<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/NCT03765788</url>
  </required_header>
  <id_info>
    <org_study_id>CAIN457ADE11C</org_study_id>
    <secondary_id>2018-002610-12</secondary_id>
    <nct_id>NCT03765788</nct_id>
  </id_info>
  <brief_title>A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis</brief_title>
  <acronym>TitAIN</acronym>
  <official_title>A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab (AIN457) in Patients With Giant Cell Arteritis (TitAIN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to evaluate the efficacy and safety of secukinumab compared to&#xD;
      placebo to maintain disease remission up to 28 weeks including corticosteroid tapering, as&#xD;
      well as up to 1 year (52 weeks) in patients with newly diagnosed or relapsing giant cell&#xD;
      arteritis (GCA) who were naïve to biological therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized, parallel-group, double-blind, placebo-controlled, multicenter, Phase II&#xD;
      study was designed to evaluate the efficacy of secukinumab compared to placebo in combination&#xD;
      with a 26-week prednisolone taper regimen in terms of sustained remission in patients with&#xD;
      newly diagnosed or relapsing Giant Cell Arteritis (GCA) who were naïve to biological therapy.&#xD;
      The study consisted of a Screening Period of up to 6 weeks (maximum duration), a 52-week&#xD;
      Treatment Period and an 8-week Safety Follow-up Period&#xD;
&#xD;
      Patients who did not achieve remission by Week 12, experienced a flare after remission or&#xD;
      could not adhere to the prednisolone taper regimen entered &quot;escape&quot;. Upon entering &quot;escape&quot;,&#xD;
      patients received prednisolone at a dose determined by the physician's clinical judgment and&#xD;
      continued to receive secukinumab or placebo in a blinded manner.&#xD;
&#xD;
      Safety evaluation was included in all visits including two safety follow-up visits performed&#xD;
      8 and 12 weeks after the last study drug administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Actual">June 8, 2021</completion_date>
  <primary_completion_date type="Actual">June 8, 2021</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants in Sustained Remission Until Week 28</measure>
    <time_frame>Until week 28</time_frame>
    <description>Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen.&#xD;
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (&gt;/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (&gt;/=10.0 mg/L) attributable to GCA.&#xD;
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the &quot;escape arm&quot; (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Remission at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen.&#xD;
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (&gt;/=) 30 millimeters per hour (mm/hr) and/or CRP (&gt;/=10.0 mg/L) attributable to GCA.&#xD;
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the &quot;escape arm&quot; (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First GCA Flare After Clinical Remission</measure>
    <time_frame>Up to Week 52 (included)</time_frame>
    <description>Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (&gt;/=) 30 millimeters per hour (mm/hr) and/or CRP (&gt;/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare.&#xD;
For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and patients who completed treatment and did not have a flare were censored at their last visit in the treatment phase.&#xD;
Time to first GCA flare after remission was calculated using Kaplan-Meier plot of time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks</measure>
    <time_frame>from Baseline to week 28, from baseline to week 52 weeks</time_frame>
    <description>Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With GCA Who Had Sustained Remission Until Week 52</measure>
    <time_frame>Until Week 52</time_frame>
    <description>Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (&gt;/=) 30 millimeters per hour (mm/hr) and/or CRP (&gt;/=10.0 mg/L) attributable to GCA.&#xD;
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the &quot;escape arm&quot; (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants on Prednisolone Dose ≤ 5mg/Day</measure>
    <time_frame>Week 19, Week 28, Week 52</time_frame>
    <description>Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52.&#xD;
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 [last dose].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS)</measure>
    <time_frame>Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 &amp; 52</time_frame>
    <description>Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS)</measure>
    <time_frame>Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 &amp; 52</time_frame>
    <description>Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FACIT-Fatigue Scale</measure>
    <time_frame>Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 &amp; 52</time_frame>
    <description>Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Short-Form (SF)-36 Questionnaire</measure>
    <time_frame>Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 &amp; 52</time_frame>
    <description>Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire</measure>
    <time_frame>Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 &amp; 52</time_frame>
    <description>EQ-5D-5L, a self-administered questionnaire assessing health status in adults, is divided into 2 sections. The 1st section addresses 5 dimensions (mobility, self-care, usual activity, pain/discomfort, &amp; anxiety/depression). Items are rated either &quot;no problem&quot;, &quot;slight problems&quot;, &quot;moderate problems&quot;, &quot;severe problems&quot;, or &quot;extreme problems/unable.&quot; A composite health index is defined by combining the levels for each dimension. The 2nd section measures self-rated (global) health status via vertically oriented VAS where 100 represents the &quot;best possible health state&quot; &amp; 0 represents the &quot;worst possible health state.&quot; The EQ-5D-5L contains 6 items assessing health status via a single index value or health utility score and allows &quot;weighting&quot; by the patient of health states &amp; generation of patient utilities. Published weights are available allowing for creation of a single summary health utility score. Scores range from 0 to 1, with lower scores representing a higher level of dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Erythrocyte Sedimentation Rate (ESR)</measure>
    <time_frame>Baseline, Week 28, Week 52</time_frame>
    <description>ESR is a laboratory test that provides a non-specific measure of inflammation. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in C-Reactive Protein (CRP) Level</measure>
    <time_frame>Baseline, Week 28, Week 52</time_frame>
    <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Giant Cell Arteritis</condition>
  <arm_group>
    <arm_group_label>Secukinumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Secukinumab 300 mg, s.c.</intervention_name>
    <description>Secukinumab 300 mg was administered by subcutaneous (s.c.) injections using 1 mL pre-filled syringes (PFSs) throughout the study.</description>
    <arm_group_label>Secukinumab</arm_group_label>
    <other_name>AIN457</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisolone</intervention_name>
    <description>Prednisolone was provided as tablets (1 mg, 5 mg, 10 mg, 20 mg tablets) for daily administration as tapered regimen from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 (last dose)</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Secukinumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo 300 mg was administered by subcutaneous (s.c.) injections using 1 mL pre-filled syringes (PFSs) throughout the study.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Diagnosis of GCA classified according to the following criteria:&#xD;
&#xD;
          -  Age at onset of disease ≥ 50 years.&#xD;
&#xD;
          -  History of ESR ≥ 30 mm/hr or CRP ≥ 10 mg/L.&#xD;
&#xD;
          -  Unequivocal cranial symptoms of GCA (new-onset localized headache, scalp or temporal&#xD;
             artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw&#xD;
             pain upon mastication) AND/OR symptoms of polymyalgia rheumatica (PMR) defined as&#xD;
