<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/NCT03259074</url>
  </required_header>
  <id_info>
    <org_study_id>CAIN457K2340</org_study_id>
    <nct_id>NCT03259074</nct_id>
  </id_info>
  <brief_title>Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)</brief_title>
  <acronym>SURPASS</acronym>
  <official_title>A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate the impact of secukinumab on the progression of&#xD;
      structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis&#xD;
      Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a Phase IIIb, multi-center, randomized, partially-blinded, active-controlled,&#xD;
      parallel-group design in subjects with AS. The study consisted of a screening period (up to&#xD;
      10 weeks before randomization), a treatment period (104 weeks), and two follow-up visits&#xD;
      (Weeks 112 and 120).&#xD;
&#xD;
      Subjects in both secukinumab dose groups received study treatment at baseline, Weeks 1, 2, 3&#xD;
      and 4 followed by treatment every 4 weeks through Week 100. Subjects in the GP2017 group&#xD;
      received study treatment at baseline and every two weeks through Week 102. Subjects could&#xD;
      self-administer all secukinumab / placebo and GP2017 doses at the study site or at home.&#xD;
      Study treatment (secukinumab vs. GP2017) was provided in an open-label fashion. Subjects in&#xD;
      the secukinumab groups were blinded to the dose (150 mg vs. 300 mg). Subjects who received&#xD;
      rescue treatment with prohibited medications were allowed to remain in the study but had to&#xD;
      discontinue study treatment. Subjects were treated for 104 weeks with two follow-up visits&#xD;
      (Weeks 112 and 120).&#xD;
&#xD;
      A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe,&#xD;
      North America, South America, and Asia.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2017</start_date>
  <completion_date type="Actual">November 29, 2021</completion_date>
  <primary_completion_date type="Actual">November 12, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Study was partially blinded. Subjects, investigators, site personnel, persons performing the assessments, monitors and the Sponsor remained blinded to the dose group of secukinumab (150 mg versus 300 mg)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The Participant, Care Provider, Investigator and Sponsor are blinded to Secukinumab dose</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)</measure>
    <time_frame>Baseline and at Week 104</time_frame>
    <description>Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score &lt;= 0.5.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set)</measure>
    <time_frame>Baseline and at Week 104</time_frame>
    <description>Radiographic changes in the spine were based on the change in score of the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) from baseline to Week 104.&#xD;
The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset)</measure>
    <time_frame>Baseline and at Week 104</time_frame>
    <description>Syndesmophytes are bony growths that develop on corner of the vertebrae of the spine which are indicators of AS. A participant was considered to have a syndesmophyte if at least one reader assessed vertebral corner as &gt;= 2 at on the mSASSS scale at baseline. Only participants with a syndesmophyte at baseline were evaluated at Week 104 for new syndesmophytes. A new syndesmophyte was a syndesmophyte present at Week 104 which was not present at baseline. Absence of new syndesmophyte was defined as having individual vertebral score &lt; 2 on the mSASSS scale for all interpretable locations that had no syndesmophyte at baseline. Missing responses for subjects without new syndesmophyte at Week 104 were imputed by multiple imputation (MCMC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset)</measure>
    <time_frame>Baseline and at Week 104</time_frame>
    <description>Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a minimum score of 0 and a maximum score of 24. Higher scores indicate more inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset)</measure>
    <time_frame>Baseline and at Week 104</time_frame>
    <description>Magnetic Resonance Images (MRI) of the spine were assessed for the presence and severity of bone marrow edema in the spinal vertebrae according to the Berlin modification of the ASspiMRI-a edema score with a score range of 0 to 69. Higher scores indicate more inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20)</measure>
    <time_frame>Week 104</time_frame>
    <description>Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40)</measure>
    <time_frame>Week 104</time_frame>
    <description>Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set)</measure>
    <time_frame>Week 104</time_frame>
    <description>The Assessment of SpondyloArthritis International Society (ASAS) partial remission response criteria consisted of the following assessment domains measured on visual analogue scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The ASAS partial remission criteria was defined as a value not above 2 units in each of the four domains on a scale of 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set)</measure>
    <time_frame>Week 104</time_frame>
    <description>The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. Parameters used for the ASDAS include spinal pain (BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive protein (CRP) in mg/L (Sieper 2009, Lukas 2009). Disease activity states are inactive disease, moderate disease activity, high disease activity, and very high disease activity. The 3 values selected to separate these states were &lt; 1.3 between inactive disease and moderate disease activity, &lt; 2.1 between moderate disease activity and high disease activity, and &gt; 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change ≥ 1.1 unit for &quot;minimal clinically important improvement&quot; and a change ≥ 2.0 units for &quot;major improvement&quot; (Machado 2011).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">859</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>AIN457 150 mg/placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AIN457 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GP2017 40mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes</description>
    <arm_group_label>AIN457 150 mg/placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GP2017 (adalimumab biosimilar)</intervention_name>
    <description>40 mg in pre-filled syringes was administered subcutaneously</description>
    <arm_group_label>GP2017 40mg</arm_group_label>
    <other_name>adalimumab biosimilar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AIN457 150 mg</intervention_name>
    <description>150 mg in pre-filled syringes was administered subcutaneously</description>
    <arm_group_label>AIN457 150 mg/placebo</arm_group_label>
    <arm_group_label>AIN457 300 mg</arm_group_label>
    <other_name>secukinumab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or non-pregnant, non-nursing female patients at least 18 years of age&#xD;
&#xD;
          -  Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence&#xD;
             (centrally read X-ray) fulfilling the Modified New York criteria for AS despite&#xD;
             previous or current NSAID/ nonbiologic DMARD therapy&#xD;
&#xD;
          -  Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10&#xD;
&#xD;
          -  Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)&#xD;
&#xD;
          -  Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)&#xD;
&#xD;
          -  hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with total ankylosis of the spine&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women&#xD;
