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    Clinical Trial Results:
    A randomized, double-blind, double-dummy, active controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares, for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective 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.novfor complete trial results

    Summary
    EudraCT number
    		 2010-024172-26
    Trial protocol
    		 PL  
    Global end of trial date
    19 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2018
    First version publication date
    07 Jul 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CACZ885H2358
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01362608
    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
    19 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to patient’s assessment of gout pain intensity in the most affected joint at 72 hours postdose (on a 0-100mm visual analog scale [VAS])  2) To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks
    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
    04 Jul 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
    Argentina: 4
    Country: Number of subjects enrolled
    China: 114
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Singapore: 8
    Worldwide total number of subjects
    136
    EEA total number of subjects
    10
    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)
    124
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 136 patients were randomized to treatment, 67 to canakinumab 150 mg s.c. and 69 to triamcinolone acetonide 40 mg i.m.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ACZ885 150 mg
    Arm description
    		 Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
    Arm type
    		 Experimental

    Investigational medicinal product name
    canakinumab
    Investigational medicinal product code
    ACZ885
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg S C

    Arm title
    		 Triamcinolone acetonide 40 mg
    Arm description
    		 triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Triamcinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg SC

    Number of subjects in period 1
    		ACZ885 150 mg Triamcinolone acetonide 40 mg
    Started
    67
    69
    Completed
    63
    61
    Not completed
    4
    8
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    -
    2
         Lost to follow-up
    3
    1
         Protocol deviation
    -
    1
         Lack of efficacy
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ACZ885 150 mg
    Reporting group description
    		 Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.

    Reporting group title
    Triamcinolone acetonide 40 mg
    Reporting group description
    		 triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.

    Reporting group values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg Total
    Number of subjects
    		 67 69 136
    Age Categorical
    Units: participants
        Between 18 and 65 years
    		 58 66 124
        >=65 years
    		 9 3 12
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.2 ( 11.98 ) 49.2 ( 11.37 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 1 2 3
        Male
    		 66 67 133

    End points

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    End points reporting groups
    Reporting group title
    ACZ885 150 mg
    Reporting group description
    		 Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.

    Reporting group title
    Triamcinolone acetonide 40 mg
    Reporting group description
    		 triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.

    Primary: The change in the gout pain intensity in the target joint following ACZ885 administration measured by Visual Analog Scale (VAS)

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    End point title
    		 The change in the gout pain intensity in the target joint following ACZ885 administration measured by Visual Analog Scale (VAS)
    End point description
    A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 – 4 mm), mild pain (5– 44 mm), moderate pain (45–74 mm), and severe pain (75– 100 mm)
    End point type
    Primary
    End point timeframe
    at 72 hours post-dose
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: units on a line
        least squares mean (standard error)
    18.2 ( 3.03 )
    37.9 ( 3.03 )
    Statistical analysis title
    		 ACZ885 vs Triamcinolone ANCOVA
    Comparison groups
    ACZ885 150 mg v Triamcinolone acetonide 40 mg
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -19.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.2
         upper limit
    		 -11.2

    Primary: Time to first new flare: Survival analysis by treatment: Kaplan Meier Analysis

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    End point title
    		 Time to first new flare: Survival analysis by treatment: Kaplan Meier Analysis
    End point description
    Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: Participants
        number (confidence interval 95%)
    5 (1.19 to 13.93)
    17 (15.29 to 36.71)
    Statistical analysis title
    		 ACZ885 vs Triamcinolone COX Regression
    Comparison groups
    ACZ885 150 mg v Triamcinolone acetonide 40 mg
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0043
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.71

    Secondary: The percentage of patients with at least 1 new gout flare

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    End point title
    		 The percentage of patients with at least 1 new gout flare
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: participants
        1 new flare
    3
    15
        2 new flares
    0
    1
        3 new flares
    0
    0
        > 3 new flares
    2
    1
    No statistical analyses for this end point

    Secondary: Patients Assessment of Gout Pain intensity in the most effected joint (0–100mm VAS): Summary statistics by timepoint and treatment