             shoulder and/or hip girdle pain associated with inflammatory morning stiffness&#xD;
&#xD;
          -  Temporal artery biopsy revealing features of GCA AND/OR&#xD;
&#xD;
          -  evidence of large-vessel vasculitis by angiography or cross-sectional imaging study&#xD;
             such as magnetic resonance angiography (MRA), computed tomography angiography (CTA),&#xD;
             positron emission tomography-computed tomography (PET CT), or ultrasound&#xD;
&#xD;
        Patients with new onset GCA or relapsing GCA (Definition new onset: diagnosis of GCA within&#xD;
        6 weeks of Baseline Visit; Definition relapsing GCA: diagnosis of GCA (in accordance with&#xD;
        inclusion criterion no. 4) &gt; 6 weeks before Baseline Visit and in the meantime achieved&#xD;
        remission (absence of signs and symptoms attributable to GCA and normalization of ESR (&lt; 30&#xD;
        mm/hr) and CRP (&lt;10.0mg/L) included) including previous treatment with ≥ 25 mg/day&#xD;
        prednisolone equivalent for ≥ 2 weeks.)&#xD;
&#xD;
        Active disease as defined by the presence of signs and symptoms of GCA (cranial or PMR) and&#xD;
        elevated ESR ≥ 30 mm/hr, or CRP ≥ 10 mg/L, attributed to active GCA within 6 weeks of&#xD;
        Baseline.&#xD;
&#xD;
        Prednisolone dose of 25-60 mg/day at Baseline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Previous exposure to secukinumab or other biologic drug directly targeting&#xD;
        Interleukin(IL)-17 or IL-17 receptor.&#xD;
&#xD;
        Patients treated with any cell-depleting therapies including but not limited to anti-CD20&#xD;
        or investigational agents (e.g. anti-CD3, anti-CD4, anti-CD5 or anti-CD19).&#xD;
&#xD;
        Patients who have previously been treated with any biologic agent including but not limited&#xD;
        to tocilizumab, sirukumab, abatacept, or tumor necrosis factor alpha (TNFα) inhibitors&#xD;
        (infliximab, adalimumab, etanercept, certolizumab, golimumab).&#xD;
&#xD;
        Patients who have previously been treated with tofacitinib or baricitinib.&#xD;
&#xD;
        Patients treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to&#xD;
        Baseline.&#xD;
&#xD;
        Patients treated with cyclophosphamide, tacrolimus or everolimus within 6 months prior to&#xD;
        Baseline.&#xD;
&#xD;
        Patients treated with hydroxychloroquine, cyclosporine A, azathioprine, sulfasalazine or&#xD;
        mycophenolate mofetil within 4 weeks of Baseline.&#xD;
&#xD;
        Patients treated with leflunomide within 8 weeks of Baseline unless a cholestyramine&#xD;
        washout has been performed in which case the patient must be treated within 4 weeks of&#xD;
        Baseline.&#xD;
&#xD;
        Patients treated with an alkylating agent except for cyclophosphamide as mentioned above.&#xD;
&#xD;
        Patients requiring systemic chronic glucocorticoid therapy for any other reason than GCA.&#xD;
&#xD;
        Chronic systemic glucocorticoid therapy over the last 4 years or longer; or inability, in&#xD;
        the opinion of the investigator, to withdraw glucocorticoid therapy through&#xD;
        protocol-defined taper regimen due to suspected or established adrenal insufficiency.&#xD;
&#xD;
        Patients requiring chronic (i.e. not occasional &quot;prn&quot;) high potency opioid analgesics for&#xD;
        pain management.&#xD;
&#xD;
        Active ongoing inflammatory diseases or underlying metabolic, hematologic, renal, hepatic,&#xD;
        pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which&#xD;
        in the opinion of the investigator immunosuppressed the patient and/or places the patient&#xD;
        at unacceptable risk for participation in an immunomodulatory therapy.&#xD;
&#xD;
        History of renal trauma, glomerulonephritis, or patients with one kidney only, or a serum&#xD;
        creatinine level exceeding 1.8 mg/dL (159.12 μmol/L).&#xD;
&#xD;
        Screening total white blood cell (WBC) count &lt; 3000/μL, or platelets &lt; 100 000/μL or&#xD;
        neutrophils &lt; 1500/μL or hemoglobin &lt; 8.3 g/dL (83 g/L).&#xD;
&#xD;
        Major ischemic event, unrelated to GCA, within 12 weeks of screening.&#xD;
&#xD;
        Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C at&#xD;
        screening or randomization.&#xD;
&#xD;
        Life vaccinations within 6 weeks prior to Baseline or planned vaccination during study&#xD;
        participation until 12 weeks after last study treatment administration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dresden</city>
        <zip>01067</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Germering</city>
        <zip>82110</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Herne</city>
        <zip>44649</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Koeln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ludwigshafen</city>
        <zip>67063</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Luebeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Trier</city>
        <zip>54292</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Wuerzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217151&amp;amp;parentIdentifier=CAIN457ADE11C&amp;amp;attachmentIdentifier=99008743-0238-47ae-a207-9328edbb241c&amp;amp;fileName=Clinical_Trials_Results_Word_Form-CAIN457ADE11C.docx&amp;amp;versionIdentifier=</url>
    <description>Clinical_Trials_Results_Word_Form-CAIN457ADE11C.docx attachment has been refreshed from the Clinical Trials Results Word Form template. Data may be populated from the following (as available) : Study (70.0), Protocol (4.22), Results(0.22)</description>
  </link>
  <link>
    <url>https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1080</url>
    <description>A Plain Language Trial Summary is available on novctrd.com</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <results_first_submitted>June 5, 2022</results_first_submitted>
  <results_first_submitted_qc>April 24, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 26, 2023</results_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>GCA</keyword>
  <keyword>ain457</keyword>
  <keyword>Secukinumab</keyword>
  <keyword>Subcutaneous</keyword>
  <keyword>Vessel Inflammation</keyword>
  <keyword>corticosteroid tapering</keyword>
  <keyword>newly diagnosed or relapsing giant cell arteritis</keyword>
  <keyword>prednisolone taper regimen</keyword>
  <keyword>&quot;escape&quot;</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polymyalgia Rheumatica</mesh_term>
    <mesh_term>Giant Cell Arteritis</mesh_term>
    <mesh_term>Arteritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisolone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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>
    <ipd_url>https://www.clinicalstudydatarequest.com</ipd_url>
  </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>November 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03765788/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>July 15, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03765788/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in 11 investigative sites in 1 country.</recruitment_details>
      <pre_assignment_details>The screening period began once patients had signed the study informed consent. Screening evaluations were performed up to 6 weeks before the beginning of the Treatment period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Secukinumab</title>
          <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Subject decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).</population>
      <group_list>
        <group group_id="B1">
          <title>Secukinumab</title>
          <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="27"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.4" spread="5.31"/>
                    <measurement group_id="B2" value="69.6" spread="8.02"/>
                    <measurement group_id="B3" value="73.1" spread="7.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants in Sustained Remission Until Week 28</title>
        <description>Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen.&#xD;
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (&gt;/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (&gt;/=10.0 mg/L) attributable to GCA.&#xD;
