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    Clinical Trial Results:
    A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Paediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations

    Summary
    EudraCT number
    		 2008-005476-27
    Trial protocol
    		 ES   NO   FR   HU   DE   BE   SE   IT   GB   DK   GR   Outside EU/EEA  
    Global end of trial date
    02 Dec 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    01 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CACZ885G2305
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00886769
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000060-PIP02-08
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Dec 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Dec 2010
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the efficacy of canakinumab over a 4 week treatment period in subjects with systemic juvenile idiopathic arthritis (sJIA) having a flare. Response to treatment was measured using an adapted American College of Rheumatology (ACR) paediatric 30 criteria at Day 15.
    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. Subjects who did not improve with treatment, and did not meet the adapted ACR paediatric 30 at Day 15, or experienced flare between Day 15 and Day 29 were discontinued from the study. The investigator provided follow-up medical care for all subjects who prematurely withdrew from the study, or referred them for appropriate ongoing care as per standard local medical practice. This care included initiating another treatment outside of the study as deemed appropriate by the investigator. No rescue medication was allowed during the course of the study. The investigators were well-informed of additional procedures to be followed in case of early termination of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jul 2009
    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
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Peru: 3
    Country: Number of subjects enrolled
    Israel: 10
    Country: Number of subjects enrolled
    Turkey: 11
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    United States: 8
    Country: Number of subjects enrolled
    Argentina: 2
    Country: Number of subjects enrolled
    Brazil: 3
    Worldwide total number of subjects
    84
    EEA total number of subjects
    45
    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)
    60
    Adolescents (12-17 years)
    20
    Adults (18-64 years)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 40 centres in 18 countries.

    Pre-assignment
    Screening details
    		 A total of 84 subjects were screened and randomized into the study.

    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
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Randomization data were kept strictly confidential until the time of unblinding, and was accessible only to an independent, unblinded qualified study person at the investigator’s site who prepared the study medication. The identity of the treatments were concealed by the use of study drugs in form of syringes filled with reconstituted drug solutions that were all identical in appearance, but the actual vials with lyophilisate were supplied open-label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Canakinumab
    Arm description
    		 Subjects received a single dose of subcutaneous (s.c.) injection of canakinumab [4 milligrams (mg)/kilograms (kg)] on Day 1 with a maximum allowed daily dose of 300 mg. Any subject who required a dose greater than 150 mg (for subjects with body weight more than 37.5 kg) received two s.c. injections of canakinumab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canakinumab
    Investigational medicinal product code
    ACZ885
    Other name
    Ilaris
    Pharmaceutical forms
    Powder for cutaneous solution
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Canakinumab (4mg/kg) s.c. solution was administered on Day 1. The maximal allowed daily dose of canakinumab was 300 mg.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received a single s.c. dose of matching placebo solution to canakinumab on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for cutaneous solution
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matching to canakinumab s.c. solution was administered on Day 1.

    Number of subjects in period 1
    		Canakinumab Placebo
    Started
    43
    41
    Completed
    37
    4
    Not completed
    6
    37
         Unsatisfactory therapeutic effect
    6
    37

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Canakinumab
    Reporting group description
    		 Subjects received a single dose of subcutaneous (s.c.) injection of canakinumab [4 milligrams (mg)/kilograms (kg)] on Day 1 with a maximum allowed daily dose of 300 mg. Any subject who required a dose greater than 150 mg (for subjects with body weight more than 37.5 kg) received two s.c. injections of canakinumab.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single s.c. dose of matching placebo solution to canakinumab on Day 1.

    Reporting group values
    		 Canakinumab Placebo Total
    Number of subjects
    		 43 41 84
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 31 29 60
        Adolescents (12-17 years)
    		 10 10 20
        Adults (18-64 years)
    		 2 2 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.3 ± 5.08 9.7 ± 4.32 -
    Gender categorical
    Units: Subjects
        Female
    		 27 23 50
        Male
    		 16 18 34

    End points

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    End points reporting groups
    Reporting group title
    Canakinumab
    Reporting group description
    		 Subjects received a single dose of subcutaneous (s.c.) injection of canakinumab [4 milligrams (mg)/kilograms (kg)] on Day 1 with a maximum allowed daily dose of 300 mg. Any subject who required a dose greater than 150 mg (for subjects with body weight more than 37.5 kg) received two s.c. injections of canakinumab.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single s.c. dose of matching placebo solution to canakinumab on Day 1.

