<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/NCT02202850</url>
  </required_header>
  <id_info>
    <org_study_id>B1801379</org_study_id>
    <secondary_id>B1801379</secondary_id>
    <secondary_id>REACH-AS</secondary_id>
    <nct_id>NCT02202850</nct_id>
  </id_info>
  <brief_title>Defining Remission With Etanercept in AS in Real Life Clinical Practice</brief_title>
  <acronym>REACH AS</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 Ankylosing Spondylitis 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>
      Determine which remission criterion at Month 6 predicts remission at Month 12 the best.&#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 6 independent variables as ASAS&#xD;
      partial remission, ASAS 5/6, ASAS60, ASAS40, BASDAI50 and ASDAS inactive disease status.&#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&#xD;
      drop-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 26, 2017</completion_date>
  <primary_completion_date type="Actual">April 26, 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 Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>ASAS partial remission was defined as a score of less than or equal to (&lt;=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>ASAS 5/6 was defined as at least greater than or equal to (&gt;=) 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, C - reactive protein (CRP) and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in milligrams per liter (mg/L) and spinal mobility was measured in centimeter (cm) as calculated as the mean of right and left measurements of lateral spinal flexion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>ASAS 60 was defined as at least &gt;= 60 percent relative improvement from baseline and an absolute change &gt;=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>ASAS 40 was defined as at least &gt;= 40 percent relative improvement from baseline and an absolute change &gt;=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least &gt;=50 percent relative improvement from baseline in BASDAI total score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>ASDAS-CRP was based on 3 domains: BASDAI, Bath Ankylosing Spondylitis Global score (BAS-G) and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12</measure>
    <time_frame>Month 6 up to Month 12</time_frame>
    <description>ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12</measure>
    <time_frame>Month 3, 6, 9 and 12</time_frame>
    <description>ASAS partial remission was defined as a score of &lt;= 2 for each of the 4 items including pain, function, PGA and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12</measure>
    <time_frame>Month 3, 6, 9 and 12</time_frame>
    <description>ASAS 5/6 was defined as at least &gt;= 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, CRP and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in mg/L and spinal mobility was measured in centimeter as calculated as the mean of right and left measurements of lateral spinal flexion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12</measure>
    <time_frame>Month 3, 6, 9 and 12</time_frame>
    <description>ASAS 60 was defined as at least &gt;= 60 percent relative improvement from baseline and an absolute change &gt;=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12</measure>
    <time_frame>Month 3, 6, 9 and 12</time_frame>
    <description>ASAS 40 was defined as at least &gt;= 40 percent relative improvement from baseline and an absolute change &gt;=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12</measure>
    <time_frame>Month 3, 6, 9 and 12</time_frame>
    <description>BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least &gt;=50 percent relative improvement from baseline in BASDAI total score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12</measure>
    <time_frame>Month 3, 6, 9 and 12</time_frame>
    <description>ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12</measure>
    <time_frame>Month 3, 6, 9 and 12</time_frame>
    <description>ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and 12</time_frame>
    <description>Participants were asked to assess their disease activity on an 11-point scale of 0 (no disease activity) to 10 (extreme disease activity), where higher score indicated higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and 12</time_frame>
    <description>Pain score is used to determine disease activity in participants with AS by measuring participants pain and swelling, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/swelling. The total pain score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of pain in participant due to AS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and 12</time_frame>
    <description>BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. Each item was scored on a scale of 0=easy, to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 to 10, where higher scores indicated more severe disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and12</time_frame>
    <description>Inflammation score is used to determine disease activity in participants with AS by measuring intensity and duration of inflammation, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of inflammation. The total inflammation score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of inflammation in participant due to AS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and 12</time_frame>
    <description>CRP is a protein marker in the blood for inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Spinal Mobility Measurement at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and 12</time_frame>
    <description>Spinal mobility was the mean of right and left measurements of lateral spinal flexion in centimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and 12</time_frame>
    <description>BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and 12</time_frame>
    <description>ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12</measure>
    <time_frame>Baseline, Month 6 and 12</time_frame>
    <description>ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>Etanercept First</arm_group_label>
    <description>Adults patients with AS receiving Etanercept as first biologic, according to prevailing reimbursement criteria in Belgium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etanercept second</arm_group_label>
    <description>Adults patients with AS receiving Etanercept as second biologic, according to prevailing reimbursement criteria in Belgium</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>
        Patients visiting Rheumatologist for which the decision has been taken to prescribe&#xD;
        Etanercept as first or second line&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with AS who start treatment with Etanercept according to prevailing&#xD;
             reimbursement criteria and dosing in line with 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. 18 years of age or older at time of consent&#xD;
&#xD;
          4. Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the patient (or a legally acceptable representative) has been informed of all&#xD;
             pertinent aspects of the study.&#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 Brugmann - Site Horta</name>
      <address>
        <city>Brussels</city>
        <state>Bruxelles-capitale, Région DE</state>
        <zip>1020</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>Private Practice</name>
      <address>
        <city>Braine L'alleud</city>
        <zip>B-1420</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>CHU St-Pierre</name>
      <address>
        <city>Brussel</city>
