<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/NCT01715896</url>
  </required_header>
  <id_info>
    <org_study_id>CD-IA-CAM-3001-1107</org_study_id>
    <nct_id>NCT01715896</nct_id>
  </id_info>
  <brief_title>A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis</brief_title>
  <official_title>A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedImmune LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedImmune LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this study is to explore the efficacy of mavrilimumab compared with&#xD;
      golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe&#xD;
      active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional&#xD;
      disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor&#xD;
      (TNF) agents (excluding golimumab) for efficacy or safety reasons.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the therapeutic improvements with recent biologic agents approved for rheumatoid&#xD;
      arthritis (RA), there is still a significant unmet medical need for the treatment of subjects&#xD;
      with this chronic disease to achieve a faster, more complete response, and higher rates of&#xD;
      remission. The aim of the current study is to compare the efficacy and safety of a&#xD;
      subcutaneous dose of mavrilimumab with a marketed treatment for RA (golimumab) in 120 adult&#xD;
      subjects with moderate-to-severe active RA who have had an inadequate response to one or two&#xD;
      anti-TNF agents with mavrilimumab. The design of the study was exploratory and not formerly&#xD;
      statistically powered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>The ACR20 was defined as greater than or equal to (&gt;=) 20 percent (%) improvement, in: swollen joint count (SJC) and tender joint count (TJC) and &gt;=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity (MDGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (CRP). If CRP was missing and Erythrocyte sedimentation rate (ESR) was present then ESR was to be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>The ACR50 was defined as &gt;=50% improvement, in: SJC and TJC and &gt;=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>The ACR70 was defined as &gt;=70% improvement, in: SJC and TJC and &gt;=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the visual analogue scale (VAS) of 0 (= best), 100 (= worst) plus levels of CRP (milligram/Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (&lt;) 3.2 = low disease activity, &gt;=3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission. Participants with score less than 2.6 were analysed. The percentage of participants were calculated by logistic regression model method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and &gt;= 0.25 at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>The HAQ-DI: 20-item scale assessing participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arising, eating, hygiene, walking, reaching, grip, and errands/chores over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. Participants with change from baseline more than or equal to (&gt;=) 0.25 were reported. The percentage of participants were calculated by logistic regression model method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)</measure>
    <time_frame>Baseline up to Day 169</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. TEAE and TESAE were reported as per relatedness and severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Baseline up to Day 169</time_frame>
    <description>Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (leukocytosis, neutropenia, anaemia of chronic disease); serum chemistry (alanine aminotransferase, blood parathyroid hormone, gamma glutamyl transferase, hepatic enzyme, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hypertriglyceridaemia); urinalysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Baseline up to Day 169</time_frame>
    <description>Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169</measure>
    <time_frame>Day 85 and 169</time_frame>
    <description>Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), forced vital capacity (FVC), and diffusing capacity for carbon monoxide (DLCO). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as more than (&gt;) 20% reduction (RD) and absolute value (AV) less than (&lt;) 80% predicted (PR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea Score at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>Borg dyspnea scale was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169</measure>
    <time_frame>Baseline and Day 169</time_frame>
    <description>DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (&lt;) 3.2 = low disease activity, greater than or equal to (&gt;=) 3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169</measure>
    <time_frame>Baseline up to Day 169</time_frame>
    <description>ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Mean indicates adjusted mean (Adj mean).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American College of Rheumatology (ACR) Hybrid Score at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>ACR Hybrid score was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline &gt;1.2 with baseline DAS28 (CRP) &lt;3.2; moderate response: change from baseline &gt;1.2 with baseline DAS28 (CRP) &gt;=3.2 to less than or equal to (=&lt;) 5.1 or change from baseline &gt;=0.6 to =&lt; 1.2 with baseline DAS28 (CRP) &gt;=3.2 to =&lt;5.1; no response: change from baseline &lt;0.6 or change from baseline &gt;=0.6 and =&lt;1.2 with baseline DAS28 (CRP) &gt;5.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Onset DAS28 (CRP) Remission at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) &lt;3.2 = low disease activity, &gt;=3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission. Participants with score less than 2.6 were analysed. Onset of DAS28(CRP) remission ≤ 2.6 defined as the first study day in which the DAS28 score met the criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of DAS28 (CRP) Remission at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) &lt;3.2 = low disease activity, &gt;=3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission. Participants with score less than 2.6 were analysed. Duration of DAS28(CRP) remission for each subject was defined as number of days from onset of remission to when the subject was no longer in remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) &lt; 2.6 at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>The DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) &lt;3.2 = low disease activity, &gt;=3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission. The percentage of participants were calculated by logistic regression model method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Simplified Disease Activity Index (SDAI) Remission at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 centimetre (cm) VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3. The percentage of participants were calculated by logistic regression model method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>The ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Swollen and Tender Joint Count at Day 169</measure>
    <time_frame>Baseline and Day 169</time_frame>
    <description>Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Mean here indicates adjusted mean.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Patient Assessment of Pain at Day 169</measure>
    <time_frame>Baseline and Day 169</time_frame>
    <description>Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169</measure>
    <time_frame>Baseline and Day 169</time_frame>
