<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/NCT03258814</url>
  </required_header>
  <id_info>
    <org_study_id>P15-710</org_study_id>
    <nct_id>NCT03258814</nct_id>
  </id_info>
  <brief_title>A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis (axSpA)</brief_title>
  <acronym>Treat &amp; Train</acronym>
  <official_title>Treat and Train - A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a non-interventional, longitudinal and non-confirmatory study to compare an&#xD;
      active supervised training (AST) with standard of care (SOC) physiotherapy in patients with&#xD;
      axial spondyloarthritis and stable response to adalimumab (HUMIRA®) with respect to&#xD;
      health-related outcomes. The primary objective is the improvement in spinal mobility after a&#xD;
      6 month training program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment of axSpA patients with adalimumab (HUMIRA®) was according to the local adalimumab&#xD;
      product label and local standard of care. AxSpA patients who responded to newly initialized&#xD;
      adalimumab treatment based on physicians' decision, and who were eligible for active&#xD;
      physiotherapy were enrolled in the study. Although this was a non-interventional study,&#xD;
      participants were randomly assigned to receive either active supervised and standardized&#xD;
      training physiotherapy or standard of care physiotherapy in order to provide adequate numbers&#xD;
      of participants in each comparison group.&#xD;
&#xD;
      Participants who consented to participate in the study were observed for up to 12 months from&#xD;
      Baseline (defined as the Randomization visit where participants were assigned to one of the&#xD;
      two physiotherapy options).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low or No Enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">December 8, 2017</start_date>
  <completion_date type="Actual">September 14, 2018</completion_date>
  <primary_completion_date type="Actual">September 14, 2018</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>Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 3</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>The Bath Ankylosing Spondylitis Functional Index (BASFI) is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities, each on a numeric rating scale (NRS) ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher score indicating more limitations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. The ASAS HI consists of 17 questions, each answered by the participant as agree (1) or disagree (0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, with a lower score indicating a better and a higher score indicating an inferior health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a BASDAI 50 Response</measure>
    <time_frame>Month 3</time_frame>
    <description>The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.&#xD;
A BASDAI 50 response is defined as improvement of 50% or more from baseline in BASDAI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (C-reactive protein [CRP]) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ASDAS Inactive Disease</measure>
    <time_frame>Month 3</time_frame>
    <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with ASDAS inactive disease, defined as ASDAS &lt; 1.3, is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ASDAS Low Disease Activity</measure>
    <time_frame>Month 3</time_frame>
    <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with ASDAS low disease activity, defined as ASDAS &lt; 2.1, is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ASDAS Moderate Disease Activity</measure>
    <time_frame>Month 3</time_frame>
    <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with ASDAS moderate disease activity, defined as an ASDAS ≥ 1.3 to &lt; 2.1, is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ASDAS High Disease Activity</measure>
    <time_frame>Month 3</time_frame>
    <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with high disease activity, defined as an ASDAS ≥ 2.1 to &lt; 3.5, is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ASDAS Very High Disease Activity</measure>
    <time_frame>Month 3</time_frame>
    <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with very high disease activity, defined as an ASDAS ≥ 3.5, is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ASDAS Major Improvement</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>ASDAS Major Improvement is defined as a change from Baseline ≥ 2.0. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ASDAS Clinically Important Improvement</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>ASDAS clinically important improvement is defined as a change from Baseline ≥ 1.1.&#xD;
ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:&#xD;
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);&#xD;
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);&#xD;
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);&#xD;
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving an ASAS 40 Response</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:&#xD;
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);&#xD;
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);&#xD;
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);&#xD;
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ASAS Partial Remission</measure>
    <time_frame>Month 3</time_frame>
    <description>ASAS partial remission is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:&#xD;
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);&#xD;
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);&#xD;
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);&#xD;
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient's Global Assessment of Pain</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>The patient's global assessment of pain was assessed on a NRS from 0 (no pain) to 10 (pain as bad as it could be).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient's Assessment of Total Back Pain</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>The patient's assessment of total back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient's Assessment of Nocturnal Back Pain</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>The patient's assessment of nocturnal back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Modified Work Ability Index (WAI)</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>This is used to assess participant's work ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fatigue</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>Fatigue was assessed as Question 1 of the BASDAI, on a NRS from 0 (none) to 10 (very severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Severity and Duration of Morning Stiffness</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>Morning stiffness was measured as the mean of the 2 morning stiffness-related BASDAI NRS scores:&#xD;