        <zip>B-1000</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>Private Practice</name>
      <address>
        <city>Flemalles Haute</city>
        <zip>B-4400</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>Grand Hopital de Charleroi</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 de Liège</name>
      <address>
        <city>Liege</city>
        <zip>B-4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice of Dr. Geert Ghyselen</name>
      <address>
        <city>Lokeren</city>
        <zip>9160</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>Hôpital Sainte Thérèse/ Department of Rheumatology</name>
      <address>
        <city>Montignies-sur-Sambre</city>
        <zip>6061</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology</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>Rheumatology</name>
      <address>
        <city>Sijsele-Damme</city>
        <zip>8340</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>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=B1801379&amp;StudyName=Defining%20remission%20with%20etanercept%20in%20AS%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 23, 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">November 30, 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">November 30, 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>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</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>May 20, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT02202850/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Etanercept First Cohort</title>
          <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
        </group>
        <group group_id="P2">
          <title>Etanercept Second Cohort</title>
          <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Enbrel treatment discontinued</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="3"/>
              </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>Baseline analysis set (BAS) included all randomized participants enrolled in the study who were present at baseline, whether from first or second cohort.</population>
      <group_list>
        <group group_id="B1">
          <title>Etanercept First Cohort</title>
          <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
        </group>
        <group group_id="B2">
          <title>Etanercept Second Cohort</title>
          <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</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="70"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="84"/>
          </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="70"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.83" spread="13.84"/>
                    <measurement group_id="B2" value="41.37" spread="9.74"/>
                    <measurement group_id="B3" value="42.58" spread="13.20"/>
                  </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="70"/>
                    <count group_id="B2" value="14"/>
                    <count group_id="B3" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="38"/>
                  </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 Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12</title>
        <description>ASAS partial remission was defined as a score of less than or equal to (&lt;=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12</title>
          <description>ASAS partial remission was defined as a score of less than or equal to (&lt;=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this 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="34"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.7" lower_limit="4.95" upper_limit="31.1"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12</title>
        <description>ASAS 5/6 was defined as at least greater than or equal to (&gt;=) 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, C - reactive protein (CRP) and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in milligrams per liter (mg/L) and spinal mobility was measured in centimeter (cm) as calculated as the mean of right and left measurements of lateral spinal flexion.</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12</title>
          <description>ASAS 5/6 was defined as at least greater than or equal to (&gt;=) 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, C - reactive protein (CRP) and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in milligrams per liter (mg/L) and spinal mobility was measured in centimeter (cm) as calculated as the mean of right and left measurements of lateral spinal flexion.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this 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="30"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.3" lower_limit="25.5" upper_limit="62.6"/>
                    <measurement group_id="O2" value="60.0" lower_limit="14.7" upper_limit="94.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12</title>
        <description>ASAS 60 was defined as at least &gt;= 60 percent relative improvement from baseline and an absolute change &gt;=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12</title>
          <description>ASAS 60 was defined as at least &gt;= 60 percent relative improvement from baseline and an absolute change &gt;=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this 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="34"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.4" lower_limit="15.1" upper_limit="47.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12</title>
        <description>ASAS 40 was defined as at least &gt;= 40 percent relative improvement from baseline and an absolute change &gt;=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12</title>
          <description>ASAS 40 was defined as at least &gt;= 40 percent relative improvement from baseline and an absolute change &gt;=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this 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="34"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.4" lower_limit="17.4" upper_limit="50.5"/>
                    <measurement group_id="O2" value="20.0" lower_limit="0.51" upper_limit="71.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12</title>
        <description>BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least &gt;=50 percent relative improvement from baseline in BASDAI total score.</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12</title>
          <description>BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least &gt;=50 percent relative improvement from baseline in BASDAI total score.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this 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="36"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" lower_limit="14.2" upper_limit="45.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12</title>
        <description>ASDAS-CRP was based on 3 domains: BASDAI, Bath Ankylosing Spondylitis Global score (BAS-G) and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12</title>
          <description>ASDAS-CRP was based on 3 domains: BASDAI, Bath Ankylosing Spondylitis Global score (BAS-G) and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this 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="28"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" lower_limit="2.27" upper_limit="28.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12</title>
        <description>ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
        <time_frame>Month 6 up to Month 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12</title>