    Primary: Percentage of subjects achieving the adapted American College of Rheumatology (ACR) Paediatric 30 criteria at Day 15

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    End point title
    		 Percentage of subjects achieving the adapted American College of Rheumatology (ACR) Paediatric 30 criteria at Day 15
    End point description
    Adapted ACR Paediatric 30 criteria was assessed based on following 7 variables: 1.Physician’s Global Assessment on a 0-100 millimetres (mm) visual analog scale (VAS); 2.Patient Global Assessment on a 0-100 mm VAS in the Child Health Assessment Questionnaire (CHAQ); 3.Functional ability; 4.Joints count with active arthritis; 5.Joints count with limitation of motion; 6.Laboratory measure of C-reactive protein (CRP) and 7.Absence of intermittent fever due to sJIA during the preceding week. Response was defined as more than or equal to (≥) 30% improvement in at least 3 of the response variables 1 to 6 and no intermittent fever (i.e. body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. The analysis was performed on Full analysis set (FAS), defined as all randomized subjects who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Day 15
    End point values
    		 Canakinumab Placebo
    Number of subjects analysed
    43
    41
    Units: Percentage of subjects
        number (not applicable)
    83.7
    9.8
    Statistical analysis title
    		 Odd's ratio of treatment responders
    Statistical analysis description
    Comparison of treatment groups using exact Cochran-Mantel-Haenszel (CMH) test adjusting for stratification factors.
    Comparison groups
    Canakinumab v Placebo
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    62.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.68
         upper limit
    		 306.07
    Notes
    [1] - Null hypothesis stated odds ratio was equal to 1, i.e. the probability to respond to treatment was same for both groups. While, alternative hypothesis stated odds ratio to be greater than 1, i.e. the probability to respond to treatment was higher for canakinumab.

    Secondary: Percentage of subjects achieving the adapted ACR Paediatric 30 criteria at Day 29

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    End point title
    		 Percentage of subjects achieving the adapted ACR Paediatric 30 criteria at Day 29
    End point description
    Adapted ACR Paediatric 30 criteria was assessed based on following 7 variables: 1.Physician’s Global Assessment on a 0-100 mm VAS; 2.Patient Global Assessment on a 0-100 mm VAS in the CHAQ; 3.Functional ability; 4.Joints count with active arthritis; 5.Joints count with limitation of motion; 6.Laboratory measure of CRP and 7.Absence of intermittent fever due to sJIA during the preceding week. Response was defined as ≥ 30% improvement from baseline in at least 3 of the response variables 1 to 6 and no intermittent fever (i.e. body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. The analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 Canakinumab Placebo
    Number of subjects analysed
    43
    41
    Units: percentage of subjects
        number (not applicable)
    81.4
    9.8
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving the adapted ACR Paediatric 50 criteria

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    End point title
    		 Percentage of subjects achieving the adapted ACR Paediatric 50 criteria
    End point description
    Adapted ACR Paediatric 50 criteria was assessed based on following 7 variables: 1.Physician’s Global Assessment on a 0-100 mm VAS; 2.Patient Global Assessment on a 0-100 mm VAS in the CHAQ; 3.Functional ability; 4.Joints count with active arthritis; 5.Joints count with limitation of motion; 6.Laboratory measure of CRP and 7.Absence of intermittent fever due to sJIA during the preceding week. Response was defined as ≥50% improvement from baseline in at least 3 of the response variables 1 to 6 and no intermittent fever (i.e. body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. The analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    Day 15, Day 29
    End point values
    		 Canakinumab Placebo
    Number of subjects analysed
    43
    41
    Units: Percentage of subjects
    number (not applicable)
        Day 15
    67.4
    4.9
        Day 29
    79.1
    4.9
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving the adapted ACR Paediatric 70 criteria

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    End point title
    		 Percentage of subjects achieving the adapted ACR Paediatric 70 criteria
    End point description
    Adapted ACR Paediatric 70 criteria was assessed based on following 7 variables: 1.Physician’s Global Assessment on a 0-100 mm VAS; 2.Patient Global Assessment on a 0-100 mm VAS in the CHAQ; 3.Functional ability; 4.Joints count with active arthritis; 5.Joints count with limitation of motion; 6.Laboratory measure of CRP and 7.Absence of intermittent fever due to sJIA during the preceding week. Response was defined as ≥70% improvement from baseline in at least 3 of the response variables 1 to 6 and no intermittent fever (i.e. body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. The analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    Day 15, Day 29
    End point values
    		 Canakinumab Placebo
    Number of subjects analysed
    43
    41
    Units: Percentage of subjects
    number (not applicable)
        Day 15
    60.5
    2.4
        Day 29
    67.4
    2.4
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving the adapted ACR Paediatric 90 criteria