    <description>Participants responded to a question, &quot;Considering all the ways your arthritis affects you, how are you feeling today?&quot; by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169</measure>
    <time_frame>Baseline and Day 169</time_frame>
    <description>Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169</measure>
    <time_frame>Baseline and Day 169</time_frame>
    <description>HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline</measure>
    <time_frame>Baseline and Day 169</time_frame>
    <description>The ratio of change from baseline for CRP was analyzed and reported. The CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erythrocyte Sedimentation Rate (ESR) at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Concentrations of Mavrilimumab</measure>
    <time_frame>Baseline, Day 8, 15, 29, 85, 141, and 169</time_frame>
    <description>Serum concentrations after subcutaneous dose of mavrilimumab were calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab</measure>
    <time_frame>Day 1 to Day 169</time_frame>
    <description>Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">215</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Golimumab 50 mg alternating with Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received alternating doses of golimumab 50 milligram (mg) (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mavrilimumab 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received Mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Golimumab 50 mg</intervention_name>
    <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
    <arm_group_label>Golimumab 50 mg alternating with Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Mavrilimumab 100 mg</intervention_name>
    <description>Participants received Mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
    <arm_group_label>Mavrilimumab 100 mg</arm_group_label>
    <other_name>CAM-3001</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 through 80 years&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
          -  Diagnosis of adult onset Rheumatoid Arthritis (RA) as defined by the 2010 American&#xD;
             College of Rheumatology European League Against Rheumatism (ACR/EULAR) classification&#xD;
             criteria&#xD;
&#xD;
          -  Moderately active disease as defined by disease activity score in 28 joints C-reactive&#xD;
             protein (DAS28[CRP]) greater than or equal to (&gt;=) 3.2 at screening and DAS28&#xD;
             erythrocyte sedimentation rate(ESR) ≥ 3.2 at Day 1&#xD;
&#xD;
          -  Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs&#xD;
             (DMARDs)&#xD;
&#xD;
          -  At least 4 swollen joints&#xD;
&#xD;
          -  Inadequate response to one or two anti-TNF agents other than the study comparator, as&#xD;
             defined by the protocol&#xD;
&#xD;
          -  Receiving oral or injectable methotrexate, as defined by the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A rheumatic autoimmune disease or other inflammatory joint disease other than RA&#xD;
&#xD;
          -  Previous treatment with biologic therapies other than anti-TNF for RA&#xD;
&#xD;
          -  Treatment with other DMARDs or non-steroidal anti-inflammatory drugs (NSAIDs), as&#xD;
             defined by the protocol.&#xD;
&#xD;
          -  Medical history as defined by the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marius Albulescu</last_name>
    <role>Study Director</role>
    <affiliation>MedImmune Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cordoba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barranquilla</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 2</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Uherske Hradiste</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zlin</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montpellier cedex 5</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Heraklion</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Larissa</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baja</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Balatonfured</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ashkelon</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kfar-Saba</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Petach-Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rehovot</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Merida</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Coimbra</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lisboa</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Viseu</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kazan</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Niska Banja</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bardejov</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bratislava</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kosice - Saca</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Malaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birkenhead</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Colombia</country>
    <country>Czech Republic</country>
    <country>France</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Mexico</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Turkey</country>
  </removed_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <results_first_submitted>March 8, 2016</results_first_submitted>
  <results_first_submitted_qc>September 12, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 31, 2016</results_first_posted>
  <last_update_submitted>September 12, 2016</last_update_submitted>
  <last_update_submitted_qc>September 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Golimumab</keyword>
  <keyword>Mavrilimumab</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>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Golimumab</mesh_term>
    <mesh_term>Mavrilimumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Overall, 215 participants were screened, of which 77 participants were considered as screen failures and 138 participants were randomized and completed in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Golimumab 50 Milligram (mg) Alternating With Placebo</title>
          <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
        </group>
        <group group_id="P2">
          <title>Mavrilimumab 100 mg</title>
          <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <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="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The modified intent to treat (mITT) population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
      <group_list>
        <group group_id="B1">
          <title>Golimumab 50 Milligram (mg) Alternating With Placebo</title>
          <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
        </group>
        <group group_id="B2">
          <title>Mavrilimumab 100 mg</title>
          <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</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="68"/>
            <count group_id="B2" value="70"/>
            <count group_id="B3" value="138"/>
          </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="49.9" spread="11.4"/>
                    <measurement group_id="B2" value="50.2" spread="13.3"/>
                    <measurement group_id="B3" value="50.0" spread="12.4"/>
                  </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="57"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169</title>
        <description>The ACR20 was defined as greater than or equal to (&gt;=) 20 percent (%) improvement, in: swollen joint count (SJC) and tender joint count (TJC) and &gt;=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity (MDGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (CRP). If CRP was missing and Erythrocyte sedimentation rate (ESR) was present then ESR was to be used.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169</title>