          <description>ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this 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="20"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="3.21" upper_limit="37.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12</title>
        <description>ASAS partial remission was defined as a score of &lt;= 2 for each of the 4 items including pain, function, PGA and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.</description>
        <time_frame>Month 3, 6, 9 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12</title>
          <description>ASAS partial remission was defined as a score of &lt;= 2 for each of the 4 items including pain, function, PGA and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="40"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="4.19" upper_limit="26.8"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="41.0"/>
                  </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="34"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.7" lower_limit="6.76" upper_limit="34.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="52.2"/>
                  </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="30"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="5.64" upper_limit="34.7"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="45.9"/>
                  </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="42"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4" lower_limit="10.3" upper_limit="36.8"/>
                    <measurement group_id="O2" value="14.3" lower_limit="0.36" upper_limit="57.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12</title>
        <description>ASAS 5/6 was defined as at least &gt;= 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, CRP and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in mg/L and spinal mobility was measured in centimeter as calculated as the mean of right and left measurements of lateral spinal flexion.</description>
        <time_frame>Month 3, 6, 9 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12</title>
          <description>ASAS 5/6 was defined as at least &gt;= 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, CRP and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in mg/L and spinal mobility was measured in centimeter as calculated as the mean of right and left measurements of lateral spinal flexion.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="35"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.4" lower_limit="34.0" upper_limit="68.6"/>
                    <measurement group_id="O2" value="20.0" lower_limit="0.51" upper_limit="71.6"/>
                  </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="30"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7" lower_limit="28.3" upper_limit="65.7"/>
                    <measurement group_id="O2" value="60.0" lower_limit="14.7" upper_limit="94.7"/>
                  </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="26"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.7" lower_limit="36.9" upper_limit="76.7"/>
                    <measurement group_id="O2" value="33.3" lower_limit="4.33" upper_limit="77.7"/>
                  </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="39"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.5" lower_limit="44.6" upper_limit="76.6"/>
                    <measurement group_id="O2" value="60.0" lower_limit="14.7" upper_limit="97.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12</title>
        <description>ASAS 60 was defined as at least &gt;= 60 percent relative improvement from baseline and an absolute change &gt;=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).</description>
        <time_frame>Month 3, 6, 9 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12</title>
          <description>ASAS 60 was defined as at least &gt;= 60 percent relative improvement from baseline and an absolute change &gt;=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="40"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0" lower_limit="16.6" upper_limit="46.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="41.0"/>
                  </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="34"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.4" lower_limit="17.4" upper_limit="50.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="52.2"/>
                  </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="30"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="17.3" upper_limit="52.8"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="45.9"/>
                  </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="41"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.3" lower_limit="16.1" upper_limit="45.5"/>
                    <measurement group_id="O2" value="14.3" lower_limit="0.36" upper_limit="57.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12</title>
        <description>ASAS 40 was defined as at least &gt;= 40 percent relative improvement from baseline and an absolute change &gt;=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).</description>
        <time_frame>Month 3, 6, 9 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12</title>
          <description>ASAS 40 was defined as at least &gt;= 40 percent relative improvement from baseline and an absolute change &gt;=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="40"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5" lower_limit="22.7" upper_limit="54.2"/>
                    <measurement group_id="O2" value="28.6" lower_limit="3.67" upper_limit="71.0"/>
                  </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="34"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.2" lower_limit="24.7" upper_limit="59.3"/>
                    <measurement group_id="O2" value="20.0" lower_limit="0.51" upper_limit="71.6"/>
                  </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="30"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7" lower_limit="28.3" upper_limit="65.7"/>
                    <measurement group_id="O2" value="16.7" lower_limit="0.42" upper_limit="64.1"/>
                  </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="41"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.3" lower_limit="30.7" upper_limit="62.6"/>
                    <measurement group_id="O2" value="42.9" lower_limit="9.90" upper_limit="81.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12</title>
        <description>BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least &gt;=50 percent relative improvement from baseline in BASDAI total score.</description>
        <time_frame>Month 3, 6, 9 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12</title>
          <description>BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least &gt;=50 percent relative improvement from baseline in BASDAI total score.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="41"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.5" lower_limit="26.3" upper_limit="57.9"/>
                    <measurement group_id="O2" value="14.3" lower_limit="0.36" upper_limit="57.9"/>
                  </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="36"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.6" lower_limit="16.4" upper_limit="48.1"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.00" upper_limit="52.2"/>
                  </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="31"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.2" lower_limit="27.3" upper_limit="64.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="45.9"/>
