<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/NCT01664117</url>
  </required_header>
  <id_info>
    <org_study_id>ML28356</org_study_id>
    <secondary_id>ROC-BIO-2011-01</secondary_id>
    <nct_id>NCT01664117</nct_id>
  </id_info>
  <brief_title>An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy</brief_title>
  <official_title>Study of the Profile and Clinical Management of Patients With Rheumatoid Arthritis Treated With Biologic Therapy Alone</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 observational multicenter study will evaluate the management of disease and safety in&#xD;
      clinical practice in patients with moderate to severe rheumatoid arthritis receiving any&#xD;
      biological therapies in monotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Level of Education Completed</measure>
    <time_frame>At Visit 1 (Single visit study)</time_frame>
    <description>Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Smoking Habits</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Smoking habits is a component of socio-demographic characteristics. Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Smoking-habit for Smokers or Ex-smokers (Packs in Years)</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Smoking-habit included number of pack per years is reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Smoking-habit included years of smoking/quit smoking is reported for participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Time of Onset of Rheumatoid Arthritis</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Onset of rheumatoid arthritis is a component of clinical characteristics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Family History of Rheumatoid Arthritis</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Co-morbidities</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Extra-articular Manifestations at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty's syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Number of Painful and Swollen Joints at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physician's Global Assessment of Disease Activity at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>The Physician's global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (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; (maximum arthritis disease activity).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient's Global Assessment of Disease Activity at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Patient global assessment of disease activity visual analog scale is 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; (maximum arthritis disease activity).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Pain Visual Analog Scale Score at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as &quot;no pain&quot; and the right-hand extreme equals 10 as &quot;unbearable pain&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Joint Damage at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Number of participants with joint damage is recorded as yes and no.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Disease Activity Score by Categorization at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>DAS28 is divided into 4 categories as: remission &lt;2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high &gt;5.1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Score on Clinical Disease Activity Index at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinical Disease Activity by Categorization at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>CDAI is divided into 4 categories as: remission &lt;2.8, low activity 2.8-10, moderate 10-22 and high&gt;22.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Score on Simple Disease Activity Index at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>SDAI is divided into 4 categories as: remission (&lt;3.3), low activity (3.3-11), moderate activity (11-26) and high activity (&gt;26).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Each sDMARD Before The Study</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Last sDMARD Prescribed Before the Study</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Prescribed First bDMARD Before the Study</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Number of participants prescribed first bDMARD before the study was presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Each bDMARD Before the Study</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Time Between the Last sDMARD and bDMARD Received at Visit 1</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Changing the Previous sDMARD/ bDMARD</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. There may be more than one reason for changing sDMARD/ bDMARD per participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy)</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Number of sDMARD and bDMARDs received by Participants before the study was presented</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment</measure>
    <time_frame>At Visit 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Discontinued the Previous Treatment and Started the Study Treatment</measure>
    <time_frame>At Visit 1</time_frame>
    <description>The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Median time in months taking the Biologic Agent in monotherapy before the study was presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Treated With Concomitant Medications Before the Study</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs [NSAID], and other treatment) before the study were presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Received Current bDMARD Treatment at the Time of the Study</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Reasons for Starting Current Biologic Monotherapy</measure>
    <time_frame>At Visit 1</time_frame>
    <description>The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA</measure>
    <time_frame>At Visit 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)</measure>
    <time_frame>At Visit 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study</measure>
    <time_frame>At Visit 1</time_frame>
    <description>Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events Leading to a Change of Treatment</measure>
    <time_frame>At the time of change of treatment</time_frame>
    <description>An Adverse Event was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Adverse events were collected as a reason for the change to monotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Adverse Events and Any Serious Adverse Events</measure>
    <time_frame>At the time of change of treatment (to the current treatment)</time_frame>
    <description>An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">210</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>bDMARD Monotherapy</arm_group_label>
    <description>Patients with moderate to severe rheumatoid arthritis (RA) will be treated with bDMARD (biologic disease-modifying antirheumatic drug) monotherapy under routine clinical practice conditions at rheumatology clinics</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with moderate to severe rheumatoid arthritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/=18 years of age&#xD;
&#xD;
          -  Patients with moderate to severe rheumatoid arthritis who have had an inadequate&#xD;
             response or intolerance to disease modifying antirheumatic drugs (DMARDs) or other&#xD;
             biological drugs&#xD;
&#xD;
          -  Patients treated with biologic DMARDs alone for at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not willing or unable to give written informed consent for participation in&#xD;
             this study&#xD;
&#xD;
          -  Patients who are participating in any clinical trial at the time of this study&#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>Vitoria</city>
        <state>Alava</state>
        <zip>01009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zafra</city>
        <state>Badajoz</state>
        <zip>06300</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Viladecans</city>
        <state>Barcelona</state>
