<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/NCT01734993</url>
  </required_header>
  <id_info>
    <org_study_id>ML28544</org_study_id>
    <nct_id>NCT01734993</nct_id>
  </id_info>
  <brief_title>A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).</brief_title>
  <official_title>A Multicenter, Open-Label Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This multicenter, open-label, single arm, interventional, long-term extension (LTE) study&#xD;
      will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French&#xD;
      participants with moderate to severe RA who have completed the Week 97 visit of WA22762 LTE&#xD;
      study (NCT01194414) (EudraCT Number 2010-018375-22). Participants from France, who completed&#xD;
      the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having&#xD;
      improvement in disease activity score based on 28-joint count [DAS28] of greater than [&gt;] 1.2&#xD;
      points) will continue TCZ treatment within this local LTE study for a maximum of 156 weeks of&#xD;
      subcutaneous (SC) TCZ treatment, or until SC TCZ becomes commercially available, whichever&#xD;
      occurs first.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to approximately 142 weeks</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A SAE was any untoward medical occurrence that at any dose resulted in death, was life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, and congenital anomaly/birth defect. AEs included SAEs as well as non-serious AEs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With AEs and SAEs Related to TCZ</measure>
    <time_frame>Baseline up to approximately 142 weeks</time_frame>
    <description>An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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. AEs included SAEs as well as non-serious AEs. Causality of AEs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AEs with causality of certain, probable/likely, and possible were considered TCZ related.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Adverse Events of Special Interest (AESIs)</measure>
    <time_frame>Baseline up to approximately 142 weeks</time_frame>
    <description>Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With AESIs Related to TCZ</measure>
    <time_frame>Baseline up to approximately 142 weeks</time_frame>
    <description>AESI for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Percentage of participants with AESI related to the drug were presented. Causality of AESIs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on DC, relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AESIs with causality of certain, probable/likely, and possible were considered TCZ related.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification</measure>
    <time_frame>Baseline up to approximately 142 weeks</time_frame>
    <description>An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Percentage of participants with AE causing drug discontinuation, interruption and increase or decrease in dose of drug was presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities</measure>
    <time_frame>Baseline up to approximately 142 weeks</time_frame>
    <description>Criteria for potentially clinically important (PCI) change in vital signs: heart rate value of less than (&lt;) 40 beats per minute and value greater than (&gt;) 150 beats per minute, systolic blood pressure (SBP) of &lt; 80 or &gt;210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of &lt;40 or &gt;130 mmHg, body temperature &lt;32 or &gt; 40 degrees Celsius, respiratory rate of &lt;10 or &gt; 50 breaths/minute and criteria for PCI change in physical examination: &gt;/=10% increase or decrease of body weight in kilograms (kg).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Clinically Significant Laboratory Abnormalities</measure>
    <time_frame>Baseline up to approximately 142 weeks</time_frame>
    <description>Criteria for laboratory tests clinically significant abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(&lt; 0.8*lower limit of normal[LLN]); leucocytes (&lt;0.6/greater than [&gt;]1.5*upper limit of normal [ULN]); platelets (&lt;0.5*LLN&gt;&lt;/0&gt;1.75*ULN); neutrophils, lymphocytes (&lt;0.8*LLN&gt;&lt;/0&gt;1.2*ULN); eosinophils, basophils, monocytes (&gt;1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (&gt;1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (&gt;3*ULN), total protein, albumin (&lt;0.8*LLN&gt;&lt;/0&gt;1.2*ULN); creatinine, urea (&gt;1.3*ULN); glucose (&lt;0.6*LLN&gt;&lt;/0&gt;1.5*ULN); uric acid (&gt;1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (&lt;0.9*LLN&gt;&lt;/0&gt;1.1*ULN); urine RBCs, urine white blood cells (WBCs) (&gt; or equal[=]20 high-powered field), urine bacteria &gt;20 high-powered field. Overall percentage of participants with any clinically significant laboratory abnormality was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Anti-TCZ Antibodies</measure>
    <time_frame>Baseline up to approximately 142 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score</measure>
    <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
    <description>The DAS 28 ESR score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment (PtGA) of disease activity (visual analog scale [VAS]: 0 millimeter [mm] = no disease activity to 100 mm=maximum disease activity) and the erythrocyte sedimentation rate (ESR in millimeters per hour [mm/hr]). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt (SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating more severe disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Simplified Disease Activity Index (SDAI) Score</measure>
    <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
    <description>The SDAI was calculated as (SJC [28 joints] + TJC [28 joints] + VAS ptGA + VAS physician global assessment of disease activity + C-reactive Protein (CRP) level in milligram/deciliter [mg/dL]). VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in TJC</measure>
    <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
    <description>For TJC a total of 28 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 28 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SJC</measure>
    <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
    <description>For SJC, a total of 28 joints were assessed. The presence of a swollen joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 28 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Remission</measure>
    <time_frame>Week 48, 108</time_frame>
    <description>Clinical remission defined as:DAS28-ESR score &lt; 2.6 and/or SDAI score &lt;/= 3.3.DAS28 score is measure of subject's disease activity calculated using TJC [28 joints],SJC [28 joints],PtGA of disease activity [ VAS:0mm= no disease activity to 100 mm=maximum disease activity] and ESR (mm/hr). DAS28 was calculated as DAS28-ESR = 0.56*sqrt (TJC28) + 0.28*sqrt(SJC28) + 0.70* ln ESR + 0.014*PtGA of disease activity. DAS28-ESR score ranged from 0 to approximately 10, higher score indicating more severe disease activity. SDAI was calculated =[SJC (28 joints) + TJC (28 joints) + VAS PtGA + VAS physician global assessment of disease activity+CRP level(mg/dL)]. VAS assessments:0 mm=no disease activity to 100 mm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Concomitant Corticosteroid Discontinuation</measure>
    <time_frame>Baseline up to approximately 142 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Concomitant Corticosteroid Dose Reduction</measure>
