<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/NCT02202837</url>
  </required_header>
  <id_info>
    <org_study_id>B1801378</org_study_id>
    <secondary_id>B1801378</secondary_id>
    <secondary_id>REACH-RA</secondary_id>
    <nct_id>NCT02202837</nct_id>
  </id_info>
  <brief_title>Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice</brief_title>
  <acronym>REACH RA</acronym>
  <official_title>Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Rheumatoid Arthritis Patients Treated With Etanercept (Enbrel (Registered))</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life&#xD;
      Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The analysis of the primary endpoint will be based on a logistic regression defining the&#xD;
      dependent variable as the remission at Month 12 and the 5 independent variables as CDAI,&#xD;
      SDAI, DAS28, DAS28 and Ultrasound, and EULAR Boolean definition for clinical practice and&#xD;
      clinical studies.&#xD;
&#xD;
      This analysis will be conducted in each arm of the study as well as after a pooling of both&#xD;
      patient groups.&#xD;
&#xD;
      In this context it seems reasonable to ensure the completion of the study by a total&#xD;
      approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50&#xD;
      completers in each arm, 70 patients will be recruited at baseline, taking into account a drop&#xD;
      out rate of 30% over 1 year period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 12, 2014</start_date>
  <completion_date type="Actual">April 24, 2017</completion_date>
  <primary_completion_date type="Actual">April 24, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) Less Than (&lt;) 2.6 at Month 6 and Maintained Till Month 12</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, C-reactive protein (CRP) (milligrams per liter [mg/L]) or erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) levels and patient global assessment (PGA) of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 [less than or equal to] &lt;=3.2 implied low disease activity and greater than (&gt;) 3.2 to &lt;=5.1 implied moderate disease activity, &gt;5.1 implied high disease activity, and DAS28 less than (&lt;) 2.6 implied remission.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (&lt;=) 3.3 at Month 6 and Maintained Till Month 12</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, physician (evaluator) global assessment of disease (EGA) and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI &gt;3.4 to 11 implied low disease activity, &gt;11 to 26 implied moderate disease activity, &gt;26 implied high disease activity and &lt;=3.3 implied disease remission.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Clinical Disease Activity Index (CDAI) &lt;=2.8 at Month 6 and Maintained Till Month 12</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) &lt;=1; SJC (in 28 joints) &lt;=1; CRP&lt;=1 mg/dl; PGA&lt;=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) &lt;=1; SJC (in 28 joints) &lt;=1 and PGA&lt;=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till Month 12</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>A participant was in remission based on US7: if US7 synovitis sum score in grey-scale Ultrasonography (GSUS) =0, Power Doppler Ultrasonography (PDUS) =0 and erosion sum score in GSUS=0. US7 score is musculoskeletal ultrasonography (MKUS) composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, metacarpophalangeal (MCP) II and III, proximal interphalangeal (PIP) II and III, metatarsophalangeal (MTP) II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = &gt;=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Maintained Till Month 12</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>Remission based on DAS28 + US7: DAS28 &lt;2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = &gt;=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) &lt;2.6 at Month 3, 6, 9 and 12</measure>
    <time_frame>Month 3, 6, 9 and 12</time_frame>
    <description>DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR) (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 &lt;=3.2 implied low disease activity and &gt; 3.2 to &lt;=5.1 implied moderate disease activity, &gt;5.1 implied high disease activity, and DAS28 &lt;2.6 implied remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Simplified Disease Activity Index (SDAI) &lt;=3.3 at Month 3, 6, 9 and 12</measure>
    <time_frame>Month 3, 6, 9 and 12</time_frame>
    <description>The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI &gt;3.4 to 11 implied low disease activity, &gt;11 to 26 implied moderate disease activity, &gt;26 implied high disease activity and &lt;=3.3 implied disease remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Disease Activity Index (CDAI) &lt;=2.8 at Month 3, 6, 9 and 12</measure>
    <time_frame>Month 3, 6, 9 and 12</time_frame>
    <description>The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12</measure>
    <time_frame>Month 3, 6, 9 and 12</time_frame>
    <description>The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) &lt;=1; SJC (in 28 joints) &lt;=1; CRP&lt;=1 mg/dl; PGA&lt;=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12</measure>
    <time_frame>Month 3, 6, 9 and 12</time_frame>
    <description>The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) &lt;=1; SJC (in 28 joints) &lt;=1 and PGA&lt;=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12</measure>
    <time_frame>Month 6 and 12</time_frame>
    <description>A participant was in remission based on US7: if US7 synovitis sum score in GSUS =0, PDUS =0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, MCP II and III, PIP II and III, MTP II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = &gt;=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Month 12</measure>
    <time_frame>Month 6 and 12</time_frame>
