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    Clinical Trial Results:
    β-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line use of Canakinumab An open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA)

    Summary
    EudraCT number
    2013-004867-29
    Trial protocol
    SE   AT   ES   HU   DE   IT   NL   BE  
    Global end of trial date
    25 Apr 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Oct 2018
    First version publication date
    10 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CACZ885G2306
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111, Novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Apr 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate if at least 40% of patients in clinical remission (i.e., inactive disease for at least 24 weeks) on 4 mg/kg canakinumab (+/- concomitant NSAID only) were able to remain at a reduced canakinumab dose (2 mg/kg every 4 weeks) or prolonged canakinumab dose interval (4 mg/kg every 8 weeks) for at least 24 consecutive weeks in either treatment arm (Part II).
    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
    17 Nov 2014
    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
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Brazil: 5
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    France: 24
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    Hungary: 13
    Country: Number of subjects enrolled
    Israel: 15
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Netherlands: 8
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Russian Federation: 31
    Country: Number of subjects enrolled
    Spain: 14
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    Turkey: 8
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    182
    EEA total number of subjects
    111
    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)
    112
    Adolescents (12-17 years)
    61
    Adults (18-64 years)
    9
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    182 enrolled but 16 qualified immediately for Part II & were randomized while 166 continued in Part I & were treated with canakinumab 4 mg/kg every 4 weeks until study end unless they discontinued, or until they qualified for Part II. Of these, 40 discontinued. Most frequent reason was lack of efficacy

    Pre-assignment
    Screening details
    75 patients (Cohort 1: 56 and Cohort 2: 20) qualified for Study Part II and were randomized to receive canakinumab at either a reduced dose (n=38) or a prolonged dose interval (n=37)

    Period 1
    Period 1 title
    Part 1
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part 1 Cohort 1
    Arm description
    Participants from study CACZ885G2301E1, aged ≥ 2 to < 20 years at the time of the patient’s first dose of canakinumab, who at the time of evaluation for participation in CACZ885G2306 were being treated with canakinumab 4mg/kg and had inactive disease
    Arm type
    Experimental

    Investigational medicinal product name
    canakinumab
    Investigational medicinal product code
    ACZ885
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    dose of canakinumab allowed was 300 mg, which was administered as 2 sc 150 mg injections, once every 4 weeks.

    Arm title
    PART 1: Cohort 2
    Arm description
    Participants who at screening were aged ≥ 2 to < 20 years, had active SJIA (as per protocol), and were canakinumab treatment-naïve
    Arm type
    Experimental

    Investigational medicinal product name
    canakinumab
    Investigational medicinal product code
    ACZ885
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants from study CACZ885G2301E1, aged ≥ 2 to < 20 years at the time of the patient’s first dose of canakinumab, who at the time of evaluation for participation in CACZ885G2306 were being treated with canakinumab 4mg/kg and had inactive disease Dose interval prologation All participants received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of this study

    Number of subjects in period 1 [1]
    Part 1 Cohort 1 PART 1: Cohort 2
    Started
    68
    98
    Completed
    61
    65
    Not completed
    7
    33
         Protocol deviation
    -
    1
         New therapy for study indication
    -
    1
         Lack of efficacy
    5
    17
         Study terminated by sponsor
    -
    1
         Adverse event, non-fatal
    2
    11
         Consent withdrawn by subject
    -
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 182 enrolled but 16 qualified immediately for Part II & were randomized while 166 continued in Part I & were treated with canakinumab 4 mg/kg every 4 weeks until study end unless they discontinued, or until they qualified for Part II. Of these, 40 discontinued. Most frequent reason was lack of efficacy 75 patients (Cohort 1: 56 and Cohort 2: 20) qualified for Study Part II and were randomized to receive canakinumab at either a reduced dose (n=38) or a prolonged dose interval (n=37)
    Period 2
    Period 2 title
    Part 2
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part II Dose Reduction
    Arm description
    canakinumab 4 mg/kg every 4 weeks until study end unless discontinuation occurred, or until they qualified & entered Part II
    Arm type
    Experimental

    Investigational medicinal product name
    Canakinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 mg/kg q4 wks followed by 1 mg/kg q4 wk and drug discontinuation if appropriate.

    Arm title
    Part II Dose interval prolongation
    Arm description
    canakinumab 4 mg/kg every 4 weeks until study end unless discontinuation occurred, or until they qualified & entered Part II
    Arm type
    Experimental

    Investigational medicinal product name
    Canakinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    4 mg/kg q8 wks followed by 4 mg/kg q12 wk and drug discontinuation if appropriate.