    <time_frame>Baseline up to approximately 142 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Concomitant Corticosteroid Discontinuation</measure>
    <time_frame>Baseline up to approximately 142 weeks</time_frame>
    <description>Time to corticosteroid discontinuation = (End date of corticosteroid treatment - date of first drug intake of this extension study) + 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Concomitant Corticosteroid Dose Reduction</measure>
    <time_frame>Baseline up to approximately 142 weeks</time_frame>
    <description>Time to corticosteroid dose reduction (days) = (Date of the first dose reduction of corticosteroid treatment - date of first drug intake of this extension study) + 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PtGA of Disease Activity</measure>
    <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
    <description>PtGA of disease activity over the previous 24 hours using a 100 mm VAS where left end of the line 0 mm =no disease activity and right end of the line 100 mm =maximum disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient's Assessment of Pain</measure>
    <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
    <description>Patient's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 mm=no pain to right end of the line 100 mm=unbearable pain. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score</measure>
    <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
    <description>The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physician's Global Assessment of Disease Activity</measure>
    <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
    <description>The Physician's Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as &quot;no disease activity&quot; (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as &quot;maximum disease activity&quot;. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ESR</measure>
    <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
    <description>Blood samples were collected for ESR, which is an acute phase reactant and provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CRP</measure>
    <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
    <description>Blood samples were collected for CRP, which is an acute phase reactant and a measure of inflammation. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Tocilizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Moderate to severe rheumatoid arthritis participants from France, who completed the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having improvement in DAS28 of &gt;1.2 points) will continue tocilizumab treatment within this local LTE study for a maximum of 156 weeks, or until SC TCZ becomes commercially available, whichever occurs first.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tocilizumab</intervention_name>
    <description>Participants will receive TCZ 162 milligrams (mg) SC injection once a week.</description>
    <arm_group_label>Tocilizumab</arm_group_label>
    <other_name>RoActemra</other_name>
    <other_name>Actemra</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Negative pregnancy test at screening and baseline&#xD;
&#xD;
          -  Participants who have completed the 97-week WA22762 LTE study on SC or intravenous&#xD;
             (IV) TCZ and who experienced, at any time during WA22762, clinically significant&#xD;
             improvement in DAS28 (&gt;1.2 points), and based on the investigator's judgment may&#xD;
             continue to benefit from TCZ treatment in this study investigating the SC formulation&#xD;
&#xD;
          -  No current or recent adverse events or laboratory findings preventing the use of the&#xD;
             study drug dose of TCZ 162 mg SC at baseline visit&#xD;
&#xD;
          -  Receiving treatment on an outpatient basis&#xD;
&#xD;
          -  Females of childbearing potential and males with female partners of childbearing&#xD;
             potential must agree to use reliable means of contraception during the study and for&#xD;
             at least 3 months following the last dose of study drug&#xD;
&#xD;
          -  Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the&#xD;
             recommended dose are permitted if on stable dose regimen for greater than and equal to&#xD;
             (&gt;/=) 4 weeks prior to baseline&#xD;
&#xD;
          -  Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have prematurely withdrawn from the WA22762 LTE study for any reason&#xD;
&#xD;
          -  Previous treatment with any cell-depleting therapies, including investigational agents&#xD;
             or approved therapies&#xD;
&#xD;
          -  Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent,&#xD;
             or a T-cell co stimulation modulator since the last administration of study drug in&#xD;
             the WA22762 LTE study&#xD;
&#xD;
          -  Immunization with a live/attenuated vaccine since the last administration of study&#xD;
             drug in the WA22762 LTE study&#xD;
&#xD;
          -  Diagnosis, since last WA22762 visit (Week 97), of rheumatic autoimmune disease other&#xD;
             than rheumatoid arthritis; secondary Sjörgen's syndrome with RA is permitted&#xD;
&#xD;
          -  Diagnosis, since last WA22762 visit (Week 97), of inflammatory joint disease other&#xD;
             than RA&#xD;
&#xD;
          -  Uncontrolled disease states, such as asthma or inflammatory bowel disease, where&#xD;
             flares are commonly treated with oral or parenteral corticosteroids&#xD;
&#xD;
          -  Evidence of serious uncontrolled concomitant disease&#xD;
&#xD;
          -  Known active current or history of recurrent infection&#xD;
&#xD;
          -  Primary or secondary immunodeficiency (history of or currently active)&#xD;
&#xD;
          -  Body weight &gt;150 kilograms (kg)&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Inadequate hematologic, renal or liver function&#xD;
&#xD;
          -  History of alcohol, drug or chemical abuse within 1 year prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nantes</city>
        <zip>44035</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <results_first_submitted>October 5, 2016</results_first_submitted>
  <results_first_submitted_qc>October 5, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 28, 2016</results_first_posted>
  <last_update_submitted>October 5, 2016</last_update_submitted>
  <last_update_submitted_qc>October 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 12 participants were screened at 6 sites in France, of which 11 participants were enrolled.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Tocilizumab</title>
          <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 long term extension (LTE) study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of greater than [&gt;] 1.2 points) were administered tocilizumab (TCZ) in this long-term extension study, at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included all participants who received at least one dose of study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Tocilizumab</title>
          <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </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="63.91" spread="11.96"/>
                  </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A SAE was any untoward medical occurrence that at any dose resulted in death, was life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, and congenital anomaly/birth defect. AEs included SAEs as well as non-serious AEs.</description>