    <description>Remission based on DAS28 + US7: DAS28 &lt;2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = &gt;=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 &lt;=3.2 implied low disease activity and &gt; 3.2 to &lt;=5.1 implied moderate disease activity, &gt;5.1 implied high disease activity, and DAS28 &lt;2.6 implied remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI &gt;3.4 to 11 implied low disease activity, &gt;11 to 26 implied moderate disease activity, &gt;26 implied high disease activity and &lt;=3.3 implied disease remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS is a scoring system use to determine synovitis. The joints were examined by GSUS for synovitis from a dorsal and palmar aspect. The US7 synovitis sum score in GSUS was the sum of the scores for 9 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 3 palmar, PIP 2 palmar, PIP 3 palmar, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0 =no synovitis to 3=severe synovitis. Total US7 GSUS score ranged from 0 (no synovitis) to 27 (severe synovitis), higher score= more synovitis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 synovitis sum score in PDUS was the sum of the scores of 13 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 2 dorsal, MCP 3 palmar, MCP 3 dorsal, PIP 2 palmar, PIP 2 dorsal, PIP 3 palmar, PIP 3 dorsal, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0=no intraarticular color signal to 3 = &gt;=50% of the intraarticular area filled with color signals. Total US7 PSUS scores ranges from 0=no intraarticular color signal to 39 = &gt;=50% of the intraarticular area filled with color signals; higher scores= more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the tenosynovitis/paratenonitis. The joints were examined by GSUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in GSUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP I2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis GSUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and Month 12</time_frame>
    <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in PDUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP 2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis PDUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12</measure>
    <time_frame>Month 6 and Month 12</time_frame>
    <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the erosions. The joints were examined by GSUS for erosions from a dorsal, palmar/plantar and radial/lateral (only MCP 2 and MTP 5) aspect. The US7 erosion sum score in GSUS was the sum of the 14 following scores (MCP 2 dorsal, MCP 2 palmar, MCP 2 radial, MCP 3 dorsal, MCP 3 palmar, PIP 2 dorsal, PIP 2 palmar, PIP 3 dorsal, PIP 3 palmar, MTP 2 dorsal, MTP 2 plantar, MTP 5 dorsal, MTP 5 plantar and MTP 5 lateral) ranging from 0 to 1. Total score ranged from 0 (no erosions) to 14 (severe erosions), higher score= more erosions. The score was based on measurements made at fingers and toes and were calculated for both left and right sides, the score of the clinically most affected side.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">157</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Etanercept First</arm_group_label>
    <description>Adult patients with RA who receive etanercept as first biologic, according to prevailing Belgian reimbursement criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etanercept second</arm_group_label>
    <description>Adult patients who receive etanercept as second biologic, according to prevailing Belgian reimbursement criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>etanercept</intervention_name>
    <description>etanercept 1 x 50 mg/week or 2 x 25mg/week</description>
    <arm_group_label>Etanercept First</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>etanercept</intervention_name>
    <description>etanercept 1 x 50 mg/week or 2 x 25mg/week</description>
    <arm_group_label>Etanercept second</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients presenting with moderate-to-severe RA in daily clinical practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with active RA who start treatment with etanercept according to the&#xD;
             prevailing reimbursement criteria and dosing in line with the SmPC.&#xD;
&#xD;
               1. First cohort: Etanercept is the first biological product prescribed.&#xD;
&#xD;
               2. Second cohort: Etanercept is the second biological product prescribed.&#xD;
&#xD;
          2. Capable of understanding and willing to provide signed and dated written, voluntary&#xD;
             informed consent before any protocol-specific procedures are performed.&#xD;
&#xD;
          3. Eighteen (18) years of age or older at time of consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. History of or current psychiatric illness that would interfere with the subject's&#xD;
        ability to comply with protocol requirements or to give informed consent.&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Dinant Godinne</name>
      <address>
        <city>Yvoir</city>
        <state>Namur</state>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASZ Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Stedelijk Ziekenhuis</name>
      <address>
        <city>Aalst</city>
        <zip>B-9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouw Ziekenhuis Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>B-9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouw Ziekenhuis</name>
      <address>
        <city>Aalst</city>
        <zip>B-9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Lucas ZH</name>
      <address>
        <city>Assebroeck</city>
        <zip>8310</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St-Lucas Ziekenhuis</name>
      <address>
        <city>Assebroek</city>
        <zip>B-8310</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitarie Brugmann</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHIREC</name>
      <address>
        <city>Brussels</city>
        <zip>1040</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice</name>
      <address>
        <city>Champion</city>
        <zip>B-5020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint Blasius</name>
      <address>
        <city>Dendermonde</city>
        <zip>9200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Alma</name>
      <address>
        <city>Eeklo</city>
        <zip>9900</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biomedical Research Institute/ Department of Rheumatology</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice Rheumatology</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ReumaClinic</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reumatologie Associatie</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice</name>
      <address>
        <city>Genk</city>
        <zip>B-3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GHdC</name>
      <address>
        <city>Gilly</city>
        <zip>B-6060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice</name>
      <address>
        <city>Grand-Manil</city>
        <zip>5030</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge Campus Sint Maarten</name>
      <address>
        <city>Kortrijk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Tivoli</name>
      <address>
        <city>La Louviere</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Sart Tilman, Department of Rheumatology</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Liege</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Sart Tilman/ Department of Rheumatology</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisastraat 18</name>
      <address>
        <city>Mechelen</city>