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the &quot;escape arm&quot; (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.</description>
        <time_frame>Until week 28</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Sustained Remission Until Week 28</title>
          <description>Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen.&#xD;
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (&gt;/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (&gt;/=10.0 mg/L) attributable to GCA.&#xD;
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the &quot;escape arm&quot; (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="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>
            <groups_desc>Odds Ratio</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>9.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.54</ci_lower_limit>
            <ci_upper_limit>26.29</ci_upper_limit>
            <estimate_desc>Odd Ratio (posterior median) median and 95% credibility interval calculated using the Bayesian inference</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Remission at Week 12</title>
        <description>Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen.&#xD;
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (&gt;/=) 30 millimeters per hour (mm/hr) and/or CRP (&gt;/=10.0 mg/L) attributable to GCA.&#xD;
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the &quot;escape arm&quot; (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.</description>
        <time_frame>Week 12</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Remission at Week 12</title>
          <description>Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen.&#xD;
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (&gt;/=) 30 millimeters per hour (mm/hr) and/or CRP (&gt;/=10.0 mg/L) attributable to GCA.&#xD;
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the &quot;escape arm&quot; (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First GCA Flare After Clinical Remission</title>
        <description>Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (&gt;/=) 30 millimeters per hour (mm/hr) and/or CRP (&gt;/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare.&#xD;
For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and patients who completed treatment and did not have a flare were censored at their last visit in the treatment phase.&#xD;
Time to first GCA flare after remission was calculated using Kaplan-Meier plot of time.</description>
        <time_frame>Up to Week 52 (included)</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First GCA Flare After Clinical Remission</title>
          <description>Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (&gt;/=) 30 millimeters per hour (mm/hr) and/or CRP (&gt;/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare.&#xD;
For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and patients who completed treatment and did not have a flare were censored at their last visit in the treatment phase.&#xD;
Time to first GCA flare after remission was calculated using Kaplan-Meier plot of time.</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA: not enough participants with events to calculate the median &amp; CI</measurement>
                    <measurement group_id="O2" value="197.0" lower_limit="101.0" upper_limit="280.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks</title>
        <description>Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted.</description>
        <time_frame>from Baseline to week 28, from baseline to week 52 weeks</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks</title>
          <description>Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted.</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).</population>
          <units>milligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2689.70" spread="935.860"/>
                    <measurement group_id="O2" value="2693.74" spread="1241.907"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2841.26" spread="1116.192"/>
                    <measurement group_id="O2" value="3375.58" spread="1720.978"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With GCA Who Had Sustained Remission Until Week 52</title>
        <description>Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (&gt;/=) 30 millimeters per hour (mm/hr) and/or CRP (&gt;/=10.0 mg/L) attributable to GCA.&#xD;
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the &quot;escape arm&quot; (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.</description>
        <time_frame>Until Week 52</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With GCA Who Had Sustained Remission Until Week 52</title>
          <description>Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (&gt;/=) 30 millimeters per hour (mm/hr) and/or CRP (&gt;/=10.0 mg/L) attributable to GCA.&#xD;
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the &quot;escape arm&quot; (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants on Prednisolone Dose ≤ 5mg/Day</title>
        <description>Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52.&#xD;
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 [last dose].</description>
        <time_frame>Week 19, Week 28, Week 52</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). n represents the number of participants with a value for a specific categorical variable at Week 19, 28 and 52.</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants on Prednisolone Dose ≤ 5mg/Day</title>
          <description>Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52.&#xD;
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 [last dose].</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). n represents the number of participants with a value for a specific categorical variable at Week 19, 28 and 52.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 19 (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 (n = 23, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 (n = 21, 17)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS)</title>
        <description>Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.</description>
        <time_frame>Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 &amp; 52</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS)</title>
          <description>Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (n = 27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" spread="14.43"/>
                    <measurement group_id="O2" value="-3.2" spread="18.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (n = 26, 21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="12.77"/>
                    <measurement group_id="O2" value="2.1" spread="18.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" spread="21.93"/>
                    <measurement group_id="O2" value="-3.1" spread="10.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" spread="15.62"/>
                    <measurement group_id="O2" value="0.7" spread="13.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20 (n = 24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.9" spread="14.78"/>
                    <measurement group_id="O2" value="-1.5" spread="14.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n = 23, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3" spread="15.92"/>
                    <measurement group_id="O2" value="2.2" spread="17.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 (23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.4" spread="15.61"/>
                    <measurement group_id="O2" value="3.9" spread="21.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.7" spread="18.45"/>
                    <measurement group_id="O2" value="0.7" spread="17.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44 (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.5" spread="16.87"/>
                    <measurement group_id="O2" value="1.1" spread="15.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.5" spread="16.72"/>
                    <measurement group_id="O2" value="4.0" spread="21.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS)</title>
        <description>Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.</description>
        <time_frame>Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 &amp; 52</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS)</title>