        <zip>08840</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jerez de la Frontera</city>
        <state>Cadiz</state>
        <zip>11407</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vinaroz</city>
        <state>Castellon</state>
        <zip>12500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cenes de la vega</city>
        <state>Granada</state>
        <zip>18190</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Granda</city>
        <state>Granada</state>
        <zip>18190</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Sebastian</city>
        <state>Guipuzcoa</state>
        <zip>20080</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ibiza</city>
        <state>Islas Baleares</state>
        <zip>07800</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Inca</city>
        <state>Islas Baleares</state>
        <zip>07300</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manacor (Islas Baleares)</city>
        <state>Islas Baleares</state>
        <zip>07500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jaén</city>
        <state>Jaen</state>
        <zip>23007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Coruna</city>
        <state>La Coruña</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alcala de Henares</city>
        <state>Madrid</state>
        <zip>28805</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Benalmadena</city>
        <state>Malaga</state>
        <zip>29630</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36214</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gandia</city>
        <state>Valencia</state>
        <zip>46700</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Burgos</city>
        <zip>06006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Caceres</city>
        <zip>10310</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cordoba</city>
        <zip>14001</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <zip>28905</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Malaga</city>
        <zip>29005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Murcia</city>
        <zip>30008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palencia</city>
        <zip>34005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sevilla</city>
        <zip>41018</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tenerife</city>
        <zip>38010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toledo</city>
        <zip>45004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Valladolid</city>
        <zip>47005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zamora</city>
        <zip>49022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>February 1, 2016</results_first_submitted>
  <results_first_submitted_qc>March 15, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 4, 2016</results_first_posted>
  <last_update_submitted>March 15, 2016</last_update_submitted>
  <last_update_submitted_qc>March 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 4, 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 210 participants were enrolled from 38 rheumatology units in Spain. This study was conducted between June 2012 and June 2013.</recruitment_details>
      <pre_assignment_details>Of 210 participants, one participant was excluded from the study because of past history of biologic disease-modifying antirheumatic drug (bDMARD) monotherapy under 6 months. Therefore, 209 participants were evaluated in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>bDMARD Monotherapy</title>
          <description>Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="209"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="209"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>bDMARD Monotherapy</title>
          <description>Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="209"/>
          </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="57.61" spread="13.59"/>
                  </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="173"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Level of Education Completed</title>
        <description>Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)</description>
        <time_frame>At Visit 1 (Single visit study)</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Level of Education Completed</title>
          <description>Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)</description>
          <population>Analysis population included all enrolled participants who met the screening criteria</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cannot read</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No formal education</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Primary education or equivalent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General secondary education</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vocational education</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Higher education or equivalent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Smoking Habits</title>
        <description>Smoking habits is a component of socio-demographic characteristics. Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Smoking Habits</title>
          <description>Smoking habits is a component of socio-demographic characteristics. Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ex-smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Smoking-habit for Smokers or Ex-smokers (Packs in Years)</title>
        <description>Smoking-habit included number of pack per years is reported.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria. n = number of evaluated participants</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Smoking-habit for Smokers or Ex-smokers (Packs in Years)</title>
          <description>Smoking-habit included number of pack per years is reported.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria. n = number of evaluated participants</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of pack-years, smoker, n = 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120.20" spread="138.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of pack-years, ex-smoker, n = 23</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122.26" spread="122.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )</title>
        <description>Smoking-habit included years of smoking/quit smoking is reported for participants.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria. 'n' = number of evaluated participants</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )</title>
          <description>Smoking-habit included years of smoking/quit smoking is reported for participants.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria. 'n' = number of evaluated participants</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Years smoking/quit smoking, smoker, n = 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.73" spread="9.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Years smoking/quit smoking, ex-smoker, n = 23</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.35" spread="8.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Time of Onset of Rheumatoid Arthritis</title>
        <description>Onset of rheumatoid arthritis is a component of clinical characteristics.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Time of Onset of Rheumatoid Arthritis</title>
          <description>Onset of rheumatoid arthritis is a component of clinical characteristics.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.45" spread="8.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Family History of Rheumatoid Arthritis</title>
        <description>Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Family History of Rheumatoid Arthritis</title>
          <description>Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Co-morbidities</title>
        <description>Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Co-morbidities</title>
          <description>Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Extra-articular Manifestations at Visit 1</title>
        <description>Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty's syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Extra-articular Manifestations at Visit 1</title>