        <zip>2800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Ambroise Pare</name>
      <address>
        <city>Mons</city>
        <zip>B-7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saintethérèse</name>
      <address>
        <city>Montigny Sur Sambre</city>
        <zip>6061</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISPPC de Charleroi</name>
      <address>
        <city>Montigny-le-tilleul</city>
        <zip>6110</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Damiaan</name>
      <address>
        <city>Oostende</city>
        <zip>8400</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of Maenaut Kristien</name>
      <address>
        <city>Schoten</city>
        <zip>B-2900</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint-Andries Ziekenhuis</name>
      <address>
        <city>Tielt</city>
        <zip>B-8700</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Peltzer-Tourelle</name>
      <address>
        <city>Verviers</city>
        <zip>B-4800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avenue G Therasse 1</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires UCL de Mont-Godinne</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801378&amp;StudyName=Study%20with%20Etanercept%20focusing%20on%20remission%20and%20predictability%20of%20remission%20in%20real%20life%20clinical%20practice</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>April 23, 2018</results_first_submitted>
  <results_first_submitted_qc>April 23, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 3, 2018</results_first_posted>
  <last_update_submitted>April 23, 2018</last_update_submitted>
  <last_update_submitted_qc>April 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etanercept</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 26, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT02202837/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Etanercept: First Intention</title>
          <description>Participants with rheumatoid arthritis (RA) who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on Summary of Product Characteristics (SmPC).</description>
        </group>
        <group group_id="P2">
          <title>Etanercept: Second Intention</title>
          <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Enbrel treatment discontinued</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline analysis set (BAS) consisted of all participants enrolled in the study who were seen at baseline, whether from first or second cohort.</population>
      <group_list>
        <group group_id="B1">
          <title>Etanercept: First Intention</title>
          <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
        </group>
        <group group_id="B2">
          <title>Etanercept: Second Intention</title>
          <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="140"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="157"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.21" spread="13.55"/>
                    <measurement group_id="B2" value="56.16" spread="11.63"/>
                    <measurement group_id="B3" value="56.21" spread="13.32"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) Less Than (&lt;) 2.6 at Month 6 and Maintained Till Month 12</title>
        <description>DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, C-reactive protein (CRP) (milligrams per liter [mg/L]) or erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) levels and patient global assessment (PGA) of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 [less than or equal to] &lt;=3.2 implied low disease activity and greater than (&gt;) 3.2 to &lt;=5.1 implied moderate disease activity, &gt;5.1 implied high disease activity, and DAS28 less than (&lt;) 2.6 implied remission.</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>The completers analysis data set (CAS) consisted of all participants enrolled in study and who completed 12-month study, whether or not they missed some follow-up visits and regardless of cohort (first or second intention). Here, &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) Less Than (&lt;) 2.6 at Month 6 and Maintained Till Month 12</title>
          <description>DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, C-reactive protein (CRP) (milligrams per liter [mg/L]) or erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) levels and patient global assessment (PGA) of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 [less than or equal to] &lt;=3.2 implied low disease activity and greater than (&gt;) 3.2 to &lt;=5.1 implied moderate disease activity, &gt;5.1 implied high disease activity, and DAS28 less than (&lt;) 2.6 implied remission.</description>
          <population>The completers analysis data set (CAS) consisted of all participants enrolled in study and who completed 12-month study, whether or not they missed some follow-up visits and regardless of cohort (first or second intention). Here, &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.4" lower_limit="32.1" upper_limit="55.3"/>
                    <measurement group_id="O2" value="30.0" lower_limit="6.67" upper_limit="65.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (&lt;=) 3.3 at Month 6 and Maintained Till Month 12</title>
        <description>The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, physician (evaluator) global assessment of disease (EGA) and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI &gt;3.4 to 11 implied low disease activity, &gt;11 to 26 implied moderate disease activity, &gt;26 implied high disease activity and &lt;=3.3 implied disease remission.</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (&lt;=) 3.3 at Month 6 and Maintained Till Month 12</title>
          <description>The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, physician (evaluator) global assessment of disease (EGA) and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI &gt;3.4 to 11 implied low disease activity, &gt;11 to 26 implied moderate disease activity, &gt;26 implied high disease activity and &lt;=3.3 implied disease remission.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.7" lower_limit="6.77" upper_limit="23.8"/>
                    <measurement group_id="O2" value="22.2" lower_limit="2.81" upper_limit="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Clinical Disease Activity Index (CDAI) &lt;=2.8 at Month 6 and Maintained Till Month 12</title>
        <description>The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Disease Activity Index (CDAI) &lt;=2.8 at Month 6 and Maintained Till Month 12</title>
          <description>The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.85" lower_limit="0.80" upper_limit="10.8"/>
