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    Clinical Trial Results:
    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 Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.

    Summary
    EudraCT number
    		 2018-002610-12
    Trial protocol
    		 DE  
    Global end of trial date
    08 Jun 2021

    Results information
    Results version number
    		 v1
    This version publication date
    19 Jun 2022
    First version publication date
    19 Jun 2022
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457ADE11C
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03765788
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma, AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma, AG, +41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma, AG, +41 613241111, novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Jun 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of secukinumab compared to placebo, in combination with a 26-week prednisolone taper regimen, based on the proportion of patients with giant cell arteritis (GCA) who had sustained remission. - Definition of remission: Absence of flare. - Definition of sustained remission: Patients without flare until Week 28 and in adherence to the protocol prednisolone taper regimen. - Definition of flare: Determined by the investigator and defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) ≥ 30 mm/hr and/or C-reactive protein (CRP) ≥ 10 mg/L attributable to GCA.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jan 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    9
    From 65 to 84 years
    42
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in 11 investigative sites in 1 country.

    Pre-assignment
    Screening 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.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab
    Arm 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 type
    		 Experimental

    Investigational medicinal product name
    prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    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)

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    secukinumab 300 mg (2 injections of 150 mg) provided in 2 x 1.0 mL Prefilled syringe (PFS) weekly from Week 0 to 4 then every 4 weeks from Week 4 to Week 48

    Arm title
    		 Placebo
    Arm 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.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Secukinumab Placebo
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Secukinumab placebo 300 mg (2 injections of 150 mg) provided in 2 x 1.0 mL Prefilled syringe (PFS) weekly from Week 0 to 4 then every 4 weeks from Week 4 to Week 48

    Investigational medicinal product name
    prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    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)

    Number of subjects in period 1
    		Secukinumab Placebo
    Started
    27
    25
    Completed
    22
    17
    Not completed
    5
    8
         Adverse event, serious fatal
    -
    1
         Physician decision
    2
    4
         Subject decision
    2
    3
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab
    Reporting group 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.

    Reporting group title
    Placebo
    Reporting group 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.

    Reporting group values
    		 Secukinumab Placebo Total
    Number of subjects
    		 27 25 52
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 0 9 9
        From 65-84 years
    		 26 16 42
        85 years and over
    		 1 0 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 76.4 ( 5.31 ) 69.6 ( 8.02 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 17 18 35
        Male
    		 10 7 17
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 27 25 52

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab
    Reporting group 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.

    Reporting group title
    Placebo
    Reporting group 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.

    Primary: Percentage of participants in sustained remission until Week 28

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    End point title
    		 Percentage of participants in sustained remission until Week 28
    End point 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.
    End point type
    Primary
    End point timeframe
    Until week 28
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: Participants
    19
    6
    Statistical analysis title
    		 Sustained Remission until week 28
    Statistical analysis description
    Odds Ratio
    Comparison groups
    Secukinumab v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    9.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.54
         upper limit
    		 26.29

    Secondary: Percentage of participants in remission at Week 12

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    End point title
    		 Percentage of participants in remission at Week 12
    End point 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.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: Participants
    22
    12
    No statistical analyses for this end point

    Secondary: Time to first GCA flare after clinical remission

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    End point title
    		 Time to first GCA flare after clinical remission
    End point 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.
    End point type
    Secondary
    End point timeframe
    Up to Week 52 (included)
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: days
        median (confidence interval 95%)
    999 (999 to 999)
    197.0 (101.0 to 280.0)
    No statistical analyses for this end point

    Secondary: Total cumulative prednisolone dose over 28 weeks and 52 weeks

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    End point title
    		 Total cumulative prednisolone dose over 28 weeks and 52 weeks
    End point 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.
    End point type
    Secondary
    End point timeframe
    from Baseline to week 28, from baseline to week 52 weeks
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: milligrams
    arithmetic mean (standard deviation)
        Baseline to Week 28
    2689.70 ( 935.860 )
    2693.74 ( 1241.907 )
        Baseline to Week 52
    2841.26 ( 1116.192 )
    3375.58 ( 1720.978 )
    No statistical analyses for this end point