          <description>Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (n = 27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.8" spread="28.17"/>
                    <measurement group_id="O2" value="-0.5" spread="23.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (n = 26, 21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.8" spread="27.61"/>
                    <measurement group_id="O2" value="-10.8" spread="27.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.0" spread="29.43"/>
                    <measurement group_id="O2" value="-11.9" spread="31.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.6" spread="19.39"/>
                    <measurement group_id="O2" value="-8.8" spread="31.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20 (n = 24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.18" spread="30.68"/>
                    <measurement group_id="O2" value="-6.9" spread="31.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n = 23, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.9" spread="28.84"/>
                    <measurement group_id="O2" value="-7.0" spread="30.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.4" spread="25.46"/>
                    <measurement group_id="O2" value="-8.0" spread="31.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n = 21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.9" spread="22.31"/>
                    <measurement group_id="O2" value="-8.6" spread="29.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44 (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.7" spread="27.35"/>
                    <measurement group_id="O2" value="-9.4" spread="30.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.2" spread="27.35"/>
                    <measurement group_id="O2" value="-15.9" spread="24.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FACIT-Fatigue Scale</title>
        <description>Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue).</description>
        <time_frame>Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 &amp; 52</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FACIT-Fatigue Scale</title>
          <description>Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue).</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (n = 27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.11" spread="9.613"/>
                    <measurement group_id="O2" value="-0.96" spread="7.358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (n = 26, 21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.19" spread="10.190"/>
                    <measurement group_id="O2" value="0.81" spread="7.498"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" spread="11.175"/>
                    <measurement group_id="O2" value="-0.25" spread="10.047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.12" spread="8.876"/>
                    <measurement group_id="O2" value="-0.36" spread="8.884"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20 (n =24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.42" spread="8.617"/>
                    <measurement group_id="O2" value="0.05" spread="10.318"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n = 23, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.91" spread="10.409"/>
                    <measurement group_id="O2" value="-3.10" spread="11.281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.61" spread="11.044"/>
                    <measurement group_id="O2" value="0.42" spread="9.203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n = 21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.90" spread="7.245"/>
                    <measurement group_id="O2" value="1.84" spread="8.719"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44 (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.67" spread="5.986"/>
                    <measurement group_id="O2" value="0.31" spread="10.928"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.19" spread="7.033"/>
                    <measurement group_id="O2" value="0.19" spread="8.848"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Short-Form (SF)-36 Questionnaire</title>
        <description>Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores.</description>
        <time_frame>Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 &amp; 52</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Short-Form (SF)-36 Questionnaire</title>
          <description>Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores.</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4: Physical Functioning (PF) (n = 27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="7.562"/>
                    <measurement group_id="O2" value="-1.25" spread="4.417"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: PF (n = 26 ,21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.44" spread="8.849"/>
                    <measurement group_id="O2" value="0.18" spread="4.987"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: PF (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="6.322"/>
                    <measurement group_id="O2" value="-0.38" spread="8.750"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: PF (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.00" spread="8.646"/>
                    <measurement group_id="O2" value="-0.86" spread="6.814"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: PF (n = 24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="8.098"/>
                    <measurement group_id="O2" value="-0.10" spread="6.495"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: PF (n = 22, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" spread="5.702"/>
                    <measurement group_id="O2" value="-2.11" spread="8.667"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: PF (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.25" spread="5.276"/>
                    <measurement group_id="O2" value="-0.40" spread="6.460"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: PF (n = 21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.37" spread="5.778"/>
                    <measurement group_id="O2" value="-1.31" spread="6.631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: PF (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="6.674"/>
                    <measurement group_id="O2" value="-0.36" spread="8.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: PF (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.46" spread="4.770"/>
                    <measurement group_id="O2" value="0.12" spread="5.696"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Role-Physical (R-P) (n =27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.49" spread="7.886"/>
                    <measurement group_id="O2" value="0.49" spread="10.616"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: R-P (n =26, 21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.80" spread="9.628"/>
                    <measurement group_id="O2" value="-0.75" spread="10.515"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: R-P (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.32" spread="9.3301"/>
                    <measurement group_id="O2" value="1.01" spread="9.539"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: R-P (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.58" spread="8.947"/>
                    <measurement group_id="O2" value="-1.12" spread="8.847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: R-P (n = 24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.40" spread="9.538"/>
                    <measurement group_id="O2" value="-0.45" spread="8.163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: R-P (n = 22, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.37" spread="7.458"/>
                    <measurement group_id="O2" value="-0.00" spread="10.094"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: R-P (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.96" spread="10.034"/>
                    <measurement group_id="O2" value="1.77" spread="8.553"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: R-P (n = 21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.99" spread="6.444"/>