                    <measurement group_id="O2" value="18.2" lower_limit="2.28" upper_limit="51.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion</title>
        <description>The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) &lt;=1; SJC (in 28 joints) &lt;=1; CRP&lt;=1 mg/dl; PGA&lt;=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion</title>
          <description>The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) &lt;=1; SJC (in 28 joints) &lt;=1; CRP&lt;=1 mg/dl; PGA&lt;=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.70" lower_limit="0.33" upper_limit="9.42"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion</title>
        <description>The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) &lt;=1; SJC (in 28 joints) &lt;=1 and PGA&lt;=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion</title>
          <description>The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) &lt;=1; SJC (in 28 joints) &lt;=1 and PGA&lt;=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="5.34" upper_limit="20.5"/>
                    <measurement group_id="O2" value="18.2" lower_limit="2.28" upper_limit="51.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till Month 12</title>
        <description>A participant was in remission based on US7: if US7 synovitis sum score in grey-scale Ultrasonography (GSUS) =0, Power Doppler Ultrasonography (PDUS) =0 and erosion sum score in GSUS=0. US7 score is musculoskeletal ultrasonography (MKUS) composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, metacarpophalangeal (MCP) II and III, proximal interphalangeal (PIP) II and III, metatarsophalangeal (MTP) II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = &gt;=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till Month 12</title>
          <description>A participant was in remission based on US7: if US7 synovitis sum score in grey-scale Ultrasonography (GSUS) =0, Power Doppler Ultrasonography (PDUS) =0 and erosion sum score in GSUS=0. US7 score is musculoskeletal ultrasonography (MKUS) composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, metacarpophalangeal (MCP) II and III, proximal interphalangeal (PIP) II and III, metatarsophalangeal (MTP) II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = &gt;=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="70.8"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="84.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Maintained Till Month 12</title>
        <description>Remission based on DAS28 + US7: DAS28 &lt;2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = &gt;=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Maintained Till Month 12</title>
          <description>Remission based on DAS28 + US7: DAS28 &lt;2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = &gt;=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="70.8"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="84.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) &lt;2.6 at Month 3, 6, 9 and 12</title>
        <description>DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR) (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 &lt;=3.2 implied low disease activity and &gt; 3.2 to &lt;=5.1 implied moderate disease activity, &gt;5.1 implied high disease activity, and DAS28 &lt;2.6 implied remission.</description>
        <time_frame>Month 3, 6, 9 and 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) &lt;2.6 at Month 3, 6, 9 and 12</title>
          <description>DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR) (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 &lt;=3.2 implied low disease activity and &gt; 3.2 to &lt;=5.1 implied moderate disease activity, &gt;5.1 implied high disease activity, and DAS28 &lt;2.6 implied remission.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="36.3" upper_limit="63.7"/>
                    <measurement group_id="O2" value="33.3" lower_limit="7.49" upper_limit="70.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.6" lower_limit="44.7" upper_limit="67.9"/>
                    <measurement group_id="O2" value="60.0" lower_limit="26.2" upper_limit="87.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.9" lower_limit="36.8" upper_limit="64.9"/>
                    <measurement group_id="O2" value="28.6" lower_limit="3.67" upper_limit="71.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.3" lower_limit="39.6" upper_limit="63.0"/>
                    <measurement group_id="O2" value="40.0" lower_limit="12.2" upper_limit="73.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Simplified Disease Activity Index (SDAI) &lt;=3.3 at Month 3, 6, 9 and 12</title>
        <description>The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI &gt;3.4 to 11 implied low disease activity, &gt;11 to 26 implied moderate disease activity, &gt;26 implied high disease activity and &lt;=3.3 implied disease remission.</description>
        <time_frame>Month 3, 6, 9 and 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Simplified Disease Activity Index (SDAI) &lt;=3.3 at Month 3, 6, 9 and 12</title>
          <description>The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI &gt;3.4 to 11 implied low disease activity, &gt;11 to 26 implied moderate disease activity, &gt;26 implied high disease activity and &lt;=3.3 implied disease remission.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" lower_limit="5.27" upper_limit="24.5"/>
                    <measurement group_id="O2" value="12.5" lower_limit="0.32" upper_limit="52.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="10.9" upper_limit="30.1"/>
                    <measurement group_id="O2" value="44.4" lower_limit="13.7" upper_limit="78.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0" lower_limit="16.2" upper_limit="42.5"/>
                    <measurement group_id="O2" value="14.3" lower_limit="0.36" upper_limit="57.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" lower_limit="9.32" upper_limit="28.4"/>
                    <measurement group_id="O2" value="11.1" lower_limit="0.28" upper_limit="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Disease Activity Index (CDAI) &lt;=2.8 at Month 3, 6, 9 and 12</title>
        <description>The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.</description>
        <time_frame>Month 3, 6, 9 and 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Disease Activity Index (CDAI) &lt;=2.8 at Month 3, 6, 9 and 12</title>
          <description>The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" lower_limit="5.47" upper_limit="22.8"/>
                    <measurement group_id="O2" value="18.2" lower_limit="2.28" upper_limit="51.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.69" lower_limit="2.88" upper_limit="16.0"/>