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    End point title
    		 Patients Assessment of Gout Pain intensity in the most effected joint (0–100mm VAS): Summary statistics by timepoint and treatment
    End point description
    A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 – 4 mm), mild pain (5– 44 mm), moderate pain (45–74 mm), and severe pain (75– 100 mm)
    End point type
    Secondary
    End point timeframe
    baseline through 12 weeks
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: unit on a scale
    arithmetic mean (standard deviation)
        baseline
    72.3 ( 13.18 )
    74.5 ( 12.88 )
        6 hours post-dose
    53 ( 22.06 )
    58.8 ( 23.83 )
        12 hours post-dose
    41.7 ( 19.56 )
    51.8 ( 27.07 )
        24 hours post-dose
    30.9 ( 18.23 )
    48.6 ( 29.13 )
        48 hours post-dose
    22 ( 18.64 )
    43.9 ( 30.69 )
        72 hours post-dose
    17.4 ( 17.02 )
    36.6 ( 30.62 )
        7 days post-dose
    10.1 ( 15.61 )
    24 ( 27.31 )
        4 weeks post-dose
    9.5 ( 17.25 )
    17.9 ( 25.31 )
        8 weeks post-dose
    6.8 ( 13.64 )
    16 ( 24.24 )
        12 weeks post-dose
    6.8 ( 12.92 )
    13 ( 19.77 )
    No statistical analyses for this end point

    Secondary: Patient's assessment of Gout pain intensity in the most affected joint (Likert scale): Frequency table by timepoint and treatment

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    End point title
    		 Patient's assessment of Gout pain intensity in the most affected joint (Likert scale): Frequency table by timepoint and treatment
    End point description
    Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme).
    End point type
    Secondary
    End point timeframe
    baseline through week 12
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: participants
        baseline none
    0
    0
        baseline mild
    2
    3
        baseline moderate
    25
    18
        baseline severe
    37
    44
        baseline extreme
    3
    4
        6 hours post-dose none
    0
    0
        6 hours post-dose mild
    18
    14
        6 hours post-dose moderate
    28
    26
        6 hours post-dose severe
    17
    29
        6 hours post-dose extreme
    2
    0
        12 hours post-dose none
    1
    2
        12 hours post-dose mild
    28
    19
        12 hours post-dose moderate
    28
    26
        12 hours post-dose severe
    7
    21
        12 hours post-dose extreme
    1
    1
        24 hours post-dose none
    3
    4
        24 hours post-dose mild
    40
    20
        24 hours post-dose moderate
    19
    25
        24 hours post-dose severe
    2
    20
        24 hours post-dose extreme
    1
    0
        48 hours post-dose none
    10
    10
        48 hours post-dose mild
    48
    21
        48 hours post-dose moderate
    7
    20
        48 hours post-dose severe
    2
    14
        48 hours post-dose extreme
    0
    2
        72 hours post-dose none
    14
    12
        72 hours post-dose mild
    45
    26
        72 hours post-dose moderate
    8
    16
        72 hours post-dose severe
    0
    9
        72 hours post-dose extreme
    0
    4
        4 days post-dose none
    21
    14
        4 days post-dose mild
    39
    29
        4 days post-dose moderate
    7
    13
        4 days post-dose severe
    0
    10
        4 days post-dose extreme
    0
    0
        7 days post-dose none
    32
    23
        7 days post-dose mild
    29
    25
        7 days post-dose moderate
    5
    10
        7 days post-dose severe
    1
    8
        7 days post-dose extreme
    0
    0
        4 weeks post-dose none
    43
    24
        4 weeks post-dose mild
    17
    25
        4 weeks post-dose moderate
    4
    6
        4 weeks post-dose severe
    1
    0
        4 weeks post-dose extreme
    0
    0
        8 weeks post-dose none
    39
    30
        8 weeks post-dose mild
    22
    21
        8 weeks post-dose moderate
    2
    6
        8 weeks post-dose severe
    2
    2
        8 weeks post-dose extreme
    0
    0
        12 weeks post-dose none
    41
    25
        12 weeks post-dose mild
    18
    28
        12 weeks post-dose moderate
    3
    8
        12 weeks post-dose severe
    2
    1
        12 weeks post-dose extreme
    0
    1
    No statistical analyses for this end point

    Secondary: Patient’s global assessment of response to treatment: Frequency table by timepoint and treatment using a Likert scale.