        <time_frame>Baseline up to approximately 142 weeks</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A SAE was any untoward medical occurrence that at any dose resulted in death, was life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, and congenital anomaly/birth defect. AEs included SAEs as well as non-serious AEs.</description>
          <population>Safety population</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With AEs and SAEs Related to TCZ</title>
        <description>An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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. AEs included SAEs as well as non-serious AEs. Causality of AEs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AEs with causality of certain, probable/likely, and possible were considered TCZ related.</description>
        <time_frame>Baseline up to approximately 142 weeks</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With AEs and SAEs Related to TCZ</title>
          <description>An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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. AEs included SAEs as well as non-serious AEs. Causality of AEs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AEs with causality of certain, probable/likely, and possible were considered TCZ related.</description>
          <population>Safety population</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Adverse Events of Special Interest (AESIs)</title>
        <description>Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events.</description>
        <time_frame>Baseline up to approximately 142 weeks</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events of Special Interest (AESIs)</title>
          <description>Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events.</description>
          <population>Safety population</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With AESIs Related to TCZ</title>
        <description>AESI for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Percentage of participants with AESI related to the drug were presented. Causality of AESIs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on DC, relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AESIs with causality of certain, probable/likely, and possible were considered TCZ related.</description>
        <time_frame>Baseline up to approximately 142 weeks</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With AESIs Related to TCZ</title>
          <description>AESI for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Percentage of participants with AESI related to the drug were presented. Causality of AESIs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on DC, relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AESIs with causality of certain, probable/likely, and possible were considered TCZ related.</description>
          <population>Safety population</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification</title>
        <description>An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Percentage of participants with AE causing drug discontinuation, interruption and increase or decrease in dose of drug was presented.</description>
        <time_frame>Baseline up to approximately 142 weeks</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification</title>
          <description>An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Percentage of participants with AE causing drug discontinuation, interruption and increase or decrease in dose of drug was presented.</description>
          <population>Safety Population</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AE Leading to Discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE Leading to Interruption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE Leading to Dose Modification</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities</title>
        <description>Criteria for potentially clinically important (PCI) change in vital signs: heart rate value of less than (&lt;) 40 beats per minute and value greater than (&gt;) 150 beats per minute, systolic blood pressure (SBP) of &lt; 80 or &gt;210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of &lt;40 or &gt;130 mmHg, body temperature &lt;32 or &gt; 40 degrees Celsius, respiratory rate of &lt;10 or &gt; 50 breaths/minute and criteria for PCI change in physical examination: &gt;/=10% increase or decrease of body weight in kilograms (kg).</description>
        <time_frame>Baseline up to approximately 142 weeks</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities</title>
          <description>Criteria for potentially clinically important (PCI) change in vital signs: heart rate value of less than (&lt;) 40 beats per minute and value greater than (&gt;) 150 beats per minute, systolic blood pressure (SBP) of &lt; 80 or &gt;210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of &lt;40 or &gt;130 mmHg, body temperature &lt;32 or &gt; 40 degrees Celsius, respiratory rate of &lt;10 or &gt; 50 breaths/minute and criteria for PCI change in physical examination: &gt;/=10% increase or decrease of body weight in kilograms (kg).</description>
          <population>Safety population</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Clinically Significant Laboratory Abnormalities</title>
        <description>Criteria for laboratory tests clinically significant abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(&lt; 0.8*lower limit of normal[LLN]); leucocytes (&lt;0.6/greater than [&gt;]1.5*upper limit of normal [ULN]); platelets (&lt;0.5*LLN&gt;&lt;/0&gt;1.75*ULN); neutrophils, lymphocytes (&lt;0.8*LLN&gt;&lt;/0&gt;1.2*ULN); eosinophils, basophils, monocytes (&gt;1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (&gt;1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (&gt;3*ULN), total protein, albumin (&lt;0.8*LLN&gt;&lt;/0&gt;1.2*ULN); creatinine, urea (&gt;1.3*ULN); glucose (&lt;0.6*LLN&gt;&lt;/0&gt;1.5*ULN); uric acid (&gt;1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (&lt;0.9*LLN&gt;&lt;/0&gt;1.1*ULN); urine RBCs, urine white blood cells (WBCs) (&gt; or equal[=]20 high-powered field), urine bacteria &gt;20 high-powered field. Overall percentage of participants with any clinically significant laboratory abnormality was reported.</description>
        <time_frame>Baseline up to approximately 142 weeks</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinically Significant Laboratory Abnormalities</title>
          <description>Criteria for laboratory tests clinically significant abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(&lt; 0.8*lower limit of normal[LLN]); leucocytes (&lt;0.6/greater than [&gt;]1.5*upper limit of normal [ULN]); platelets (&lt;0.5*LLN&gt;&lt;/0&gt;1.75*ULN); neutrophils, lymphocytes (&lt;0.8*LLN&gt;&lt;/0&gt;1.2*ULN); eosinophils, basophils, monocytes (&gt;1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (&gt;1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (&gt;3*ULN), total protein, albumin (&lt;0.8*LLN&gt;&lt;/0&gt;1.2*ULN); creatinine, urea (&gt;1.3*ULN); glucose (&lt;0.6*LLN&gt;&lt;/0&gt;1.5*ULN); uric acid (&gt;1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (&lt;0.9*LLN&gt;&lt;/0&gt;1.1*ULN); urine RBCs, urine white blood cells (WBCs) (&gt; or equal[=]20 high-powered field), urine bacteria &gt;20 high-powered field. Overall percentage of participants with any clinically significant laboratory abnormality was reported.</description>
          <population>Safety population</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Anti-TCZ Antibodies</title>