                    <measurement group_id="O2" value="36.4" lower_limit="10.9" upper_limit="69.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2" lower_limit="13.0" upper_limit="36.4"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.7" lower_limit="7.56" upper_limit="24.7"/>
                    <measurement group_id="O2" value="10.0" lower_limit="0.25" upper_limit="44.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12</title>
        <description>The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) &lt;=1; SJC (in 28 joints) &lt;=1; CRP&lt;=1 mg/dl; PGA&lt;=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).</description>
        <time_frame>Month 3, 6, 9 and 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12</title>
          <description>The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) &lt;=1; SJC (in 28 joints) &lt;=1; CRP&lt;=1 mg/dl; PGA&lt;=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.36" lower_limit="1.12" upper_limit="14.9"/>
                    <measurement group_id="O2" value="11.1" lower_limit="0.28" upper_limit="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.76" lower_limit="2.23" upper_limit="15.1"/>
                    <measurement group_id="O2" value="11.1" lower_limit="0.28" upper_limit="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.88" lower_limit="1.23" upper_limit="16.2"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="41.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.59" lower_limit="3.94" upper_limit="18.8"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="30.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12</title>
        <description>The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) &lt;=1; SJC (in 28 joints) &lt;=1 and PGA&lt;=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).</description>
        <time_frame>Month 3, 6, 9 and 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention).</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12</title>
          <description>The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) &lt;=1; SJC (in 28 joints) &lt;=1 and PGA&lt;=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="4.37" upper_limit="20.6"/>
                    <measurement group_id="O2" value="16.7" lower_limit="2.09" upper_limit="48.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.5" lower_limit="9.06" upper_limit="26.5"/>
                    <measurement group_id="O2" value="45.5" lower_limit="16.8" upper_limit="76.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.3" lower_limit="15.5" upper_limit="39.7"/>
                    <measurement group_id="O2" value="25.0" lower_limit="3.19" upper_limit="65.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.8" lower_limit="10.9" upper_limit="29.0"/>
                    <measurement group_id="O2" value="18.2" lower_limit="2.28" upper_limit="51.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12</title>
        <description>A participant was in remission based on US7: if US7 synovitis sum score in GSUS =0, PDUS =0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, MCP II and III, PIP II and III, MTP II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = &gt;=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.</description>
        <time_frame>Month 6 and 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12</title>
          <description>A participant was in remission based on US7: if US7 synovitis sum score in GSUS =0, PDUS =0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, MCP II and III, PIP II and III, MTP II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = &gt;=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="0.00" upper_limit="70.8"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="70.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="0.00" upper_limit="70.8"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="70.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Month 12</title>
        <description>Remission based on DAS28 + US7: DAS28 &lt;2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = &gt;=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).</description>
        <time_frame>Month 6 and 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Month 12</title>
          <description>Remission based on DAS28 + US7: DAS28 &lt;2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = &gt;=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="0.00" upper_limit="70.8"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="84.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="0.00" upper_limit="70.8"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="84.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12</title>
        <description>DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 &lt;=3.2 implied low disease activity and &gt; 3.2 to &lt;=5.1 implied moderate disease activity, &gt;5.1 implied high disease activity, and DAS28 &lt;2.6 implied remission.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12</title>
          <description>DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 &lt;=3.2 implied low disease activity and &gt; 3.2 to &lt;=5.1 implied moderate disease activity, &gt;5.1 implied high disease activity, and DAS28 &lt;2.6 implied remission.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.06" spread="1.15"/>
                    <measurement group_id="O2" value="5.32" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.39" spread="1.21"/>
                    <measurement group_id="O2" value="1.92" spread="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.36" spread="1.29"/>
                    <measurement group_id="O2" value="1.37" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12</title>
        <description>The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI &gt;3.4 to 11 implied low disease activity, &gt;11 to 26 implied moderate disease activity, &gt;26 implied high disease activity and &lt;=3.3 implied disease remission.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12</title>
          <description>The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI &gt;3.4 to 11 implied low disease activity, &gt;11 to 26 implied moderate disease activity, &gt;26 implied high disease activity and &lt;=3.3 implied disease remission.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.2" spread="13.67"/>
                    <measurement group_id="O2" value="35.83" spread="19.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.06" spread="11.17"/>
                    <measurement group_id="O2" value="19.62" spread="18.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.30" spread="12.49"/>
                    <measurement group_id="O2" value="12.10" spread="8.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12</title>
        <description>The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12</title>