&#xD;
          -  Evidence of ongoing infectious or malignant process&#xD;
&#xD;
          -  Previous exposure to any biologic immunomodulating agent, including those targeting&#xD;
             IL-17, IL-17 receptor or TNFα&#xD;
&#xD;
          -  Subjects taking high potency opioid analgesics&#xD;
&#xD;
          -  Previous treatment with any cell-depleting therapies including but not limited to&#xD;
             anti-CD20, investigational agents&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143 0138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71101</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Wheaton</city>
        <state>Maryland</state>
        <zip>20902</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68516</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45402</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
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      <name>Novartis Investigative Site</name>
      <address>
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        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
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      <name>Novartis Investigative Site</name>
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        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
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        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
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    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mesquite</city>
        <state>Texas</state>
        <zip>75150</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kennewick</city>
        <state>Washington</state>
        <zip>99336</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Franklin</city>
        <state>Wisconsin</state>
        <zip>53132</zip>
        <country>United States</country>
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    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ciudad Autonoma de Bs As</city>
        <zip>C1428AZF</zip>
        <country>Argentina</country>
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      <name>Novartis Investigative Site</name>
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        <state>Victoria</state>
        <zip>3145</zip>
        <country>Australia</country>
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    <facility>
      <name>Novartis Investigative Site</name>
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        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
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    <facility>
      <name>Novartis Investigative Site</name>
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        <state>Manitoba</state>
        <zip>R3A 1M1</zip>
        <country>Canada</country>
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        <state>Ontario</state>
        <zip>L4M 6L2</zip>
        <country>Canada</country>
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    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Trois Rivieres</city>
        <state>Quebec</state>
        <zip>G8Z 1Y2</zip>
        <country>Canada</country>
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    <facility>
      <name>Novartis Investigative Site</name>
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        <country>Canada</country>
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      <name>Novartis Investigative Site</name>
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        <city>Santiago</city>
        <state>RM</state>
        <zip>7500588</zip>
        <country>Chile</country>
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        <city>Concepcion</city>
        <country>Chile</country>
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    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santiago</city>
        <zip>8207257</zip>
        <country>Chile</country>
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    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
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    <facility>
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        <state>Santander</state>
        <zip>0001</zip>
        <country>Colombia</country>
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      <name>Novartis Investigative Site</name>
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        <zip>61500</zip>
        <country>Czechia</country>
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    <facility>
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      <address>
        <city>Brno</city>
        <zip>63800</zip>
        <country>Czechia</country>
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        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Joensuu</city>
        <zip>80210</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nice</city>
        <state>Cedex1</state>
        <zip>06001</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boulogne Billancourt</city>
        <zip>92104</zip>
        <country>France</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Le Mans</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Monaco</city>
        <zip>98000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Paris Cedex 14</city>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bad Doberan</city>
        <zip>18209</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bayreuth</city>
        <zip>95444</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>12163</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>14059</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Chemnitz</city>
        <zip>09130</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Erlangen</city>
        <zip>91056</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gottingen</city>
        <zip>37075</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20095</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamburg</city>
        <zip>22415</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Herne</city>
        <zip>44649</zip>
        <country>Germany</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Magdeburg</city>
        <zip>39110</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Planegg</city>
        <zip>82152</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ratingen</city>
        <zip>40878</zip>
        <country>Germany</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Thessaloniki</city>
        <state>GR</state>
        <zip>564 29</zip>
        <country>Greece</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Athens</city>
        <zip>115 27</zip>
        <country>Greece</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Athens</city>
        <zip>145 61</zip>
        <country>Greece</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Haifa</city>
        <zip>3339419</zip>
        <country>Israel</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nishinomiya</city>
        <state>Hyogo</state>
        <zip>663 8501</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kita-gun</city>
        <state>Kagawa</state>
        <zip>761-0793</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nankoku city</city>
        <state>Kochi</state>
        <zip>783 8505</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tenri</city>
        <state>Nara</state>
        <zip>632-8552</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bunkyo ku</city>
        <state>Tokyo</state>
        <zip>113-8431</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Chuo ku</city>
        <state>Tokyo</state>
        <zip>104-8560</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Meguro</city>
