<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/NCT01706926</url>
  </required_header>
  <id_info>
    <org_study_id>CD-IA-CAM-3001-1071</org_study_id>
    <nct_id>NCT01706926</nct_id>
  </id_info>
  <brief_title>A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis</brief_title>
  <official_title>A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedImmune LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MedImmune Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>MedImmune LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of&#xD;
      mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with&#xD;
      moderate-to-severe adult onset Rheumatoid Arthritis (RA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the therapeutic improvements with recent biologic agents approved for rheumatoid&#xD;
      arthritis, there is still significant unmet medical need for the treatment of subjects with&#xD;
      this chronic disease to achieve a faster, more complete response, and higher rates of&#xD;
      remission. The aim of the study is to explore the optimum dose of mavrilimumab for further&#xD;
      clinical development and more fully investigate the efficacy and safety profile of&#xD;
      mavrilimumab after longer drug exposure (that is, 24 weeks). The results of this study will&#xD;
      form the basis for future clinical studies with mavrilimumab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85</measure>
    <time_frame>Baseline and Day 85</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. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.</description>
  </primary_outcome>
  <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>ACR20 was defined as &gt;=20 percent (%) improvement, in: SJC and 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; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage 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 pretreatment state.</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 (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and 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>Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169</measure>
    <time_frame>Day 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), and forced vital capacity (FVC). 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. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=&lt;) 15 percent (%), more than (&gt;) 15 to =&lt;20%, and &gt;20%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea Score at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>Borg dyspnea scale is 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 indicate greater difficulty in breathing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation Level at Day 169</measure>
    <time_frame>Day 169</time_frame>
    <description>Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.</description>
  </secondary_outcome>
  <secondary_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>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.</description>
  </secondary_outcome>
  <secondary_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>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.</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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage 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>Percentage 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>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.</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 millimeter (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 centimeter (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 From Baseline in C-Reactive Protein (CRP) at Day 169</measure>
    <time_frame>Baseline, Day 169</time_frame>
    <description>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>Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169</measure>
    <time_frame>Baseline, 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>Percentage of Participants With 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 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.</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>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 Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169</measure>
    <time_frame>Baseline and Day 169</time_frame>
    <description>FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue.</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 multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). Geometric coefficient of variation at Baseline for cohorts 30mg and 150mg were calculated as the negligible mean value was observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit</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>4</number_of_arms>
  <enrollment type="Actual">420</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mavrilimumab 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mavrilimumab (CAM-3001) 30 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>
  <arm_group>
    <arm_group_label>Mavrilimumab 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mavrilimumab (CAM-3001) 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>
  <arm_group>
    <arm_group_label>Mavrilimumab 150 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mavrilimumab (CAM-3001) 150 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>Mavrilimumab 30 mg</intervention_name>
    <description>Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks</description>
    <arm_group_label>Mavrilimumab 30 mg</arm_group_label>
    <other_name>CAM-3001</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Mavrilimumab 100 mg</intervention_name>
    <description>Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.</description>
    <arm_group_label>Mavrilimumab 100 mg</arm_group_label>
    <other_name>CAM-3001</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Mavrilimumab 150 mg</intervention_name>
    <description>Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.</description>
    <arm_group_label>Mavrilimumab 150 mg</arm_group_label>
    <other_name>CAM-3001</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of adult onset Rheumatoid Arthritis (RA) in line with the protocol&#xD;
&#xD;
          -  Moderately active disease in line with the protocol&#xD;
&#xD;
          -  A pre-defined number of swollen joints in line with the protocol&#xD;
&#xD;
          -  Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs&#xD;
             (DMARDs)&#xD;
&#xD;
          -  No evidence of respiratory disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A rheumatic autoimmune disease other than RA, or significant systemic extra-articular&#xD;
             involvement secondary to RA&#xD;
&#xD;
          -  A history of, or current, inflammatory joint disease other than RA&#xD;
&#xD;
          -  Previous treatment with the investigational drug&#xD;
&#xD;
          -  Discontinuation of a biologic DMARD due to lack of efficacy&#xD;
&#xD;
          -  Non-compliant concurrent medications&#xD;
&#xD;
          -  Non-compliance with medical history criteria.&#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, MD</last_name>
    <role>Study Director</role>
    <affiliation>MedImmune Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rosario</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>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vina del Mar</city>
        <country>Chile</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>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bruntal</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jihlava</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ostrava - Trebovice</city>
        <country>Czech Republic</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>Praha 4</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>Tallinn</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hildesheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Magdeburg</city>
        <country>Germany</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>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gdynia</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Grodzisk Mazowiecki</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barnaul</city>
        <country>Russian Federation</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>Novosibirsk</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>Yaroslavl</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>Durban</city>