          <description>The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.12" spread="13.15"/>
                    <measurement group_id="O2" value="34.17" spread="18.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.06" spread="10.46"/>
                    <measurement group_id="O2" value="15.64" spread="16.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.85" spread="13.04"/>
                    <measurement group_id="O2" value="13.20" spread="11.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12</title>
        <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS is a scoring system use to determine synovitis. The joints were examined by GSUS for synovitis from a dorsal and palmar aspect. The US7 synovitis sum score in GSUS was the sum of the scores for 9 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 3 palmar, PIP 2 palmar, PIP 3 palmar, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0 =no synovitis to 3=severe synovitis. Total US7 GSUS score ranged from 0 (no synovitis) to 27 (severe synovitis), higher score= more synovitis.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12</title>
          <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS is a scoring system use to determine synovitis. The joints were examined by GSUS for synovitis from a dorsal and palmar aspect. The US7 synovitis sum score in GSUS was the sum of the scores for 9 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 3 palmar, PIP 2 palmar, PIP 3 palmar, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0 =no synovitis to 3=severe synovitis. Total US7 GSUS score ranged from 0 (no synovitis) to 27 (severe synovitis), higher score= more synovitis.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.21" spread="2.67"/>
                    <measurement group_id="O2" value="9.50" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.24" spread="3.95"/>
                    <measurement group_id="O2" value="8.36" spread="2.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.24" spread="4.20"/>
                    <measurement group_id="O2" value="3.00" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12</title>
        <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 synovitis sum score in PDUS was the sum of the scores of 13 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 2 dorsal, MCP 3 palmar, MCP 3 dorsal, PIP 2 palmar, PIP 2 dorsal, PIP 3 palmar, PIP 3 dorsal, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0=no intraarticular color signal to 3 = &gt;=50% of the intraarticular area filled with color signals. Total US7 PSUS scores ranges from 0=no intraarticular color signal to 39 = &gt;=50% of the intraarticular area filled with color signals; higher scores= more severe disease.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12</title>
          <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 synovitis sum score in PDUS was the sum of the scores of 13 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 2 dorsal, MCP 3 palmar, MCP 3 dorsal, PIP 2 palmar, PIP 2 dorsal, PIP 3 palmar, PIP 3 dorsal, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0=no intraarticular color signal to 3 = &gt;=50% of the intraarticular area filled with color signals. Total US7 PSUS scores ranges from 0=no intraarticular color signal to 39 = &gt;=50% of the intraarticular area filled with color signals; higher scores= more severe disease.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.90" spread="3.76"/>
                    <measurement group_id="O2" value="6.50" spread="7.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.29" spread="3.87"/>
                    <measurement group_id="O2" value="5.85" spread="8.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.90" spread="2.81"/>
                    <measurement group_id="O2" value="0.50" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12</title>
        <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the tenosynovitis/paratenonitis. The joints were examined by GSUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in GSUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP I2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis GSUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12</title>
          <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the tenosynovitis/paratenonitis. The joints were examined by GSUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in GSUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP I2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis GSUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" spread="2.65"/>
                    <measurement group_id="O2" value="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="0.71"/>
                    <measurement group_id="O2" value="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="0.71"/>
                    <measurement group_id="O2" value="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12</title>
        <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in PDUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP 2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis PDUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.</description>
        <time_frame>Baseline, Month 6 and Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12</title>
          <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in PDUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP 2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis PDUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" spread="1.15"/>
                    <measurement group_id="O2" value="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="1.41"/>
                    <measurement group_id="O2" value="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="1.41"/>
                    <measurement group_id="O2" value="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12</title>
        <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the erosions. The joints were examined by GSUS for erosions from a dorsal, palmar/plantar and radial/lateral (only MCP 2 and MTP 5) aspect. The US7 erosion sum score in GSUS was the sum of the 14 following scores (MCP 2 dorsal, MCP 2 palmar, MCP 2 radial, MCP 3 dorsal, MCP 3 palmar, PIP 2 dorsal, PIP 2 palmar, PIP 3 dorsal, PIP 3 palmar, MTP 2 dorsal, MTP 2 plantar, MTP 5 dorsal, MTP 5 plantar and MTP 5 lateral) ranging from 0 to 1. Total score ranged from 0 (no erosions) to 14 (severe erosions), higher score= more erosions. The score was based on measurements made at fingers and toes and were calculated for both left and right sides, the score of the clinically most affected side.</description>
        <time_frame>Month 6 and Month 12</time_frame>
        <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: First Intention</title>