        <state>Tokyo</state>
        <zip>153-8515</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160 8582</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <state>Seocho Gu</state>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gwangju</city>
        <zip>61469</zip>
        <country>Korea, Republic of</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>04763</zip>
        <country>Korea, Republic of</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>05278</zip>
        <country>Korea, Republic of</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mexicali</city>
        <state>Baja California</state>
        <zip>21100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Torreon</city>
        <state>Coahulia</state>
        <zip>27000</zip>
        <country>Mexico</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Culiacan</city>
        <state>MEX</state>
        <zip>80000</zip>
        <country>Mexico</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64460</zip>
        <country>Mexico</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Luis potosi</city>
        <zip>78213</zip>
        <country>Mexico</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leiden</city>
        <state>Zuid-Holland</state>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leeuwarden</city>
        <zip>8934 AD</zip>
        <country>Netherlands</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Maastricht</city>
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        <country>Netherlands</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rotterdam</city>
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        <country>Netherlands</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Jesus Maria</city>
        <state>Lima</state>
        <zip>11</zip>
        <country>Peru</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Isidro</city>
        <state>Lima</state>
        <zip>27</zip>
        <country>Peru</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santiago de Surco</city>
        <state>Lima</state>
        <zip>33</zip>
        <country>Peru</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lima</city>
        <zip>1</zip>
        <country>Peru</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Manila</city>
        <zip>1008</zip>
        <country>Philippines</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Quezon City</city>
        <zip>1102</zip>
        <country>Philippines</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Quezon City</city>
        <zip>1118</zip>
        <country>Philippines</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85 168</zip>
        <country>Poland</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dopiewo</city>
        <zip>62 069</zip>
        <country>Poland</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Krakow</city>
        <zip>30 002</zip>
        <country>Poland</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Poznan</city>
        <zip>61 113</zip>
        <country>Poland</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sopot</city>
        <zip>81 756</zip>
        <country>Poland</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Almada</city>
        <zip>2801 951</zip>
        <country>Portugal</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1050-034</zip>
        <country>Portugal</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1349 019</zip>
        <country>Portugal</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ponte de Lima</city>
        <zip>4990 041</zip>
        <country>Portugal</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Porto</city>
        <zip>4200 319</zip>
        <country>Portugal</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vila Nova de Gaia</city>
        <zip>4434 502</zip>
        <country>Portugal</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucharest</city>
        <zip>030167</zip>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>011172</zip>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cluj Napoca</city>
        <zip>400006</zip>
        <country>Romania</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barnaul</city>
        <zip>656050</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <zip>454076</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <zip>620137</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ivanovo</city>
        <zip>153005</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kazan</city>
        <zip>420097</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kemerovo</city>
        <zip>650029</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kemerovo</city>
        <zip>650066</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>115522</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>129110</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Petrozavodsk</city>
        <zip>185019</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St Petersburg</city>
        <zip>190068</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ufa</city>
        <zip>450005</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bratislava</city>
        <state>Slovak Republic</state>
        <zip>813 69</zip>
        <country>Slovakia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Piestany</city>
        <state>SVK</state>
        <zip>921 12</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bratislava</city>
        <zip>85101</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kosice</city>
        <zip>04011</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Stara Lubovna</city>
        <zip>06401</zip>
        <country>Slovakia</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Villajoyosa</city>
        <state>Alicante</state>
        <zip>703570</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Vicente De Barakaldo</city>
        <state>Bizkaia</state>
        <zip>48903</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Badalona</city>
        <state>Catalunya</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>La Coruna</city>
        <state>Galicia</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>Galicia</state>
        <zip>15706</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bilbao</city>
        <state>Pais Vasco</state>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36200</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vitoria</city>
        <state>Vitoria Gasteiz</state>
        <zip>01009</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28942</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Taichung</city>
        <state>Taiwan ROC</state>
        <zip>40201</zip>
        <country>Taiwan</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dalin</city>
        <zip>622</zip>
        <country>Taiwan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kaohsiung</city>
        <zip>80756</zip>
        <country>Taiwan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kaohsiung</city>
        <zip>81346</zip>
        <country>Taiwan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Istanbul</city>
        <state>TUR</state>
        <zip>34098</zip>
        <country>Turkey</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ankara</city>
        <zip>06230</zip>
        <country>Turkey</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ankara</city>
        <zip>06560</zip>
        <country>Turkey</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Eskisehir</city>
        <zip>26040</zip>
        <country>Turkey</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kocaeli</city>
        <zip>41380</zip>
        <country>Turkey</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Christchurch</city>
        <state>Dorset</state>