        <country>South Africa</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>Santiago de Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Donetsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kiev</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lutsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vinnytsia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Bulgaria</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Czech Republic</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Ukraine</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
    <country>Mexico</country>
  </removed_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>May 31, 2016</results_first_submitted>
  <results_first_submitted_qc>August 3, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 27, 2016</results_first_posted>
  <last_update_submitted>August 3, 2016</last_update_submitted>
  <last_update_submitted_qc>August 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Mavrilimumab</keyword>
  <keyword>CAM-3001</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mavrilimumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 420 participants were screened out of which 326 participants were randomized and received investigational product in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
        </group>
        <group group_id="P2">
          <title>Mavrilimumab 30 mg</title>
          <description>Mavrilimumab (CAM-3001) 30 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="P3">
          <title>Mavrilimumab 100 mg</title>
          <description>Mavrilimumab (CAM-3001) 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="P4">
          <title>Mavrilimumab 150 mg</title>
          <description>Mavrilimumab (CAM-3001) 150 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="81"/>
                <participants group_id="P2" count="81"/>
                <participants group_id="P3" count="85"/>
                <participants group_id="P4" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="77"/>
                <participants group_id="P3" count="79"/>
                <participants group_id="P4" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="5"/>
              </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="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
              </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>Placebo</title>
          <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
        </group>
        <group group_id="B2">
          <title>Mavrilimumab 30 mg</title>
          <description>Mavrilimumab (CAM-3001) 30 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>Mavrilimumab 100 mg</title>
          <description>Mavrilimumab (CAM-3001) 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="B4">
          <title>Mavrilimumab 150 mg</title>
          <description>Mavrilimumab (CAM-3001) 150 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="B5">
          <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="81"/>
            <count group_id="B2" value="81"/>
            <count group_id="B3" value="85"/>
            <count group_id="B4" value="79"/>
            <count group_id="B5" value="326"/>
          </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="52.8" spread="10.6"/>
                    <measurement group_id="B2" value="51.2" spread="11.6"/>
                    <measurement group_id="B3" value="50.8" spread="11.9"/>
                    <measurement group_id="B4" value="52.6" spread="10.3"/>
                    <measurement group_id="B5" value="51.8" spread="11.1"/>
                  </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="75"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="70"/>
                    <measurement group_id="B4" value="67"/>
                    <measurement group_id="B5" value="282"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85</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. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.</description>
        <time_frame>Baseline and Day 85</time_frame>
        <population>The modified intent-to-treat (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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 85</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. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.</description>
          <population>The modified intent-to-treat (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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=81, 81, 85, 79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.78" spread="0.090"/>
                    <measurement group_id="O2" value="5.73" spread="0.104"/>
                    <measurement group_id="O3" value="5.91" spread="0.096"/>
                    <measurement group_id="O4" value="5.67" spread="0.086"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 85 (n=77, 76, 79, 78)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.68" spread="0.136"/>
                    <measurement group_id="O2" value="-1.37" spread="0.136"/>
                    <measurement group_id="O3" value="-1.64" spread="0.132"/>
                    <measurement group_id="O4" value="-1.90" spread="0.136"/>
                  </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 DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95 percent (%) confidence interval (CI) was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-0.69</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.193</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.06</ci_lower_limit>
            <ci_upper_limit>-0.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-0.96</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.190</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.33</ci_lower_limit>
            <ci_upper_limit>-0.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-1.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.193</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.60</ci_lower_limit>
            <ci_upper_limit>-0.84</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169</title>
        <description>ACR20 was defined as &gt;=20 percent (%) improvement, in: SJC and 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; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.</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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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>ACR20 was defined as &gt;=20 percent (%) improvement, in: SJC and 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; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.</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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.7"/>
                    <measurement group_id="O2" value="50.6"/>
                    <measurement group_id="O3" value="61.2"/>
                    <measurement group_id="O4" value="73.4"/>
                  </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>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>25.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.5</ci_lower_limit>
            <ci_upper_limit>40.3</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>36.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>22.5</ci_lower_limit>
            <ci_upper_limit>50.5</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>48.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>35.2</ci_lower_limit>
            <ci_upper_limit>62.3</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage 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 pretreatment state.</description>
        <time_frame>Baseline up to Day 169</time_frame>
        <population>The safety population included all participants who received any dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 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 pretreatment state.</description>
          <population>The safety population included all participants who received any dose of investigational product.</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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.9"/>
                    <measurement group_id="O2" value="50.6"/>
                    <measurement group_id="O3" value="42.4"/>
                    <measurement group_id="O4" value="54.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TESAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="4.9"/>
                    <measurement group_id="O3" value="5.9"/>
                    <measurement group_id="O4" value="2.5"/>
                  </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 (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and urinalysis.</description>