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    End point title
    		 Patient’s global assessment of response to treatment: Frequency table by timepoint and treatment using a Likert scale.
    End point description
    Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done).
    End point type
    Secondary
    End point timeframe
    72 hours through week 12
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: participants
        72 hours post-dose excellent
    7
    3
        72 hours post-dose good
    40
    17
        72 hours post-dose acceptable
    14
    18
        72 hours post-dose slight
    4
    11
        72 hours post-dose poor
    1
    10
        72 hours post-dose very poor
    0
    0
        72 hours post-dose not done
    0
    1
        7 days post-dose excellent
    16
    4
        7 days post-dose good
    38
    20
        7 days post-dose acceptable
    9
    18
        7 days post-dose slight
    1
    7
        7 days post-dose poor
    1
    16
        7 days post-dose very poor
    0
    0
        7 days post-dose not done
    0
    1
        4 weeks post-dose excellent
    15
    6
        4 weeks post-dose good
    33
    19
        4 weeks post-dose acceptable
    13
    14
        4 weeks post-dose slight
    4
    7
        4 weeks post-dose poor
    0
    9
        4 weeks post-dose very poor
    0
    0
        4 weeks post-dose not done
    0
    2
        8 weeks post-dose excellent
    18
    8
        8 weeks post-dose good
    35
    16
        8 weeks post-dose acceptable
    10
    18
        8 weeks post-dose slight
    2
    9
        8 weeks post-dose poor
    0
    8
        8 weeks post-dose very poor
    0
    0
        8 weeks post-dose not done
    0
    1
        12 weeks post-dose excellent
    16
    4
        12 weeks post-dose good
    37
    21
        12 weeks post-dose acceptable
    10
    21
        12 weeks post-dose slight
    0
    7
        12 weeks post-dose poor
    1
    9
        12 weeks post-dose very poor
    0
    0
        12 weeks post-dose not done
    3
    3
    No statistical analyses for this end point

    Secondary: Physician’s assessment of tenderness: Frequency table by timepoint and treatment

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    End point title
    		 Physician’s assessment of tenderness: Frequency table by timepoint and treatment
    End point description
    Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
    End point type
    Secondary
    End point timeframe
    baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: participants
        Baseline no pain
    0
    0
        Baseline pain
    15
    16
        Baseline pain and winces
    31
    29
        Baseline pain, winces and withdraws
    21
    24
        Baseline not assessed
    0
    0
        72 hours post-dose no pain
    23
    16
        72 hours post-dose pain
    37
    26
        72 hours post-dose pain and winces
    5
    11
        72 hours post-dose pain, winces and withdraws
    1
    3
        72 hours post-dose not assessed
    0
    0
        7 days post-dose no pain
    41
    26
        7 days post-dose pain
    23
    27
        7 days post-dose pain and winces
    2
    10
        7 days post-dose pain , winces and withdraws
    0
    2
        7 days post-dose not assessed
    0
    0
        4 weeks post-dose no pain
    54
    30
        4 weeks post-dose pain
    10
    19
        4 weeks post-dose pain and winces
    1
    3
        4 weeks post-dose pain, winces and withdraws
    0
    3
        4 weeks post-dose not assessed
    0
    0
        8 weeks post-dose no pain
    54
    38
        8 weeks post-dose pain
    11
    19
        8 weeks post-dose pain and winces
    0
    1
        8 weeks post-dose pain winces and withdraws
    0
    1
        8 weeks post-dose not assessed
    0
    0
        12 weeks post-dose no pain
    53
    39
        12 weeks post-dose pain
    7
    22
        12 weeks post-dose pain and winces
    2
    1
        12 weeks post-dose pain, winces and withdraws
    2
    0
        12 weeks post-dose not assessed
    0
    0
    No statistical analyses for this end point

    Secondary: Physician’s assessment of swelling: Frequency table by timepoint and treatment