                    <measurement group_id="O2" value="0.24" spread="10.121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: R-P (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.13" spread="6.515"/>
                    <measurement group_id="O2" value="0.70" spread="11.262"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: R-P (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.20" spread="6.659"/>
                    <measurement group_id="O2" value="1.40" spread="9.126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Bodily Pain (BP) (n = 27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.03" spread="13.272"/>
                    <measurement group_id="O2" value="7.68" spread="11.235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: BP (n = 26, 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.80" spread="14.475"/>
                    <measurement group_id="O2" value="9.68" spread="10.485"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: BP (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.92" spread="13.426"/>
                    <measurement group_id="O2" value="6.84" spread="11.674"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: BP (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.69" spread="14.841"/>
                    <measurement group_id="O2" value="4.50" spread="13.560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: BP (n = 24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.10" spread="14.072"/>
                    <measurement group_id="O2" value="8.63" spread="12.457"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: BP (n = 22, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.97" spread="12.689"/>
                    <measurement group_id="O2" value="3.93" spread="11.952"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: BP (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.47" spread="12.643"/>
                    <measurement group_id="O2" value="6.32" spread="13.149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: BP (n = 21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.20" spread="13.724"/>
                    <measurement group_id="O2" value="7.81" spread="10.794"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: BP (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.01" spread="15.378"/>
                    <measurement group_id="O2" value="9.00" spread="7.910"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: BP (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.49" spread="12.328"/>
                    <measurement group_id="O2" value="8.39" spread="11.866"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: General Health (GH) ( n = 27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.49" spread="9.207"/>
                    <measurement group_id="O2" value="0.23" spread="6.761"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: GH (n = 26, 21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.74" spread="8.119"/>
                    <measurement group_id="O2" value="0.18" spread="6.758"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: GH (n = 25, 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.22" spread="7.383"/>
                    <measurement group_id="O2" value="0.62" spread="8.158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: GH (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.28" spread="8.235"/>
                    <measurement group_id="O2" value="-0.74" spread="7.858"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: GH (n = 24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" spread="6.774"/>
                    <measurement group_id="O2" value="-0.38" spread="7.933"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: GH (n = 22, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.85" spread="7.149"/>
                    <measurement group_id="O2" value="-0.19" spread="9.031"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: GH (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.53" spread="7.285"/>
                    <measurement group_id="O2" value="1.18" spread="7.837"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36:GH (n = 21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.42" spread="6.680"/>
                    <measurement group_id="O2" value="-0.47" spread="7.833"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: GH (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" spread="8.127"/>
                    <measurement group_id="O2" value="-0.30" spread="9.597"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: GH (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.03" spread="6.733"/>
                    <measurement group_id="O2" value="0.15" spread="10.277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Vitality (n = 27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.07" spread="8.607"/>
                    <measurement group_id="O2" value="-1.42" spread="7.699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Vitality (n = 26, 21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.17" spread="7.952"/>
                    <measurement group_id="O2" value="0.71" spread="8.185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Vitality (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.57" spread="7.477"/>
                    <measurement group_id="O2" value="-0.30" spread="9.241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Vitality (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.28" spread="7.431"/>
                    <measurement group_id="O2" value="-0.45" spread="7.847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: Vitality (n = 24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.70" spread="8.445"/>
                    <measurement group_id="O2" value="0.45" spread="9.652"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Vitality (n = 22, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.78" spread="7.112"/>
                    <measurement group_id="O2" value="-1.93" spread="11.697"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: Vitality (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.20" spread="7.489"/>
                    <measurement group_id="O2" value="0.16" spread="6.679"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: Vitality (n = 21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.07" spread="7.060"/>
                    <measurement group_id="O2" value="1.41" spread="5.635"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: Vitality (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.08" spread="8.375"/>
                    <measurement group_id="O2" value="-0.93" spread="12.497"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: Vitality (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.21" spread="8.690"/>
                    <measurement group_id="O2" value="0.37" spread="11.474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Social Functioning (SF) (n = 27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.71" spread="7.939"/>
                    <measurement group_id="O2" value="1.74" spread="7.499"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: SF (n = 26, 21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.82" spread="8.327"/>
                    <measurement group_id="O2" value="2.63" spread="9.979"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: SF (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.01" spread="9.154"/>
                    <measurement group_id="O2" value="1.76" spread="7.325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: SF (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.21" spread="11.069"/>
                    <measurement group_id="O2" value="0.75" spread="7.325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: SF (n = 24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.81" spread="10.080"/>
                    <measurement group_id="O2" value="3.51" spread="8.150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: SF (n = 22, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.56" spread="8.602"/>
                    <measurement group_id="O2" value="0.00" spread="10.912"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: SF (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.49" spread="8.476"/>
                    <measurement group_id="O2" value="3.17" spread="9.631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: SF (n = 21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.16" spread="10.703"/>