    Secondary: Percentage of participants with GCA who had sustained remission until Week 52

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    End point title
    		 Percentage of participants with GCA who had sustained remission until Week 52
    End point 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.
    End point type
    Secondary
    End point timeframe
    Until Week 52
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: Participants
    16
    2
    No statistical analyses for this end point

    Secondary: Percentage of participants on prednisolone dose ≤ 5mg/day

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    End point title
    		 Percentage of participants on prednisolone dose ≤ 5mg/day
    End point description
    Percentage 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].
    End point type
    Secondary
    End point timeframe
    Week 19, Week 28, Week 52
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: Participants
        Week 19 (n = 25, 20)
    22
    10
        Week 28 (n = 23, 20)
    19
    9
        Week 52 (n = 21, 17)
    19
    13
    No statistical analyses for this end point

    Secondary: Physicians global assessment (PhGA) of disease activity: Change from Baseline Score via visual analogue scale (VAS)

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    End point title
    		 Physicians global assessment (PhGA) of disease activity: Change from Baseline Score via visual analogue scale (VAS)
    End point 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.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: scores on a scale
    arithmetic mean (standard error)
        Week 4 (n = 27, 23)
    -4.8 ( 14.43 )
    -3.2 ( 18.45 )
        Week 8 (n = 26, 21)
    -5.8 ( 12.77 )
    2.1 ( 18.94 )
        Week 12 (n = 25, 20)
    -3.4 ( 21.93 )
    -3.1 ( 10.81 )
        Week 16 (n = 25, 20)
    -4.1 ( 15.62 )
    0.7 ( 13.97 )
        Week 20 (n = 24, 20)
    -6.9 ( 14.78 )
    -1.5 ( 14.32 )
        Week 24 (n = 23, 20)
    -4.3 ( 15.92 )
    2.2 ( 17.22 )
        Week 28 (23, 19)
    -5.4 ( 15.61 )
    3.9 ( 21.47 )
        Week 36 (21, 19)
    -8.7 ( 18.45 )
    0.7 ( 17.45 )
        Week 44 (n = 21, 16)
    -5.5 ( 16.87 )
    1.1 ( 15.20 )
        Week 52 (n = 21, 16)
    -9.5 ( 16.72 )
    4.0 ( 21.24 )
    No statistical analyses for this end point

    Secondary: Patients global assessment (PGA) of disease activity: Change from Baseline via visual analogue scale (VAS)

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    End point title
    		 Patients global assessment (PGA) of disease activity: Change from Baseline via visual analogue scale (VAS)
    End point 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.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 4 (n = 27, 23)
    -15.8 ( 28.17 )
    -0.5 ( 23.58 )
        Week 8 (n = 26, 21)
    -15.8 ( 27.61 )
    -10.8 ( 27.64 )
        Week 12 (n = 25, 20)
    -8.0 ( 29.43 )
    -11.9 ( 31.46 )
        Week 16 (n = 25, 20)
    -18.6 ( 19.39 )
    -8.8 ( 31.43 )
        Week 20 (n = 24, 20)
    -19.18 ( 30.68 )
    -6.9 ( 31.94 )
        Week 24 (n = 23, 20)
    -14.9 ( 28.84 )
    -7.0 ( 30.61 )
        Week 28 (n = 23, 19)
    -14.4 ( 25.46 )
    -8.0 ( 31.31 )
        Week 36 (n = 21, 19)
    -20.9 ( 22.31 )
    -8.6 ( 29.90 )
        Week 44 (n = 21, 16)
    -21.7 ( 27.35 )
    -9.4 ( 30.58 )
        Week 52 (n = 21, 16)
    -19.2 ( 27.35 )
    -15.9 ( 24.04 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in FACIT-Fatigue scale