Question 5: Level of morning stiffness assessed by the patient on a scale from 0 (none) to 10 (very severe), and Question 6: Duration of morning stiffness assessed by the patient on a scale from 0 (0 hours) to 10 (2 hours or more duration).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fear-Avoidance Belief Questionnaire Score (FABQ)</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>The FABQ measures patients' fear of pain and consequent avoidance of physical activity because of their fear. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale, where 0 = completely disagree, 6 = completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">17</enrollment>
  <condition>Axial Spondyloarthritis</condition>
  <arm_group>
    <arm_group_label>Active Supervised Training (AST)</arm_group_label>
    <description>Participants with axSpA and treated with adalimumab (HUMIRA®) according to the local product label and local standard of care were to receive active supervised and standardized training (AST).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (SOC) Physiotherapy</arm_group_label>
    <description>Participants with axSpA and treated with adalimumab (HUMIRA®) according to the local product label and local standard of care were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Supervised Training (AST)</intervention_name>
    <description>The active supervised and standardized training consisted of 24 units of exercise within 20 weeks performed in certified training centers and was focused on back fitness, core strengthening and patient engagement to treat back pain and functional impairment.</description>
    <arm_group_label>Active Supervised Training (AST)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care (SOC) Physiotherapy</intervention_name>
    <description>Standard of care physiotherapy as used in this study included active as well as passive training and massages according to the physiotherapist discretion.</description>
    <arm_group_label>Standard of Care (SOC) Physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with axial spondyloarthritis who received Humira® per local product label at&#xD;
        rheumatology centers in Germany.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants diagnosed with axial spondyloarthritis (axSpA) (either ankylosing&#xD;
             spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA)), fulfilling&#xD;
             the Assessment of Spondyloarthritis International Society (ASAS) classification, aged&#xD;
             at least 18 years&#xD;
&#xD;
          -  Prescription of Humira® (adalimumab) for treating axSpA according to the local product&#xD;
             label&#xD;
&#xD;
          -  Eligibility for active physiotherapy according to the rheumatologist and&#xD;
             physiotherapist&#xD;
&#xD;
          -  Participants must have signed written informed consent before starting any study&#xD;
             related assessments or procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with total spinal ankylosis based on the investigators' assessments of&#xD;
             available radiographs&#xD;
&#xD;
          -  Participants who are not eligible for active supervised training or active&#xD;
             physiotherapy at the discretion of the rheumatologist and/or the physiotherapist&#xD;
&#xD;
          -  Participants with poorly controlled medical condition(s), which in the opinion of the&#xD;
             investigator, would put the participant at risk by participation in the protocol&#xD;
&#xD;
          -  Any prior treatment with a biologic disease-modifying antirheumatic drugs (DMARD) is&#xD;
             prohibited.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rheumahaus Studien GbR, Potsdam, DE /ID# 164494</name>
      <address>
        <city>Potsdam</city>
        <state>Brandenburg</state>
        <zip>14467</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MVZ Wittenbergplatz PP Orthos /ID# 204802</name>
      <address>
        <city>Berlin</city>
        <zip>10787</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumapraxis /ID# 164461</name>
      <address>
        <city>Halle</city>
        <zip>06128</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Ortho DE /ID# 204149</name>
      <address>
        <city>Hamburg</city>
        <zip>22415</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis internistische Rheumato /ID# 164463</name>
      <address>
        <city>Leipzig</city>
        <zip>04129</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus St. Josef /ID# 164501</name>
      <address>
        <city>Wuppertal</city>
        <zip>42105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.rxabbvie.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <results_first_submitted>September 9, 2019</results_first_submitted>
  <results_first_submitted_qc>September 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 2, 2019</results_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>axial spondyloarthritis</keyword>
  <keyword>active supervised training</keyword>
  <keyword>physical training</keyword>
  <keyword>adalimumab</keyword>
  <keyword>spinal mobility</keyword>
  <keyword>physiotherapy</keyword>
  <keyword>physical function</keyword>
  <keyword>health-related quality of life</keyword>
  <keyword>pain</keyword>
  <keyword>disease activity</keyword>
  <keyword>psychosocial risk factors</keyword>
  <keyword>workability</keyword>
  <keyword>Bath Ankylosing Spondylitis Metrology Index (BASMI)</keyword>
  <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>Axial Spondyloarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03258814/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03258814/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study enrolled participants with axial spondyloarthritis (AS) at 7 study sites in Germany. Eligible participants were receiving treatment with adalimumab (HUMIRA®) based on therapist's decision and local label requirements, must have had a response to adalimumab and have been eligible for active physiotherapy.</recruitment_details>
      <pre_assignment_details>An enrollment period of treatment initiation and response assessment for 3 to 5 months preceded Randomization. This study was terminated early due to slow enrollment. Up to study termination 17 patients met all inclusion and none of the exclusion criteria and were enrolled in the study. A total of 7 of these patients were randomized into the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Active Supervised Training (AST)</title>
          <description>Participants were to receive active supervised and standardized training (AST).</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care (SOC) Physiotherapy</title>
          <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
        </group>
        <group group_id="P3">
          <title>Not Randomized</title>
          <description>Participants who were enrolled in the study but were not randomized.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Early Termination</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants</population>
