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    Clinical Trial Results:
    A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2011-001220-38
    Trial protocol
    		 GB   DE   BE  
    Global end of trial date
    13 Feb 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 Jul 2016
    First version publication date
    31 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    A decimal point was missing from the least squares mean for the placebo arm of secondary outcome measure on DAS28 , under HLA-DRB1*SE carrier category.

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457F2208
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01426789
    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,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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
    13 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether the treatment effect of secukinumab vs. placebo at Week 12 (measured by ACR20 response rate and change from baseline in DAS28) is associated with the presence/absence of the HLA-DRB1 *04 allelic group in rheumatoid arthritis (RA) patients
    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
    08 Aug 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Russian Federation: 63
    Country: Number of subjects enrolled
    United States: 28
    Worldwide total number of subjects
    100
    EEA total number of subjects
    9
    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)
    92
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study included a 12 week, randomized, double blind phase (part 1), a 40 week, open label phase (part 2), and a 3 month safety follow-up. Participants from the secukinumab arm, who completed part 1 and had an ACR50 or greater response at week 12, and participants from the placebo arm, who completed part 1, were eligible for the open label phase.

    Pre-assignment
    Screening details
    		 101 Patients were enrolled in the study. One subject randomized to the placebo arm withdrew from the study before the first dose administration. One hundred participants received study treatment in part 1. Ten participants discontinued during part 1. At the end of part 1, 76 participants were eligible to take secukinumab treatment in part 2.

    Period 1
    Period 1 title
    Part 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab
    Arm description
    		 10 mg/kg intravenous (I.V.)
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    In Part 1 (blinded period) participants randomized to AIN457 recived 10 mg/kg I.V.

    Arm title
    		 Placebo
    Arm description
    		 Placebo i.v.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Matching Placebo to AIN457 I.V.

    Number of subjects in period 1
    		Secukinumab Placebo
    Started
    68
    32
    Completed
    62
    28
    Not completed
    6
    4
         Adverse event, non-fatal
    3
    -
         Protocol deviation
    -
    1
         Lost to follow-up
    1
    2
         Lack of efficacy
    2
    1
    Period 2
    Period 2 title
    Part 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly

    Arm title
    		 Group 2
    Arm description
    		 Part 1: secukinumab 6 x 10 mg/kg i.v.; part 2: no study treatment
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 3
    Arm description
    		 Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukiumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly

    Arm title
    		 Group 4
    Arm description
    		 Part 1: placebo; Part 2: no study treatment
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Group 1 Group 2 Group 3 Group 4
    Started
    49
    13
    27
    1
    Completed
    34
    12
    19
    1
    Not completed
    15
    1
    8
    0
         Adverse event, serious fatal
    1
    -
    1
    -
         Consent withdrawn by subject
    -
    1
    2
    -
         Adverse event, non-fatal
    2
    -
    1
    -
         Protocol deviation
    1
    -
    -
    -
         Administrative problems
    2
    -
    1
    -
         Lost to follow-up
    4
    -
    1
    -
         Lack of efficacy
    5
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab
    Reporting group description
    		 10 mg/kg intravenous (I.V.)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo i.v.

    Reporting group values
    		 Secukinumab Placebo Total
    Number of subjects
    		 68 32 100
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 65 27 92
        From 65-84 years
    		 3 5 8
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 49.5 ± 11.45 54.5 ± 10.3 -
    Gender, Male/Female
    Units: Participants
        Female
    		 48 25 73
        Male
    		 20 7 27

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab
    Reporting group description
    		 10 mg/kg intravenous (I.V.)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo i.v.
    Reporting group title
    Group 1
    Reporting group description
    		 Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly

    Reporting group title
    Group 2
    Reporting group description
    		 Part 1: secukinumab 6 x 10 mg/kg i.v.; part 2: no study treatment

    Reporting group title
    Group 3
    Reporting group description
    		 Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly

    Reporting group title
    Group 4
    Reporting group description
    		 Part 1: placebo; Part 2: no study treatment

    Primary: Percentage of participants who achieve American College of Rheumatology Response of 20 (ACR20 ) in association with the presence or absence of the HLA-DRB1 *4 allelic group