          <description>Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty's syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Number of Painful and Swollen Joints at Visit 1</title>
        <description>Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Painful and Swollen Joints at Visit 1</title>
          <description>Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Number of 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="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Painful joints</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.92" spread="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swollen joints</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.84" spread="2.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Physician's Global Assessment of Disease Activity at Visit 1</title>
        <description>The Physician's global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (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; (maximum arthritis disease activity).</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Physician's Global Assessment of Disease Activity at Visit 1</title>
          <description>The Physician's global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (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; (maximum arthritis disease activity).</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</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="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.49" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient's Global Assessment of Disease Activity at Visit 1</title>
        <description>Patient global assessment of disease activity visual analog scale is 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; (maximum arthritis disease activity).</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient's Global Assessment of Disease Activity at Visit 1</title>
          <description>Patient global assessment of disease activity visual analog scale is 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; (maximum arthritis disease activity).</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</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="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.11" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1</title>
        <description>Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1</title>
          <description>Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>WBC, n = 183</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets, n = 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RBC, n = 170</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, n = 192</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Haematocrit, n = 174</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, n = 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils, n = 169</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, n = 168</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, n = 173</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, n = 168</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1</title>
        <description>Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria. 'n' =number of evaluated participants</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1</title>
          <description>Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria. 'n' =number of evaluated participants</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT, n = 184</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, n = 172</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides, n = 144</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total cholesterol, n = 156</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL, n = 101</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL, n = 102</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total lipids, n = 23</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies</title>
        <description>Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies</title>
          <description>Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>RF - positive for presence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RF - negative for presence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RF - not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-CCP antibodies - positive for presence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-CCP antibodies - negative for presence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-CCP antibodies - not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1</title>
        <description>The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1</title>
          <description>The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CRP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ESR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Pain Visual Analog Scale Score at Visit 1</title>
        <description>Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as &quot;no pain&quot; and the right-hand extreme equals 10 as &quot;unbearable pain&quot;</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria. Out of 209 participants, 207 were analysed for patient pain visual analog scale.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Pain Visual Analog Scale Score at Visit 1</title>
          <description>Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as &quot;no pain&quot; and the right-hand extreme equals 10 as &quot;unbearable pain&quot;</description>
          <population>Analysis population included all enrolled participants who met the screening criteria. Out of 209 participants, 207 were analysed for patient pain visual analog scale.</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="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.09" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Joint Damage at Visit 1</title>
        <description>Number of participants with joint damage is recorded as yes and no.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Joint Damage at Visit 1</title>
          <description>Number of participants with joint damage is recorded as yes and no.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1</title>
        <description>Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1</title>
          <description>Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</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="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.70" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Disease Activity Score by Categorization at Visit 1</title>
        <description>DAS28 is divided into 4 categories as: remission &lt;2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high &gt;5.1.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Disease Activity Score by Categorization at Visit 1</title>
          <description>DAS28 is divided into 4 categories as: remission &lt;2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high &gt;5.1.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Score on Clinical Disease Activity Index at Visit 1</title>
        <description>Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Score on Clinical Disease Activity Index at Visit 1</title>
          <description>Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Scores 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="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.36" spread="6.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinical Disease Activity by Categorization at Visit 1</title>
        <description>CDAI is divided into 4 categories as: remission &lt;2.8, low activity 2.8-10, moderate 10-22 and high&gt;22.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Disease Activity by Categorization at Visit 1</title>
          <description>CDAI is divided into 4 categories as: remission &lt;2.8, low activity 2.8-10, moderate 10-22 and high&gt;22.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Score on Simple Disease Activity Index at Visit 1</title>
        <description>Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Score on Simple Disease Activity Index at Visit 1</title>