      <group_list>
        <group group_id="B1">
          <title>Active Supervised Training (AST)</title>
          <description>Participants were to receive active supervised and standardized training (AST).</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care (SOC) Physiotherapy</title>
          <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</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="4"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="7"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" lower_limit="37" upper_limit="66"/>
                    <measurement group_id="B2" value="31" lower_limit="30" upper_limit="43"/>
                    <measurement group_id="B3" value="38" lower_limit="30" upper_limit="66"/>
                  </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="4"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </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>
          <title>Bath Ankylosing Spondylitis Metrology Index (BASMI)</title>
          <description>BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total score ranges from 0 to 10, reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis.</description>
          <population>Participants with available data</population>
          <units>units on a scale</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="2"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.9" spread="3.3"/>
                    <measurement group_id="B2" value="2.2" spread="0.8"/>
                    <measurement group_id="B3" value="2.6" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 6</title>
        <description>BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>No participants had a Month 6 visit due to early study termination, hence the primary endpoint could not be assessed.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 6</title>
          <description>BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis</description>
          <population>No participants had a Month 6 visit due to early study termination, hence the primary endpoint could not be assessed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 3</title>
        <description>BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis.</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 3</title>
          <description>BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis.</description>
          <population>Participants with available data</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.4"/>
                  </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)</title>
        <description>The Bath Ankylosing Spondylitis Functional Index (BASFI) is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities, each on a numeric rating scale (NRS) ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher score indicating more limitations.</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)</title>
          <description>The Bath Ankylosing Spondylitis Functional Index (BASFI) is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities, each on a numeric rating scale (NRS) ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher score indicating more limitations.</description>
          <population>Participants with available data</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)</title>
        <description>The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. The ASAS HI consists of 17 questions, each answered by the participant as agree (1) or disagree (0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, with a lower score indicating a better and a higher score indicating an inferior health status.</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)</title>
          <description>The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. The ASAS HI consists of 17 questions, each answered by the participant as agree (1) or disagree (0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, with a lower score indicating a better and a higher score indicating an inferior health status.</description>
          <population>Participants with available data</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)</title>
        <description>The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)</title>
          <description>The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.</description>
          <population>Participants with available data</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a BASDAI 50 Response</title>
        <description>The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.&#xD;
A BASDAI 50 response is defined as improvement of 50% or more from baseline in BASDAI score.</description>
        <time_frame>Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a BASDAI 50 Response</title>
          <description>The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.&#xD;
A BASDAI 50 response is defined as improvement of 50% or more from baseline in BASDAI score.</description>
          <population>Participants with available data</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)</title>
        <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (C-reactive protein [CRP]) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot;</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)</title>
          <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (C-reactive protein [CRP]) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot;</description>
          <population>Participants with available data</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ASDAS Inactive Disease</title>
        <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with ASDAS inactive disease, defined as ASDAS &lt; 1.3, is reported.</description>
        <time_frame>Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ASDAS Inactive Disease</title>
          <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with ASDAS inactive disease, defined as ASDAS &lt; 1.3, is reported.</description>
          <population>Participants with available data</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ASDAS Low Disease Activity</title>
        <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with ASDAS low disease activity, defined as ASDAS &lt; 2.1, is reported.</description>
        <time_frame>Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ASDAS Low Disease Activity</title>
          <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with ASDAS low disease activity, defined as ASDAS &lt; 2.1, is reported.</description>
          <population>Participants with available data</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ASDAS Moderate Disease Activity</title>
        <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with ASDAS moderate disease activity, defined as an ASDAS ≥ 1.3 to &lt; 2.1, is reported.</description>
        <time_frame>Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ASDAS Moderate Disease Activity</title>