        <time_frame>Baseline up to approximately 142 weeks</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Anti-TCZ Antibodies</title>
          <population>Safety population</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score</title>
        <description>The DAS 28 ESR score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment (PtGA) of disease activity (visual analog scale [VAS]: 0 millimeter [mm] = no disease activity to 100 mm=maximum disease activity) and the erythrocyte sedimentation rate (ESR in millimeters per hour [mm/hr]). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt (SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating more severe disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
        <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
        <population>Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score</title>
          <description>The DAS 28 ESR score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment (PtGA) of disease activity (visual analog scale [VAS]: 0 millimeter [mm] = no disease activity to 100 mm=maximum disease activity) and the erythrocyte sedimentation rate (ESR in millimeters per hour [mm/hr]). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt (SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating more severe disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
          <population>Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.81" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.32" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 60 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 72 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 84 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 96 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 108 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="1.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 120 (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.75" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Completer last visit (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Early withdrawal (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.76" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Last visit (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="1.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Simplified Disease Activity Index (SDAI) Score</title>
        <description>The SDAI was calculated as (SJC [28 joints] + TJC [28 joints] + VAS ptGA + VAS physician global assessment of disease activity + C-reactive Protein (CRP) level in milligram/deciliter [mg/dL]). VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
        <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
        <population>Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Simplified Disease Activity Index (SDAI) Score</title>
          <description>The SDAI was calculated as (SJC [28 joints] + TJC [28 joints] + VAS ptGA + VAS physician global assessment of disease activity + C-reactive Protein (CRP) level in milligram/deciliter [mg/dL]). VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
          <population>Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.</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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.21" spread="4.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12 (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.17" spread="12.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.48" spread="7.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" spread="4.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48 (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.02" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 60 (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.02" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 72 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.19" spread="1.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 84 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.83" spread="3.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 96 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.60" spread="4.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 108 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.25" spread="8.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 120 (n=0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participant was evaluable for the specified time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Completer last visit (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" spread="5.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Early withdrawal (n=1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.38" spread="NA">Standard deviation data is not applicable since only 1 participant was evaluable at indicated time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Last visit (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.25" spread="10.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in TJC</title>
        <description>For TJC a total of 28 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 28 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
        <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
        <population>Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in TJC</title>
          <description>For TJC a total of 28 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 28 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
          <population>Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.</population>
          <units>Tender Joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.27" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.20" spread="3.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 60 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.20" spread="5.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 72 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.60" spread="3.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 84 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44" spread="1.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 96 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 108 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.57" spread="5.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 120 (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Completer Last Visit (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.44" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Early Withdrawal n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.50" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Last Visit (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" spread="3.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SJC</title>
        <description>For SJC, a total of 28 joints were assessed. The presence of a swollen joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 28 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
        <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
        <population>Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SJC</title>
          <description>For SJC, a total of 28 joints were assessed. The presence of a swollen joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 28 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
          <population>Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.</population>