        <time_frame>Baseline up to Day 169</time_frame>
        <population>The safety population included all participants who received any dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and urinalysis.</description>
          <population>The safety population included all participants who received any dose 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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophilia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </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 group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine aminotransferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate aminotransferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gamma-glutamyltransferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertransaminasaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dislipidaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypercholesterolaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </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="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperkalaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </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 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 dose 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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pyrexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hot flush</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Pulmonary Function Test Values Below Threshold Values at Day 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), and forced vital capacity (FVC). 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. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=&lt;) 15 percent (%), more than (&gt;) 15 to =&lt;20%, and &gt;20%.</description>
        <time_frame>Day 169</time_frame>
        <population>The safety population included all participants who received any dose 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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 Pulmonary Function Test Values Below Threshold Values at Day 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), and forced vital capacity (FVC). 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. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=&lt;) 15 percent (%), more than (&gt;) 15 to =&lt;20%, and &gt;20%.</description>
          <population>The safety population included all participants who received any dose 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>percent of pulmonary test values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FEV1 =&lt;15% (n=42,67,75,75)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.6"/>
                    <measurement group_id="O2" value="98.5"/>
                    <measurement group_id="O3" value="96.0"/>
                    <measurement group_id="O4" value="89.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FEV1 &gt;15 to 20% (n=42,67,75,75)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="1.3"/>
                    <measurement group_id="O4" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FEV1 &gt;20% (n=42,67,75,75)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                    <measurement group_id="O2" value="1.5"/>
                    <measurement group_id="O3" value="2.7"/>
                    <measurement group_id="O4" value="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FEV6 =&lt;15% (n=41,66,71,68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.6"/>
                    <measurement group_id="O2" value="97.0"/>
                    <measurement group_id="O3" value="94.4"/>
                    <measurement group_id="O4" value="89.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FEV6 &gt;15 to 20% (n=41,66,71,68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="1.5"/>
                    <measurement group_id="O3" value="1.4"/>
                    <measurement group_id="O4" value="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FEV6 &gt;20% (n=41,66,71,68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                    <measurement group_id="O2" value="1.5"/>
                    <measurement group_id="O3" value="4.2"/>
                    <measurement group_id="O4" value="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FVC =&lt;15% (n=42,67,75,75)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.6"/>
                    <measurement group_id="O2" value="98.5"/>
                    <measurement group_id="O3" value="94.7"/>
                    <measurement group_id="O4" value="94.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FVC &gt;15 to 20% (n=42,67,75,75)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="1.3"/>
                    <measurement group_id="O4" value="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FVC &gt;20% (n=42,67,75,75)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                    <measurement group_id="O2" value="1.5"/>
                    <measurement group_id="O3" value="4.0"/>
                    <measurement group_id="O4" value="2.7"/>
                  </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 is 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 indicate greater difficulty in breathing.</description>
        <time_frame>Day 169</time_frame>
        <population>The safety population included all participants who received any dose 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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 is 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 indicate greater difficulty in breathing.</description>
          <population>The safety population included all participants who received any dose 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="41"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="73"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="0.62"/>
                    <measurement group_id="O2" value="0.22" spread="0.54"/>
                    <measurement group_id="O3" value="0.32" spread="0.73"/>
                    <measurement group_id="O4" value="0.28" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oxygen Saturation Level at Day 169</title>
        <description>Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.</description>
        <time_frame>Day 169</time_frame>
        <population>The safety population included all participants who received any dose 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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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>Oxygen Saturation Level at Day 169</title>
          <description>Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.</description>
          <population>The safety population included all participants who received any dose of investigational product. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>percent saturation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="73"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.4" spread="1.4"/>
                    <measurement group_id="O2" value="97.4" spread="1.1"/>
                    <measurement group_id="O3" value="97.4" spread="1.1"/>
                    <measurement group_id="O4" value="97.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169</title>
        <description>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.</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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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>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.</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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3"/>
                    <measurement group_id="O2" value="28.4"/>
                    <measurement group_id="O3" value="25.9"/>
                    <measurement group_id="O4" value="40.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.013</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>16.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.9</ci_lower_limit>
            <ci_upper_limit>28.2</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.030</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>13.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.8</ci_lower_limit>
            <ci_upper_limit>25.3</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>28.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.2</ci_lower_limit>
            <ci_upper_limit>41.1</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169</title>