          <description>Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Scores 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="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.76" spread="7.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1</title>
        <description>SDAI is divided into 4 categories as: remission (&lt;3.3), low activity (3.3-11), moderate activity (11-26) and high activity (&gt;26).</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1</title>
          <description>SDAI is divided into 4 categories as: remission (&lt;3.3), low activity (3.3-11), moderate activity (11-26) and high activity (&gt;26).</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study</title>
        <description>Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study</title>
          <description>Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First sDMARD as monotherapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>First sDMARD as combination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug</title>
        <description>Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria. 'n' = number of participants prescribed with first sDMARD or bDMARD.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug</title>
          <description>Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria. 'n' = number of participants prescribed with first sDMARD or bDMARD.</population>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>sDMARD, n = 209</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.53" spread="52.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>bDMARD, n = 126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.81" spread="86.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Each sDMARD Before The Study</title>
        <description>Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Each sDMARD Before The Study</title>
          <description>Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Azathioprine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Penicillamine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sulfasalazine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hydroxychloroquine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gold salts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloroquine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leflunomide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ciclosporin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Methotrexate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chlorambucil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Last sDMARD Prescribed Before the Study</title>
        <description>Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Last sDMARD Prescribed Before the Study</title>
          <description>Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Azathioprine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Penicillamine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sulfasalazine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hydroxychloroquine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gold salts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leflunomide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ciclosporin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Methotrexate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leflunomide + methotrexate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Prescribed First bDMARD Before the Study</title>
        <description>Number of participants prescribed first bDMARD before the study was presented.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Prescribed First bDMARD Before the Study</title>
          <description>Number of participants prescribed first bDMARD before the study was presented.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Each bDMARD Before the Study</title>
        <description>Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Each bDMARD Before the Study</title>
          <description>Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Etanercept</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infliximab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Golimumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adalimumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abatacept</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tocilizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rituximab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anakinra</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Certolizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Time Between the Last sDMARD and bDMARD Received at Visit 1</title>
        <description>Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the inclusion criteria. 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Time Between the Last sDMARD and bDMARD Received at Visit 1</title>
          <description>Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.</description>
          <population>Analysis Population included all enrolled participants who met the inclusion criteria. 'n' signifies the number of participants analyzed at specified time point.</population>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>sDMARD, n=64</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.39" spread="19.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sDMARD + Biologic agent, n=95</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.78" spread="9.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monotherapy, n=50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.69" spread="32.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Changing the Previous sDMARD/ bDMARD</title>
        <description>Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. There may be more than one reason for changing sDMARD/ bDMARD per participant.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria. 'n' represents the number of participants analyzed at a specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Changing the Previous sDMARD/ bDMARD</title>
          <description>Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. There may be more than one reason for changing sDMARD/ bDMARD per participant.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria. 'n' represents the number of participants analyzed at a specified time point.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>sDMARD, Lack of efficacy, n = 209</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sDMARD, Adverse events, n = 209</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sDMARD, Intolerance, n = 209</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sDMARD, Clinical improvement, n = 209</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sDMARD, Other, n = 209</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>bDMARD, Lack of efficacy, n = 126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>bDMARD, Adverse events, n = 126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>bDMARD, Intolerance, n = 126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>bDMARD, Clinical improvement, n = 126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>bDMARD, Other, n = 126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy)</title>
        <description>Number of sDMARD and bDMARDs received by Participants before the study was presented</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria. 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy)</title>
          <description>Number of sDMARD and bDMARDs received by Participants before the study was presented</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria. 'n' signifies the number of participants analyzed at specified time point.</population>
          <units>Number of sDMARD/bDMARD</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of sDMARD received before the study, n=209</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.63" spread="1.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of bDMARD received before the study, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.67" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment</title>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment</title>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>sDMARD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sDMARD+ bDMARD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>bDMARD</title>