                  </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="45"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.2" lower_limit="27.7" upper_limit="57.9"/>
                    <measurement group_id="O2" value="25.0" lower_limit="3.19" upper_limit="65.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12</title>
        <description>ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
        <time_frame>Month 3, 6, 9 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12</title>
          <description>ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="33"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.2" lower_limit="11.1" upper_limit="42.3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="52.2"/>
                  </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="28"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9" lower_limit="6.06" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="52.2"/>
                  </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="23"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.1" lower_limit="10.2" upper_limit="48.4"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="52.2"/>
                  </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="39"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8" lower_limit="17.0" upper_limit="47.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12</title>
        <description>ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
        <time_frame>Month 3, 6, 9 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12</title>
          <description>ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="25"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0" lower_limit="4.54" upper_limit="36.1"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="52.2"/>
                  </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="20"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="5.73" upper_limit="43.7"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="60.2"/>
                  </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="13"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="1.92" upper_limit="45.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="60.2"/>
                  </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="31"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" lower_limit="7.45" upper_limit="37.5"/>
                    <measurement group_id="O2" value="20.0" lower_limit="0.51" upper_limit="71.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12</title>
        <description>Participants were asked to assess their disease activity on an 11-point scale of 0 (no disease activity) to 10 (extreme disease activity), where higher score indicated higher disease activity.</description>
        <time_frame>Baseline, Month 6 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12</title>
          <description>Participants were asked to assess their disease activity on an 11-point scale of 0 (no disease activity) to 10 (extreme disease activity), where higher score indicated higher disease activity.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="46"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.61" spread="1.78"/>
                    <measurement group_id="O2" value="7.63" spread="0.92"/>
                  </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="34"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.62" spread="2.81"/>
                    <measurement group_id="O2" value="2.60" spread="2.30"/>
                  </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="42"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.43" spread="2.96"/>
                    <measurement group_id="O2" value="3.00" spread="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12</title>
        <description>Pain score is used to determine disease activity in participants with AS by measuring participants pain and swelling, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/swelling. The total pain score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of pain in participant due to AS.</description>
        <time_frame>Baseline, Month 6 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12</title>
          <description>Pain score is used to determine disease activity in participants with AS by measuring participants pain and swelling, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/swelling. The total pain score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of pain in participant due to AS.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="46"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.40" spread="2.05"/>
                    <measurement group_id="O2" value="7.00" spread="1.39"/>
                  </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="36"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.15" spread="2.61"/>
                    <measurement group_id="O2" value="1.70" spread="1.57"/>
                  </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="45"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.60" spread="2.96"/>
                    <measurement group_id="O2" value="2.81" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12</title>
        <description>BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. Each item was scored on a scale of 0=easy, to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 to 10, where higher scores indicated more severe disease activity.</description>
        <time_frame>Baseline, Month 6 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12</title>
          <description>BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. Each item was scored on a scale of 0=easy, to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 to 10, where higher scores indicated more severe disease activity.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="46"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.90" spread="2.35"/>
                    <measurement group_id="O2" value="7.34" spread="1.15"/>
                  </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="36"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.07" spread="2.50"/>
                    <measurement group_id="O2" value="1.90" spread="0.47"/>
                  </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="44"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.15" spread="2.65"/>
                    <measurement group_id="O2" value="2.39" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12</title>
        <description>Inflammation score is used to determine disease activity in participants with AS by measuring intensity and duration of inflammation, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of inflammation. The total inflammation score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of inflammation in participant due to AS.</description>
        <time_frame>Baseline, Month 6 and12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12</title>
          <description>Inflammation score is used to determine disease activity in participants with AS by measuring intensity and duration of inflammation, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of inflammation. The total inflammation score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of inflammation in participant due to AS.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="46"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.98" spread="2.24"/>
                    <measurement group_id="O2" value="6.81" spread="1.56"/>