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    End point title
    		 Change from Baseline in FACIT-Fatigue scale
    End point 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).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 4 (n = 27, 23)
    2.11 ( 9.613 )
    -0.96 ( 7.358 )
        Week 8 (n = 26, 21)
    2.19 ( 10.190 )
    0.81 ( 7.498 )
        Week 12 (n = 25, 20)
    0.96 ( 11.175 )
    -0.25 ( 10.047 )
        Week 16 (n = 25, 20)
    2.12 ( 8.876 )
    -0.36 ( 8.884 )
        Week 20 (n =24, 20)
    3.42 ( 8.617 )
    0.05 ( 10.318 )
        Week 24 (n = 23, 20)
    2.91 ( 10.409 )
    -3.10 ( 11.281 )
        Week 28 (n = 23, 19)
    3.61 ( 11.044 )
    0.42 ( 9.203 )
        Week 36 (n = 21, 19)
    3.90 ( 7.245 )
    1.84 ( 8.719 )
        Week 44 (n = 21, 16)
    2.67 ( 5.986 )
    0.31 ( 10.928 )
        Week 52 (n = 21, 16)
    3.19 ( 7.033 )
    0.19 ( 8.848 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Short-Form (SF)-36 questionnaire

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    End point title
    		 Change from Baseline in Short-Form (SF)-36 questionnaire
    End point 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. 2 overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The higher the score (change from baseline) the more favorable the outcome. The values were evaluated as follows: -SF-36 domain scores: SF-36 domain score responders: Type I responders (improvement of ≥ 5 points in ≥ 6 domains); Type II responders (improvement of ≥ 10 points in ≥ 3 domains) -SF-36 PCS and MCS scores SF-36 PCS and MCS score responders: Type I responders (improvement of ≥ 2.5 points) Type II responders (improvement of ≥ 5 points
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 4: Physical Functioning (PF) (n = 27, 23)
    44.36 ( 11.226 )
    43.98 ( 10.159 )
        Week 8: PF (n = 26 ,21)
    -0.44 ( 8.849 )
    0.18 ( 4.987 )
        Week 12: PF (n = 25, 20)
    0.38 ( 6.322 )
    -0.38 ( 8.750 )
        Week 16: PF (n = 25, 20)
    -0.00 ( 8.646 )
    -0.86 ( 6.814 )
        Week 20: PF (n = 24, 20)
    0.80 ( 8.098 )
    -0.10 ( 6.495 )
        Week 24: PF (n = 22, 20)
    0.52 ( 5.702 )
    -2.11 ( 8.667 )
        Week 28: PF (n = 23, 19)
    1.25 ( 5.276 )
    -0.40 ( 6.460 )
        Week 36: PF (n = 21, 19)
    1.37 ( 5.778 )
    -1.31 ( 6.631 )
        Week 44: PF (n = 21, 16)
    1.00 ( 6.674 )
    -0.36 ( 8.065 )
        Week 52: PF (n = 21, 16)
    2.46 ( 4.770 )
    0.12 ( 5.696 )
        Week 4: Role-Physical (R-P) (n =27, 23)
    3.49 ( 7.886 )
    0.49 ( 10.616 )