          <units>Swollen Joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.60" spread="2.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.80" spread="1.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 60 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.70" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 72 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.30" spread="2.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 84 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.78" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 96 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.67" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 108 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="2.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 120 (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Completer Last Visit (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="2.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Early Withdrawal (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Last Visit (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="2.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Remission</title>
        <description>Clinical remission defined as:DAS28-ESR score &lt; 2.6 and/or SDAI score &lt;/= 3.3.DAS28 score is measure of subject's disease activity calculated using TJC [28 joints],SJC [28 joints],PtGA of disease activity [ VAS:0mm= no disease activity to 100 mm=maximum disease activity] and ESR (mm/hr). DAS28 was calculated as DAS28-ESR = 0.56*sqrt (TJC28) + 0.28*sqrt(SJC28) + 0.70* ln ESR + 0.014*PtGA of disease activity. DAS28-ESR score ranged from 0 to approximately 10, higher score indicating more severe disease activity. SDAI was calculated =[SJC (28 joints) + TJC (28 joints) + VAS PtGA + VAS physician global assessment of disease activity+CRP level(mg/dL)]. VAS assessments:0 mm=no disease activity to 100 mm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity.</description>
        <time_frame>Week 48, 108</time_frame>
        <population>Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Remission</title>
          <description>Clinical remission defined as:DAS28-ESR score &lt; 2.6 and/or SDAI score &lt;/= 3.3.DAS28 score is measure of subject's disease activity calculated using TJC [28 joints],SJC [28 joints],PtGA of disease activity [ VAS:0mm= no disease activity to 100 mm=maximum disease activity] and ESR (mm/hr). DAS28 was calculated as DAS28-ESR = 0.56*sqrt (TJC28) + 0.28*sqrt(SJC28) + 0.70* ln ESR + 0.014*PtGA of disease activity. DAS28-ESR score ranged from 0 to approximately 10, higher score indicating more severe disease activity. SDAI was calculated =[SJC (28 joints) + TJC (28 joints) + VAS PtGA + VAS physician global assessment of disease activity+CRP level(mg/dL)]. VAS assessments:0 mm=no disease activity to 100 mm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity.</description>
          <population>Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 108 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Concomitant Corticosteroid Discontinuation</title>
        <time_frame>Baseline up to approximately 142 weeks</time_frame>
        <population>Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Concomitant Corticosteroid Discontinuation</title>
          <population>Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.</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="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Concomitant Corticosteroid Dose Reduction</title>
        <time_frame>Baseline up to approximately 142 weeks</time_frame>
        <population>Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Concomitant Corticosteroid Dose Reduction</title>
          <population>Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.</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="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Concomitant Corticosteroid Discontinuation</title>
        <description>Time to corticosteroid discontinuation = (End date of corticosteroid treatment - date of first drug intake of this extension study) + 1.</description>
        <time_frame>Baseline up to approximately 142 weeks</time_frame>
        <population>Safety population. Here N (number of participants analyzed) represents the participants who discontinued concomitant corticosteroids</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Concomitant Corticosteroid Discontinuation</title>
          <description>Time to corticosteroid discontinuation = (End date of corticosteroid treatment - date of first drug intake of this extension study) + 1.</description>
          <population>Safety population. Here N (number of participants analyzed) represents the participants who discontinued concomitant corticosteroids</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="472.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Concomitant Corticosteroid Dose Reduction</title>
        <description>Time to corticosteroid dose reduction (days) = (Date of the first dose reduction of corticosteroid treatment - date of first drug intake of this extension study) + 1.</description>
        <time_frame>Baseline up to approximately 142 weeks</time_frame>
        <population>Safety population. Here, N (number of participants analyzed) represents the participants who had concomitant corticosteroid dose reduction.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Concomitant Corticosteroid Dose Reduction</title>
          <description>Time to corticosteroid dose reduction (days) = (Date of the first dose reduction of corticosteroid treatment - date of first drug intake of this extension study) + 1.</description>
          <population>Safety population. Here, N (number of participants analyzed) represents the participants who had concomitant corticosteroid dose reduction.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" lower_limit="15.0" upper_limit="758.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PtGA of Disease Activity</title>
        <description>PtGA of disease activity over the previous 24 hours using a 100 mm VAS where left end of the line 0 mm =no disease activity and right end of the line 100 mm =maximum disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
        <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
        <population>Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PtGA of Disease Activity</title>
          <description>PtGA of disease activity over the previous 24 hours using a 100 mm VAS where left end of the line 0 mm =no disease activity and right end of the line 100 mm =maximum disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
          <population>Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.55" spread="21.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12 (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.82" spread="36.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" spread="12.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.90" spread="26.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.89" spread="14.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 60 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.89" spread="20.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 72 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.44" spread="17.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 84 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="16.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 96 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.11" spread="16.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 108 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.00" spread="24.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 120 (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.50" spread="23.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Completer last visit (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.38" spread="14.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Early withdrawal (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.00" spread="15.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Last visit (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.70" spread="21.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient's Assessment of Pain</title>