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    End point title
    		 Percentage of subjects achieving the adapted ACR Paediatric 90 criteria
    End point description
    Adapted ACR Paediatric 90 criteria was assessed based on following 7 variables: 1.Physician’s Global Assessment on a 0-100 mm VAS; 2.Patient Global Assessment on a 0-100 mm VAS in the CHAQ; 3.Functional ability; 4.Joints count with active arthritis; 5.Joints count with limitation of motion; 6.Laboratory measure of CRP and 7.Absence of intermittent fever due to sJIA during the preceding week. Response was defined as ≥90% improvement from baseline in at least 3 of the response variables 1 to 6 and no intermittent fever (i.e. body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. The analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    Day 15, Day 29
    End point values
    		 Canakinumab Placebo
    Number of subjects analysed
    43
    41
    Units: Percentage of subjects
    number (not applicable)
        Day 15
    41.9
    0
        Day 29
    46.5
    2.4
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving the adapted ACR Paediatric 100 criteria

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    End point title
    		 Percentage of subjects achieving the adapted ACR Paediatric 100 criteria
    End point description
    Adapted ACR Paediatric 100 criteria was assessed based on following 7 variables: 1.Physician’s Global Assessment on a 0-100 mm VAS; 2.Patient Global Assessment on a 0-100 mm VAS in the CHAQ; 3.Functional ability; 4.Joints count with active arthritis; 5.Joints count with limitation of motion; 6.Laboratory measure of CRP and 7.Absence of intermittent fever due to sJIA during the preceding week. Response was defined as 100% improvement from baseline in at least 3 of the response variables 1 to 6 and no intermittent fever (i.e. body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. The analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    Day 15, Day 29
    End point values
    		 Canakinumab Placebo
    Number of subjects analysed
    43
    41
    Units: Percentage of subjects
    number (not applicable)
        Day 15
    32.6
    0
        Day 29
    32.6
    2.4
    No statistical analyses for this end point

    Secondary: Percentage of subjects with normal body temperature at Day 3

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    End point title
    		 Percentage of subjects with normal body temperature at Day 3
    End point description
    Subjects who had body temperature of less than or equal to 38 degree Celsius were counted. Body temperature was derived from vital signs evaluation and normal body temperature indicated treatment response. The analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    Day 3
    End point values
    		 Canakinumab Placebo
    Number of subjects analysed
    43
    38 [2]
    Units: Percentage of subjects
        number (not applicable)
    100
    86.8
    Notes
    [2] - Only 38 subjects were evaluable for this measure at specified time point
    No statistical analyses for this end point

    Secondary: Subject's pain intensity at Day 15 and Day 29

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    End point title
    		 Subject's pain intensity at Day 15 and Day 29
    End point description
    Subject's pain intensity was assessed by parents and adult subjects (18-20 years old) as a part of Childhood Health Assessment Questionnaire (CHAQ). Parents responded to the following question of CHAQ: “How much pain do you think your child has had because of his/her illness in the past week?” on a VAS scale of 0-100 mm (0 mm: no pain to 100: very severe pain). The analysis was performed on FAS population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 15, Day 29
    End point values
    		 Canakinumab Placebo
    Number of subjects analysed
    43
    41
    Units: Units on a scale
    least squares mean (standard error)
        Day 15 (n=43, 25)
    20.3 ± 5.08
    66.7 ± 6.35
        Day 29 (n=38,7)
    20.6 ± 5.59
    62.5 ± 9.7
    No statistical analyses for this end point

    Secondary: Change from baseline in Health-Related Quality of Life (HRQoL) over time by use of Child Health Questionnaire - Parent Form (CHQ-PF50)