        <description>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.</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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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>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.</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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7"/>
                    <measurement group_id="O2" value="12.3"/>
                    <measurement group_id="O3" value="10.6"/>
                    <measurement group_id="O4" value="13.9"/>
                  </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>0.079</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>8.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4</ci_lower_limit>
            <ci_upper_limit>16.9</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.133</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>6.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>14.6</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.026</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>10.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.5</ci_lower_limit>
            <ci_upper_limit>18.9</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.</estimate_desc>
          </analysis>
        </analysis_list>
      </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.</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; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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.</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 participants who were evaluable for this measure.</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="38"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.25" spread="4.630"/>
                    <measurement group_id="O2" value="29.04" spread="3.828"/>
                    <measurement group_id="O3" value="30.24" spread="3.623"/>
                    <measurement group_id="O4" value="40.72" spread="3.644"/>
                  </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>0.009</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted Mean difference</param_type>
            <param_value>15.79</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.007</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.96</ci_lower_limit>
            <ci_upper_limit>27.61</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>16.99</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.879</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.42</ci_lower_limit>
            <ci_upper_limit>28.56</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>27.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.892</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.87</ci_lower_limit>
            <ci_upper_limit>39.07</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage 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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 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>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.4" spread="0.090"/>
                    <measurement group_id="O2" value="30.9" spread="0.104"/>
                    <measurement group_id="O3" value="28.2" spread="0.096"/>
                    <measurement group_id="O4" value="19.0" spread="0.086"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" spread="0.136"/>
                    <measurement group_id="O2" value="35.8" spread="0.136"/>
                    <measurement group_id="O3" value="40.0" spread="0.132"/>
                    <measurement group_id="O4" value="41.8" spread="0.136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="31.8"/>
                    <measurement group_id="O4" value="39.2"/>
                  </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>&lt;0.001</p_value>
            <method>Proportional odds analysis</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.56</ci_lower_limit>
            <ci_upper_limit>8.80</ci_upper_limit>
            <estimate_desc>Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios greater than (&gt;) one favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Proportional odds analysis</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.64</ci_lower_limit>
            <ci_upper_limit>8.92</ci_upper_limit>
            <estimate_desc>Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios &gt;one favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Proportional odds analysis</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>7.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.85</ci_lower_limit>
            <ci_upper_limit>13.40</ci_upper_limit>
            <estimate_desc>Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios &gt;one favored mavrilimumab.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage 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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 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>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DAS28 (CRP) Remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9"/>
                    <measurement group_id="O2" value="21.0"/>
                    <measurement group_id="O3" value="17.6"/>
                    <measurement group_id="O4" value="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low Disease Activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="31.8"/>
                    <measurement group_id="O4" value="41.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>16.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.0</ci_lower_limit>
            <ci_upper_limit>26.1</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.014</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>12.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.3</ci_lower_limit>
            <ci_upper_limit>22.1</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.007</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>14.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.2</ci_lower_limit>
            <ci_upper_limit>23.9</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.</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>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>24.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.7</ci_lower_limit>
            <ci_upper_limit>36.6</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</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>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>23.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.5</ci_lower_limit>
            <ci_upper_limit>34.8</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</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>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Percent difference</param_type>
            <param_value>33.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.7</ci_lower_limit>
            <ci_upper_limit>45.6</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.</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.</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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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.</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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SJC: Baseline (n=81,81,85,79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.44" spread="0.765"/>
                    <measurement group_id="O2" value="17.80" spread="1.126"/>
                    <measurement group_id="O3" value="16.82" spread="0.930"/>
                    <measurement group_id="O4" value="15.72" spread="0.795"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC: Change at Day 169 (n=40,65,73,74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.97" spread="0.932"/>
                    <measurement group_id="O2" value="-10.65" spread="0.809"/>
                    <measurement group_id="O3" value="-11.18" spread="0.771"/>
                    <measurement group_id="O4" value="-11.96" spread="0.787"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC: Baseline (n=81,81,85,79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.26" spread="1.250"/>
                    <measurement group_id="O2" value="27.48" spread="1.553"/>
                    <measurement group_id="O3" value="26.96" spread="1.544"/>
                    <measurement group_id="O4" value="26.70" spread="1.284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC: Change at Day 169 (n=40,65,73,74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.90" spread="1.447"/>
                    <measurement group_id="O2" value="-15.14" spread="1.265"/>