                  </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="36"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.71" spread="2.34"/>
                    <measurement group_id="O2" value="3.40" spread="1.95"/>
                  </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="45"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.07" spread="2.60"/>
                    <measurement group_id="O2" value="2.50" spread="2.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12</title>
        <description>CRP is a protein marker in the blood for inflammation.</description>
        <time_frame>Baseline, Month 6 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12</title>
          <description>CRP is a protein marker in the blood for inflammation.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
          <units>milligrams per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="8"/>
              </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="45"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.49" spread="14.14"/>
                    <measurement group_id="O2" value="6.06" spread="4.83"/>
                  </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="30"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.45" spread="46.86"/>
                    <measurement group_id="O2" value="5.04" spread="1.28"/>
                  </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="41"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.50" spread="14.70"/>
                    <measurement group_id="O2" value="-2.03" spread="9.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Spinal Mobility Measurement at Month 6 and 12</title>
        <description>Spinal mobility was the mean of right and left measurements of lateral spinal flexion in centimeters.</description>
        <time_frame>Baseline, Month 6 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Spinal Mobility Measurement at Month 6 and 12</title>
          <description>Spinal mobility was the mean of right and left measurements of lateral spinal flexion in centimeters.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="8"/>
              </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="35"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.04" spread="4.87"/>
                    <measurement group_id="O2" value="10.80" spread="4.51"/>
                  </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="18"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.13" spread="3.41"/>
                    <measurement group_id="O2" value="-0.83" spread="3.82"/>
                  </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="27"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.73" spread="5.30"/>
                    <measurement group_id="O2" value="1.08" spread="4.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12</title>
        <description>BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity.</description>
        <time_frame>Baseline, Month 6 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12</title>
          <description>BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="46"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.45" spread="1.61"/>
                    <measurement group_id="O2" value="7.14" spread="0.90"/>
                  </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="36"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.16" spread="2.36"/>
                    <measurement group_id="O2" value="2.16" spread="1.47"/>
                  </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="45"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.62" spread="2.53"/>
                    <measurement group_id="O2" value="2.48" spread="2.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12</title>
        <description>ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
        <time_frame>Baseline, Month 6 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12</title>
          <description>ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="45"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.73" spread="0.86"/>
                    <measurement group_id="O2" value="3.54" spread="0.87"/>
                  </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="28"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.44" spread="1.06"/>
                    <measurement group_id="O2" value="1.54" spread="0.61"/>
                  </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="39"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.70" spread="1.15"/>
                    <measurement group_id="O2" value="1.17" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12</title>
        <description>ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
        <time_frame>Baseline, Month 6 and 12</time_frame>
        <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept First Cohort</title>
            <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept Second Cohort</title>
            <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12</title>
          <description>ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of &lt;1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.</description>
          <population>Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.</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="46"/>
                <count group_id="O2" value="8"/>
              </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="33"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.25" spread="0.75"/>
                    <measurement group_id="O2" value="3.51" spread="0.69"/>
                  </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="16"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.17" spread="0.65"/>
                    <measurement group_id="O2" value="1.11" spread="0.45"/>
                  </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="26"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" spread="0.87"/>
                    <measurement group_id="O2" value="1.25" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Month 12</time_frame>
      <desc>Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.</desc>
      <group_list>
        <group group_id="E1">
          <title>Etanercept First Cohort</title>
          <description>Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.</description>
        </group>
        <group group_id="E2">
          <title>Etanercept Second Cohort</title>
          <description>Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.</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="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperventilation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </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="18" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </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="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Injection site inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </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="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical dysplasia</sub_title>
                <description>This event was gender specific.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Large Intestinal Polypectomy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </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_Inquires@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/NCT02202850
org study id: B1801379
secondary id: B1801379
secondary id: REACH-AS
nct id: NCT02202850
lead sponsor: 
has dmc: No
Determine which remission criterion at Month 6 predicts remission at Month 12 the best.