          <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with ASDAS moderate disease activity, defined as an ASDAS ≥ 1.3 to &lt; 2.1, is reported.</description>
          <population>Participants with available data</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ASDAS High Disease Activity</title>
        <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with high disease activity, defined as an ASDAS ≥ 2.1 to &lt; 3.5, is reported.</description>
        <time_frame>Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ASDAS High Disease Activity</title>
          <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with high disease activity, defined as an ASDAS ≥ 2.1 to &lt; 3.5, is reported.</description>
          <population>Participants with available data</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ASDAS Very High Disease Activity</title>
        <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with very high disease activity, defined as an ASDAS ≥ 3.5, is reported.</description>
        <time_frame>Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ASDAS Very High Disease Activity</title>
          <description>ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot; The percentage of participants with very high disease activity, defined as an ASDAS ≥ 3.5, is reported.</description>
          <population>Participants with available data</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving ASDAS Major Improvement</title>
        <description>ASDAS Major Improvement is defined as a change from Baseline ≥ 2.0. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot;</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving ASDAS Major Improvement</title>
          <description>ASDAS Major Improvement is defined as a change from Baseline ≥ 2.0. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot;</description>
          <population>Participants with available data</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving ASDAS Clinically Important Improvement</title>
        <description>ASDAS clinically important improvement is defined as a change from Baseline ≥ 1.1.&#xD;
ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot;</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving ASDAS Clinically Important Improvement</title>
          <description>ASDAS clinically important improvement is defined as a change from Baseline ≥ 1.1.&#xD;
ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: &lt; 1.3 for &quot;inactive disease&quot;; ≥ 1.3 to &lt; 2.1 for &quot;moderate disease activity&quot;; ≥ 2.1 to ≤ 3.5 for &quot;high disease activity&quot; and ≥ 3.5 for &quot;very high disease activity.&quot;</description>
          <population>Participants with available data</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response</title>
        <description>ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:&#xD;
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);&#xD;
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);&#xD;
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);&#xD;
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response</title>
          <description>ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:&#xD;
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);&#xD;
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);&#xD;
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);&#xD;
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).</description>
          <population>Participants with available data</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving an ASAS 40 Response</title>
        <description>ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:&#xD;
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);&#xD;
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);&#xD;
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);&#xD;
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving an ASAS 40 Response</title>
          <description>ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:&#xD;
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);&#xD;
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);&#xD;
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);&#xD;
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).</description>
          <population>Participants with available data</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving ASAS Partial Remission</title>
        <description>ASAS partial remission is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:&#xD;
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);&#xD;
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);&#xD;
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);&#xD;
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).</description>
        <time_frame>Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving ASAS Partial Remission</title>
          <description>ASAS partial remission is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:&#xD;
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);&#xD;
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);&#xD;
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);&#xD;
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).</description>
          <population>Participants with available data</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient's Global Assessment of Pain</title>
        <description>The patient's global assessment of pain was assessed on a NRS from 0 (no pain) to 10 (pain as bad as it could be).</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient's Global Assessment of Pain</title>
          <description>The patient's global assessment of pain was assessed on a NRS from 0 (no pain) to 10 (pain as bad as it could be).</description>
          <population>Participants with available data</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient's Assessment of Total Back Pain</title>
        <description>The patient's assessment of total back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient's Assessment of Total Back Pain</title>
          <description>The patient's assessment of total back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).</description>
          <population>Participants with available data</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient's Assessment of Nocturnal Back Pain</title>
        <description>The patient's assessment of nocturnal back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient's Assessment of Nocturnal Back Pain</title>
          <description>The patient's assessment of nocturnal back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).</description>
          <population>Participants with available data</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Modified Work Ability Index (WAI)</title>
        <description>This is used to assess participant's work ability.</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>No participants had available WAI data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Modified Work Ability Index (WAI)</title>