        <description>Patient's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 mm=no pain to right end of the line 100 mm=unbearable pain. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
        <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
        <population>Safety Population. Here, 'n' represents the number of participants available for assessment at a given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient's Assessment of Pain</title>
          <description>Patient's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 mm=no pain to right end of the line 100 mm=unbearable pain. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
          <population>Safety Population. Here, 'n' represents the number of participants available for assessment at a given time point.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.18" spread="20.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12 (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.91" spread="36.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.80" spread="14.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.90" spread="20.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.44" spread="11.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 60 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.78" spread="15.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 72 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.11" spread="16.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 84 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="14.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 96 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.22" spread="13.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 108 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.86" spread="18.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 120 (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.00" spread="26.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Completer last visit (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" spread="29.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Early withdrawal (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.50" spread="16.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Last visit (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.10" spread="30.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score</title>
        <description>The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
        <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
        <population>Safety population, Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score</title>
          <description>The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
          <population>Safety population, Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.77" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 60 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 72 (n=6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.25" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 84 (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 96 (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 108 (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 120 (n=1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Standard deviation data is not applicable since only 1 participant was evaluable at indicated time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Completer Last Visit (n=6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Early Withdrawal (n=1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Standard deviation data is not applicable since only 1 participant was evaluable at indicated time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Last Visit (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physician's Global Assessment of Disease Activity</title>
        <description>The Physician's Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as &quot;no disease activity&quot; (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as &quot;maximum disease activity&quot;. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
        <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
        <population>Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physician's Global Assessment of Disease Activity</title>
          <description>The Physician's Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as &quot;no disease activity&quot; (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as &quot;maximum disease activity&quot;. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
          <population>Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.00" spread="10.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.60" spread="31.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.22" spread="12.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.22" spread="17.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.11" spread="7.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 60 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.13" spread="6.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 72 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.75" spread="7.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 84 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="9.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 96 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" spread="19.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 108 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="6.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 120 (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="7.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Completer last visit (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.71" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Early withdrawal (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.5" spread="10.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Last visit (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.33" spread="17.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ESR</title>
        <description>Blood samples were collected for ESR, which is an acute phase reactant and provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
        <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
        <population>Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ESR</title>
          <description>Blood samples were collected for ESR, which is an acute phase reactant and provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
          <population>Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.</population>