        Week 8: R-P (n =26, 21)
    3.80 ( 9.628 )
    -0.75 ( 10.515 )
        Week 12: R-P (n = 25, 20)
    3.32 ( 9.3301 )
    1.01 ( 9.539 )
        Week 16: R-P (n = 25, 20)
    4.58 ( 8.947 )
    -1.12 ( 8.847 )
        Week 20: R-P (n = 24, 20)
    4.40 ( 9.538 )
    -0.45 ( 8.163 )
        Week 24: R-P (n = 22, 20)
    3.37 ( 7.458 )
    -0.00 ( 10.094 )
        Week 28: R-P (n = 23, 19)
    5.96 ( 10.034 )
    1.77 ( 8.553 )
        Week 36: R-P (n = 21, 19)
    5.99 ( 6.444 )
    0.24 ( 10.121 )
        Week 44: R-P (n = 21, 16)
    5.13 ( 6.515 )
    0.70 ( 11.262 )
        Week 52: R-P (n = 21, 16)
    6.20 ( 6.659 )
    1.40 ( 9.126 )
        Week 4: Bodily Pain (BP) (n = 27, 23)
    8.03 ( 13.272 )
    7.68 ( 11.235 )
        Week 8: BP (n = 26, 21
    5.80 ( 14.475 )
    9.68 ( 10.485 )
        Week 12: BP (n = 25, 20)
    6.92 ( 13.426 )
    6.84 ( 11.674 )
        Week 16: BP (n = 25, 20)
    7.69 ( 14.841 )
    4.50 ( 13.560 )
        Week 20: BP (n = 24, 20)
    6.10 ( 14.072 )
    8.63 ( 12.457 )
        Week 24: BP (n = 22, 20)
    5.97 ( 12.689 )
    3.93 ( 11.952 )
        Week 28: BP (n = 23, 19)
    6.47 ( 12.643 )
    6.32 ( 13.149 )
        Week 36: BP (n = 21, 19)
    7.20 ( 13.724 )
    7.81 ( 10.794 )
        Week 44: BP (n = 21, 16)
    8.01 ( 15.378 )
    9.00 ( 7.910 )
        Week 52: BP (n = 21, 16)
    5.49 ( 12.328 )
    8.39 ( 11.866 )
        Week 4: General Health (GH) ( n = 27, 23)
    3.49 ( 9.207 )
    0.23 ( 6.761 )
        Week 8: GH (n = 26, 21)
    2.74 ( 8.119 )
    0.18 ( 6.758 )
        Week 12: GH (n = 25, 20
    2.22 ( 7.383 )
    0.62 ( 8.158 )
        Week 16: GH (n = 25, 20)
    2.28 ( 8.235 )
    -0.74 ( 7.858 )
        Week 20: GH (n = 24, 20)
    4.50 ( 6.774 )
    -0.38 ( 7.933 )
        Week 24: GH (n = 22, 20)
    2.85 ( 7.149 )
    -0.19 ( 9.031 )
        Week 28: GH (n = 23, 19)
    3.53 ( 7.285 )
    1.18 ( 7.837 )
        Week 36:GH (n = 21, 19)
    3.42 ( 6.680 )
    -0.47 ( 7.833 )
        Week 44: GH (n = 21, 16)
    1.02 ( 8.127 )
    -0.30 ( 9.597 )
        Week 52: GH (n = 21, 16)
    3.03 ( 6.733 )
    0.15 ( 10.277 )
        Week 4: Vitality (n = 27, 23)
    4.07 ( 8.607 )
    -1.42 ( 7.699 )
        Week 8: Vitality (n = 26, 21)
    2.17 ( 7.952 )
    0.71 ( 8.185 )
        Week 12: Vitality (n = 25, 20)
    3.57 ( 7.477 )
    -0.30 ( 9.241 )
        Week 16: Vitality (n = 25, 20)
    4.28 ( 7.431 )
    -0.45 ( 7.847 )
        Week 20: Vitality (n = 24, 20)
    4.70 ( 8.445 )
    0.45 ( 9.652 )
        Week 24: Vitality (n = 22, 20)
    3.78 ( 7.112 )
    -1.93 ( 11.697 )