              <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>Number of Participants Discontinued the Previous Treatment and Started the Study Treatment</title>
        <description>The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Discontinued the Previous Treatment and Started the Study Treatment</title>
          <description>The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lack of efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intolerance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment</title>
        <description>Median time in months taking the Biologic Agent in monotherapy before the study was presented.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria. 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment</title>
          <description>Median time in months taking the Biologic Agent in monotherapy before the study was presented.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria. 'n' signifies the number of participants analyzed at specified time point.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Etanercept, n = 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.4" lower_limit="0.7" upper_limit="95.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infliximab, n = 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.9" lower_limit="8.2" upper_limit="118.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Golimumab, n = 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.5" lower_limit="59.5" upper_limit="59.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adalimumab, n = 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="2.0" upper_limit="47.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abatacept, n = 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.6" lower_limit="14.3" upper_limit="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tocilizumab, n = 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" lower_limit="10.1" upper_limit="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rituximab, n = 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" lower_limit="0.0" upper_limit="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Treated With Concomitant Medications Before the Study</title>
        <description>Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs [NSAID], and other treatment) before the study were presented.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Treated With Concomitant Medications Before the Study</title>
          <description>Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs [NSAID], and other treatment) before the study were presented.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Corticosteroids</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-steroidal anti-inflammatories drugs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Received Current bDMARD Treatment at the Time of the Study</title>
        <description>Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Received Current bDMARD Treatment at the Time of the Study</title>
          <description>Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Etanercept</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infliximab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adalimumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abatacept</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tocilizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rituximab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Certolizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy</title>
        <description>Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy</title>
          <description>Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Corticosteroids</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NSAID</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corticosteroid + NSAID</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Reasons for Starting Current Biologic Monotherapy</title>
        <description>The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Reasons for Starting Current Biologic Monotherapy</title>
          <description>The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lack of efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intolerance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study</title>
        <description>Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study</title>
          <description>Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tocilizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ANTI-TNF</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA</title>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria. 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA</title>
          <population>Analysis Population included all enrolled participants who met the screening criteria. 'n' signifies the number of participants analyzed at specified time point.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tocilizumab, n = 122</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.34" spread="7.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other, n = 87</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.23" spread="9.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)</title>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria. 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)</title>
          <population>Analysis Population included all enrolled participants who met the screening criteria. 'n' signifies the number of participants analyzed at specified time point.</population>
          <units>Number of sDMARD/bDMARDs/Other</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No. of sDMARDs tocilizumab before the study,n=122</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.59" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other before the study, n=87</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.69" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>bDMARDs-Tocilizumab before the study,n=122</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.34" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>bDMARDs-Other before the study, n=87</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study</title>
        <description>Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study.</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants on tocilizumab for RA in routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Other Treatments</title>
            <description>Participants on Other treatments for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study</title>
          <description>Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study.</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</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="122"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DAS28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.52" spread="1.06"/>
                    <measurement group_id="O2" value="2.97" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CDAI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.66" spread="7.30"/>
                    <measurement group_id="O2" value="7.94" spread="6.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SDAI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.94" spread="7.34"/>
                    <measurement group_id="O2" value="8.52" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score</title>
        <description>Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study .</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants on tocilizumab for RA in routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Other Treatments</title>
            <description>Participants on Other treatments for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score</title>
          <description>Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study .</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DAS28-Remission/low activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAS28-Moderate/high activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CDAI- Remission/low activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CDAI- Moderate/high activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SDAI- Remission/low activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SDAI- Moderate/high activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study</title>