    Number of subjects in period 2 [2]
    Part II Dose Reduction Part II Dose interval prolongation
    Started
    38
    37
    Completed
    35
    37
    Not completed
    3
    0
         Lack of efficacy
    1
    -
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    1
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 182 enrolled but 16 qualified immediately for Part II & were randomized while 166 continued in Part I & were treated with canakinumab 4 mg/kg every 4 weeks until study end unless they discontinued, or until they qualified for Part II. Of these, 40 discontinued. Most frequent reason was lack of efficacy 75 patients (Cohort 1: 56 and Cohort 2: 20) qualified for Study Part II and were randomized to receive canakinumab at either a reduced dose (n=38) or a prolonged dose interval (n=37)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1 Cohort 1
    Reporting group description
    Participants from study CACZ885G2301E1, aged ≥ 2 to < 20 years at the time of the patient’s first dose of canakinumab, who at the time of evaluation for participation in CACZ885G2306 were being treated with canakinumab 4mg/kg and had inactive disease

    Reporting group title
    PART 1: Cohort 2
    Reporting group description
    Participants who at screening were aged ≥ 2 to < 20 years, had active SJIA (as per protocol), and were canakinumab treatment-naïve

    Reporting group values
    Part 1 Cohort 1 PART 1: Cohort 2 Total
    Number of subjects
    68 98 166
    Age, Customized
    Units: Subjects
        2y - <12 y
    31 73 104
        12 y - <18 y
    30 25 55
        18 y - <65y
    7 0 7
        65 y - <85 y
    0 0 0
        >=85 years
    0 0 0
    Age Continuous
    Units: Participants
        arithmetic mean (standard deviation)
    11.8 ± 4.53 8.3 ± 4.20 -
    Sex: Female, Male
    Units: Subjects
        Female
    34 56 90
        Male
    34 42 76
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 1 1
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Black or African American
    1 1 2
        White
    66 81 147
        More than one race
    0 0 0
        Unknown
    0 1 1
        Other
    1 12 13
        Asian
    0 2 2

    End points

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    End points reporting groups
    Reporting group title
    Part 1 Cohort 1
    Reporting group description
    Participants from study CACZ885G2301E1, aged ≥ 2 to < 20 years at the time of the patient’s first dose of canakinumab, who at the time of evaluation for participation in CACZ885G2306 were being treated with canakinumab 4mg/kg and had inactive disease

    Reporting group title
    PART 1: Cohort 2
    Reporting group description
    Participants who at screening were aged ≥ 2 to < 20 years, had active SJIA (as per protocol), and were canakinumab treatment-naïve
    Reporting group title
    Part II Dose Reduction
    Reporting group description
    canakinumab 4 mg/kg every 4 weeks until study end unless discontinuation occurred, or until they qualified & entered Part II

    Reporting group title
    Part II Dose interval prolongation
    Reporting group description
    canakinumab 4 mg/kg every 4 weeks until study end unless discontinuation occurred, or until they qualified & entered Part II

    Primary: Number of participants in clinical remission on canakinumab who are able to remain at an initial reduced canakinumab dose or prolonged canakinumab dose interval.

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    End point title
    Number of participants in clinical remission on canakinumab who are able to remain at an initial reduced canakinumab dose or prolonged canakinumab dose interval.
    End point description
    End point type
    Primary
    End point timeframe
    baseline to 24 weeks
    End point values
    Part II Dose Reduction Part II Dose interval prolongation
    Number of subjects analysed
    38
    37
    Units: participants
        Able to remain on dose
    27
    31
        Not able to remain on dose
    11
    6
    Statistical analysis title
    Clinical Remission
    Comparison groups
    Part II Dose Reduction v Part II Dose interval prolongation
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.0001
    Method
    exact binomial test
    Confidence interval

    Secondary: Number and percentage of patients with adverse events as a measure of long-term safety and tolerability of canakinumab - PART 1

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    End point title
    Number and percentage of patients with adverse events as a measure of long-term safety and tolerability of canakinumab - PART 1
    End point description
    AEs, Deaths, other serious adverse events or discontinuations due to AE, Part I (Safety set)
    End point type
    Secondary
    End point timeframe
    During study parts I and II. The estimated study duration is not more than 216 weeks (with an average expected duration of 108 weeks).
    End point values
    Part 1 Cohort 1 PART 1: Cohort 2
    Number of subjects analysed
    68
    98
    Units: number of participants
        Number of patients with at least one AE|
    57
    91
        Number of patients with death|
    0
    0
        Number of patients with at least one SAE|
    10
    23
    No statistical analyses for this end point