                    <measurement group_id="O3" value="-16.35" spread="1.207"/>
                    <measurement group_id="O4" value="-18.32" spread="1.234"/>
                  </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>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-5.68</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.237</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.12</ci_lower_limit>
            <ci_upper_limit>-3.24</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</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>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-6.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.211</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.60</ci_lower_limit>
            <ci_upper_limit>-3.82</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</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>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-7.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.219</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.40</ci_lower_limit>
            <ci_upper_limit>-4.59</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</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>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-7.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.922</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.02</ci_lower_limit>
            <ci_upper_limit>-3.45</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</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>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-8.45</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.884</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.16</ci_lower_limit>
            <ci_upper_limit>-4.74</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</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>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-10.42</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.901</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.17</ci_lower_limit>
            <ci_upper_limit>-6.67</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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>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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=81, 81, 85, 79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.16" spread="2.093"/>
                    <measurement group_id="O2" value="62.65" spread="2.110"/>
                    <measurement group_id="O3" value="63.58" spread="2.034"/>
                    <measurement group_id="O4" value="62.35" spread="2.217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 169 (n=40, 65, 73, 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.20" spread="3.006"/>
                    <measurement group_id="O2" value="-23.14" spread="2.563"/>
                    <measurement group_id="O3" value="-23.31" spread="2.446"/>
                    <measurement group_id="O4" value="-26.53" spread="2.483"/>
                  </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>0.045</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-7.94</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.950</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.72</ci_lower_limit>
            <ci_upper_limit>-0.17</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.037</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-8.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.876</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.73</ci_lower_limit>
            <ci_upper_limit>-0.48</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-11.32</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.899</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.00</ci_lower_limit>
            <ci_upper_limit>-3.65</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</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 millimeter (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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 millimeter (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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=81, 81, 85, 79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.86" spread="1.892"/>
                    <measurement group_id="O2" value="63.79" spread="2.074"/>
                    <measurement group_id="O3" value="63.71" spread="1.957"/>
                    <measurement group_id="O4" value="62.39" spread="2.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 169 (n=40, 65, 73, 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.21" spread="3.148"/>
                    <measurement group_id="O2" value="-21.06" spread="2.685"/>
                    <measurement group_id="O3" value="-22.40" spread="2.560"/>
                    <measurement group_id="O4" value="-25.69" spread="2.600"/>
                  </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>0.837</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-0.85</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.137</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.99</ci_lower_limit>
            <ci_upper_limit>7.29</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.589</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-2.19</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.058</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.18</ci_lower_limit>
            <ci_upper_limit>5.79</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.180</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-5.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.083</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.52</ci_lower_limit>
            <ci_upper_limit>2.55</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</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 centimeter (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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 centimeter (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>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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=81, 81, 85, 79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.60" spread="0.168"/>
                    <measurement group_id="O2" value="6.60" spread="0.162"/>
                    <measurement group_id="O3" value="6.81" spread="0.144"/>
                    <measurement group_id="O4" value="6.42" spread="0.166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 169 (n=40, 65, 73, 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.39" spread="0.305"/>
                    <measurement group_id="O2" value="-3.81" spread="0.254"/>
                    <measurement group_id="O3" value="-3.85" spread="0.241"/>
                    <measurement group_id="O4" value="-3.95" spread="0.243"/>
                  </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>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-1.41</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.397</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.20</ci_lower_limit>
            <ci_upper_limit>-0.63</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-1.46</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.389</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.23</ci_lower_limit>
            <ci_upper_limit>-0.69</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-1.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.391</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.33</ci_lower_limit>
            <ci_upper_limit>-0.79</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=81, 80, 85, 79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.63" spread="0.054"/>
                    <measurement group_id="O2" value="1.52" spread="0.070"/>
                    <measurement group_id="O3" value="1.58" spread="0.056"/>
                    <measurement group_id="O4" value="1.58" spread="0.059"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 169 (n=40, 65, 73, 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.29" spread="0.081"/>
                    <measurement group_id="O2" value="-0.37" spread="0.072"/>
                    <measurement group_id="O3" value="-0.46" spread="0.068"/>
                    <measurement group_id="O4" value="-0.55" spread="0.069"/>
                  </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>0.479</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-0.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.108</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.29</ci_lower_limit>