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    End point title
    		 Percentage of participants who achieve American College of Rheumatology Response of 20 (ACR20 ) in association with the presence or absence of the HLA-DRB1 *4 allelic group
    End point description
    A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    62
    28
    Units: Percentage of participants
    number (not applicable)
        HLADRB1 *04 carriers
    45.2
    10.7
        HLADRB1 *04 non-carriers
    41.9
    14.3
    Statistical analysis title
    		 Change from Baseline ACR20 at 12 Weeks
    Comparison groups
    Placebo v Secukinumab
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.303
    Method
    		 ANCOVA
    Confidence interval

    Primary: Change from baseline in Disease Activity Score 28 (DAS28) in association with the presence or absence of HLA-DRB1 04

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    End point title
    		 Change from baseline in Disease Activity Score 28 (DAS28) in association with the presence or absence of HLA-DRB1 04
    End point description
    The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) = 0.36*ln(CRP+1) + 0.014*GH = 0.96. A DAS28-CRP score > 5.1 implies active disease, <3.2 implies controlled disease and <2.6 implied remission. A negative change from baseline indicates improvement.
    End point type
    Primary
    End point timeframe
    baseline, 12 weeks
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    62
    28
    Units: score on a scale
    least squares mean (standard error)
        HLA-DRB1 *04 carriers
    -2.5 ± 0.5273
    -0.6 ± 0.575
        HLA-DRB1 *04 non-carriers
    -2.2 ± 0.5618
    -0.8 ± 0.6098
    Statistical analysis title
    		 Change from Baseline of DAS28-CRP
    Comparison groups
    Secukinumab v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.364
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percentage of participants who achieve ACR50 and ACR70 with the presence/absence of the HLA-DRB1*04 allelic group

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    End point title
    		 Percentage of participants who achieve ACR50 and ACR70 with the presence/absence of the HLA-DRB1*04 allelic group
    End point description
    A participant was considered to be a responder according to the ACR50 or ACR70 criteria if the participant had at least 50% or 70% improvement, respectively, in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    62
    28
    Units: Percentage of participants
    number (not applicable)
        ACR50: HLADRB1 *04 presence
    38.7
    7.1
        ACR50: HLADRB1 *04 absence
    35.5
    10.7
        ACR70: HLADRB1 *04 presence
    8.1
    0
        ACR70: HLADRB1 *04 absence
    8.1
    7.1
    No statistical analyses for this end point

    Secondary: Change from baseline in DAS28 in association with the presence or absence of HLA-DRB1 *SE (positive), HLA-DRB1 *401 (carrier) and HLA-DRB1 position 11 V/L and in association with other biomarkers

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    End point title
    		 Change from baseline in DAS28 in association with the presence or absence of HLA-DRB1 *SE (positive), HLA-DRB1 *401 (carrier) and HLA-DRB1 position 11 V/L and in association with other biomarkers
    End point description
    The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) = 0.36*ln(CRP+1) + 0.014*GH = 0.96. A DAS28-CRP score > 5.1 implies active disease, <3.2 implies controlled disease and <2.6 implied remission. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline, 12 weeks
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    62
    28
    Units: score on a scale
    least squares mean (standard error)
        HLA-DRB1 *SE carrier
    -2.6 ± 0.5049
    -0.5 ± 0.524
        HLA-DRB1 *SE non-carrier
    -2.3 ± 0.5376
    -2.2 ± 0.6977
        HLA-DRB1 *0401 carrier
    -2.4 ± 0.5922
    0.1 ± 0.7503
        HLA-DRB1 *401 non-carrier
    -2.3 ± 0.5133
    -0.9 ± 0.5456
        HLA-DRB1 position 11 V/L carrier
    -2.5 ± 0.4901
    -0.4 ± 0.5218
        HLA-DRB1 position 11 V/L non-carrier
    -2.2 ± 0.5706
    -2.2 ± 0.6954
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    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
    16.1
    Reporting groups
    Reporting group title
    Part 1: Secukinumab 10 mg/kg iv
    Reporting group description
    		 Part 1: Secukinumab 10 mg/kg iv

    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 Part 1: Placebo

    Reporting group title
    Part 2: Group 1
    Reporting group description
    		 Part 2: Group 1

    Reporting group title
    Part 2: Group 3
    Reporting group description
    		 Part 2: Group 3