    Secondary: Number and percentage of patients with adverse events as a measure of long-term safety and tolerability of canakinumab - PART 2

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    End point title
    Number and percentage of patients with adverse events as a measure of long-term safety and tolerability of canakinumab - PART 2
    End point description
    AEs, Deaths, other serious adverse events or discontinuations due to AE, Part II (Safety set)
    End point type
    Secondary
    End point timeframe
    During study parts I and II, estimated study duration was not more than 216 weeks (with an average duration of 108 weeks).
    End point values
    Part II Dose Reduction Part II Dose interval prolongation
    Number of subjects analysed
    38
    37
    Units: number of participants
        Number of patients with at least one AE|
    38
    34
        Number of patients with death|
    0
    0
        Number of patients with at least one SAE|
    4
    1
    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
    21.0
    Reporting groups
    Reporting group title
    Any ACZ Treatment Group
    Reporting group description
    Any ACZ Treatment Group

    Serious adverse events
    Any ACZ Treatment Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 182 (20.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Pericarditis
         subjects affected / exposed
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Alveolar proteinosis
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Histiocytosis haematophagic
         subjects affected / exposed
    5 / 182 (2.75%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Idiopathic intracranial hypertension
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Eye swelling
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lichen planus
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash pruritic
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash scarlatiniform
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Juvenile idiopathic arthritis
         subjects affected / exposed
    8 / 182 (4.40%)
         occurrences causally related to treatment / all
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Still's disease
         subjects affected / exposed
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Otitis media
         subjects affected / exposed
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Any ACZ Treatment Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    164 / 182 (90.11%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    34 / 182 (18.68%)
         occurrences all number
    53
    Oropharyngeal pain
         subjects affected / exposed
    24 / 182 (13.19%)
         occurrences all number
    48
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    13 / 182 (7.14%)
         occurrences all number
    15
    Nervous system disorders
    Headache
         subjects affected / exposed
    36 / 182 (19.78%)
         occurrences all number
    81
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    13 / 182 (7.14%)
         occurrences all number
    27
    Pyrexia
         subjects affected / exposed
    51 / 182 (28.02%)
         occurrences all number
    101
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    24 / 182 (13.19%)
         occurrences all number
    34
    Abdominal pain upper
         subjects affected / exposed
    16 / 182 (8.79%)
         occurrences all number
    25
    Diarrhoea
         subjects affected / exposed
    23 / 182 (12.64%)
         occurrences all number
    49
    Nausea
         subjects affected / exposed
    17 / 182 (9.34%)
         occurrences all number
    25
    Vomiting
         subjects affected / exposed
    20 / 182 (10.99%)
         occurrences all number
    26
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    18 / 182 (9.89%)
         occurrences all number
    31
    Pruritus
         subjects affected / exposed
    12 / 182 (6.59%)
         occurrences all number
    15
    Rash
         subjects affected / exposed
    23 / 182 (12.64%)
         occurrences all number
    41
    Urticaria
         subjects affected / exposed
    10 / 182 (5.49%)
         occurrences all number
    17
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    38 / 182 (20.88%)
         occurrences all number
    73
    Back pain
         subjects affected / exposed
    15 / 182 (8.24%)
         occurrences all number
    22
    Juvenile idiopathic arthritis
         subjects affected / exposed
    33 / 182 (18.13%)
         occurrences all number
    39
    Pain in extremity
         subjects affected / exposed
    18 / 182 (9.89%)
         occurrences all number
    33
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    14 / 182 (7.69%)
         occurrences all number
    19
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    16 / 182 (8.79%)
         occurrences all number
    18
    Gastroenteritis
         subjects affected / exposed
    20 / 182 (10.99%)
         occurrences all number
    26
    Influenza
         subjects affected / exposed
    24 / 182 (13.19%)
         occurrences all number
    34
    Nasopharyngitis
         subjects affected / exposed
    48 / 182 (26.37%)
         occurrences all number
    105
    Pharyngitis
         subjects affected / exposed
    25 / 182 (13.74%)
         occurrences all number
    35
    Respiratory tract infection
         subjects affected / exposed
    20 / 182 (10.99%)
         occurrences all number
    28
    Rhinitis
         subjects affected / exposed
    29 / 182 (15.93%)
         occurrences all number
    45
    Tonsillitis
         subjects affected / exposed
    15 / 182 (8.24%)
         occurrences all number
    25
    Upper respiratory tract infection
         subjects affected / exposed
    34 / 182 (18.68%)
         occurrences all number
    62
    Viral infection
         subjects affected / exposed
    17 / 182 (9.34%)
         occurrences all number
    26

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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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