                    <measurement group_id="O2" value="5.01" spread="7.285"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: SF (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.45" spread="8.988"/>
                    <measurement group_id="O2" value="0.63" spread="11.561"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: SF (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.16" spread="8.621"/>
                    <measurement group_id="O2" value="2.82" spread="9.681"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Role-Emotional (RE) (n = 27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.77" spread="12.454"/>
                    <measurement group_id="O2" value="3.48" spread="12.985"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: RE (n = 26, 21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.08" spread="11.457"/>
                    <measurement group_id="O2" value="1.99" spread="13.239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: RE (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.42" spread="12.076"/>
                    <measurement group_id="O2" value="0.52" spread="13.188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: RE (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.76" spread="10.586"/>
                    <measurement group_id="O2" value="-0.00" spread="11.465"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: RE (n = 24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.48" spread="11.058"/>
                    <measurement group_id="O2" value="0.35" spread="11.569"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: RE (n = 22, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.85" spread="11.753"/>
                    <measurement group_id="O2" value="-1.22" spread="16.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: RE (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.63" spread="11.853"/>
                    <measurement group_id="O2" value="1.10" spread="11.725"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: RE (n = 21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.47" spread="10.066"/>
                    <measurement group_id="O2" value="0.73" spread="16.518"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: RE (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.15" spread="12.293"/>
                    <measurement group_id="O2" value="3.26" spread="16.354"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: RE (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.14" spread="11.385"/>
                    <measurement group_id="O2" value="0.43" spread="19.234"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Mental Health (MH) (n = 27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="8.514"/>
                    <measurement group_id="O2" value="0.57" spread="8.420"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: MH (n = 26, 21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.82" spread="10.643"/>
                    <measurement group_id="O2" value="1.49" spread="6.950"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: MH (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.14" spread="10.786"/>
                    <measurement group_id="O2" value="4.45" spread="7.690"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: MH (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.29" spread="8.337"/>
                    <measurement group_id="O2" value="5.36" spread="6.379"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20: MH (n = 24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.49" spread="10.926"/>
                    <measurement group_id="O2" value="6.41" spread="7.984"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: MH (n = 22, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.62" spread="8.730"/>
                    <measurement group_id="O2" value="2.61" spread="13.149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: MH (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.84" spread="9.816"/>
                    <measurement group_id="O2" value="6.06" spread="7.350"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36: MH (n = 21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.98" spread="8.111"/>
                    <measurement group_id="O2" value="5.64" spread="8.988"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44: MH (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="8.969"/>
                    <measurement group_id="O2" value="1.14" spread="11.891"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: MH (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.73" spread="7.473"/>
                    <measurement group_id="O2" value="4.25" spread="11.257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire</title>
        <description>EQ-5D-5L, a self-administered questionnaire assessing health status in adults, is divided into 2 sections. The 1st section addresses 5 dimensions (mobility, self-care, usual activity, pain/discomfort, &amp; anxiety/depression). Items are rated either &quot;no problem&quot;, &quot;slight problems&quot;, &quot;moderate problems&quot;, &quot;severe problems&quot;, or &quot;extreme problems/unable.&quot; A composite health index is defined by combining the levels for each dimension. The 2nd section measures self-rated (global) health status via vertically oriented VAS where 100 represents the &quot;best possible health state&quot; &amp; 0 represents the &quot;worst possible health state.&quot; The EQ-5D-5L contains 6 items assessing health status via a single index value or health utility score and allows &quot;weighting&quot; by the patient of health states &amp; generation of patient utilities. Published weights are available allowing for creation of a single summary health utility score. Scores range from 0 to 1, with lower scores representing a higher level of dysfunction.</description>
        <time_frame>Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 &amp; 52</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire</title>
          <description>EQ-5D-5L, a self-administered questionnaire assessing health status in adults, is divided into 2 sections. The 1st section addresses 5 dimensions (mobility, self-care, usual activity, pain/discomfort, &amp; anxiety/depression). Items are rated either &quot;no problem&quot;, &quot;slight problems&quot;, &quot;moderate problems&quot;, &quot;severe problems&quot;, or &quot;extreme problems/unable.&quot; A composite health index is defined by combining the levels for each dimension. The 2nd section measures self-rated (global) health status via vertically oriented VAS where 100 represents the &quot;best possible health state&quot; &amp; 0 represents the &quot;worst possible health state.&quot; The EQ-5D-5L contains 6 items assessing health status via a single index value or health utility score and allows &quot;weighting&quot; by the patient of health states &amp; generation of patient utilities. Published weights are available allowing for creation of a single summary health utility score. Scores range from 0 to 1, with lower scores representing a higher level of dysfunction.</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EQ-5D-5L VAS: Week 4 (n = 27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.26" spread="16.819"/>
                    <measurement group_id="O2" value="1.87" spread="21.467"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L VAS: Week 8 (n = 26, 21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.58" spread="16.650"/>
                    <measurement group_id="O2" value="5.52" spread="29.646"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L VAS: Week 12 (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.64" spread="19.598"/>
                    <measurement group_id="O2" value="3.30" spread="22.850"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L VAS: Week 16 (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.000" spread="19.530"/>
                    <measurement group_id="O2" value="4.40" spread="27.354"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L VAS: Week 20 (n = 24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.88" spread="19.077"/>