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    End point title
    		 Physician’s assessment of swelling: Frequency table by timepoint and treatment
    End point description
    Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
    End point type
    Secondary
    End point timeframe
    baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: participants
        Baseline No swelling
    1
    3
        Baseline Palpable
    13
    12
        Baseline Visible
    29
    39
        Baseline Bulging beyond the joint margins
    24
    15
        Baseline not assessed
    0
    0
        72 hours post-dose No swelling
    38
    22
        72 hours post-dose Palpable
    15
    15
        72 hours post-dose Visible
    12
    18
        72 hrs post-dose Bulging beyond the joint margins
    1
    1
        72 hours post-dose not assessed
    0
    0
        7 days post-dose No swelling
    53
    35
        7 days post-dose Palpable
    9
    18
        7 days post-dose Visible
    3
    9
        7 days post-dose Bulging beyond the joint margins
    1
    3
        7 days post-dose not assessed0
    0
    0
        4 weeks post-dose No swelling
    60
    40
        4 weeks post-dose Palpable
    2
    9
        4 weeks post-dose Visible
    3
    4
        4 weeks post-dose Bulging beyond the joint margins
    0
    2
        4 weeks post-dose not assessed
    0
    0
        8 weeks post-dose No swelling
    63
    49
        8 weeks post-dose Palpable
    0
    6
        8 weeks post-dose Visible
    2
    4
        8 weeks post-dose Bulging beyond the joint margins
    0
    0
        8 weeks post-dose not assessed
    0
    0
        12 weeks post-dose No swelling
    61
    52
        12 weeks post-dose Palpable
    1
    6
        12 weeks post-dose Visible
    2
    2
        12 wks post-dose Bulging beyond the joint margins
    0
    2
        12 weeks post-dose not assessed
    0
    0
    No statistical analyses for this end point

    Secondary: Physician’s assessment of erythema: Frequency table by timepoint and treatment

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    End point title
    		 Physician’s assessment of erythema: Frequency table by timepoint and treatment
    End point description
    Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable).
    End point type
    Secondary
    End point timeframe
    baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: participants
        Baseline Absent
    19
    19
        Baseline present
    48
    50
        Baseline not assessed
    0
    0
        Baseline not assessable
    0
    0
        72 hours post-dose absent
    54
    41
        72 hours post-dose present
    11
    15
        72 hours post-dose not assessed
    0
    0
        72 hrs post-dose not assessable
    1
    0
        7 days post-dose absent
    62
    57
        7 days post-dose present
    3
    8
        7 days post-dose not assessed
    0
    0
        7 days post-dose not assessable
    1
    0
        4 weeks post-dose absent
    63
    49
        4 weeks post-dose present
    1
    6
        4 weeks post-dose not assessed
    0
    0
        4 weeks post-dose not assessable
    1
    0
        8 weeks post-dose absent
    65
    56
        8 weeks post-dose present
    0
    3
        8 weeks post-dose not assessed
    0
    0
        8 weeks post-dose not assessable
    0
    0
        12 weeks post-dose absent
    62
    61
        12 weeks post-dose present
    1
    1
        12 weeks post-dose not assessed
    0
    0
        12 wks post-dose not assessable
    1
    0
    No statistical analyses for this end point

    Secondary: Physician’s assessment of range of motion: Frequency table by timepoint and treatment

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    End point title
    		 Physician’s assessment of range of motion: Frequency table by timepoint and treatment
    End point description
    Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized).
    End point type
    Secondary
    End point timeframe
    baseline through week 12
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: participants
        baseline normal
    0
    0
        baseline mildly restricted
    3
    6
        baseline moderately restricted
    32
    24
        baseline severely restricted
    27
    39
        baseline immobilzed
    5
    0
        72 hours post-dose normal
    20
    15
        72 hours post-dose mildly restricted
    33
    19
        72 hours post-dose moderately restricted
    11
    14
        72 hours post-dose severely restricted
    2
    7
        72 hours post-dose immobilized
    0
    1
        7 days post-dose normal
    35
    26
        7 days post-dose mildly restricted
    25
    20
        7 days post-dose moderately restricted
    4
    15
        7 days post-dose severely restricted
    1
    3
        7 days post-dose immobilized
    0
    1
        4 weeks post-dose normal
    49
    25
        4 weeks post-dose mildly restricted
    12
    22
        4 weeks post-dose moderately restricted
    3
    7
        4 weeks post-dose severely restricted
    1
    1
        4 weeks post-dose immobilized
    0
    0
        8 weeks post-dose normal
    51
    32
        8 weeks post-dose mildly restricted
    12
    18
        8 weeks post-dose moderately restricted
    1
    6
        8 weeks post-dose severely restricted
    1
    3
        8 weeks post-dose immobilized
    0
    0
        12 weeks post-dose normal
    50
    30
        12 weeks post-dose mildly restrcted
    1
    23
        12 weeks post-dose moderately restricted
    2
    6
        12 weeks post-dose severely restricted
    1
    3
        12 weeks post-dose immobilized
    0
    0
    No statistical analyses for this end point