            <ci_upper_limit>0.14</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.124</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-0.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.106</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.37</ci_lower_limit>
            <ci_upper_limit>0.04</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.017</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-0.26</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.107</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.47</ci_lower_limit>
            <ci_upper_limit>-0.05</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &lt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169</title>
        <description>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, 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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 From Baseline in C-Reactive Protein (CRP) at Day 169</title>
          <description>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="38"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2971" spread="83.3"/>
                    <measurement group_id="O2" value="0.8784" spread="102.8"/>
                    <measurement group_id="O3" value="0.5197" spread="287.4"/>
                    <measurement group_id="O4" value="0.5856" spread="153.3"/>
                  </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>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.017</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted geometric mean ratio</param_type>
            <param_value>0.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>0.92</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% 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. Ratio &lt;1 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted geometric mean ratio</param_type>
            <param_value>0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>0.66</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% 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. Ratio &lt;1 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted geometric mean ratio</param_type>
            <param_value>0.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.31</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% 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. Ratio &lt;1 favored mavrilimumab.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ratio of Change From Baseline in 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>Baseline, 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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 From Baseline in 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.</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="40"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="73"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="57.0"/>
                    <measurement group_id="O2" value="0.67" spread="56.4"/>
                    <measurement group_id="O3" value="0.62" spread="55.3"/>
                    <measurement group_id="O4" value="0.58" spread="61.0"/>
                  </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>0.003</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted geometric mean ratio</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% 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. Ratio &lt;1 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted geometric mean ratio</param_type>
            <param_value>0.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>0.84</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% 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. Ratio &lt;1 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted geometric mean ratio</param_type>
            <param_value>0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>0.75</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% 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. Ratio &lt;1 favored mavrilimumab.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With 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 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.</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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 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 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.</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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.054"/>
                    <measurement group_id="O2" value="6.2" spread="0.070"/>
                    <measurement group_id="O3" value="2.4" spread="0.056"/>
                    <measurement group_id="O4" value="5.1" spread="0.059"/>
                  </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>0.210</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>4.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>10.7</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences &gt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.000</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.9</ci_lower_limit>
            <ci_upper_limit>5.1</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences &gt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.207</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>3.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>9.2</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences &gt;0 favored mavrilimumab.</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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.054"/>
                    <measurement group_id="O2" value="6.2" spread="0.070"/>
                    <measurement group_id="O3" value="3.5" spread="0.056"/>
                    <measurement group_id="O4" value="7.6" spread="0.059"/>
                  </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>0.210</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>4.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>10.7</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences &gt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.621</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>2.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.3</ci_lower_limit>
            <ci_upper_limit>6.9</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences &gt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.062</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>6.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>12.7</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences &gt;0 favored mavrilimumab.</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>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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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>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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.054"/>
                    <measurement group_id="O2" value="3.7" spread="0.070"/>
                    <measurement group_id="O3" value="1.2" spread="0.056"/>
                    <measurement group_id="O4" value="1.3" spread="0.059"/>
                  </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>0.245</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>3.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>7.8</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences &gt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.000</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>3.5</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences &gt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.494</p_value>
            <method>Fisher Exact</method>
            <param_type>Percent difference</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>3.7</ci_upper_limit>
            <estimate_desc>95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences &gt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169</title>
        <description>FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue.</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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169</title>
          <description>FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue.</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="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=79, 80, 84, 79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.75" spread="0.824"/>
                    <measurement group_id="O2" value="28.91" spread="1.078"/>
                    <measurement group_id="O3" value="28.45" spread="0.998"/>