        <zip>BH23 2JX</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>London</city>
        <state>Edmonton</state>
        <zip>N18 1QX</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>London</city>
        <state>GBR</state>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Portsmouth</city>
        <state>Hants</state>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leytonstone</city>
        <state>London</state>
        <zip>E11 1NR</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Stoke on Trent</city>
        <state>Staffordshire</state>
        <zip>ST6 7AG</zip>
        <country>United Kingdom</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bristol</city>
        <zip>BS1 3NU</zip>
        <country>United Kingdom</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Liverpool</city>
        <zip>L9 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Norwich</city>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Torquay</city>
        <zip>TQ2 7AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Monaco</country>
  </removed_countries>
  <link>
    <url>https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1307</url>
    <description>A Plain Language Trial Summary is available on novctrd.com</description>
  </link>
  <verification_date>August 2023</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>November 21, 2022</results_first_submitted>
  <results_first_submitted_qc>February 10, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 9, 2023</results_first_posted>
  <disposition_first_submitted>July 8, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>February 10, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 9, 2023</disposition_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ankylosing spondylitis</keyword>
  <keyword>AS</keyword>
  <keyword>secukinumab</keyword>
  <keyword>GP2017</keyword>
  <keyword>adalimumab biosimilar</keyword>
  <keyword>mSASSS</keyword>
  <keyword>ASAS20</keyword>
  <keyword>ASAS40</keyword>
  <keyword>adult</keyword>
  <keyword>r-axSpA</keyword>
  <keyword>AIN457</keyword>
  <keyword>radiographic</keyword>
  <keyword>SURPASS</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>Spondylitis, Ankylosing</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </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 4, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03259074/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>May 10, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03259074/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe, North America, South America, and Asia</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AIN457 150 mg/Placebo</title>
          <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
        </group>
        <group group_id="P2">
          <title>AIN457 300 mg</title>
          <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
        </group>
        <group group_id="P3">
          <title>GP2017 40mg</title>
          <description>GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="287"/>
                <participants group_id="P2" count="286"/>
                <participants group_id="P3" count="286"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="254"/>
                <participants group_id="P2" count="237"/>
                <participants group_id="P3" count="243"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="43"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>New Therapy For Study Indication</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject/Guardian Decision</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AIN457 150 mg/Placebo</title>
          <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
        </group>
        <group group_id="B2">
          <title>AIN457 300 mg</title>
          <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
        </group>
        <group group_id="B3">
          <title>GP2017 40mg</title>
          <description>GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104</description>
        </group>
        <group group_id="B4">
          <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="287"/>
            <count group_id="B2" value="286"/>
            <count group_id="B3" value="286"/>
            <count group_id="B4" value="859"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="287"/>
                    <count group_id="B2" value="286"/>
                    <count group_id="B3" value="286"/>
                    <count group_id="B4" value="859"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.1" spread="11.99"/>
                    <measurement group_id="B2" value="42.2" spread="12.47"/>
                    <measurement group_id="B3" value="41.9" spread="12.68"/>
                    <measurement group_id="B4" value="42.1" spread="12.37"/>
                  </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="287"/>
                    <count group_id="B2" value="286"/>
                    <count group_id="B3" value="286"/>
                    <count group_id="B4" value="859"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="185"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="230"/>
                    <measurement group_id="B2" value="223"/>
                    <measurement group_id="B3" value="221"/>
                    <measurement group_id="B4" value="674"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="287"/>
                    <count group_id="B2" value="286"/>
                    <count group_id="B3" value="286"/>
                    <count group_id="B4" value="859"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="225"/>
                    <measurement group_id="B2" value="227"/>
                    <measurement group_id="B3" value="228"/>
                    <measurement group_id="B4" value="680"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="287"/>
                    <count group_id="B2" value="286"/>
                    <count group_id="B3" value="286"/>
                    <count group_id="B4" value="859"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="287"/>
                    <count group_id="B2" value="286"/>
                    <count group_id="B3" value="286"/>
                    <count group_id="B4" value="859"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="287"/>
                    <count group_id="B2" value="286"/>
                    <count group_id="B3" value="286"/>
                    <count group_id="B4" value="859"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="287"/>
                    <count group_id="B2" value="286"/>
                    <count group_id="B3" value="286"/>
                    <count group_id="B4" value="859"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="287"/>
                    <count group_id="B2" value="286"/>
                    <count group_id="B3" value="286"/>
                    <count group_id="B4" value="859"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) scores</title>
          <description>The modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) evaluates the outside corners of the vertebral spine for erosions, sclerosis, squaring, bony growths and spinal bridging. The mSASSS assesses the participant's spinal vertebrae for structural changes and scores each vertebrae from 0 (normal vertebrae) to 3 (bony growth that bridges one vertebrae to the neighboring vertebrae). A total of 24 vertebral corners are scored for a possible maximum grade of 72.</description>
          <population>The baseline mSASSS was determined only from those participants who provided evaluable baseline X-ray images.</population>
          <units>score 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="283"/>