            <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Second Intention</title>
            <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12</title>
          <description>US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the erosions. The joints were examined by GSUS for erosions from a dorsal, palmar/plantar and radial/lateral (only MCP 2 and MTP 5) aspect. The US7 erosion sum score in GSUS was the sum of the 14 following scores (MCP 2 dorsal, MCP 2 palmar, MCP 2 radial, MCP 3 dorsal, MCP 3 palmar, PIP 2 dorsal, PIP 2 palmar, PIP 3 dorsal, PIP 3 palmar, MTP 2 dorsal, MTP 2 plantar, MTP 5 dorsal, MTP 5 plantar and MTP 5 lateral) ranging from 0 to 1. Total score ranged from 0 (no erosions) to 14 (severe erosions), higher score= more erosions. The score was based on measurements made at fingers and toes and were calculated for both left and right sides, the score of the clinically most affected side.</description>
          <population>The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, &quot;N&quot; signifies those participants who were evaluable for this specified outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" spread="0.58"/>
                    <measurement group_id="O2" value="5.00" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="0.58"/>
                    <measurement group_id="O2" value="1.50" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="0.58"/>
                    <measurement group_id="O2" value="0.50" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Day 1 up to 28 days after end of treatment (12 months)</time_frame>
      <desc>Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Etanercept: First Intention</title>
          <description>Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
        </group>
        <group group_id="E2">
          <title>Etanercept: Second Intention</title>
          <description>Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pain Chest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <description>This event is a gender specific event.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Eye Irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Injection site hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Body tinea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Chlamydial infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Sjogren's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Polyneuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depressive mood</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Skin Irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT02202837
org study id: B1801378
secondary id: B1801378
secondary id: REACH-RA
nct id: NCT02202837
lead sponsor: 
has dmc: No
Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life
      Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept
The analysis of the primary endpoint will be based on a logistic regression defining the
      dependent variable as the remission at Month 12 and the 5 independent variables as CDAI,
      SDAI, DAS28, DAS28 and Ultrasound, and EULAR Boolean definition for clinical practice and
      clinical studies.

      This analysis will be conducted in each arm of the study as well as after a pooling of both
      patient groups.

      In this context it seems reasonable to ensure the completion of the study by a total
      approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50
      completers in each arm, 70 patients will be recruited at baseline, taking into account a drop
      out rate of 30% over 1 year period.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) Less Than (<) 2.6 at Month 6 and Maintained Till Month 12
time frame: Month 6 up to Month 12
description: DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, C-reactive protein (CRP) (milligrams per liter [mg/L]) or erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) levels and patient global assessment (PGA) of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 [less than or equal to] <=3.2 implied low disease activity and greater than (>) 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28 less than (<) 2.6 implied remission.
measure: Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 at Month 6 and Maintained Till Month 12
time frame: Month 6 up to Month 12
description: The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, physician (evaluator) global assessment of disease (EGA) and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI >3.4 to 11 implied low disease activity, >11 to 26 implied moderate disease activity, >26 implied high disease activity and <=3.3 implied disease remission.
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 6 and Maintained Till Month 12
time frame: Month 6 up to Month 12
description: The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.
measure: Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion
time frame: Month 6 up to Month 12
description: The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1; CRP<=1 mg/dl; PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).
measure: Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion
time frame: Month 6 up to Month 12
description: The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1 and PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).
measure: Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till Month 12
time frame: Month 6 up to Month 12
description: A participant was in remission based on US7: if US7 synovitis sum score in grey-scale Ultrasonography (GSUS) =0, Power Doppler Ultrasonography (PDUS) =0 and erosion sum score in GSUS=0. US7 score is musculoskeletal ultrasonography (MKUS) composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, metacarpophalangeal (MCP) II and III, proximal interphalangeal (PIP) II and III, metatarsophalangeal (MTP) II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.
measure: Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Maintained Till Month 12
time frame: Month 6 up to Month 12
description: Remission based on DAS28 + US7: DAS28 <2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).
measure: Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12
time frame: Month 3, 6, 9 and 12
description: DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR) (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 <=3.2 implied low disease activity and > 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28 <2.6 implied remission.
measure: Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12
time frame: Month 3, 6, 9 and 12
description: The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI >3.4 to 11 implied low disease activity, >11 to 26 implied moderate disease activity, >26 implied high disease activity and <=3.3 implied disease remission.