                    <measurement group_id="O4" value="27.82" spread="0.950"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 169 (n=40, 65, 73, 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.53" spread="1.225"/>
                    <measurement group_id="O2" value="5.72" spread="1.039"/>
                    <measurement group_id="O3" value="6.80" spread="0.988"/>
                    <measurement group_id="O4" value="8.45" spread="0.997"/>
                  </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>0.463</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>1.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.608</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.99</ci_lower_limit>
            <ci_upper_limit>4.35</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &gt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.151</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>2.27</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.574</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.83</ci_lower_limit>
            <ci_upper_limit>5.37</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &gt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.014</p_value>
            <method>Repeated measures model</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>3.92</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.578</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>7.02</ci_upper_limit>
            <estimate_desc>An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences &gt;0 favored mavrilimumab.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Concentrations of Mavrilimumab</title>
        <description>Serum concentrations after multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). Geometric coefficient of variation at Baseline for cohorts 30mg and 150mg were calculated as the negligible mean value was observed.</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 arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O2">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O3">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). Geometric coefficient of variation at Baseline for cohorts 30mg and 150mg were calculated as the negligible mean value was observed.</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 arm, respectively.</population>
          <units>nanogram per milliliter</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="81"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=80, 85, 79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="894.4"/>
                    <measurement group_id="O2" value="0.00" spread="NA">Geometric coefficient of variation could not be calculated as mean and geometric mean were zero at this time point.</measurement>
                    <measurement group_id="O3" value="0.00" spread="862.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8 (n=78, 83, 78)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="617.49" spread="111.8"/>
                    <measurement group_id="O2" value="3563.31" spread="49.3"/>
                    <measurement group_id="O3" value="6087.06" spread="43.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15 (n=78, 84, 78)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154.60" spread="194.2"/>
                    <measurement group_id="O2" value="2479.96" spread="52.1"/>
                    <measurement group_id="O3" value="4616.35" spread="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29 (n=77, 85, 76)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="217.67" spread="248.3"/>
                    <measurement group_id="O2" value="4503.97" spread="54.8"/>
                    <measurement group_id="O3" value="7843.66" spread="42.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85 (n=74, 81, 77)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="201.57" spread="162.8"/>
                    <measurement group_id="O2" value="6538.22" spread="52.7"/>
                    <measurement group_id="O3" value="13213.93" spread="50.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 141 (n=67, 75, 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="258.77" spread="136.9"/>
                    <measurement group_id="O2" value="2932.80" spread="75.6"/>
                    <measurement group_id="O3" value="9241.31" spread="52.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169 (n=63, 73, 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="348.97" spread="141.2"/>
                    <measurement group_id="O2" value="5282.37" spread="62.0"/>
                    <measurement group_id="O3" value="9178.47" spread="56.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit</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>Placebo</title>
            <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
          </group>
          <group group_id="O2">
            <title>Mavrilimumab 30 mg</title>
            <description>Mavrilimumab (CAM-3001) 30 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="O3">
            <title>Mavrilimumab 100 mg</title>
            <description>Mavrilimumab (CAM-3001) 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="O4">
            <title>Mavrilimumab 150 mg</title>
            <description>Mavrilimumab (CAM-3001) 150 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 Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit</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>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="16.0"/>
                    <measurement group_id="O3" value="3.5"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Day 169</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.</description>
        </group>
        <group group_id="E2">
          <title>Mavrilimumab 30 mg</title>
          <description>Mavrilimumab (CAM-3001) 30 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="E3">
          <title>Mavrilimumab 100 mg</title>
          <description>Mavrilimumab (CAM-3001) 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="E4">
          <title>Mavrilimumab 150 mg</title>
          <description>Mavrilimumab (CAM-3001) 150 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 16.1</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="1" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of the cervix</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cystocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="81"/>
                <counts group_id="E3" subjects_affected="36" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="43" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia supraventricular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Gingival swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Mouth cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertransaminasaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Body tinea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="81"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Lyme disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="81"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Omphalitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Tinea versicolour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Bone contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Chemical poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Epicondylitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Injection related reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Muscle contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Rheumatoid nodule</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Sjogren's syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </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="81"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="81"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E4" events="8" subjects_affected="6" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Intercostal neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Dyssomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical dysplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchiectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Obstructive airways disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Venous insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </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/NCT01706926
org study id: CD-IA-CAM-3001-1071
nct id: NCT01706926
lead sponsor: 
collaborator: 
has dmc: Yes
The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of
      mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with
      moderate-to-severe adult onset Rheumatoid Arthritis (RA).