        Week 28: Vitality (n = 23, 19)
    6.20 ( 7.489 )
    0.16 ( 6.679 )
        Week 36: Vitality (n = 21, 19)
    7.07 ( 7.060 )
    1.41 ( 5.635 )
        Week 44: Vitality (n = 21, 16)
    6.08 ( 8.375 )
    -0.93 ( 12.497 )
        Week 52: Vitality (n = 21, 16)
    7.21 ( 8.690 )
    0.37 ( 11.474 )
        Week 4: Social Functioning (SF) (n = 27, 23)
    3.71 ( 7.939 )
    1.74 ( 7.499 )
        Week 8: SF (n = 26, 21)
    4.82 ( 8.327 )
    2.63 ( 9.979 )
        Week 12: SF (n = 25, 20)
    4.01 ( 9.154 )
    1.76 ( 7.325 )
        Week 16: SF (n = 25, 20)
    5.21 ( 11.069 )
    0.75 ( 7.325 )
        Week 20: SF (n = 24, 20)
    4.81 ( 10.080 )
    3.51 ( 8.150 )
        Week 24: SF (n = 22, 20)
    4.56 ( 8.602 )
    0.00 ( 10.912 )
        Week 28: SF (n = 23, 19)
    3.49 ( 8.476 )
    3.17 ( 9.631 )
        Week 36: SF (n = 21, 19)
    7.16 ( 10.703 )
    5.01 ( 7.285 )
        Week 44: SF (n = 21, 16)
    6.45 ( 8.988 )
    0.63 ( 11.561 )
        Week 52: SF (n = 21, 16)
    7.16 ( 8.621 )
    2.82 ( 9.681 )
        Week 4: Role-Emotional (RE) (n = 27, 23)
    -0.77 ( 12.454 )
    3.48 ( 12.985 )
        Week 8: RE (n = 26, 21)
    3.08 ( 11.457 )
    1.99 ( 13.239 )
        Week 12: RE (n = 25, 20)
    -0.42 ( 12.076 )
    0.52 ( 13.188 )
        Week 16: RE (n = 25, 20)
    3.76 ( 10.586 )
    -0.00 ( 11.465 )
        Week 20: RE (n = 24, 20)
    3.48 ( 11.058 )
    0.35 ( 11.569 )
        Week 24: RE (n = 22, 20)
    2.85 ( 11.753 )
    -1.22 ( 16.025 )
        Week 28: RE (n = 23, 19)
    3.63 ( 11.853 )
    1.10 ( 11.725 )
        Week 36: RE (n = 21, 19)
    5.47 ( 10.066 )
    0.73 ( 16.518 )
        Week 44: RE (n = 21, 16)
    4.15 ( 12.293 )
    3.26 ( 16.354 )
        Week 52: RE (n = 21, 16)
    6.14 ( 11.385 )
    0.43 ( 19.234 )
        Week 4: Mental Health (MH) (n = 27, 23)
    3.0 ( 8.514 )
    0.57 ( 8.420 )
        Week 8: MH (n = 26, 21)
    2.82 ( 10.643 )
    1.49 ( 6.950 )
        Week 12: MH (n = 25, 20)
    3.14 ( 10.786 )
    4.45 ( 7.690 )
        Week 16: MH (n = 25, 20)
    4.29 ( 8.337 )
    5.36 ( 6.379 )
        Week 20: MH (n = 24, 20)
    3.49 ( 10.926 )
    6.41 ( 7.984 )
        Week 24: MH (n = 22, 20)
    2.62 ( 8.730 )
    2.61 ( 13.149 )
        Week 28: MH (n = 23, 19)
    2.84 ( 9.816 )
    6.06 ( 7.350 )
        Week 36: MH (n = 21, 19)
    5.98 ( 8.111 )
    5.64 ( 8.988 )
        Week 44: MH (n = 21, 16)
    4.11 ( 8.969 )
    1.14 ( 11.891 )
        Week 52: MH (n = 21, 16)
    5.73 ( 7.473 )
    4.25 ( 11.257 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in EQ-5D-5L (EuroQol 5D) questionnaire