          <description>This is used to assess participant's work ability.</description>
          <population>No participants had available WAI data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fatigue</title>
        <description>Fatigue was assessed as Question 1 of the BASDAI, on a NRS from 0 (none) to 10 (very severe).</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fatigue</title>
          <description>Fatigue was assessed as Question 1 of the BASDAI, on a NRS from 0 (none) to 10 (very severe).</description>
          <population>Participants with available data</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Severity and Duration of Morning Stiffness</title>
        <description>Morning stiffness was measured as the mean of the 2 morning stiffness-related BASDAI NRS scores:&#xD;
Question 5: Level of morning stiffness assessed by the patient on a scale from 0 (none) to 10 (very severe), and Question 6: Duration of morning stiffness assessed by the patient on a scale from 0 (0 hours) to 10 (2 hours or more duration).</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>Participants with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Severity and Duration of Morning Stiffness</title>
          <description>Morning stiffness was measured as the mean of the 2 morning stiffness-related BASDAI NRS scores:&#xD;
Question 5: Level of morning stiffness assessed by the patient on a scale from 0 (none) to 10 (very severe), and Question 6: Duration of morning stiffness assessed by the patient on a scale from 0 (0 hours) to 10 (2 hours or more duration).</description>
          <population>Participants with available data</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fear-Avoidance Belief Questionnaire Score (FABQ)</title>
        <description>The FABQ measures patients' fear of pain and consequent avoidance of physical activity because of their fear. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale, where 0 = completely disagree, 6 = completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.</description>
        <time_frame>Baseline and Month 3</time_frame>
        <population>No participants had available FABQ data</population>
        <group_list>
          <group group_id="O1">
            <title>Active Supervised Training (AST)</title>
            <description>Participants were to receive active supervised and standardized training (AST).</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care (SOC) Physiotherapy</title>
            <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fear-Avoidance Belief Questionnaire Score (FABQ)</title>
          <description>The FABQ measures patients' fear of pain and consequent avoidance of physical activity because of their fear. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale, where 0 = completely disagree, 6 = completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.</description>
          <population>No participants had available FABQ data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Active Supervised Training (AST)</title>
          <description>Participants were to receive active supervised and standardized training (AST).</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care (SOC) Physiotherapy</title>
          <description>Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.</description>
        </group>
        <group group_id="E3">
          <title>Not Randomized</title>
          <description>Participants who were enrolled in the study but were not randomized.</description>
        </group>
      </group_list>
      <serious_events>
        <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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pulpitis dental</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Axial spondyloarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bone lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to early termination of the study, no interpretations or conclusions can be made based on the results.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.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/NCT03258814
org study id: P15-710
nct id: NCT03258814
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study is a non-interventional, longitudinal and non-confirmatory study to compare an
      active supervised training (AST) with standard of care (SOC) physiotherapy in patients with
      axial spondyloarthritis and stable response to adalimumab (HUMIRA®) with respect to
      health-related outcomes. The primary objective is the improvement in spinal mobility after a
      6 month training program.
Treatment of axSpA patients with adalimumab (HUMIRA®) was according to the local adalimumab
      product label and local standard of care. AxSpA patients who responded to newly initialized
      adalimumab treatment based on physicians' decision, and who were eligible for active
      physiotherapy were enrolled in the study. Although this was a non-interventional study,
      participants were randomly assigned to receive either active supervised and standardized
      training physiotherapy or standard of care physiotherapy in order to provide adequate numbers
      of participants in each comparison group.

      Participants who consented to participate in the study were observed for up to 12 months from
      Baseline (defined as the Randomization visit where participants were assigned to one of the
      two physiotherapy options).
observational model: Cohort
time perspective: Prospective
measure: Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 6
time frame: Baseline and Month 6
description: BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
measure: Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 3
time frame: Baseline and Month 3
description: BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis.
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
time frame: Baseline and Month 3
description: The Bath Ankylosing Spondylitis Functional Index (BASFI) is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities, each on a numeric rating scale (NRS) ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher score indicating more limitations.
measure: Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)
time frame: Baseline and Month 3
description: The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. The ASAS HI consists of 17 questions, each answered by the participant as agree (1) or disagree (0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, with a lower score indicating a better and a higher score indicating an inferior health status.
measure: Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
time frame: Baseline and Month 3
description: The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.
measure: Percentage of Participants Achieving a BASDAI 50 Response
time frame: Month 3
description: The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.
A BASDAI 50 response is defined as improvement of 50% or more from baseline in BASDAI score.