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 6 independent variables as ASAS
      partial remission, ASAS 5/6, ASAS60, ASAS40, BASDAI50 and ASDAS inactive disease status.

      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 Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12
time frame: Month 6 up to Month 12
description: ASAS partial remission was defined as a score of less than or equal to (<=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12
time frame: Month 6 up to Month 12
description: ASAS 5/6 was defined as at least greater than or equal to (>=) 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, C - reactive protein (CRP) and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in milligrams per liter (mg/L) and spinal mobility was measured in centimeter (cm) as calculated as the mean of right and left measurements of lateral spinal flexion.
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12
time frame: Month 6 up to Month 12
description: ASAS 60 was defined as at least >= 60 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12
time frame: Month 6 up to Month 12
description: ASAS 40 was defined as at least >= 40 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).
measure: Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12
time frame: Month 6 up to Month 12
description: BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least >=50 percent relative improvement from baseline in BASDAI total score.
measure: Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12
time frame: Month 6 up to Month 12
description: ASDAS-CRP was based on 3 domains: BASDAI, Bath Ankylosing Spondylitis Global score (BAS-G) and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
measure: Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12
time frame: Month 6 up to Month 12
description: ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12
time frame: Month 3, 6, 9 and 12
description: ASAS partial remission was defined as a score of <= 2 for each of the 4 items including pain, function, PGA and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12
time frame: Month 3, 6, 9 and 12
description: ASAS 5/6 was defined as at least >= 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, CRP and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in mg/L and spinal mobility was measured in centimeter as calculated as the mean of right and left measurements of lateral spinal flexion.
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12
time frame: Month 3, 6, 9 and 12
description: ASAS 60 was defined as at least >= 60 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12
time frame: Month 3, 6, 9 and 12
description: ASAS 40 was defined as at least >= 40 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).
measure: Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12
time frame: Month 3, 6, 9 and 12
description: BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least >=50 percent relative improvement from baseline in BASDAI total score.
measure: Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12
time frame: Month 3, 6, 9 and 12
description: ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
measure: Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12
time frame: Month 3, 6, 9 and 12
description: ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
measure: Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12
time frame: Baseline, Month 6 and 12
description: Participants were asked to assess their disease activity on an 11-point scale of 0 (no disease activity) to 10 (extreme disease activity), where higher score indicated higher disease activity.
measure: Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12
time frame: Baseline, Month 6 and 12
description: Pain score is used to determine disease activity in participants with AS by measuring participants pain and swelling, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/swelling. The total pain score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of pain in participant due to AS.
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12
time frame: Baseline, Month 6 and 12
description: BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. Each item was scored on a scale of 0=easy, to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 to 10, where higher scores indicated more severe disease activity.
measure: Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12
time frame: Baseline, Month 6 and12
description: Inflammation score is used to determine disease activity in participants with AS by measuring intensity and duration of inflammation, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of inflammation. The total inflammation score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of inflammation in participant due to AS.
measure: Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12
time frame: Baseline, Month 6 and 12
description: CRP is a protein marker in the blood for inflammation.
measure: Change From Baseline in Spinal Mobility Measurement at Month 6 and 12
time frame: Baseline, Month 6 and 12
description: Spinal mobility was the mean of right and left measurements of lateral spinal flexion in centimeters.
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12
time frame: Baseline, Month 6 and 12
description: BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity.
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12
time frame: Baseline, Month 6 and 12
description: ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12
time frame: Baseline, Month 6 and 12
description: ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
arm group label: Etanercept First
description: Adults patients with AS receiving Etanercept as first biologic, according to prevailing reimbursement criteria in Belgium
arm group label: Etanercept second
description: Adults patients with AS receiving Etanercept as second biologic, according to prevailing reimbursement criteria in Belgium
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: 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=B1801379&StudyName=Defining%20remission%20with%20etanercept%20in%20AS%20in%20real%20life%20clinical%20practice
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Etanercept
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 