          <description>The ACR20 was defined as greater than or equal to (&gt;=) 20 percent (%) improvement, in: swollen joint count (SJC) and tender joint count (TJC) and &gt;=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity (MDGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (CRP). If CRP was missing and Erythrocyte sedimentation rate (ESR) was present then ESR was to be used.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</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="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.6"/>
                    <measurement group_id="O2" value="62.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.666</p_value>
            <method>Logit response Model</method>
            <param_type>Percent difference</param_type>
            <param_value>-3.5</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.8</ci_lower_limit>
            <ci_upper_limit>9.8</ci_upper_limit>
            <estimate_desc>P-value and 90% unconditional exact confidence interval (CI) was calculated using the model of logit (response) = strata + treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169</title>
        <description>The ACR50 was defined as &gt;=50% improvement, in: SJC and TJC and &gt;=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169</title>
          <description>The ACR50 was defined as &gt;=50% improvement, in: SJC and TJC and &gt;=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</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="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.4"/>
                    <measurement group_id="O2" value="34.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.293</p_value>
            <method>Logit response Model</method>
            <param_type>Percent difference</param_type>
            <param_value>-8.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.0</ci_lower_limit>
            <ci_upper_limit>4.8</ci_upper_limit>
            <estimate_desc>P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169</title>
        <description>The ACR70 was defined as &gt;=70% improvement, in: SJC and TJC and &gt;=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169</title>
          <description>The ACR70 was defined as &gt;=70% improvement, in: SJC and TJC and &gt;=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</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="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9"/>
                    <measurement group_id="O2" value="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.156</p_value>
            <method>Logit Response Model</method>
            <param_type>Percent difference</param_type>
            <param_value>-9.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.1</ci_lower_limit>
            <ci_upper_limit>1.4</ci_upper_limit>
            <estimate_desc>P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169</title>
        <description>The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the visual analogue scale (VAS) of 0 (= best), 100 (= worst) plus levels of CRP (milligram/Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (&lt;) 3.2 = low disease activity, &gt;=3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission. Participants with score less than 2.6 were analysed. The percentage of participants were calculated by logistic regression model method.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169</title>
          <description>The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the visual analogue scale (VAS) of 0 (= best), 100 (= worst) plus levels of CRP (milligram/Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (&lt;) 3.2 = low disease activity, &gt;=3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission. Participants with score less than 2.6 were analysed. The percentage of participants were calculated by logistic regression model method.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</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="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0"/>
                    <measurement group_id="O2" value="17.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.108</p_value>
            <method>Logit Response Model</method>
            <param_type>Percent difference</param_type>
            <param_value>-11.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.2</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
            <estimate_desc>P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and &gt;= 0.25 at Day 169</title>
        <description>The HAQ-DI: 20-item scale assessing participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arising, eating, hygiene, walking, reaching, grip, and errands/chores over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. Participants with change from baseline more than or equal to (&gt;=) 0.25 were reported. The percentage of participants were calculated by logistic regression model method.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and &gt;= 0.25 at Day 169</title>
          <description>The HAQ-DI: 20-item scale assessing participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arising, eating, hygiene, walking, reaching, grip, and errands/chores over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. Participants with change from baseline more than or equal to (&gt;=) 0.25 were reported. The percentage of participants were calculated by logistic regression model method.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</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="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.0"/>
                    <measurement group_id="O2" value="58.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2080</p_value>
            <method>Logit Response Model</method>
            <param_type>Percent difference</param_type>
            <param_value>-10.3</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.7</ci_lower_limit>
            <ci_upper_limit>3.0</ci_upper_limit>
            <estimate_desc>P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. TEAE and TESAE were reported as per relatedness and severity.</description>
        <time_frame>Baseline up to Day 169</time_frame>
        <population>The safety population included all participants who received any amount of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. TEAE and TESAE were reported as per relatedness and severity.</description>
          <population>The safety population included all participants who received any amount of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TESAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Investigational-product-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute Severe TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Investigational-product-related TESAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (leukocytosis, neutropenia, anaemia of chronic disease); serum chemistry (alanine aminotransferase, blood parathyroid hormone, gamma glutamyl transferase, hepatic enzyme, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hypertriglyceridaemia); urinalysis.</description>
        <time_frame>Baseline up to Day 169</time_frame>
        <population>The safety population included all participants who received any amount of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (leukocytosis, neutropenia, anaemia of chronic disease); serum chemistry (alanine aminotransferase, blood parathyroid hormone, gamma glutamyl transferase, hepatic enzyme, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hypertriglyceridaemia); urinalysis.</description>
