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    Clinical Trial Results:
    A Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects with Enthesitis Related Arthritis

    Summary
    EudraCT number
    2009-017938-46
    Trial protocol
    DE   FR   ES   IE   SE   IT   Outside EU/EEA  
    Global end of trial date
    30 Dec 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Jul 2016
    First version publication date
    15 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M11-328
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01166282
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    1 North Waukegan Road, North Chicago, IL, United States, 60064
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    Jaclyn Anderson, DO, MS, AbbVie, jaclyn.anderson@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000366-PIP01-08
    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
    30 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with Enthesitis Related Arthritis (ERA).
    Protection of trial subjects
    Subject and/or parent or legal guardian read and understood the information provided about the study and gave written informed consent; pediatric subjects provided written verbal and/or informed assent. If a subject became of legal age (according to local regulations) during the course of the study, then that subject signed the informed consent form as well.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Sep 2010
    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
    Poland: 8
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Mexico: 9
    Country: Number of subjects enrolled
    Switzerland: 4
    Country: Number of subjects enrolled
    Canada: 2
    Worldwide total number of subjects
    46
    EEA total number of subjects
    31
    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)
    15
    Adolescents (12-17 years)
    30
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study included a 30-day screening period.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Double-blind Placebo EOW
    Arm description
    Placebo for adalimumab every other week (eow) for 12 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    placebo for adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for adalimumab solution for subcutaneous injection.

    Arm title
    Double-blind Adalimumab EOW
    Arm description
    Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    adalimumab
    Investigational medicinal product code
    Other name
    ABT-D2E7, Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab solution for subcutaneous injection.

    Number of subjects in period 1
    Double-blind Placebo EOW Double-blind Adalimumab EOW
    Started
    15
    31
    Completed
    15
    31
    Period 2
    Period 2 title
    Open-label Period
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Open-label Adalimumab EOW
    Arm description
    Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    adalimumab
    Investigational medicinal product code
    Other name
    ABT-D2E7, Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab solution for subcutaneous injection.

    Number of subjects in period 2
    Open-label Adalimumab EOW
    Started
    46
    Completed
    29
    Not completed
    17
         Adverse event
    6
         Remission
    4
         Withdrawal by subject
    4
         Lack of efficacy
    2
         Irregular compliance
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Double-blind Placebo EOW
    Reporting group description
    Placebo for adalimumab every other week (eow) for 12 weeks.

    Reporting group title
    Double-blind Adalimumab EOW
    Reporting group description
    Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.

    Reporting group values
    Double-blind Placebo EOW Double-blind Adalimumab EOW Total
    Number of subjects
    15 31 46
    Age categorical
    Units: Subjects
    Age continuous
    Intent-to-treat (ITT) population: All randomized subjects who received at least 1 dose of study drug.
    Units: years
        arithmetic mean (standard deviation)
    11.9 ( 2.85 ) 13.4 ( 2.86 ) -
    Gender categorical
    ITT population
    Units: Subjects
        Female
    6 9 15
        Male
    9 22 31

    End points

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    End points reporting groups
    Reporting group title
    Double-blind Placebo EOW
    Reporting group description
    Placebo for adalimumab every other week (eow) for 12 weeks.

    Reporting group title
    Double-blind Adalimumab EOW
    Reporting group description
    Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
    Reporting group title
    Open-label Adalimumab EOW
    Reporting group description
    Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks.

    Subject analysis set title
    Any Adalimumab
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All subjects in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.

    Primary: Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12

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    End point title
    Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12
    End point description
    A joint assessment was recorded at all study visits to assess the number of active joints, with a total possible score of 0 (no active joints) to 72 (all active joints). A total of 72 joints were assessed for swelling not due to deformity or joints with loss of motion (LOM) plus pain and/or tenderness. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Last Observation Carried Forward (LOCF) was used for missing data.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    Double-blind Placebo EOW Double-blind Adalimumab EOW
    Number of subjects analysed
    15 [1]
    31 [2]
    Units: percent change
        arithmetic mean (standard deviation)
    -11.6 ( 100.5 )
    -62.6 ( 59.53 )
    Notes
    [1] - ITT population
    [2] - ITT population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Double-blind Placebo EOW v Double-blind Adalimumab EOW
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.039
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -51.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -99.69
         upper limit
    -2.66