                    <count group_id="B2" value="280"/>
                    <count group_id="B3" value="283"/>
                    <count group_id="B4" value="846"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.602" spread="21.3286"/>
                    <measurement group_id="B2" value="16.527" spread="20.8153"/>
                    <measurement group_id="B3" value="15.695" spread="19.4955"/>
                    <measurement group_id="B4" value="16.609" spread="20.5506"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)</title>
        <description>Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score &lt;= 0.5.</description>
        <time_frame>Baseline and at Week 104</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 150 mg/Placebo</title>
            <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O2">
            <title>AIN457 300 mg</title>
            <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O3">
            <title>GP2017 40mg</title>
            <description>GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)</title>
          <description>Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score &lt;= 0.5.</description>
          <population>Full analysis set</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="287"/>
                <count group_id="O2" value="286"/>
                <count group_id="O3" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.1"/>
                    <measurement group_id="O2" value="66.9"/>
                    <measurement group_id="O3" value="65.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7164</p_value>
            <p_value_desc>Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Marginal difference</param_type>
            <param_value>1.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.63</ci_lower_limit>
            <ci_upper_limit>9.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6925</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method.</method_desc>
            <param_type>Marginal difference</param_type>
            <param_value>1.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.61</ci_lower_limit>
            <ci_upper_limit>9.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set)</title>
        <description>Radiographic changes in the spine were based on the change in score of the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) from baseline to Week 104.&#xD;
The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72.</description>
        <time_frame>Baseline and at Week 104</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 150 mg/Placebo</title>
            <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O2">
            <title>AIN457 300 mg</title>
            <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O3">
            <title>GP2017 40mg</title>
            <description>GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set)</title>
          <description>Radiographic changes in the spine were based on the change in score of the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) from baseline to Week 104.&#xD;
The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72.</description>
          <population>Full analysis set</population>
          <units>mSASSS scores</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="287"/>
                <count group_id="O2" value="286"/>
                <count group_id="O3" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="0.175"/>
                    <measurement group_id="O2" value="0.55" spread="0.180"/>
                    <measurement group_id="O3" value="0.72" spread="0.177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.</non_inferiority_desc>
            <param_type>LS mean difference</param_type>
            <param_value>-0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.646</ci_lower_limit>
            <ci_upper_limit>0.293</ci_upper_limit>
            <estimate_desc>ANCOVA model with treatment as a factor and baseline mSASSS score as a covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.</non_inferiority_desc>
            <param_type>LS mean difference</param_type>
            <param_value>-0.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.639</ci_lower_limit>
            <ci_upper_limit>0.315</ci_upper_limit>
            <estimate_desc>ANCOVA model with treatment as a factor and baseline mSASSS score as a covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset)</title>
        <description>Syndesmophytes are bony growths that develop on corner of the vertebrae of the spine which are indicators of AS. A participant was considered to have a syndesmophyte if at least one reader assessed vertebral corner as &gt;= 2 at on the mSASSS scale at baseline. Only participants with a syndesmophyte at baseline were evaluated at Week 104 for new syndesmophytes. A new syndesmophyte was a syndesmophyte present at Week 104 which was not present at baseline. Absence of new syndesmophyte was defined as having individual vertebral score &lt; 2 on the mSASSS scale for all interpretable locations that had no syndesmophyte at baseline. Missing responses for subjects without new syndesmophyte at Week 104 were imputed by multiple imputation (MCMC).</description>
        <time_frame>Baseline and at Week 104</time_frame>
        <population>Syndesmophyte subset only included participants who had a syndesmophyte at baseline as measured on the mSASSS scale.</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 150 mg/Placebo</title>
            <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O2">
            <title>AIN457 300 mg</title>
            <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O3">
            <title>GP2017 40mg</title>
            <description>GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset)</title>
          <description>Syndesmophytes are bony growths that develop on corner of the vertebrae of the spine which are indicators of AS. A participant was considered to have a syndesmophyte if at least one reader assessed vertebral corner as &gt;= 2 at on the mSASSS scale at baseline. Only participants with a syndesmophyte at baseline were evaluated at Week 104 for new syndesmophytes. A new syndesmophyte was a syndesmophyte present at Week 104 which was not present at baseline. Absence of new syndesmophyte was defined as having individual vertebral score &lt; 2 on the mSASSS scale for all interpretable locations that had no syndesmophyte at baseline. Missing responses for subjects without new syndesmophyte at Week 104 were imputed by multiple imputation (MCMC).</description>
          <population>Syndesmophyte subset only included participants who had a syndesmophyte at baseline as measured on the mSASSS scale.</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="211"/>
                <count group_id="O2" value="204"/>
                <count group_id="O3" value="212"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.9"/>
                    <measurement group_id="O2" value="53.8"/>
                    <measurement group_id="O3" value="53.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.</non_inferiority_desc>
            <param_type>Marginal difference</param_type>
            <param_value>4.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.62</ci_lower_limit>
            <ci_upper_limit>14.27</ci_upper_limit>
            <estimate_desc>Logistic regression model with treatment as a factor and baseline count of vertebral corners with syndesmophyte as a covariate using marginal standardization method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.</non_inferiority_desc>
            <param_type>Marginal difference</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.13</ci_lower_limit>
            <ci_upper_limit>11.31</ci_upper_limit>