          <population>The safety population included all participants who received any amount of investigational product.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Leukocytosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anaemia of chronic disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine aminotransferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood parathyroid hormone increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gamma-glutamyltransferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatic enzyme increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyslipidaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypercholesterolaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperlipidaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertriglyceridaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinalysis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.</description>
        <time_frame>Baseline up to Day 169</time_frame>
        <population>The safety population included all participants who received any amount of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.</description>
          <population>The safety population included all participants who received any amount of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pyrexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169</title>
        <description>Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), forced vital capacity (FVC), and diffusing capacity for carbon monoxide (DLCO). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as more than (&gt;) 20% reduction (RD) and absolute value (AV) less than (&lt;) 80% predicted (PR).</description>
        <time_frame>Day 85 and 169</time_frame>
        <population>The safety population included all participants who received any amount of investigational product. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169</title>
          <description>Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), forced vital capacity (FVC), and diffusing capacity for carbon monoxide (DLCO). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as more than (&gt;) 20% reduction (RD) and absolute value (AV) less than (&lt;) 80% predicted (PR).</description>
          <population>The safety population included all participants who received any amount of investigational product. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 85: FEV1 &gt; 20% RD (n=64, 63)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169: FEV1 &gt; 20% RD (n=64, 64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: FEV1 &gt; 20% RD and AV &lt; 80% PR (n=64, 63)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169: FEV1 &gt; 20% RD and AV &lt; 80% PR (n=64, 64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: FEV6 &gt; 20% RD (n=54, 55)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169: FEV6 &gt; 20% RD (n=54, 56)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: FEV6 &gt; 20% RD and AV &lt; 80% PR (n=54, 55)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169: FEV6 &gt; 20% RD and AV &lt; 80% PR (n=54, 56)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: FVC &gt; 20% RD (n=64, 63)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169: FVC &gt; 20% RD (n=64, 64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: FVC &gt; 20% RD and AV &lt; 80% PR (n=64, 63)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169: FVC &gt; 20% RD and AV &lt; 80% PR (n=64, 64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: DLCO &gt; 15-20% RD (n=18, 21)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169: DLCO &gt; 15-20% RD (n=22, 23)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85: DLCO &gt; 20% RD (n=18, 21)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169: DLCO &gt; 20% RD (n=22, 23)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dyspnea Score at Day 169</title>
        <description>Borg dyspnea scale was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.</description>
        <time_frame>Day 169</time_frame>
        <population>The safety population included all participants who received any amount of investigational product. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Dyspnea Score at Day 169</title>
          <description>Borg dyspnea scale was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.</description>
          <population>The safety population included all participants who received any amount of investigational product. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</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="64"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.81"/>
                    <measurement group_id="O2" value="0.42" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169</title>
        <description>DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (&lt;) 3.2 = low disease activity, greater than or equal to (&gt;=) 3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission.</description>
        <time_frame>Baseline and Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169</title>
          <description>DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (&lt;) 3.2 = low disease activity, greater than or equal to (&gt;=) 3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively</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="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=68, 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.72" spread="0.83"/>
                    <measurement group_id="O2" value="5.82" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169 (n=62, 62)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.40" spread="1.42"/>
                    <measurement group_id="O2" value="-2.11" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169</title>
        <description>ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Mean indicates adjusted mean (Adj mean).</description>
        <time_frame>Baseline up to Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169</title>
          <description>ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Mean indicates adjusted mean (Adj mean).</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.49" spread="5.406"/>
                    <measurement group_id="O2" value="33.06" spread="5.199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.213</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted Mean difference</param_type>
            <param_value>-7.42</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.24</ci_lower_limit>
            <ci_upper_limit>2.40</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>American College of Rheumatology (ACR) Hybrid Score at Day 169</title>
        <description>ACR Hybrid score was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>American College of Rheumatology (ACR) Hybrid Score at Day 169</title>
          <description>ACR Hybrid score was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.99" lower_limit="-9.0" upper_limit="98.2"/>
                    <measurement group_id="O2" value="41.66" lower_limit="-1.0" upper_limit="90.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169</title>
        <description>DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline &gt;1.2 with baseline DAS28 (CRP) &lt;3.2; moderate response: change from baseline &gt;1.2 with baseline DAS28 (CRP) &gt;=3.2 to less than or equal to (=&lt;) 5.1 or change from baseline &gt;=0.6 to =&lt; 1.2 with baseline DAS28 (CRP) &gt;=3.2 to =&lt;5.1; no response: change from baseline &lt;0.6 or change from baseline &gt;=0.6 and =&lt;1.2 with baseline DAS28 (CRP) &gt;5.1.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169</title>