          <units>mm/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.82" spread="7.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.44" spread="8.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.11" spread="8.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.89" spread="17.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.90" spread="10.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 60 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="12.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 72 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.60" spread="7.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 84 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.80" spread="11.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 96 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.22" spread="9.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 108 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" spread="21.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 120 (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Completer last visit (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.22" spread="6.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Early withdrawal (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.00" spread="15.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Last visit (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.36" spread="9.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CRP</title>
        <description>Blood samples were collected for CRP, which is an acute phase reactant and a measure of inflammation. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
        <time_frame>Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)</time_frame>
        <population>Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CRP</title>
          <description>Blood samples were collected for CRP, which is an acute phase reactant and a measure of inflammation. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.</description>
          <population>Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.</population>
          <units>milligrams per liter (mg/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12 (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24 (n=2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.25" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 60 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 72 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 84 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 96 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 108 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.55" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 120 (n=0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participant was evaluable for the specified time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Completer last visit (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>change at Early withdrawal (n=1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.79" spread="NA">Standard deviation data is not applicable since only 1 participant was evaluable at indicated time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Last visit (n=4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" spread="2.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to approximately 142 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tocilizumab</title>
          <description>Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of &gt; 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Inflammatory pseudotumour</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Extremity necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dacryostenosis acquired</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Radicular cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Lip injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Scan abdomen abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Lipid metabolism disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rheumatoid nodule</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sjogren's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Benign neoplasm of spinal cord</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pyelocaliectasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Tooth extraction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.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/NCT01734993
org study id: ML28544
nct id: NCT01734993
lead sponsor: 
This multicenter, open-label, single arm, interventional, long-term extension (LTE) study
      will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French
      participants with moderate to severe RA who have completed the Week 97 visit of WA22762 LTE
      study (NCT01194414) (EudraCT Number 2010-018375-22). Participants from France, who completed
      the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having
      improvement in disease activity score based on 28-joint count [DAS28] of greater than [>] 1.2
      points) will continue TCZ treatment within this local LTE study for a maximum of 156 weeks of
      subcutaneous (SC) TCZ treatment, or until SC TCZ becomes commercially available, whichever
      occurs first.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to approximately 142 weeks
description: An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A SAE was any untoward medical occurrence that at any dose resulted in death, was life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, and congenital anomaly/birth defect. AEs included SAEs as well as non-serious AEs.
measure: Percentage of Participants With AEs and SAEs Related to TCZ
time frame: Baseline up to approximately 142 weeks
description: An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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. AEs included SAEs as well as non-serious AEs. Causality of AEs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AEs with causality of certain, probable/likely, and possible were considered TCZ related.
measure: Percentage of Participants With Adverse Events of Special Interest (AESIs)
time frame: Baseline up to approximately 142 weeks
description: Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events.
measure: Percentage of Participants With AESIs Related to TCZ
time frame: Baseline up to approximately 142 weeks
description: AESI for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Percentage of participants with AESI related to the drug were presented. Causality of AESIs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on DC, relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AESIs with causality of certain, probable/likely, and possible were considered TCZ related.
measure: Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification
time frame: Baseline up to approximately 142 weeks
description: An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Percentage of participants with AE causing drug discontinuation, interruption and increase or decrease in dose of drug was presented.
measure: Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities
time frame: Baseline up to approximately 142 weeks
description: Criteria for potentially clinically important (PCI) change in vital signs: heart rate value of less than (<) 40 beats per minute and value greater than (>) 150 beats per minute, systolic blood pressure (SBP) of < 80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, body temperature <32 or > 40 degrees Celsius, respiratory rate of <10 or > 50 breaths/minute and criteria for PCI change in physical examination: >/=10% increase or decrease of body weight in kilograms (kg).