    Secondary: Number of Sites of Enthesitis: Change From Baseline to Week 12

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    End point title
    Number of Sites of Enthesitis: Change From Baseline to Week 12
    End point description
    The presence of enthesitis was assessed by pressure at 35 anatomical locations. Enthesitis was classifed as either present or absent. Scores range from 0 to 35, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Double-blind Placebo EOW Double-blind Adalimumab EOW
    Number of subjects analysed
    15 [3]
    31 [4]
    Units: sites of enthesitis
    arithmetic mean (standard deviation)
        Baseline
    7.8 ( 7.49 )
    8.3 ( 8.89 )
        Week 12
    5.1 ( 8.92 )
    3.9 ( 6.6 )
        Change from Baseline to Week 12
    -2.7 ( 4.98 )
    -4.4 ( 6.2 )
    Notes
    [3] - ITT population
    [4] - ITT population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Double-blind Placebo EOW v Double-blind Adalimumab EOW
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.382
    Method
    1-way ANOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.32
         upper limit
    2.08

    Secondary: Tender Joint Count (TJC72): Change From Baseline to Week 12

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    End point title
    Tender Joint Count (TJC72): Change From Baseline to Week 12
    End point description
    Seventy-two joints were assessed by pressure on physical examination. Joint tenderness was classified as either present or absent. Scores range from 0 to 72, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Double-blind Placebo EOW Double-blind Adalimumab EOW
    Number of subjects analysed
    15 [5]
    31 [6]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    11.9 ( 9.34 )
    13.4 ( 10.49 )
        Week 12
    7.5 ( 8.06 )
    5.5 ( 8.77 )
        Change from Baseline to Week 12
    -4.5 ( 8.97 )
    -7.9 ( 8.25 )
    Notes
    [5] - ITT population
    [6] - ITT population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Double-blind Placebo EOW v Double-blind Adalimumab EOW
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.209
    Method
    1-way ANOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.78
         upper limit
    1.97

    Secondary: Swollen Joint Count (SJC68): Change From Baseline to Week 12

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    End point title
    Swollen Joint Count (SJC68): Change From Baseline to Week 12
    End point description
    Sixty-eight joints were assessed by physical examination. Joint swelling was classified as present or absent. Scores range from 0 to 68, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Double-blind Placebo EOW Double-blind Adalimumab EOW
    Number of subjects analysed
    15 [7]
    31 [8]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    5.2 ( 3.69 )
    6.7 ( 7.3 )
        Week 12
    2.8 ( 2.83 )
    3.2 ( 7.27 )
        Change from Baseline to Week 12
    -2.4 ( 4.66 )
    -3.5 ( 5.61 )
    Notes
    [7] - ITT population
    [8] - ITT population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Double-blind Placebo EOW v Double-blind Adalimumab EOW
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.509
    Method
    1-way ANOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.49
         upper limit
    2.26

    Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30)

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    End point title
    Percentage of Subjects Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30)
    End point description
    The ACR Pedi30 response is defined as ≥30% improvement in at least 3 of 6 juvenile rheumatoid arthritis (JRA) core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of subject's disease activity, Parent's Global Assessment of subject's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation (NRI) was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Double-blind Placebo EOW Double-blind Adalimumab EOW
    Number of subjects analysed
    15 [9]
    31 [10]
    Units: percentage of subjects
        number (not applicable)
    60
    71
    Notes
    [9] - ITT population
    [10] - ITT population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Double-blind Placebo EOW v Double-blind Adalimumab EOW
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.514
    Method
    Fisher exact
    Parameter type
    Mean difference (final values)
    Point estimate
    11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -18.5
         upper limit
    40.5

    Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50)

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    End point title
    Percentage of Subjects Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50)
    End point description
    The ACR Pedi50 response is defined as ≥50% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of subject's disease activity, Parent's Global Assessment of subject's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. NRI was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Double-blind Placebo EOW Double-blind Adalimumab EOW
    Number of subjects analysed
    15 [11]
    31 [12]
    Units: percentage of subjects
        number (not applicable)
    40
    67.7
    Notes
    [11] - ITT population
    [12] - ITT population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Double-blind Placebo EOW v Double-blind Adalimumab EOW
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.111
    Method
    Fisher exact
    Parameter type
    Mean difference (final values)
    Point estimate
    27.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2
         upper limit
    57.5

    Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70)

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    End point title
    Percentage of Subjects Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70)
    End point description
    The ACR Pedi70 response is defined as ≥70% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of subject's disease activity, Parent's Global Assessment of subject's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation NRI was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Double-blind Placebo EOW Double-blind Adalimumab EOW
    Number of subjects analysed
    15 [13]
    31 [14]
    Units: percentage of subjects
        number (not applicable)
    20
    54.8
    Notes
    [13] - ITT population
    [14] - ITT population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Double-blind Placebo EOW v Double-blind Adalimumab EOW
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.031
    Method
    Fisher exact
    Parameter type
    Mean difference (final values)
    Point estimate
    34.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.1
         upper limit
    61.6