            <estimate_desc>Logistic regression model with treatment as a factor and baseline count of vertebral corners with syndesmophyte as a covariate using marginal standardization method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset)</title>
        <description>Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a minimum score of 0 and a maximum score of 24. Higher scores indicate more inflammation.</description>
        <time_frame>Baseline and at Week 104</time_frame>
        <population>MRI subset only included participants who had an MRI performed at selected centers</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 150 mg/Placebo</title>
            <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O2">
            <title>AIN457 300 mg</title>
            <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O3">
            <title>GP2017 40mg</title>
            <description>GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset)</title>
          <description>Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a minimum score of 0 and a maximum score of 24. Higher scores indicate more inflammation.</description>
          <population>MRI subset only included participants who had an MRI performed at selected centers</population>
          <units>scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="137"/>
                <count group_id="O2" value="137"/>
                <count group_id="O3" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.527" spread="0.1057"/>
                    <measurement group_id="O2" value="-1.378" spread="0.1097"/>
                    <measurement group_id="O3" value="-1.710" spread="0.1087"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 104 - 150 mg</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.</non_inferiority_desc>
            <param_type>LS Means</param_type>
            <param_value>0.183</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1517</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.12</ci_lower_limit>
            <ci_upper_limit>0.48</ci_upper_limit>
            <estimate_desc>LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 104 - 300 mg</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented</non_inferiority_desc>
            <param_type>LS Means</param_type>
            <param_value>0.332</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1545</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.03</ci_lower_limit>
            <ci_upper_limit>0.64</ci_upper_limit>
            <estimate_desc>LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset)</title>
        <description>Magnetic Resonance Images (MRI) of the spine were assessed for the presence and severity of bone marrow edema in the spinal vertebrae according to the Berlin modification of the ASspiMRI-a edema score with a score range of 0 to 69. Higher scores indicate more inflammation.</description>
        <time_frame>Baseline and at Week 104</time_frame>
        <population>MRI subset only included participants who had an MRI performed at selected centers</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 150 mg/Placebo</title>
            <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O2">
            <title>AIN457 300 mg</title>
            <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O3">
            <title>GP2017 40mg</title>
            <description>GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset)</title>
          <description>Magnetic Resonance Images (MRI) of the spine were assessed for the presence and severity of bone marrow edema in the spinal vertebrae according to the Berlin modification of the ASspiMRI-a edema score with a score range of 0 to 69. Higher scores indicate more inflammation.</description>
          <population>MRI subset only included participants who had an MRI performed at selected centers</population>
          <units>Berlin mod. of ASspiMRI-a edema scores</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="137"/>
                <count group_id="O2" value="137"/>
                <count group_id="O3" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.224" spread="0.2306"/>
                    <measurement group_id="O2" value="-1.683" spread="0.2373"/>
                    <measurement group_id="O3" value="-2.101" spread="0.2378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 104 - 150 mg</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.</non_inferiority_desc>
            <param_type>LS Means</param_type>
            <param_value>0.877</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.3316</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.22</ci_lower_limit>
            <ci_upper_limit>1.53</ci_upper_limit>
            <estimate_desc>LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 104 - 300 mg</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented</non_inferiority_desc>
            <param_type>LS Means</param_type>
            <param_value>0.419</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.3357</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.24</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
            <estimate_desc>LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20)</title>
        <description>Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity.</description>
        <time_frame>Week 104</time_frame>
        <population>Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms.</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 150 mg/Placebo</title>
            <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O2">
            <title>AIN457 300 mg</title>
            <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20)</title>
          <description>Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity.</description>
          <population>Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="287"/>
                <count group_id="O2" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.1" lower_limit="77.8" upper_limit="87.4"/>
                    <measurement group_id="O2" value="82.9" lower_limit="77.3" upper_limit="87.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.</non_inferiority_desc>
            <param_type>Marginal difference</param_type>
            <param_value>1.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.10</ci_lower_limit>
            <ci_upper_limit>8.18</ci_upper_limit>
            <estimate_desc>Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40)</title>
        <description>Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.</description>
        <time_frame>Week 104</time_frame>
        <population>Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms.</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 150 mg/Placebo</title>
            <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O2">
            <title>AIN457 300 mg</title>
            <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40)</title>
          <description>Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.</description>
          <population>Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="287"/>
                <count group_id="O2" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.9" lower_limit="63.7" upper_limit="75.4"/>
                    <measurement group_id="O2" value="73.5" lower_limit="67.3" upper_limit="78.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.</non_inferiority_desc>
            <param_type>Marginal difference</param_type>
            <param_value>-2.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.18</ci_lower_limit>
            <ci_upper_limit>5.51</ci_upper_limit>
            <estimate_desc>Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set)</title>