        <description>Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ).</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants on tocilizumab for RA in routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Other Treatments</title>
            <description>Participants on Other treatments for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study</title>
          <description>Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ).</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>Number of 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="122"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean number of NPJ</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.16" spread="3.30"/>
                    <measurement group_id="O2" value="1.57" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean number of NSJ</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" spread="2.32"/>
                    <measurement group_id="O2" value="0.68" spread="1.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study</title>
        <description>Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).</description>
        <time_frame>At Visit 1</time_frame>
        <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants on tocilizumab for RA in routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Other Treatments</title>
            <description>Participants on Other treatments for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study</title>
          <description>Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).</description>
          <population>Analysis Population included all enrolled participants who met the screening criteria.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Falling Within Reference Values For CRP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Falling Within Reference Values For ESR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events Leading to a Change of Treatment</title>
        <description>An Adverse Event was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Adverse events were collected as a reason for the change to monotherapy.</description>
        <time_frame>At the time of change of treatment</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events Leading to a Change of Treatment</title>
          <description>An Adverse Event was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Adverse events were collected as a reason for the change to monotherapy.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Adverse Events and Any Serious Adverse Events</title>
        <description>An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.</description>
        <time_frame>At the time of change of treatment (to the current treatment)</time_frame>
        <population>Analysis population included all enrolled participants who met the screening criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>bDMARD Monotherapy</title>
            <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Adverse Events and Any Serious Adverse Events</title>
          <description>An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.</description>
          <population>Analysis population included all enrolled participants who met the screening criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>At the time of change of treatment (to the current treatment)</time_frame>
      <desc>Serious adverse events (SAEs) and non-serious AEs reported leading to a change of treatment</desc>
      <group_list>
        <group group_id="E1">
          <title>bDMARD Monotherapy</title>
          <description>Participants on bDMARD monotherapy for RA in routine clinical practice.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="209"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="209"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="209"/>
              </event>
              <event>
                <sub_title>Thrombopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="209"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="209"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="209"/>
              </event>
              <event>
                <sub_title>Pancreatitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="209"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="209"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="209"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Transaminase value increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="209"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Interstitial pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="209"/>
              </event>
              <event>
                <sub_title>Interstitial pulmonary fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="209"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="209"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="209"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="209"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="209"/>
              </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>Roche Trial Information Hotline</name_or_title>
      <organization>F. Hoffmann-La Roche AG</organization>
      <phone>+41 616878333</phone>
      <email>global.trial_information@roche.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/NCT01664117
org study id: ML28356
secondary id: ROC-BIO-2011-01
nct id: NCT01664117
lead sponsor: 
This observational multicenter study will evaluate the management of disease and safety in
      clinical practice in patients with moderate to severe rheumatoid arthritis receiving any
      biological therapies in monotherapy.
observational model: Cohort
time perspective: Cross-Sectional
measure: Number of Participants With Level of Education Completed
time frame: At Visit 1 (Single visit study)
description: Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)
measure: Number of Participants With Smoking Habits
time frame: At Visit 1
description: Smoking habits is a component of socio-demographic characteristics. Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.
measure: Smoking-habit for Smokers or Ex-smokers (Packs in Years)
time frame: At Visit 1
description: Smoking-habit included number of pack per years is reported.
measure: Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )
time frame: At Visit 1
description: Smoking-habit included years of smoking/quit smoking is reported for participants.
measure: Mean Time of Onset of Rheumatoid Arthritis
time frame: At Visit 1
description: Onset of rheumatoid arthritis is a component of clinical characteristics.
measure: Number of Participants With Family History of Rheumatoid Arthritis
time frame: At Visit 1
description: Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.
measure: Number of Participants With Co-morbidities
time frame: At Visit 1
description: Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.
measure: Number of Participants With Extra-articular Manifestations at Visit 1
time frame: At Visit 1
description: Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty's syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.
measure: Mean Number of Painful and Swollen Joints at Visit 1
time frame: At Visit 1
description: Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.
measure: Physician's Global Assessment of Disease Activity at Visit 1
time frame: At Visit 1
description: The Physician's global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (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" (maximum arthritis disease activity).
measure: Patient's Global Assessment of Disease Activity at Visit 1
time frame: At Visit 1
description: Patient global assessment of disease activity visual analog scale is 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" (maximum arthritis disease activity).
measure: Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1
time frame: At Visit 1
description: Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.