    Serious adverse events
    		 Part 1: Secukinumab 10 mg/kg iv Part 1: Placebo Part 2: Group 1 Part 2: Group 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 68 (5.88%)
    2 / 32 (6.25%)
    4 / 49 (8.16%)
    4 / 27 (14.81%)
         number of deaths (all causes)
    0
    0
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    1 / 49 (2.04%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Metastases to lung
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    1 / 49 (2.04%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vasculitis necrotising
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    1 / 49 (2.04%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    1 / 49 (2.04%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    1 / 49 (2.04%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multi-organ failure
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    1 / 49 (2.04%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 32 (3.13%)
    0 / 49 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute prerenal failure
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 32 (3.13%)
    0 / 49 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon disorder
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    1 / 49 (2.04%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 32 (3.13%)
    0 / 49 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    1 / 49 (2.04%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Part 1: Secukinumab 10 mg/kg iv Part 1: Placebo Part 2: Group 1 Part 2: Group 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 68 (19.12%)
    9 / 32 (28.13%)
    15 / 49 (30.61%)
    12 / 27 (44.44%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    0
    0
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    0
    0
    2
    Blood pressure increased
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    1 / 49 (2.04%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    4
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    1
    Injection site erythema
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    Injection site haematoma
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 32 (3.13%)
    0 / 49 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection site induration
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 68 (1.47%)
    1 / 32 (3.13%)
    0 / 49 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastrointestinal disorders
    Aphthous stomatitis
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    3 / 68 (4.41%)
    1 / 32 (3.13%)
    1 / 49 (2.04%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    1
    1
    Dysphagia
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 32 (3.13%)
    0 / 49 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 32 (3.13%)
    0 / 49 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 32 (3.13%)
    0 / 49 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    1 / 49 (2.04%)
    1 / 27 (3.70%)
         occurrences all number
    2
    0
    2
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 68 (2.94%)
    1 / 32 (3.13%)
    2 / 49 (4.08%)
    0 / 27 (0.00%)
         occurrences all number
    2
    1
    2
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    Xeroderma
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    Bone pain
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    Bursitis
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    1 / 49 (2.04%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    2
    1
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 68 (1.47%)
    2 / 32 (6.25%)
    7 / 49 (14.29%)
    1 / 27 (3.70%)
         occurrences all number
    1
    5
    8
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    2 / 49 (4.08%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    2
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    3 / 49 (6.12%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    2 / 49 (4.08%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 68 (0.00%)
    2 / 32 (6.25%)
    1 / 49 (2.04%)
    1 / 27 (3.70%)
         occurrences all number
    0
    2
    1
    1
    Otitis media
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    2
    Rhinitis
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    2 / 49 (4.08%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Tonsillitis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 32 (0.00%)
    1 / 49 (2.04%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 68 (4.41%)
    1 / 32 (3.13%)
    1 / 49 (2.04%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    1
    1
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 32 (0.00%)
    0 / 49 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 May 2011
    In order to reduce the complexity of the study, blood sampling for Flow Cytometry studies was removed from the protocol.
    09 May 2011
    The duration of iv infusion in both treatment arms in Part 1 of the study was shortened to30 minutes from 120 minutes. Recent results from the clinical study (CAIN457A2228) that assessed the safety and tolerability of a shorter infusion time for secukinumab administration showed that secukinumab infusion over a 30-minute period is well tolerated and safe.
    06 Jun 2011
    Prior to FSFV, subjects were offered the opportunity to change for potential benefit (for subjects randomized to placebo) or continue potential benefit (for those subjects responding to treatment) of secukinumab.
    06 Jun 2011
    Subjects randomized to the placebo treatment who completed their Week 12 visit were offered open label treatment with secukinumab sc for 52 weeks.
    06 Jun 2011
    For subjects who achieved an ACR50 or greater response at Week 12, open label treatment was extended to total treatment duration of 52 weeks.
    06 Jun 2011
    Inclusion criterion no. 6 was re-worded for clarification
    20 Mar 2012
    The protocol was amended to clarify that subjects prematurely withdrawing from the study were intended to undergo a 12 weeks follow-up period, prior to the end of study visit.
    20 Mar 2012
    The screening window was extended to 28 days to facilitate recruitment.
    20 Mar 2012
    Further changes were made to clarify the treatment for subjects randomized to placebo, which were offered open-label treatment with secukinumab, to clarify unblinding procedures, testing procedure and interim analysis, and to facilitate study visit compliance.
    21 Mar 2013
    This amendment clarified the blinding and unblinding processes as well as the release of interim results to external parties after closing study Part 1

    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.
    None reported
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