        <description>The Assessment of SpondyloArthritis International Society (ASAS) partial remission response criteria consisted of the following assessment domains measured on visual analogue scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The ASAS partial remission criteria was defined as a value not above 2 units in each of the four domains on a scale of 10.</description>
        <time_frame>Week 104</time_frame>
        <population>Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms.</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 150 mg/Placebo</title>
            <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O2">
            <title>AIN457 300 mg</title>
            <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set)</title>
          <description>The Assessment of SpondyloArthritis International Society (ASAS) partial remission response criteria consisted of the following assessment domains measured on visual analogue scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The ASAS partial remission criteria was defined as a value not above 2 units in each of the four domains on a scale of 10.</description>
          <population>Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms.</population>
          <units>Percentage participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="287"/>
                <count group_id="O2" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.5" lower_limit="25.9" upper_limit="37.7"/>
                    <measurement group_id="O2" value="30.2" lower_limit="24.5" upper_limit="36.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented</non_inferiority_desc>
            <param_type>Marginal difference</param_type>
            <param_value>2.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.34</ci_lower_limit>
            <ci_upper_limit>9.69</ci_upper_limit>
            <estimate_desc>Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set)</title>
        <description>The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. Parameters used for the ASDAS include spinal pain (BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive protein (CRP) in mg/L (Sieper 2009, Lukas 2009). Disease activity states are inactive disease, moderate disease activity, high disease activity, and very high disease activity. The 3 values selected to separate these states were &lt; 1.3 between inactive disease and moderate disease activity, &lt; 2.1 between moderate disease activity and high disease activity, and &gt; 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change ≥ 1.1 unit for &quot;minimal clinically important improvement&quot; and a change ≥ 2.0 units for &quot;major improvement&quot; (Machado 2011).</description>
        <time_frame>Week 104</time_frame>
        <population>Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms.</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 150 mg/Placebo</title>
            <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
          <group group_id="O2">
            <title>AIN457 300 mg</title>
            <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set)</title>
          <description>The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. Parameters used for the ASDAS include spinal pain (BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive protein (CRP) in mg/L (Sieper 2009, Lukas 2009). Disease activity states are inactive disease, moderate disease activity, high disease activity, and very high disease activity. The 3 values selected to separate these states were &lt; 1.3 between inactive disease and moderate disease activity, &lt; 2.1 between moderate disease activity and high disease activity, and &gt; 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change ≥ 1.1 unit for &quot;minimal clinically important improvement&quot; and a change ≥ 2.0 units for &quot;major improvement&quot; (Machado 2011).</description>
          <population>Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="287"/>
                <count group_id="O2" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.1" lower_limit="25.5" upper_limit="37.4"/>
                    <measurement group_id="O2" value="31.7" lower_limit="25.7" upper_limit="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Marginal difference</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.08</ci_lower_limit>
            <ci_upper_limit>7.74</ci_upper_limit>
            <estimate_desc>Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AIN457 150 mg/Placebo</title>
          <description>AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
        </group>
        <group group_id="E2">
          <title>AIN457 300 mg</title>
          <description>AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104</description>
        </group>
        <group group_id="E3">
          <title>GP2017 40 mg</title>
          <description>GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (25.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Iridocyclitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Retinal vein occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic gastrointestinal bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Gastroenteritis eosinophilic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Ileal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Drug intolerance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Medical device pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Immunosuppression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess intestinal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Myelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Suspected COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Exposure during pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Type 1 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Chloroma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Ovarian cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Facial paresis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Guillain-Barre syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Lacunar stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Device issue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Depression suicidal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Micturition disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Iliac artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Iliac artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (25.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="106" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="107" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="99" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="44" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ankylosing spondylitis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="285"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="286"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="285"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>+1 862 778 8300</phone>
      <email>Novartis.email@Novartis.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/NCT03259074
org study id: CAIN457K2340
nct id: NCT03259074
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to demonstrate the impact of secukinumab on the progression of
      structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis
      Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).
This was a Phase IIIb, multi-center, randomized, partially-blinded, active-controlled,
      parallel-group design in subjects with AS. The study consisted of a screening period (up to
      10 weeks before randomization), a treatment period (104 weeks), and two follow-up visits
      (Weeks 112 and 120).