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
time frame: Baseline and Month 3
description: ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (C-reactive protein [CRP]) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity."
measure: Percentage of Participants With ASDAS Inactive Disease
time frame: Month 3
description: ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." The percentage of participants with ASDAS inactive disease, defined as ASDAS < 1.3, is reported.
measure: Percentage of Participants With ASDAS Low Disease Activity
time frame: Month 3
description: ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." The percentage of participants with ASDAS low disease activity, defined as ASDAS < 2.1, is reported.
measure: Percentage of Participants With ASDAS Moderate Disease Activity
time frame: Month 3
description: ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." The percentage of participants with ASDAS moderate disease activity, defined as an ASDAS ≥ 1.3 to < 2.1, is reported.
measure: Percentage of Participants With ASDAS High Disease Activity
time frame: Month 3
description: ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." The percentage of participants with high disease activity, defined as an ASDAS ≥ 2.1 to < 3.5, is reported.
measure: Percentage of Participants With ASDAS Very High Disease Activity
time frame: Month 3
description: ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." The percentage of participants with very high disease activity, defined as an ASDAS ≥ 3.5, is reported.
measure: Percentage of Participants Achieving ASDAS Major Improvement
time frame: Baseline and Month 3
description: ASDAS Major Improvement is defined as a change from Baseline ≥ 2.0. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity."
measure: Percentage of Participants Achieving ASDAS Clinically Important Improvement
time frame: Baseline and Month 3
description: ASDAS clinically important improvement is defined as a change from Baseline ≥ 1.1.
ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity."
measure: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response
time frame: Baseline and Month 3
description: ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
measure: Percentage of Participants Achieving an ASAS 40 Response
time frame: Baseline and Month 3
description: ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
measure: Percentage of Participants Achieving ASAS Partial Remission
time frame: Month 3
description: ASAS partial remission is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
measure: Change From Baseline in Patient's Global Assessment of Pain
time frame: Baseline and Month 3
description: The patient's global assessment of pain was assessed on a NRS from 0 (no pain) to 10 (pain as bad as it could be).
measure: Change From Baseline in Patient's Assessment of Total Back Pain
time frame: Baseline and Month 3
description: The patient's assessment of total back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).
measure: Change From Baseline in Patient's Assessment of Nocturnal Back Pain
time frame: Baseline and Month 3
description: The patient's assessment of nocturnal back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).
measure: Change From Baseline in Modified Work Ability Index (WAI)
time frame: Baseline and Month 3
description: This is used to assess participant's work ability.
measure: Change From Baseline in Fatigue
time frame: Baseline and Month 3
description: Fatigue was assessed as Question 1 of the BASDAI, on a NRS from 0 (none) to 10 (very severe).
measure: Change From Baseline in Severity and Duration of Morning Stiffness
time frame: Baseline and Month 3
description: Morning stiffness was measured as the mean of the 2 morning stiffness-related BASDAI NRS scores:
Question 5: Level of morning stiffness assessed by the patient on a scale from 0 (none) to 10 (very severe), and Question 6: Duration of morning stiffness assessed by the patient on a scale from 0 (0 hours) to 10 (2 hours or more duration).
measure: Change From Baseline in Fear-Avoidance Belief Questionnaire Score (FABQ)
time frame: Baseline and Month 3
description: The FABQ measures patients' fear of pain and consequent avoidance of physical activity because of their fear. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale, where 0 = completely disagree, 6 = completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
arm group label: Active Supervised Training (AST)
description: Participants with axSpA and treated with adalimumab (HUMIRA®) according to the local product label and local standard of care were to receive active supervised and standardized training (AST).
arm group label: Standard of Care (SOC) Physiotherapy
description: Participants with axSpA and treated with adalimumab (HUMIRA®) according to the local product label and local standard of care were to receive standard of care physiotherapy, according to the physiotherapist discretion.
intervention type: Behavioral
intervention name: Active Supervised Training (AST)
description: The active supervised and standardized training consisted of 24 units of exercise within 20 weeks performed in certified training centers and was focused on back fitness, core strengthening and patient engagement to treat back pain and functional impairment.
arm group label: Active Supervised Training (AST)
intervention type: Behavioral
intervention name: Standard of Care (SOC) Physiotherapy
description: Standard of care physiotherapy as used in this study included active as well as passive training and massages according to the physiotherapist discretion.
arm group label: Standard of Care (SOC) Physiotherapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
facility: 
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country: Germany
url: http://www.rxabbvie.com/
description: Related Info
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Axial Spondyloarthritis
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to early termination of the study, no interpretations or conclusions can be made based on the results.
point of contact: 