measure: Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1
time frame: At Visit 1
description: Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.
measure: Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies
time frame: At Visit 1
description: Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.
measure: Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1
time frame: At Visit 1
description: The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.
measure: Patient Pain Visual Analog Scale Score at Visit 1
time frame: At Visit 1
description: Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as "no pain" and the right-hand extreme equals 10 as "unbearable pain"
measure: Number of Participants With Joint Damage at Visit 1
time frame: At Visit 1
description: Number of participants with joint damage is recorded as yes and no.
measure: Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1
time frame: At Visit 1
description: Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.
measure: Number of Participants With Disease Activity Score by Categorization at Visit 1
time frame: At Visit 1
description: DAS28 is divided into 4 categories as: remission <2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high >5.1.
measure: Mean Score on Clinical Disease Activity Index at Visit 1
time frame: At Visit 1
description: Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.
measure: Number of Participants With Clinical Disease Activity by Categorization at Visit 1
time frame: At Visit 1
description: CDAI is divided into 4 categories as: remission <2.8, low activity 2.8-10, moderate 10-22 and high>22.
measure: Mean Score on Simple Disease Activity Index at Visit 1
time frame: At Visit 1
description: Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.
measure: Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1
time frame: At Visit 1
description: SDAI is divided into 4 categories as: remission (<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (>26).
measure: Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study
time frame: At Visit 1
description: Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.
measure: Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug
time frame: At Visit 1
description: Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.
measure: Number of Participants Who Received Each sDMARD Before The Study
time frame: At Visit 1
description: Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications.
measure: Number of Participants Who Received Last sDMARD Prescribed Before the Study
time frame: At Visit 1
description: Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate.
measure: Number of Participants Prescribed First bDMARD Before the Study
time frame: At Visit 1
description: Number of participants prescribed first bDMARD before the study was presented.
measure: Number of Participants Who Received Each bDMARD Before the Study
time frame: At Visit 1
description: Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.
measure: Mean Time Between the Last sDMARD and bDMARD Received at Visit 1
time frame: At Visit 1
description: Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.
measure: Number of Participants With Changing the Previous sDMARD/ bDMARD
time frame: At Visit 1
description: Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. There may be more than one reason for changing sDMARD/ bDMARD per participant.
measure: Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy)
time frame: At Visit 1
description: Number of sDMARD and bDMARDs received by Participants before the study was presented
measure: Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment
time frame: At Visit 1
measure: Number of Participants Discontinued the Previous Treatment and Started the Study Treatment
time frame: At Visit 1
description: The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other.
measure: Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment
time frame: At Visit 1
description: Median time in months taking the Biologic Agent in monotherapy before the study was presented.
measure: Number of Participants Treated With Concomitant Medications Before the Study
time frame: At Visit 1
description: Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs [NSAID], and other treatment) before the study were presented.
measure: Number of Participants Received Current bDMARD Treatment at the Time of the Study
time frame: At Visit 1
description: Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.
measure: Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy
time frame: At Visit 1
description: Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.
measure: Number of Participants With Reasons for Starting Current Biologic Monotherapy
time frame: At Visit 1
description: The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.
measure: Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study
time frame: At Visit 1
description: Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.
measure: Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA
time frame: At Visit 1
measure: Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)
time frame: At Visit 1
measure: Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study
time frame: At Visit 1
description: Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study.
measure: Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score
time frame: At Visit 1
description: Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study .
measure: Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study
time frame: At Visit 1
description: Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ).
measure: Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study
time frame: At Visit 1
description: Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).
measure: Number of Participants With Adverse Events Leading to a Change of Treatment
time frame: At the time of change of treatment
description: An Adverse Event was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Adverse events were collected as a reason for the change to monotherapy.
measure: Number of Participants With Any Adverse Events and Any Serious Adverse Events
time frame: At the time of change of treatment (to the current treatment)
description: An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
arm group label: bDMARD Monotherapy
description: Patients with moderate to severe rheumatoid arthritis (RA) will be treated with bDMARD (biologic disease-modifying antirheumatic drug) monotherapy under routine clinical practice conditions at rheumatology clinics
study pop: 
sampling method: Probability Sample
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: Spain
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 