      Subjects in both secukinumab dose groups received study treatment at baseline, Weeks 1, 2, 3
      and 4 followed by treatment every 4 weeks through Week 100. Subjects in the GP2017 group
      received study treatment at baseline and every two weeks through Week 102. Subjects could
      self-administer all secukinumab / placebo and GP2017 doses at the study site or at home.
      Study treatment (secukinumab vs. GP2017) was provided in an open-label fashion. Subjects in
      the secukinumab groups were blinded to the dose (150 mg vs. 300 mg). Subjects who received
      rescue treatment with prohibited medications were allowed to remain in the study but had to
      discontinue study treatment. Subjects were treated for 104 weeks with two follow-up visits
      (Weeks 112 and 120).

      A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe,
      North America, South America, and Asia.

      .
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study was partially blinded. Subjects, investigators, site personnel, persons performing the assessments, monitors and the Sponsor remained blinded to the dose group of secukinumab (150 mg versus 300 mg)
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The Participant, Care Provider, Investigator and Sponsor are blinded to Secukinumab dose
measure: Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)
time frame: Baseline and at Week 104
description: Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score <= 0.5.
measure: Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set)
time frame: Baseline and at Week 104
description: Radiographic changes in the spine were based on the change in score of the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) from baseline to Week 104.
The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72.
measure: Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset)
time frame: Baseline and at Week 104
description: Syndesmophytes are bony growths that develop on corner of the vertebrae of the spine which are indicators of AS. A participant was considered to have a syndesmophyte if at least one reader assessed vertebral corner as >= 2 at on the mSASSS scale at baseline. Only participants with a syndesmophyte at baseline were evaluated at Week 104 for new syndesmophytes. A new syndesmophyte was a syndesmophyte present at Week 104 which was not present at baseline. Absence of new syndesmophyte was defined as having individual vertebral score < 2 on the mSASSS scale for all interpretable locations that had no syndesmophyte at baseline. Missing responses for subjects without new syndesmophyte at Week 104 were imputed by multiple imputation (MCMC).
measure: Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset)
time frame: Baseline and at Week 104
description: Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a minimum score of 0 and a maximum score of 24. Higher scores indicate more inflammation.
measure: Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset)
time frame: Baseline and at Week 104
description: Magnetic Resonance Images (MRI) of the spine were assessed for the presence and severity of bone marrow edema in the spinal vertebrae according to the Berlin modification of the ASspiMRI-a edema score with a score range of 0 to 69. Higher scores indicate more inflammation.
measure: Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20)
time frame: Week 104
description: Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity.
measure: Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40)
time frame: Week 104
description: Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.
measure: Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set)
time frame: Week 104
description: The Assessment of SpondyloArthritis International Society (ASAS) partial remission response criteria consisted of the following assessment domains measured on visual analogue scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The ASAS partial remission criteria was defined as a value not above 2 units in each of the four domains on a scale of 10.
measure: Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set)
time frame: Week 104
description: The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. Parameters used for the ASDAS include spinal pain (BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive protein (CRP) in mg/L (Sieper 2009, Lukas 2009). Disease activity states are inactive disease, moderate disease activity, high disease activity, and very high disease activity. The 3 values selected to separate these states were < 1.3 between inactive disease and moderate disease activity, < 2.1 between moderate disease activity and high disease activity, and > 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change ≥ 1.1 unit for "minimal clinically important improvement" and a change ≥ 2.0 units for "major improvement" (Machado 2011).
arm group label: AIN457 150 mg/placebo
arm group type: Experimental
description: AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
arm group label: AIN457 300 mg
arm group type: Experimental
description: AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
arm group label: GP2017 40mg
arm group type: Active Comparator
description: GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102
intervention type: Biological
intervention name: Placebo
description: Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes
arm group label: AIN457 150 mg/placebo
intervention type: Biological
intervention name: GP2017 (adalimumab biosimilar)
description: 40 mg in pre-filled syringes was administered subcutaneously
arm group label: GP2017 40mg
other name: adalimumab biosimilar
intervention type: Biological
intervention name: AIN457 150 mg
description: 150 mg in pre-filled syringes was administered subcutaneously
arm group label: AIN457 150 mg/placebo
arm group label: AIN457 300 mg
other name: secukinumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Argentina
country: Australia
country: Belgium
country: Canada
country: Chile
country: Colombia
country: Czechia
country: Denmark
country: Finland
country: France
country: Germany
country: Greece
country: Israel
country: Japan
country: Korea, Republic of
country: Mexico
country: Netherlands
country: Peru
country: Philippines
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Slovakia
country: Spain
country: Taiwan
country: Turkey
country: United Kingdom
country: United States
country: Monaco
url: https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1307
description: A Plain Language Trial Summary is available on novctrd.com
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Adalimumab
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 