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12
time frame: Month 3, 6, 9 and 12
description: The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.
measure: Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12
time frame: Month 3, 6, 9 and 12
description: The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1; CRP<=1 mg/dl; PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).
measure: Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12
time frame: Month 3, 6, 9 and 12
description: The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1 and PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).
measure: Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12
time frame: Month 6 and 12
description: A participant was in remission based on US7: if US7 synovitis sum score in GSUS =0, PDUS =0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, MCP II and III, PIP II and III, MTP II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.
measure: Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Month 12
time frame: Month 6 and 12
description: Remission based on DAS28 + US7: DAS28 <2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12
time frame: Baseline, Month 6 and Month 12
description: DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 <=3.2 implied low disease activity and > 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28 <2.6 implied remission.
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12
time frame: Baseline, Month 6 and Month 12
description: The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI >3.4 to 11 implied low disease activity, >11 to 26 implied moderate disease activity, >26 implied high disease activity and <=3.3 implied disease remission.
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12
time frame: Baseline, Month 6 and Month 12
description: The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.
measure: Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
time frame: Baseline, Month 6 and Month 12
description: US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS is a scoring system use to determine synovitis. The joints were examined by GSUS for synovitis from a dorsal and palmar aspect. The US7 synovitis sum score in GSUS was the sum of the scores for 9 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 3 palmar, PIP 2 palmar, PIP 3 palmar, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0 =no synovitis to 3=severe synovitis. Total US7 GSUS score ranged from 0 (no synovitis) to 27 (severe synovitis), higher score= more synovitis.
measure: Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
time frame: Baseline, Month 6 and Month 12
description: US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 synovitis sum score in PDUS was the sum of the scores of 13 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 2 dorsal, MCP 3 palmar, MCP 3 dorsal, PIP 2 palmar, PIP 2 dorsal, PIP 3 palmar, PIP 3 dorsal, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0=no intraarticular color signal to 3 = >=50% of the intraarticular area filled with color signals. Total US7 PSUS scores ranges from 0=no intraarticular color signal to 39 = >=50% of the intraarticular area filled with color signals; higher scores= more severe disease.
measure: Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
time frame: Baseline, Month 6 and Month 12
description: US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the tenosynovitis/paratenonitis. The joints were examined by GSUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in GSUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP I2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis GSUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.
measure: Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
time frame: Baseline, Month 6 and Month 12
description: US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in PDUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP 2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis PDUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.
measure: Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
time frame: Month 6 and Month 12
description: US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the erosions. The joints were examined by GSUS for erosions from a dorsal, palmar/plantar and radial/lateral (only MCP 2 and MTP 5) aspect. The US7 erosion sum score in GSUS was the sum of the 14 following scores (MCP 2 dorsal, MCP 2 palmar, MCP 2 radial, MCP 3 dorsal, MCP 3 palmar, PIP 2 dorsal, PIP 2 palmar, PIP 3 dorsal, PIP 3 palmar, MTP 2 dorsal, MTP 2 plantar, MTP 5 dorsal, MTP 5 plantar and MTP 5 lateral) ranging from 0 to 1. Total score ranged from 0 (no erosions) to 14 (severe erosions), higher score= more erosions. The score was based on measurements made at fingers and toes and were calculated for both left and right sides, the score of the clinically most affected side.
arm group label: Etanercept First
description: Adult patients with RA who receive etanercept as first biologic, according to prevailing Belgian reimbursement criteria
arm group label: Etanercept second
description: Adult patients who receive etanercept as second biologic, according to prevailing Belgian reimbursement criteria
intervention type: Drug
intervention name: etanercept
description: etanercept 1 x 50 mg/week or 2 x 25mg/week
arm group label: Etanercept First
intervention type: Drug
intervention name: etanercept
description: etanercept 1 x 50 mg/week or 2 x 25mg/week
arm group label: Etanercept second
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Belgium
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801378&StudyName=Study%20with%20Etanercept%20focusing%20on%20remission%20and%20predictability%20of%20remission%20in%20real%20life%20clinical%20practice
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Etanercept
provided document: 
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point of contact: 