    Secondary: Time to at least a 50% reduction in baseline pain intensity: Survival analysis by treatment

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    End point title
    		 Time to at least a 50% reduction in baseline pain intensity: Survival analysis by treatment
    End point description
    Kaplan Meier estimate
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: hours
        median (confidence interval 95%)
    24 (24 to 48)
    48 (24 to 72)
    No statistical analyses for this end point

    Secondary: Time to complete resolution of pain: Survival analysis by treatment

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    End point title
    		 Time to complete resolution of pain: Survival analysis by treatment
    End point description
    Kaplan Meier estimate
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: hours
        median (confidence interval 95%)
    168 (120 to 168)
    168 (99 to 999)
    No statistical analyses for this end point

    Secondary: Time to first rescue medication intake

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    End point title
    		 Time to first rescue medication intake
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: hours
        arithmetic mean (standard deviation)
    31.8 ( 30.45 )
    41.5 ( 38.8 )
    No statistical analyses for this end point

    Secondary: percent patients who took rescue medication

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    End point title
    		 percent patients who took rescue medication
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: percentage
    number (not applicable)
        Baseline flare (n= 29,42)
    43.3
    60.9
        Last post-baseline flare (n=3,4)
    75
    44.4
    No statistical analyses for this end point

    Secondary: Amount of rescue medication taken at baseline flare and post baseline flare.

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    End point title
    		 Amount of rescue medication taken at baseline flare and post baseline flare.
    End point description
    Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: mg
    arithmetic mean (standard deviation)
        Baseline flare Paracetamol / acetaminophen
    342.5 ( 680.53 )
    451.4 ( 744.19 )
        Baseline flare Prednisolol
    1.1 ( 4.25 )
    5 ( 15.29 )
        Baseline Flare Prednisone
    0.7 ( 5.52 )
    5.2 ( 30.42 )
        Baseline flare Codeine
    0 ( 0 )
    0.4 ( 3.61 )
        Last post-baseline flare Paraceta/acetamin n=4,9
    287.5 ( 337.58 )
    222.2 ( 666.67 )
        Last post-baseline flare Prednisolone n=4,9
    5 ( 10 )
    4.4 ( 8.82 )
        Last post-baseline flare Prednisone n=4,9
    0 ( 0 )
    0.6 ( 1.67 )
    No statistical analyses for this end point

    Secondary: To evaluate the efficacy of canakinumab with regards to inflammatory markers (high sensitivity C-reactive protein [hsCRP]) measured in the serum at 72 hours post dose

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    End point title
    		 To evaluate the efficacy of canakinumab with regards to inflammatory markers (high sensitivity C-reactive protein [hsCRP]) measured in the serum at 72 hours post dose
    End point description
    End point type
    Secondary
    End point timeframe
    72 hours post dose
    End point values
    		 ACZ885 150 mg Triamcinolone acetonide 40 mg
    Number of subjects analysed
    67
    69
    Units: mg/L
        number (confidence interval 95%)
    5.5 (4.4 to 6.9)
    7.2 (5.7 to 9.2)
    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 are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    ACZ885 150mg sc
    Reporting group description
    		 ACZ885 150mg sc

    Reporting group title
    Triam 40mg im
    Reporting group description
    		 Triam 40mg im

    Serious adverse events
    		 ACZ885 150mg sc Triam 40mg im
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 69 (1.45%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Hepatobiliary disorders
    Hepatic function abnormal
    alternative dictionary used: MedDRA 18
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Gouty arthritis
    alternative dictionary used: MedDRA 18
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ACZ885 150mg sc Triam 40mg im
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 67 (0.00%)
    4 / 69 (5.80%)
    Vascular disorders
    Hypertension
    alternative dictionary used: MedDRA 18
         subjects affected / exposed
    0 / 67 (0.00%)
    4 / 69 (5.80%)
         occurrences all number
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Apr 2011
    This amendment (Amendment 1, issued on 13-Apr-2011, before study start) rendered pre-screening for HIV, Hepatitis, TB and diabetes as mandatory in order to verify exclusion criteria prior to randomization and minimize the risk of protocol deviations

    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.
    This study was terminated early for strategic reasons, not concerns for efficacy or safety of canakinumab. Due to EudraCT system limitations, data using 999 as data points in this record are not an accurate representation of clinical 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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