measure: Percentage of Participants With Clinically Significant Laboratory Abnormalities
time frame: Baseline up to approximately 142 weeks
description: Criteria for laboratory tests clinically significant abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(< 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN></0>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN></0>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN></0>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN></0>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN></0>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Overall percentage of participants with any clinically significant laboratory abnormality was reported.
measure: Percentage of Participants With Anti-TCZ Antibodies
time frame: Baseline up to approximately 142 weeks
measure: Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score
time frame: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
description: The DAS 28 ESR score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment (PtGA) of disease activity (visual analog scale [VAS]: 0 millimeter [mm] = no disease activity to 100 mm=maximum disease activity) and the erythrocyte sedimentation rate (ESR in millimeters per hour [mm/hr]). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt (SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating more severe disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Score
time frame: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
description: The SDAI was calculated as (SJC [28 joints] + TJC [28 joints] + VAS ptGA + VAS physician global assessment of disease activity + C-reactive Protein (CRP) level in milligram/deciliter [mg/dL]). VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
measure: Change From Baseline in TJC
time frame: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
description: For TJC a total of 28 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 28 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
measure: Change From Baseline in SJC
time frame: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
description: For SJC, a total of 28 joints were assessed. The presence of a swollen joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 28 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
measure: Percentage of Participants With Clinical Remission
time frame: Week 48, 108
description: Clinical remission defined as:DAS28-ESR score < 2.6 and/or SDAI score </= 3.3.DAS28 score is measure of subject's disease activity calculated using TJC [28 joints],SJC [28 joints],PtGA of disease activity [ VAS:0mm= no disease activity to 100 mm=maximum disease activity] and ESR (mm/hr). DAS28 was calculated as DAS28-ESR = 0.56*sqrt (TJC28) + 0.28*sqrt(SJC28) + 0.70* ln ESR + 0.014*PtGA of disease activity. DAS28-ESR score ranged from 0 to approximately 10, higher score indicating more severe disease activity. SDAI was calculated =[SJC (28 joints) + TJC (28 joints) + VAS PtGA + VAS physician global assessment of disease activity+CRP level(mg/dL)]. VAS assessments:0 mm=no disease activity to 100 mm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity.
measure: Percentage of Participants With Concomitant Corticosteroid Discontinuation
time frame: Baseline up to approximately 142 weeks
measure: Percentage of Participants With Concomitant Corticosteroid Dose Reduction
time frame: Baseline up to approximately 142 weeks
measure: Time to Concomitant Corticosteroid Discontinuation
time frame: Baseline up to approximately 142 weeks
description: Time to corticosteroid discontinuation = (End date of corticosteroid treatment - date of first drug intake of this extension study) + 1.
measure: Time to Concomitant Corticosteroid Dose Reduction
time frame: Baseline up to approximately 142 weeks
description: Time to corticosteroid dose reduction (days) = (Date of the first dose reduction of corticosteroid treatment - date of first drug intake of this extension study) + 1.
measure: Change From Baseline in PtGA of Disease Activity
time frame: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
description: PtGA of disease activity over the previous 24 hours using a 100 mm VAS where left end of the line 0 mm =no disease activity and right end of the line 100 mm =maximum disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
measure: Change From Baseline in Patient's Assessment of Pain
time frame: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
description: Patient's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 mm=no pain to right end of the line 100 mm=unbearable pain. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score
time frame: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
description: The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
measure: Change From Baseline in Physician's Global Assessment of Disease Activity
time frame: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
description: The Physician's Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity". Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
measure: Change From Baseline in ESR
time frame: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
description: Blood samples were collected for ESR, which is an acute phase reactant and provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
measure: Change From Baseline in CRP
time frame: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
description: Blood samples were collected for CRP, which is an acute phase reactant and a measure of inflammation. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
arm group label: Tocilizumab
arm group type: Experimental
description: Moderate to severe rheumatoid arthritis participants from France, who completed the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having improvement in DAS28 of >1.2 points) will continue tocilizumab treatment within this local LTE study for a maximum of 156 weeks, or until SC TCZ becomes commercially available, whichever occurs first.
intervention type: Drug
intervention name: Tocilizumab
description: Participants will receive TCZ 162 milligrams (mg) SC injection once a week.
arm group label: Tocilizumab
other name: RoActemra
other name: Actemra
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
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