          <description>DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline &gt;1.2 with baseline DAS28 (CRP) &lt;3.2; moderate response: change from baseline &gt;1.2 with baseline DAS28 (CRP) &gt;=3.2 to less than or equal to (=&lt;) 5.1 or change from baseline &gt;=0.6 to =&lt; 1.2 with baseline DAS28 (CRP) &gt;=3.2 to =&lt;5.1; no response: change from baseline &lt;0.6 or change from baseline &gt;=0.6 and =&lt;1.2 with baseline DAS28 (CRP) &gt;5.1.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.129</p_value>
            <method>Proportional odds analysis</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.61</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
            <estimate_desc>Odds ratio, 90% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169</title>
        <description>DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169</title>
          <description>DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DAS28 (CRP) Remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low Disease Activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.108</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>-11.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_lower_limit>-23.2</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
            <estimate_desc>90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The analysis reported DAS28 (CRP) low disease activity response.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.145</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>-11.7</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.8</ci_lower_limit>
            <ci_upper_limit>1.4</ci_upper_limit>
            <estimate_desc>90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Onset DAS28 (CRP) Remission at Day 169</title>
        <description>The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) &lt;3.2 = low disease activity, &gt;=3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission. Participants with score less than 2.6 were analysed. Onset of DAS28(CRP) remission ≤ 2.6 defined as the first study day in which the DAS28 score met the criteria.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, &quot;N&quot; is number of participants analysed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Onset DAS28 (CRP) Remission at Day 169</title>
          <description>The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) &lt;3.2 = low disease activity, &gt;=3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission. Participants with score less than 2.6 were analysed. Onset of DAS28(CRP) remission ≤ 2.6 defined as the first study day in which the DAS28 score met the criteria.</description>
          <population>The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, &quot;N&quot; is number of participants analysed for this outcome measure.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.0" lower_limit="29.0" upper_limit="112.0"/>
                    <measurement group_id="O2" value="113.0" lower_limit="57.0" upper_limit="141.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.328</p_value>
            <method>Log Rank</method>
            <method_desc>P-value was calculated using the Log rank test.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of DAS28 (CRP) Remission at Day 169</title>
        <description>The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) &lt;3.2 = low disease activity, &gt;=3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission. Participants with score less than 2.6 were analysed. Duration of DAS28(CRP) remission for each subject was defined as number of days from onset of remission to when the subject was no longer in remission.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, &quot;N&quot; is number of participants analysed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of DAS28 (CRP) Remission at Day 169</title>
          <description>The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) &lt;3.2 = low disease activity, &gt;=3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission. Participants with score less than 2.6 were analysed. Duration of DAS28(CRP) remission for each subject was defined as number of days from onset of remission to when the subject was no longer in remission.</description>
          <population>The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, &quot;N&quot; is number of participants analysed for this outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.0" spread="0.24"/>
                    <measurement group_id="O2" value="69.6" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Weibull model</method>
            <method_desc>P-value was calculated using an Weibull model.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) &lt; 2.6 at Day 169</title>
        <description>The DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) &lt;3.2 = low disease activity, &gt;=3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission. The percentage of participants were calculated by logistic regression model method.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) &lt; 2.6 at Day 169</title>
          <description>The DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) &lt;3.2 = low disease activity, &gt;=3.2 to 5.1 = moderate to high disease activity and &lt;2.6= remission. The percentage of participants were calculated by logistic regression model method.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</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="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0"/>
                    <measurement group_id="O2" value="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.795</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>-1.7</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.4</ci_lower_limit>
            <ci_upper_limit>9.0</ci_upper_limit>
            <estimate_desc>90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Simplified Disease Activity Index (SDAI) Remission at Day 169</title>
        <description>The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 centimetre (cm) VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3. The percentage of participants were calculated by logistic regression model method.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Simplified Disease Activity Index (SDAI) Remission at Day 169</title>
          <description>The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 centimetre (cm) VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3. The percentage of participants were calculated by logistic regression model method.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</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="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9"/>
                    <measurement group_id="O2" value="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.048</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>-11.7</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.0</ci_lower_limit>
            <ci_upper_limit>-2.5</ci_upper_limit>
            <estimate_desc>90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169</title>
        <description>The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169</title>
          <description>The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</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="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6"/>
                    <measurement group_id="O2" value="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.035</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>-11.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.6</ci_lower_limit>
            <ci_upper_limit>-3.1</ci_upper_limit>
            <estimate_desc>90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169</title>
        <description>The ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169</title>