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    End point title
    		 Change from Baseline in EQ-5D-5L (EuroQol 5D) questionnaire
    End point description
    Patient Reported Outcome: The EQ-5D-5L is a widely used, self-administered questionnaire designed to assess health status in adults. The measure is divided into 2 distinct sections. The 1st section includes 1 item addressing each of 5 dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Patients rate each of these items either “no problem”, “slight problems”, "moderate problems”, “severe problems”, or “extreme problems/unable.” A composite health index is then defined by combining the levels for each dimension. The 2nd section of the questionnaire measures self-rated (global) health status utilizing a vertically oriented VAS where 100 represents the “best possible health state” and 0 represents the “worst possible health state.” The higher the score, the more favorable the outcome. Respondents were asked to rate their current health by placing a mark along this continuum.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 4 (n = 27, 23)
    11.26 ( 16.819 )
    1.87 ( 21.467 )
        Week 8 (n = 26, 21)
    5.58 ( 16.650 )
    5.52 ( 29.646 )
        Week 12 (n = 25, 20)
    4.64 ( 19.598 )
    3.30 ( 22.850 )
        Week 16 (n = 25, 20)
    7.000 ( 19.530 )
    4.40 ( 27.354 )
        Week 20 (n = 24, 20)
    7.88 ( 19.077 )
    6.30 ( 25.041 )
        Week 24 (n = 23, 20)
    6.39 ( 17.598 )
    -1.00 ( 29.902 )
        Week 28 (n = 23, 19)
    4.43 ( 17.840 )
    10.37 ( 21.670 )
        Week 36 (n = 21, 19)
    6.90 ( 17.972 )
    5.32 ( 28.825 )
        Week 44 (n = 21, 16)
    6.38 ( 19.505 )
    12.69 ( 21.941 )
        Week 52 (n = 21, 16)
    11.62 ( 16.877 )
    10.81 ( 24.109 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Erythrocyte Sedimentation Rate (ESR)