                    <measurement group_id="O2" value="6.30" spread="25.041"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L VAS: Week 24 (n = 23, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.39" spread="17.598"/>
                    <measurement group_id="O2" value="-1.00" spread="29.902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L VAS: Week 28 (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.43" spread="17.840"/>
                    <measurement group_id="O2" value="10.37" spread="21.670"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WEQ-5D-5L VAS: Week 36 (n = 21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.90" spread="17.972"/>
                    <measurement group_id="O2" value="5.32" spread="28.825"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L VAS: Week 44 (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.38" spread="19.505"/>
                    <measurement group_id="O2" value="12.69" spread="21.941"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L VAS: Week 52 (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.62" spread="16.877"/>
                    <measurement group_id="O2" value="10.81" spread="24.109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L utility index: Week 4 (n = 27, 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0166" spread="0.19559"/>
                    <measurement group_id="O2" value="-0.0702" spread="0.21239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L utility index: Week 8 (n = 26, 21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0034" spread="0.19972"/>
                    <measurement group_id="O2" value="0.0087" spread="0.9869"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L utility index: Week 12 (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0016" spread="0.16236"/>
                    <measurement group_id="O2" value="-0.0122" spread="0.15686"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L utility index: Week 16 (n = 25, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0186" spread="0.14639"/>
                    <measurement group_id="O2" value="-0.0196" spread="0.19789"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L utility index: Week 20 (n = 24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0210" spread="0.13308"/>
                    <measurement group_id="O2" value="0.0221" spread="0.16759"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L utility index: Week 24 (n = 23, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0402" spread="0.12427"/>
                    <measurement group_id="O2" value="-0.0444" spread="0.20875"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L utility index: Week 28 (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0002" spread="0.06695"/>
                    <measurement group_id="O2" value="0.0240" spread="0.13458"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L utility index: Week 36 (n = 21, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0063" spread="0.06432"/>
                    <measurement group_id="O2" value="-0.0155" spread="0.13186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L utility index: Week 44 (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0119" spread="0.08525"/>
                    <measurement group_id="O2" value="0.0090" spread="0.13033"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L utility index: Week 52 (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0076" spread="0.11997"/>
                    <measurement group_id="O2" value="0.0205" spread="0.09403"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Erythrocyte Sedimentation Rate (ESR)</title>
        <description>ESR is a laboratory test that provides a non-specific measure of inflammation. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.</description>
        <time_frame>Baseline, Week 28, Week 52</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from Baseline at each visit is calculated only for subjects with a value at Baseline and the particular visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Erythrocyte Sedimentation Rate (ESR)</title>
          <description>ESR is a laboratory test that provides a non-specific measure of inflammation. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from Baseline at each visit is calculated only for subjects with a value at Baseline and the particular visit.</population>
          <units>mm/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 28 (n = 23, 18)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.043" spread="16.1934"/>
                    <measurement group_id="O2" value="14.667" spread="23.9141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.286" spread="10.6167"/>
                    <measurement group_id="O2" value="10.000" spread="14.8728"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in C-Reactive Protein (CRP) Level</title>
        <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.</description>
        <time_frame>Baseline, Week 28, Week 52</time_frame>
        <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from Baseline at each visit is calculated only for subjects with a value at Baseline and the particular visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Secukinumab</title>
            <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in C-Reactive Protein (CRP) Level</title>
          <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.</description>
          <population>The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from Baseline at each visit is calculated only for subjects with a value at Baseline and the particular visit.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 28 (n = 23, 19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.426" spread="9.6836"/>
                    <measurement group_id="O2" value="5.216" spread="8.9820"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 (n = 21, 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.433" spread="8.7909"/>
                    <measurement group_id="O2" value="4.650" spread="14.3691"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo.</time_frame>
      <desc>Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Secukinumab</title>
          <description>Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.</description>
        </group>
        <group group_id="E3">
          <title>All Participants</title>
          <description>All participants who participated in the study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (24.0)</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="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tachyarrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Noninfective sialoadenitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Face injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Inflammatory marker increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Intracranial aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Neurological symptom</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asphyxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (24.0)</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="25" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="48" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Cushingoid</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bone contusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </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="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Polyneuropathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Giant cell arteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="52"/>
              </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 pooled data (i.e. data from all sites) in clinical trial or disclosure of trial results in their entirety.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>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/NCT03765788
org study id: CAIN457ADE11C
secondary id: 2018-002610-12
nct id: NCT03765788
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was designed to evaluate the efficacy and safety of secukinumab compared to
      placebo to maintain disease remission up to 28 weeks including corticosteroid tapering, as
      well as up to 1 year (52 weeks) in patients with newly diagnosed or relapsing giant cell
      arteritis (GCA) who were naïve to biological therapy.