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    End point title
    		 Change from baseline in Health-Related Quality of Life (HRQoL) over time by use of Child Health Questionnaire - Parent Form (CHQ-PF50)
    End point description
    The Child Health Questionnaire – Parent Form (CHQ-PF50) instrument was used to measure HRQoL aged 5 to 18 years from a parent’s perspective. This 14-concept questionnaire measured physical and psychosocial health of the subjects on following points: physical functioning, role/social emotional, role/social behavior, role/social physical, bodily pain, general behavior, mental health, self-esteem, general health perception, change in health, parental impact – emotional, parental impact – time, family activities, and family cohesion. Total score ranged from 0-100. Increase in score represented improvement in overall well-being of subjects. The analysis was performed on FAS population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 up to Day 29
    End point values
    		 Canakinumab Placebo
    Number of subjects analysed
    43
    41
    Units: Units on a scale
    least squares mean (standard error)
        CHQ-PF50 physical score (n=28, 34)
    16.9 ± 3.46
    4.9 ± 3.97
        CHQ-PF50 psychosocial score (n=28, 34)
    6.2 ± 2.15
    -1.1 ± 2.49
    No statistical analyses for this end point

    Secondary: Change in disability score over time by use of the CHAQ

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    End point title
    		 Change in disability score over time by use of the CHAQ
    End point description
    The disability dimension of CHAQ questionnaire comprised of 20 items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Subjects rated the responses from 0-3 (0: without any difficulty, 1- with some difficulty, 2: with much difficulty and 3: unable to do). Negative change in score indicated improvement. The analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 up to Day 29
    End point values
    		 Canakinumab Placebo
    Number of subjects analysed
    43
    41
    Units: Units on a scale
        least squares mean (standard error)
    -0.9 ± 0.15
    -0.2 ± 0.2
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-canakinumab antibodies at any visit

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    End point title
    		 Number of subjects with anti-canakinumab antibodies at any visit
    End point description
    Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system. The analysis was performed on the FAS population.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 29
    End point values
    		 Canakinumab Placebo
    Number of subjects analysed
    43
    41
    Units: Number of subjects
        number (not applicable)
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events (AEs), serious adverse events (SAEs)

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    End point title
    		 Number of subjects with adverse events (AEs), serious adverse events (SAEs)
    End point description
    An AE was defined as any undesirable sign, symptom or medical condition occurring after starting study drug even if the event was not considered to be related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the subject or require medical or surgical intervention to prevent one of the aforementioned outcomes. The analysis was performed on the safety set, defined as all subjects who received at least one dose of study drug and had at least one post-baseline safety assessment.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 29
    End point values
    		 Canakinumab Placebo
    Number of subjects analysed
    43
    41
    Units: Number of subjects
    number (not applicable)
        AEs
    24
    16
        SAEs
    2
    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 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
    13.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single s.c. dose of matching placebo solution to canakinumab on Day 1.

    Reporting group title
    Canakinumab
    Reporting group description
    		 Subjects received a single dose of s.c. injection of canakinumab (4 mg/kg) on Day 1 with a maximum allowed daily dose of 300 mg. Any subject who required a dose greater than 150 mg (for subjects with body weight more than 37.5 kg) received two s.c. injections of canakinumab.

    Serious adverse events
    		 Placebo Canakinumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 43 (4.65%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Histiocytosis haematophagic
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Varicella
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Canakinumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 41 (4.88%)
    8 / 43 (18.60%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jul 2009
    The purpose of this amendment was to change the criteria for which a subject would discontinue between Days 15-29 due to declining efficacy after first demonstrating a clinical response (a minimum adapted ACR Pediatric 30 response) at Day 15.
    03 Nov 2009
    This amendment addressed the feedback of health authorities to: 1) clarify absence of fever in the secondary objectives, 2) ensure that subjects were on a stable dose of corticosteroids at least 3 days prior to baseline,and 3) clarify the transition of CACZ885G2305 placebo or canakinumab subjects to study CACZ885G2301 (EudraCT number: 2008- 005479-82) or CACZ885G2301E1 (EudraCT number: 2008-008008-42), respectively, if they did not maintain a minimum adapted ACR Pediatric 30 response after Day 15.
    04 Oct 2010
    The amendment was introduced to implement an interim analysis by an Data monitoring committee in order to assess the primary efficacy endpoint (Adapted ACR pediatric 30 at Day 15).

    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.
    An unblinded interim analysis of the primary efficacy endpoint was performed to potentially avoid additional subjects to be treated with placebo. Since the interim results were found to be positive, IDMC recommended to stop the study early.
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    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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