          <description>The ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.</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="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9"/>
                    <measurement group_id="O2" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.061</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>-7.5</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.6</ci_lower_limit>
            <ci_upper_limit>-1.5</ci_upper_limit>
            <estimate_desc>90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Swollen and Tender Joint Count at Day 169</title>
        <description>Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Mean here indicates adjusted mean.</description>
        <time_frame>Baseline and Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Swollen and Tender Joint Count at Day 169</title>
          <description>Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Mean here indicates adjusted mean.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.</population>
          <units>joint count</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SJC: Baseline (n=68, 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.49" spread="0.779"/>
                    <measurement group_id="O2" value="14.07" spread="0.824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC: Change at Day 169 (n=64, 64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.07" spread="0.777"/>
                    <measurement group_id="O2" value="-10.08" spread="0.747"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC: Baseline (n=68, 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.93" spread="1.662"/>
                    <measurement group_id="O2" value="25.04" spread="1.543"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC: Change at Day 169 (n=64, 64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.42" spread="1.457"/>
                    <measurement group_id="O2" value="-14.19" spread="1.399"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis reported for change from baseline in swollen joint count at Day 169.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.993</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-0.01</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.33</ci_lower_limit>
            <ci_upper_limit>1.32</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis reported for change from baseline in Tender joint count at Day 169.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.424</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>1.23</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.31</ci_lower_limit>
            <ci_upper_limit>3.77</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Patient Assessment of Pain at Day 169</title>
        <description>Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.</description>
        <time_frame>Baseline and Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Patient Assessment of Pain at Day 169</title>
          <description>Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.</population>
          <units>millimeter (mm)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=68, 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.93" spread="2.352"/>
                    <measurement group_id="O2" value="69.81" spread="2.015"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 169 (n=64, 64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.61" spread="3.843"/>
                    <measurement group_id="O2" value="-24.72" spread="3.727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.272</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>4.89</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.46</ci_lower_limit>
            <ci_upper_limit>12.24</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169</title>
        <description>Participants responded to a question, &quot;Considering all the ways your arthritis affects you, how are you feeling today?&quot; by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly.</description>
        <time_frame>Baseline and Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169</title>
          <description>Participants responded to a question, &quot;Considering all the ways your arthritis affects you, how are you feeling today?&quot; by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=68, 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.57" spread="2.219"/>
                    <measurement group_id="O2" value="68.53" spread="2.212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 169 (n=64, 64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.50" spread="3.773"/>
                    <measurement group_id="O2" value="-24.04" spread="3.671"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.319</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>4.46</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.92</ci_lower_limit>
            <ci_upper_limit>11.84</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169</title>
        <description>Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.</description>
        <time_frame>Baseline and Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169</title>
          <description>Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.</population>
          <units>centimeter (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=68, 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.89" spread="0.159"/>
                    <measurement group_id="O2" value="7.04" spread="0.169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 169 (n=64, 64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.28" spread="0.317"/>
                    <measurement group_id="O2" value="-4.11" spread="0.307"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.640</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>0.16</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169</title>
        <description>HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.</description>
        <time_frame>Baseline and Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169</title>
          <description>HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;n&quot; signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=68, 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.58" spread="0.063"/>
                    <measurement group_id="O2" value="1.59" spread="0.070"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 169 (n=64, 64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.59" spread="0.081"/>
                    <measurement group_id="O2" value="-0.40" spread="0.078"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.055</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>0.18</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.03</ci_lower_limit>
            <ci_upper_limit>0.34</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline</title>
        <description>The ratio of change from baseline for CRP was analyzed and reported. The CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.</description>
        <time_frame>Baseline and Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;N&quot; (Number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline</title>
          <description>The ratio of change from baseline for CRP was analyzed and reported. The CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;N&quot; (Number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5036" spread="344.0"/>
                    <measurement group_id="O2" value="0.5142" spread="100.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.752</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted geometric mean ratio</param_type>