This randomized, parallel-group, double-blind, placebo-controlled, multicenter, Phase II
      study was designed to evaluate the efficacy of secukinumab compared to placebo in combination
      with a 26-week prednisolone taper regimen in terms of sustained remission in patients with
      newly diagnosed or relapsing Giant Cell Arteritis (GCA) who were naïve to biological therapy.
      The study consisted of a Screening Period of up to 6 weeks (maximum duration), a 52-week
      Treatment Period and an 8-week Safety Follow-up Period

      Patients who did not achieve remission by Week 12, experienced a flare after remission or
      could not adhere to the prednisolone taper regimen entered "escape". Upon entering "escape",
      patients received prednisolone at a dose determined by the physician's clinical judgment and
      continued to receive secukinumab or placebo in a blinded manner.

      Safety evaluation was included in all visits including two safety follow-up visits performed
      8 and 12 weeks after the last study drug administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants in Sustained Remission Until Week 28
time frame: Until week 28
description: Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen.
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (>/=10.0 mg/L) attributable to GCA.
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.
measure: Percentage of Participants in Remission at Week 12
time frame: Week 12
description: Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen.
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or CRP (>/=10.0 mg/L) attributable to GCA.
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.
measure: Time to First GCA Flare After Clinical Remission
time frame: Up to Week 52 (included)
description: Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or CRP (>/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare.
For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and patients who completed treatment and did not have a flare were censored at their last visit in the treatment phase.
Time to first GCA flare after remission was calculated using Kaplan-Meier plot of time.
measure: Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks
time frame: from Baseline to week 28, from baseline to week 52 weeks
description: Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted.
measure: Percentage of Participants With GCA Who Had Sustained Remission Until Week 52
time frame: Until Week 52
description: Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or CRP (>/=10.0 mg/L) attributable to GCA.
Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.
measure: Number of Participants on Prednisolone Dose ≤ 5mg/Day
time frame: Week 19, Week 28, Week 52
description: Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52.
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 [last dose].
measure: Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS)
time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
description: Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.
measure: Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS)
time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
description: Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.
measure: Change From Baseline in FACIT-Fatigue Scale
time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
description: Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue).
measure: Change From Baseline in Short-Form (SF)-36 Questionnaire
time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
description: Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores.
measure: Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire
time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
description: EQ-5D-5L, a self-administered questionnaire assessing health status in adults, is divided into 2 sections. The 1st section addresses 5 dimensions (mobility, self-care, usual activity, pain/discomfort, & anxiety/depression). Items are rated either "no problem", "slight problems", "moderate problems", "severe problems", or "extreme problems/unable." A composite health index is defined by combining the levels for each dimension. The 2nd section measures self-rated (global) health status via vertically oriented VAS where 100 represents the "best possible health state" & 0 represents the "worst possible health state." The EQ-5D-5L contains 6 items assessing health status via a single index value or health utility score and allows "weighting" by the patient of health states & generation of patient utilities. Published weights are available allowing for creation of a single summary health utility score. Scores range from 0 to 1, with lower scores representing a higher level of dysfunction.
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
time frame: Baseline, Week 28, Week 52
description: ESR is a laboratory test that provides a non-specific measure of inflammation. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
measure: Change From Baseline in C-Reactive Protein (CRP) Level
time frame: Baseline, Week 28, Week 52
description: The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
arm group label: Secukinumab
arm group type: Experimental
description: Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.
intervention type: Drug
intervention name: Secukinumab 300 mg, s.c.
description: Secukinumab 300 mg was administered by subcutaneous (s.c.) injections using 1 mL pre-filled syringes (PFSs) throughout the study.
arm group label: Secukinumab
other name: AIN457
intervention type: Drug
intervention name: Prednisolone
description: Prednisolone was provided as tablets (1 mg, 5 mg, 10 mg, 20 mg tablets) for daily administration as tapered regimen from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 (last dose)
arm group label: Placebo
arm group label: Secukinumab
intervention type: Drug
intervention name: Placebo
description: Placebo 300 mg was administered by subcutaneous (s.c.) injections using 1 mL pre-filled syringes (PFSs) throughout the study.
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217151&amp;parentIdentifier=CAIN457ADE11C&amp;attachmentIdentifier=99008743-0238-47ae-a207-9328edbb241c&amp;fileName=Clinical_Trials_Results_Word_Form-CAIN457ADE11C.docx&amp;versionIdentifier=
description: Clinical_Trials_Results_Word_Form-CAIN457ADE11C.docx attachment has been refreshed from the Clinical Trials Results Word Form template. Data may be populated from the following (as available) : Study (70.0), Protocol (4.22), Results(0.22)
url: https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1080
description: A Plain Language Trial Summary is available on novctrd.com
responsible party type: Sponsor
mesh term: Polymyalgia Rheumatica
mesh term: Giant Cell Arteritis
mesh term: Arteritis
mesh term: Prednisolone
sharing ipd: Yes
ipd description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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
ipd url: https://www.clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 