    Secondary: Number of Subjects With Adverse Events (AEs)

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    End point title
    Number of Subjects With Adverse Events (AEs)
    End point description
    An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either probably related to study drug, possibly related to study drug, probably not related, or not related to study drug. For more details on adverse events please see the AE section below.
    End point type
    Secondary
    End point timeframe
    Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks)
    End point values
    Double-blind Placebo EOW Double-blind Adalimumab EOW Any Adalimumab
    Number of subjects analysed
    15 [15]
    31 [16]
    46
    Units: subjects
        Any TEAE
    8
    21
    46
        TEAEs at least possibly related to study drug
    4
    9
    29
        Any severe TEAE
    0
    0
    7
        TESAE
    0
    1
    10
        Any TEAE Leading to Discontinuation of Study
    0
    0
    7
        Death
    0
    0
    0
    Notes
    [15] - Safety population: All randomized subjects who received at least 1 dose of study drug
    [16] - Safety population: All randomized subjects who received at least 1 dose of study drug
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
    Adverse event reporting additional description
    A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind [DB] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Double-blind Placebo EOW
    Reporting group description
    Placebo for adalimumab every other week (eow) for 12 weeks.

    Reporting group title
    Double-blind Adalimumab EOW
    Reporting group description
    Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.

    Reporting group title
    Any Adalimumab
    Reporting group description
    All subjects in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.