            <param_value>1.06</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Erythrocyte Sedimentation Rate (ESR) at Day 169</title>
        <description>ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.</description>
        <time_frame>Day 169</time_frame>
        <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;N&quot; (Number of participants analyzed) signifies those participants who were evaluable for this measure. &quot;n'' signifies participants evaluable for specified category for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythrocyte Sedimentation Rate (ESR) at Day 169</title>
          <description>ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.</description>
          <population>The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here &quot;N&quot; (Number of participants analyzed) signifies those participants who were evaluable for this measure. &quot;n'' signifies participants evaluable for specified category for each arm, respectively.</population>
          <units>millimeter per hour (mm/h)</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8" spread="21.0"/>
                    <measurement group_id="O2" value="27.8" spread="20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.725</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted geometric mean ratio</param_type>
            <param_value>1.05</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Concentrations of Mavrilimumab</title>
        <description>Serum concentrations after subcutaneous dose of mavrilimumab were calculated</description>
        <time_frame>Baseline, Day 8, 15, 29, 85, 141, and 169</time_frame>
        <population>The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here &quot;n&quot; signifies participants who were evaluable for the specified time point for each this arm respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Concentrations of Mavrilimumab</title>
          <description>Serum concentrations after subcutaneous dose of mavrilimumab were calculated</description>
          <population>The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here &quot;n&quot; signifies participants who were evaluable for the specified time point for each this arm respectively.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="512.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8 (n=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2837.24" spread="49.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15 (n=67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1084.43" spread="143.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29 (n=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2094.70" spread="58.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85 (n=67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2886.71" spread="64.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 141 (n=63)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1731.65" spread="79.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169 (n=64)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1701.13" spread="67.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab</title>
        <description>Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.</description>
        <time_frame>Day 1 to Day 169</time_frame>
        <population>The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.</population>
        <group_list>
          <group group_id="O1">
            <title>Golimumab 50 mg Alternating With Placebo</title>
            <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab</title>
          <description>Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.</description>
          <population>The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Day 169</time_frame>
      <desc>The safety population included all participants who received any amount of study medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>Golimumab 50 mg Alternating With Placebo</title>
          <description>Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
        </group>
        <group group_id="E2">
          <title>Mavrilimumab 100 mg</title>
          <description>Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>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="3" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroduodenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Parathyroid tumour benign</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Vertebrobasilar insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="70"/>
              </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>MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Non-compartmental analyses was not performed for pharmacokinetics parameters due to limited sampling schedule.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Marius Albulescu, Associate Medical Director</name_or_title>
      <organization>MedImmune, LLC</organization>
      <phone>301-398-0000</phone>
      <email>albulescum@medimmune.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/NCT01715896
org study id: CD-IA-CAM-3001-1107
nct id: NCT01715896
lead sponsor: 
has dmc: Yes
The primary objectives of this study is to explore the efficacy of mavrilimumab compared with
      golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe
      active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional
      disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor
      (TNF) agents (excluding golimumab) for efficacy or safety reasons.
Despite the therapeutic improvements with recent biologic agents approved for rheumatoid
      arthritis (RA), there is still a significant unmet medical need for the treatment of subjects
      with this chronic disease to achieve a faster, more complete response, and higher rates of
      remission. The aim of the current study is to compare the efficacy and safety of a
      subcutaneous dose of mavrilimumab with a marketed treatment for RA (golimumab) in 120 adult
      subjects with moderate-to-severe active RA who have had an inadequate response to one or two
      anti-TNF agents with mavrilimumab. The design of the study was exploratory and not formerly
      statistically powered.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169
time frame: Day 169
description: The ACR20 was defined as greater than or equal to (>=) 20 percent (%) improvement, in: swollen joint count (SJC) and tender joint count (TJC) and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity (MDGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (CRP). If CRP was missing and Erythrocyte sedimentation rate (ESR) was present then ESR was to be used.
measure: Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169
time frame: Day 169
description: The ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.
measure: Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169
time frame: Day 169
description: The ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.
measure: Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169
time frame: Day 169
description: The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the visual analogue scale (VAS) of 0 (= best), 100 (= worst) plus levels of CRP (milligram/Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. The percentage of participants were calculated by logistic regression model method.
measure: Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169
time frame: Day 169
description: The HAQ-DI: 20-item scale assessing participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arising, eating, hygiene, walking, reaching, grip, and errands/chores over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. Participants with change from baseline more than or equal to (>=) 0.25 were reported. The percentage of participants were calculated by logistic regression model method.