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    End point title
    		 Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
    End point 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.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 28, Week 52
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: mm/hr
    arithmetic mean (standard deviation)
        Week 28 (n = 23, 18)
    4.043 ( 16.1934 )
    14.667 ( 23.9141 )
        Week 52 (n = 21, 16)
    -3.286 ( 10.6167 )
    10.000 ( 14.8728 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in C-Reactive Protein (CRP) Level

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    End point title
    		 Change from Baseline in C-Reactive Protein (CRP) Level
    End point 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.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 28, Week 52
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    27
    25
    Units: mg/L
    arithmetic mean (standard deviation)
        Week 28 (n = 23, 19)
    4.426 ( 9.6836 )
    5.216 ( 8.9820 )
        Week 52 (n = 21, 16)
    -1.433 ( 8.7909 )
    4.650 ( 14.3691 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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).
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Secukinumab
    Reporting group description
    		 Secukinumab

    Reporting group title
    All subjects
    Reporting group description
    		 All subjects

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 Secukinumab All subjects Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 27 (22.22%)
    17 / 52 (32.69%)
    11 / 25 (44.00%)
         number of deaths (all causes)
    1
    2
    1
         number of deaths resulting from adverse events
    1
    2
    1
    Investigations
    Inflammatory marker increased
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Face injury
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 52 (3.85%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 52 (3.85%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 52 (3.85%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurological symptom
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Faecaloma
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Noninfective sialoadenitis
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asphyxia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    Aspiration
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal stenosis
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 52 (3.85%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Fluid retention
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Secukinumab All subjects Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 27 (92.59%)
    48 / 52 (92.31%)
    23 / 25 (92.00%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 52 (3.85%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 52 (5.77%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    2
    C-reactive protein increased
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 52 (5.77%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    2
    Injury, poisoning and procedural complications
    Bone contusion
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 52 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    2
    2
    0
    Rib fracture
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 52 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    2
    2
    0
    Fall
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 52 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    3
    3
    0
    Skin laceration
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 52 (5.77%)
    2 / 25 (8.00%)
         occurrences all number
    1
    4
    3
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 52 (3.85%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    2
    Tooth fracture
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 52 (5.77%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    2
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 27 (3.70%)
    4 / 52 (7.69%)
    3 / 25 (12.00%)
         occurrences all number
    1
    4
    3
    Giant cell arteritis
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 52 (5.77%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    2
    Hypertension
         subjects affected / exposed
    6 / 27 (22.22%)
    14 / 52 (26.92%)
    8 / 25 (32.00%)
         occurrences all number
    6
    15
    9
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 27 (11.11%)
    3 / 52 (5.77%)
    0 / 25 (0.00%)
         occurrences all number
    7
    7
    0
    Headache
         subjects affected / exposed
    4 / 27 (14.81%)
    7 / 52 (13.46%)
    3 / 25 (12.00%)
         occurrences all number
    10
    13
    3
    Polyneuropathy
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 52 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    3
    3
    0
    Sciatica
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 52 (5.77%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    2
    Tension headache
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 52 (5.77%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 27 (7.41%)
    3 / 52 (5.77%)
    1 / 25 (4.00%)
         occurrences all number
    2
    3
    1
    Oedema peripheral
         subjects affected / exposed
    2 / 27 (7.41%)
    6 / 52 (11.54%)
    4 / 25 (16.00%)
         occurrences all number
    2
    6
    4
    Eye disorders
    Glaucoma
         subjects affected / exposed
    2 / 27 (7.41%)
    4 / 52 (7.69%)
    2 / 25 (8.00%)
         occurrences all number
    2
    4
    2
    Vision blurred
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 52 (5.77%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    2
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 52 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    2
    2
    0
    Diarrhoea
         subjects affected / exposed
    2 / 27 (7.41%)
    4 / 52 (7.69%)
    2 / 25 (8.00%)
         occurrences all number
    2
    4
    2
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 52 (3.85%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    2
    Nausea
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 52 (3.85%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 27 (7.41%)
    3 / 52 (5.77%)
    1 / 25 (4.00%)
         occurrences all number
    2
    3
    1
    Skin ulcer
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 52 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    2
    2
    0
    Rash
         subjects affected / exposed
    2 / 27 (7.41%)
    4 / 52 (7.69%)
    2 / 25 (8.00%)
         occurrences all number
    3
    5
    2
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 52 (5.77%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 27 (11.11%)
    6 / 52 (11.54%)
    3 / 25 (12.00%)
         occurrences all number
    4
    7
    3
    Back pain
         subjects affected / exposed
    0 / 27 (0.00%)
    5 / 52 (9.62%)
    5 / 25 (20.00%)
         occurrences all number
    0
    5
    5
    Bursitis
         subjects affected / exposed
    3 / 27 (11.11%)
    4 / 52 (7.69%)
    1 / 25 (4.00%)
         occurrences all number
    3
    4
    1
    Muscle spasms
         subjects affected / exposed
    4 / 27 (14.81%)
    5 / 52 (9.62%)
    1 / 25 (4.00%)
         occurrences all number
    4
    5
    1
    Osteoporosis
         subjects affected / exposed
    2 / 27 (7.41%)
    3 / 52 (5.77%)
    1 / 25 (4.00%)
         occurrences all number
    2
    3
    1
    Osteoarthritis
         subjects affected / exposed
    3 / 27 (11.11%)
    5 / 52 (9.62%)
    2 / 25 (8.00%)
         occurrences all number
    3
    6
    3
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 52 (5.77%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    2
    Nasopharyngitis
         subjects affected / exposed
    5 / 27 (18.52%)
    10 / 52 (19.23%)
    5 / 25 (20.00%)
         occurrences all number
    5
    10
    5
    Oral candidiasis
         subjects affected / exposed
    4 / 27 (14.81%)
    5 / 52 (9.62%)
    1 / 25 (4.00%)
         occurrences all number
    4
    5
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 27 (7.41%)
    3 / 52 (5.77%)
    1 / 25 (4.00%)
         occurrences all number
    2
    3
    1
    Rhinitis
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 52 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    2
    2
    0
    Urinary tract infection
         subjects affected / exposed
    4 / 27 (14.81%)
    6 / 52 (11.54%)
    2 / 25 (8.00%)
         occurrences all number
    6
    8
    2
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 52 (5.77%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2019
    Accepted patient ultrasound/MR/images for the corresponding sub-studies taken up to 6 weeks prior to Randomization. Added measurement of HbA1c to assess all relevant domains of the GTI. questionnaire.
    13 May 2019
    Added extension phase to assess the effect of secukinumab after completed steroid tapering. Added an additional secondary endpoint to assess the proportion of patients receiving prednisolone ≤ 5 mg/day at Week 19, Week 28 and Week 52.
    29 Nov 2019
    Added an additional imaging assessment in Week 50 (ultrasound and/or MRA). Shifted the GTI endpoint to the exploratory endpoint section.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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