Despite the therapeutic improvements with recent biologic agents approved for rheumatoid
      arthritis, there is still 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 study is to explore the optimum dose of mavrilimumab for further
      clinical development and more fully investigate the efficacy and safety profile of
      mavrilimumab after longer drug exposure (that is, 24 weeks). The results of this study will
      form the basis for future clinical studies with mavrilimumab.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85
time frame: Baseline and Day 85
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. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.
measure: Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169
time frame: Day 169
description: ACR20 was defined as >=20 percent (%) improvement, in: SJC and TJC and >=20% 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 Health Assessment Questionnaire [HAQ]); and CRP.
measure: Percentage 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 pretreatment state.
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 (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and 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: Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169
time frame: Day 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), and forced vital capacity (FVC). 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. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=<) 15 percent (%), more than (>) 15 to =<20%, and >20%.
measure: Dyspnea Score at Day 169
time frame: Day 169
description: Borg dyspnea scale is 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 indicate greater difficulty in breathing.
measure: Oxygen Saturation Level at Day 169
time frame: Day 169
description: Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
measure: Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169
time frame: Day 169
description: 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.
measure: Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169
time frame: Day 169
description: 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.
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.
measure: Percentage 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: Percentage 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: 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.
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 millimeter (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 centimeter (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 From Baseline in C-Reactive Protein (CRP) at Day 169
time frame: Baseline, Day 169
description: 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: Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169
time frame: Baseline, 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: Percentage of Participants With 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 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.
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: 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 Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169
time frame: Baseline and Day 169
description: FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue.
measure: Serum Concentrations of Mavrilimumab
time frame: Baseline, Day 8, 15, 29, 85, 141, and 169
description: Serum concentrations after multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). Geometric coefficient of variation at Baseline for cohorts 30mg and 150mg were calculated as the negligible mean value was observed.
measure: Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit
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: Placebo
arm group type: Placebo Comparator
description: Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
arm group label: Mavrilimumab 30 mg
arm group type: Experimental
description: Mavrilimumab (CAM-3001) 30 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
arm group type: Experimental
description: Mavrilimumab (CAM-3001) 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 150 mg
arm group type: Experimental
description: Mavrilimumab (CAM-3001) 150 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: Mavrilimumab 30 mg
description: Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks
arm group label: Mavrilimumab 30 mg
other name: CAM-3001
intervention type: Biological
intervention name: Mavrilimumab 100 mg
description: Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.
arm group label: Mavrilimumab 100 mg
other name: CAM-3001
intervention type: Biological
intervention name: Mavrilimumab 150 mg
description: Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.
arm group label: Mavrilimumab 150 mg
other name: CAM-3001
intervention type: Other
intervention name: Placebo
description: Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Marius Albulescu, MD
role: Study Director
affiliation: MedImmune Ltd
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country: Argentina
country: Bulgaria
country: Chile
country: Colombia
country: Czech Republic
country: Estonia
country: Germany
country: Hungary
country: Poland
country: Russian Federation
country: Serbia
country: South Africa
country: Spain
country: Ukraine
country: France
country: Mexico
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Mavrilimumab
mesh term: Antibodies, Monoclonal
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: 