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
time frame: Baseline up to Day 169
description: An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. TEAE and TESAE were reported as per relatedness and severity.
measure: Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
time frame: Baseline up to Day 169
description: Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (leukocytosis, neutropenia, anaemia of chronic disease); serum chemistry (alanine aminotransferase, blood parathyroid hormone, gamma glutamyl transferase, hepatic enzyme, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hypertriglyceridaemia); urinalysis.
measure: Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
time frame: Baseline up to Day 169
description: Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.
measure: Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
time frame: Day 85 and 169
description: Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), forced vital capacity (FVC), and diffusing capacity for carbon monoxide (DLCO). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as more than (>) 20% reduction (RD) and absolute value (AV) less than (<) 80% predicted (PR).
measure: Dyspnea Score at Day 169
time frame: Day 169
description: Borg dyspnea scale was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.
measure: Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169
time frame: Baseline and Day 169
description: DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission.
measure: Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169
time frame: Baseline up to Day 169
description: ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Mean indicates adjusted mean (Adj mean).
measure: American College of Rheumatology (ACR) Hybrid Score at Day 169
time frame: Day 169
description: ACR Hybrid score was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.
measure: Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169
time frame: Day 169
description: DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.
measure: Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169
time frame: Day 169
description: DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.
measure: Time to Onset DAS28 (CRP) Remission at Day 169
time frame: Day 169
description: The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. Onset of DAS28(CRP) remission ≤ 2.6 defined as the first study day in which the DAS28 score met the criteria.
measure: Duration of DAS28 (CRP) Remission at Day 169
time frame: Day 169
description: The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. Duration of DAS28(CRP) remission for each subject was defined as number of days from onset of remission to when the subject was no longer in remission.
measure: Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169
time frame: Day 169
description: The DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. The percentage of participants were calculated by logistic regression model method.
measure: Percentage of Participants Who Achieved Simplified Disease Activity Index (SDAI) Remission at Day 169
time frame: Day 169
description: The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 centimetre (cm) VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3. The percentage of participants were calculated by logistic regression model method.
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169
time frame: Day 169
description: The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.
measure: Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169
time frame: Day 169
description: The ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.
measure: Mean Change From Baseline in Swollen and Tender Joint Count at Day 169
time frame: Baseline and Day 169
description: Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Mean here indicates adjusted mean.
measure: Mean Change From Baseline in Patient Assessment of Pain at Day 169
time frame: Baseline and Day 169
description: Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
measure: Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169
time frame: Baseline and Day 169
description: Participants responded to a question, "Considering all the ways your arthritis affects you, how are you feeling today?" by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly.
measure: Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169
time frame: Baseline and Day 169
description: Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.
measure: Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169
time frame: Baseline and Day 169
description: HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.
measure: Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline
time frame: Baseline and Day 169
description: The ratio of change from baseline for CRP was analyzed and reported. The CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.
measure: Erythrocyte Sedimentation Rate (ESR) at Day 169
time frame: Day 169
description: ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.
measure: Serum Concentrations of Mavrilimumab
time frame: Baseline, Day 8, 15, 29, 85, 141, and 169
description: Serum concentrations after subcutaneous dose of mavrilimumab were calculated
measure: Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab
time frame: Day 1 to Day 169
description: Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.
arm group label: Golimumab 50 mg alternating with Placebo
arm group type: Experimental
description: Participants received alternating doses of golimumab 50 milligram (mg) (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
arm group label: Mavrilimumab 100 mg
arm group type: Experimental
description: Participants received Mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
intervention type: Biological
intervention name: Golimumab 50 mg
description: Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
arm group label: Golimumab 50 mg alternating with Placebo
intervention type: Biological
intervention name: Mavrilimumab 100 mg
description: Participants received Mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
arm group label: Mavrilimumab 100 mg
other name: CAM-3001
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Marius Albulescu
role: Study Director
affiliation: MedImmune Ltd
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
country: Colombia
country: Czech Republic
country: France
country: Greece
country: Hungary
country: Israel
country: Mexico
country: Portugal
country: Russian Federation
country: Serbia
country: Slovakia
country: Spain
country: United Kingdom
country: Turkey
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Necrosis
mesh term: Golimumab
mesh term: Mavrilimumab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Non-compartmental analyses was not performed for pharmacokinetics parameters due to limited sampling schedule.
point of contact: 