    Serious adverse events
    Double-blind Placebo EOW Double-blind Adalimumab EOW Any Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    10 / 46 (21.74%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Tuberculin test positive
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Burns third degree
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Diffuse vasculitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Joint instability
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Juvenile idiopathic arthritis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Double-blind Placebo EOW Double-blind Adalimumab EOW Any Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 15 (53.33%)
    21 / 31 (67.74%)
    46 / 46 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Prehypertension
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Raynaud's phenomenon
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Vasculitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    2 / 46 (4.35%)
         occurrences all number
    0
    1
    2
    Fatigue
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Inflammation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Injection site erythema
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    3 / 46 (6.52%)
         occurrences all number
    0
    1
    4
    Injection site pain
         subjects affected / exposed
    1 / 15 (6.67%)
    3 / 31 (9.68%)
    5 / 46 (10.87%)
         occurrences all number
    1
    3
    6
    Injection site pruritus
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    2
    Injection site urticaria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    1
    Pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    2
    Peripheral swelling
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    6 / 46 (13.04%)
         occurrences all number
    0
    0
    7
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Penis disorder
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Scrotal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Varicocele
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Asthma
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    4 / 46 (8.70%)
         occurrences all number
    0
    0
    4
    Epistaxis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    3
    Rhinitis allergic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    3
    Tonsillar inflammation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    2
    Vasomotor rhinitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Depression
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    2 / 46 (4.35%)
         occurrences all number
    0
    1
    3
    Tic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 15 (0.00%)
    3 / 31 (9.68%)
    5 / 46 (10.87%)
         occurrences all number
    0
    3
    5
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    2 / 46 (4.35%)
         occurrences all number
    0
    1
    2
    Blood pressure increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Bone density increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    3 / 46 (6.52%)
         occurrences all number
    0
    1
    3
    Transaminases increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 31 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    0
    contusion
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Craniocerebral injury
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Fall
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Foot fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Hand fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Joint dislocation
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    1
    0
    1
    Joint injury
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    3
    Laceration
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    4 / 46 (8.70%)
         occurrences all number
    0
    0
    4
    Limb injury
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    1
    Lip injury
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Post-traumatic pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    3
    Radius fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Rib fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    2
    Road traffic accident
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Skeletal injury
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Tooth fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Traumatic haematoma
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Traumatic haemorrhage
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    1
    Wrist fracture
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 31 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    2 / 46 (4.35%)
         occurrences all number
    0
    1
    2
    Headache
         subjects affected / exposed
    0 / 15 (0.00%)
    3 / 31 (9.68%)
    10 / 46 (21.74%)
         occurrences all number
    0
    3
    16
    Migraine
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    1
    Paraesthesia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Syncope
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 31 (6.45%)
    4 / 46 (8.70%)
         occurrences all number
    0
    2
    4
    Tremor
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    3
    Blood and lymphatic system disorders
    Bruise
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    2 / 46 (4.35%)
         occurrences all number
    0
    1
    2
    Vertigo
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    2
    Eye disorders
    Astigmatism
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Cataract
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Dry eye
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    2 / 46 (4.35%)
         occurrences all number
    0
    2
    3
    Vision blurred
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    2
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    6 / 46 (13.04%)
         occurrences all number
    0
    1
    9
    Abdominal pain upper
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 31 (6.45%)
    2 / 46 (4.35%)
         occurrences all number
    1
    2
    3
    Anal fissure
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    4 / 46 (8.70%)
         occurrences all number
    0
    0
    4
    Diarrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    8 / 46 (17.39%)
         occurrences all number
    0
    1
    11
    Food poisoning
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    1
    Nausea
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 31 (6.45%)
    5 / 46 (10.87%)
         occurrences all number
    1
    2
    6
    Odynophagia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    4 / 46 (8.70%)
         occurrences all number
    0
    1
    4
    Hepatobiliary disorders
    Hepatocellular injury
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Dermatitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 31 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 31 (0.00%)
    4 / 46 (8.70%)
         occurrences all number
    1
    0
    10
    Eczema
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Erythema
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Keratosis pilaris
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Pityriasis rosea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Psoriasis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Pustular psoriasis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Rash erythematous
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Skin exfoliation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Solar dermatitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Bladder spasm
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Dysuria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    IgA nephropathy
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Leukocyturia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Back pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    2 / 46 (4.35%)
         occurrences all number
    0
    1
    2
    Foot deformity
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Growing pains
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Juvenile idiopathic arthritis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 31 (0.00%)
    6 / 46 (13.04%)
         occurrences all number
    2
    0
    9
    Muscle spasms
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    3
    Osteochondrosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Synovial cyst
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Acarodermatitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 31 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    0
    Acute sinusitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    5 / 46 (10.87%)
         occurrences all number
    0
    0
    6
    Bronchopneumonia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    1
    Candida infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    2
    Cellulitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    4
    Cystitis
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 31 (3.23%)
    1 / 46 (2.17%)
         occurrences all number
    1
    1
    1
    Ear infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    6
    Folliculitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 31 (6.45%)
    8 / 46 (17.39%)
         occurrences all number
    0
    2
    12
    Gastrointestinal infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Herpes zoster
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Influenza
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    3
    Laryngitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    4
    Latent tuberculosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Localised infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 31 (0.00%)
    11 / 46 (23.91%)
         occurrences all number
    1
    0
    19
    Oral herpes
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    4 / 46 (8.70%)
         occurrences all number
    0
    0
    17
    Orchitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    2
    Otitis media
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    4 / 46 (8.70%)
         occurrences all number
    0
    0
    7
    Otitis media acute
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    4
    Otitis media chronic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Paronychia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 31 (3.23%)
    3 / 46 (6.52%)
         occurrences all number
    1
    1
    3
    Pharyngitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    7 / 46 (15.22%)
         occurrences all number
    0
    1
    16
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    7 / 46 (15.22%)
         occurrences all number
    0
    0
    11
    Pilonidal cyst
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Rash pustular
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    4
    Rhinitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    3
    Rotavirus infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Scarlet fever
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    5 / 46 (10.87%)
         occurrences all number
    0
    1
    5
    Subcutaneous abscess
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Tinea infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Tinea pedis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Tonsillitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    4 / 46 (8.70%)
         occurrences all number
    0
    0
    4
    Tonsillitis bacterial
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Tracheitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 15 (13.33%)
    3 / 31 (9.68%)
    16 / 46 (34.78%)
         occurrences all number
    3
    3
    38
    Urinary tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    4
    Varicella
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 31 (3.23%)
    2 / 46 (4.35%)
         occurrences all number
    0
    1
    2
    Viral infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    3
    Viral tonsillitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    2 / 46 (4.35%)
         occurrences all number
    0
    0
    2
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    Metabolic syndrome
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 31 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jul 2010
    The purpose of this amendment was to update the inclusion (birth control timing after last dose of study drug, chest x-ray [CXR] requirements) and exclusion criteria (hepatitis B virus [HBV] screening), update according to new maximum dose for sulfasalazine (3 g/day), and clarify study procedures and timing.
    18 Jan 2011
    The purpose of this amendment was to update inclusion criteria (number of active joints and evidence of enthesitis, and CXR dependent on tuberculosis test results) and exclusion criteria (update information pertaining to HBV) testing, clarify time points for assessment of high sensitivity C-reactive protein (hs CRP), and clarify statistical analyses.
    02 Jul 2013
    The purpose of this amendment was to add collection requirements for events of malignancy, add prohibited biologic therapies, and update analysis population definition.
    10 Oct 2013
    The purpose of this amendment was to extend the study by 1 year (48 weeks).

    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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    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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