large Intestine Polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Hepatitis E</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Comminuted Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral Disc Protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Borderline Serous Tumour of Ovary</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 17.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Injection Site Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Injection Site Swelling</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Tinea Pedis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin Abrasion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Neutrophil Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Platelet Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>White Blood Cell Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="61"/>
              </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>A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Manager</name_or_title>
      <organization>Janssen Pharmaceutical K.K.</organization>
      <email>ClinicalTrialDisclosure@its.jnj.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/NCT01689532
org study id: CR100876
secondary id: CNTO136ARA3001
nct id: NCT01689532
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single
      therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA) who
      have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ).
This is a randomized (patients will be assigned to treatment by chance), double-blind (study
      personnel and patients will not know what treatments are being given), multicenter study. The
      expected duration of the study is 68 weeks. This will include 52 weeks of treatment with
      study agent with dosing every 2 weeks and 16 weeks of safety follow-up after the last dose.
      Disease-modifying antirheumatic drugs (DMARDs), including MTX and SSZ, are not permitted from
      4 weeks before the first dosing with study agent until Week 24. The use of DMARDs is
      discouraged at or any time after Week 24; however, patients who have less than 20%
      improvement from baseline in both swollen and tender joint counts at Week 24 will be allowed
      to take DMARDs. At or any time after Week 16, the initiation and/or adjustment of oral
      corticosteroids will be allowed for patients who have less than 20% improvement from baseline
      in both swollen and tender joint counts at Week 16.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE)
time frame: Baseline upto Week 68
description: A TEAE was defined as an event that occurred in the treatment period during which it emerged (that is [i.e.] started or worsened in severity, relation, or other attribute), and even if the event continued to be present.
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response
time frame: At Weeks 16 and 24
description: The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response
time frame: At Weeks 16 and 24
description: The ACR 50 Response is defined as >=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response
time frame: At Weeks 16 and 24
description: The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response
time frame: At Weeks 16 and 24
description: The ACR 90 Response is defined as >=90 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=90 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.
measure: Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24
time frame: Baseline, Weeks 16 and 24
description: Sixty six (66) joints were assessed for swelling by investigator to determine the number of joints that were considered swollen. A negative change from baseline in swollen joint count indicates improvement.
measure: Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24
time frame: Baseline, Weeks 16 and 24
description: Sixty eight (68) joints were assessed for tenderness to determine the number of joints that were considered tender. A negative change from baseline in the tender joint count indicates improvement.
measure: Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24
time frame: Baseline, Weeks 16 and 24
description: Participants assessed their average pain during the past week on a visual analogue scale (VAS). The scale ranged from 0 (no pain) to 10 (the worst possible pain).
measure: Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24
time frame: Baseline, Weeks 16 and 24
description: Participants rated their disease activity using the Visual Analog Scale (VAS) on a scale of 0 (very well) to 10 (very poor).
measure: Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24
time frame: Baseline, Weeks 16 and 24
description: Physician's Global Assessment of Disease Activity was assessed using the VAS on a scale of 0 (no arthritis activity) to 10 (extremely active arthritis).
measure: Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24
time frame: Baseline, Weeks 16 and 24
description: The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Here, 'n' signifies those participants who were evaluable for the specific timepoint.
measure: Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24
time frame: Baseline, Weeks 16 and 24
description: Serum CRP is a marker of systemic inflammation. A negative percent change from baseline in CRP represents improvement.
measure: Percentage of Participants Who Achieved Major Clinical Response at Week 52
time frame: Week 52
description: Major clinical response is achieving ACR 70 for 6 continuous months. The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS, (The scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP. Achievement of major clinical response reflects an enhanced level of therapeutic efficacy and sustained reduction of signs and symptoms of rheumatoid arthritis (RA).
measure: Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24
time frame: At Weeks 16 and 24
description: The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Good responders: improvement from baseline greater than (>) 1.2 with DAS28 less than or equal to (<=) 3.2; moderate responders: improvement from baseline >1.2 with DAS28 >3.2 to <=5.1 or improvement from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: improvement from baseline <=0.6 or improvement from baseline >0.6 and <=1.2 with DAS28 >5.1.
measure: Percentage of Participants Achieving DAS28 (CRP) Remission at Week 24
time frame: At Week 24
description: The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit.
measure: Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24
time frame: Baseline, Weeks 16 and 24
description: The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.
measure: Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52
time frame: At Weeks 16, 24 and 52
description: The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity on VAS, physician's global assessments of disease activity on VAS, and CRP. SDAI-based ACR/EULAR remission is defined as a SDAI value of <=3.3 at the visit.
measure: Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52
time frame: At Weeks 16, 24 and 52
description: The Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) <=1 on a 0 to 10 scale.
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24
time frame: Baseline, Weeks 16 and 24
description: The CDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score range is 0-76. Score interpretation: Remission <=2.8; Low Disease Activity CDAI > 2.8 and <=10; Moderate Disease Activity CDAI >10 and <=22; High Disease Activity CDAI > 22.
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24
time frame: Baseline, Weeks 16 and 24
description: The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. The total score range is 0-86. Score interpretation: Remission SDAI <=3.3; Low Disease Activity SDAI >3.3 and <=11; Moderate Disease Activity SDAI >11 and <=26; High Disease Activity SDAI >26.
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24
time frame: Baseline, at Week 16 and 24
description: The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
measure: Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24
time frame: At Weeks 16 and 24
description: The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI response was defined as change of > -0.22 from baseline in HAQ-DI score.
measure: Percentage of Participants Maintaining HAQ-DI Response
time frame: Baseline upto Week 52
description: The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI responders who maintain a change from baseline of > -0.22 in HAQ-DI score.
measure: Area Under Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52
time frame: Baseline, Weeks 24 and 52
description: HAQ-DI consisted of 20-question in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. AUC of change from baseline in HAQ-DI score is the AUC of change from baseline in HAQ-DI score versus the time. AUC was calculated based on the measurement (i.e., observed HAQ-DI score change from baseline) at scheduled visits using the trapezoidal rule. Functional status was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time.
measure: Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24
time frame: Baseline, Weeks 16 and 24
description: Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). Negative values for this outcome measure represent improvement, i.e. shortening of duration of morning stiffness.
measure: Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52
time frame: Baseline, Weeks 16, 24 and 52
description: The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.
measure: Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52
time frame: Baseline, Weeks 16, 24 and 52
description: The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.
measure: Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52
time frame: Baseline, Weeks 16, 24 and 52
description: The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant.
measure: Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52
time frame: Baseline, Weeks 16, 24 and 52
description: Change from Baseline to end point in Euro Quality of life (Qol)-5 Dimension Questionnaire (EQ-5D). A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.
arm group label: Sirukumab 100 mg
arm group type: Experimental
arm group label: Sirukumab 50 mg and Placebo
arm group type: Experimental
intervention type: Drug
intervention name: Sirukumab 100 mg
description: Sirukumab 100 mg subcutaneous (SC) injection, at Weeks 0, 2, and every 2 weeks through Week 52.
arm group label: Sirukumab 100 mg
intervention type: Drug
intervention name: Sirukumab 50 mg
description: Sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52.
arm group label: Sirukumab 50 mg and Placebo
intervention type: Drug
intervention name: Placebo
description: Between sirukumab injections, placebo SC at Weeks 2, 6, and every 4 weeks through Week 52.
arm group label: Sirukumab 50 mg and Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutical K.K.
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country: Japan
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Antibodies, Monoclonal
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