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    Clinical Trial Results:
    A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs)

    Summary
    EudraCT number
    2012-003195-39
    Trial protocol
    DE   BE   ES   IT   Outside EU/EEA   FR  
    Global end of trial date

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Jul 2019
    First version publication date
    12 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IM101-301
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01844518
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Route 206 and Province Line Road, Princeton, United States, NJ 08540-4000
    Public contact
    Study Director - Bristol-Myers Squibb, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Scientific contact
    Study Director - Bristol-Myers Squibb, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000118-PIP02-10
    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
    Interim
    Date of interim/final analysis
    02 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to estimate abatacept steady-state trough serum concentrations (Cminss) at Day 113 in children and adolescents with Polyarticular Juvenile Idiopathic Arthritis (pJIA) aged 6 through 17 years.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Aug 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 12
    Country: Number of subjects enrolled
    Brazil: 6
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Germany: 73
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Mexico: 25
    Country: Number of subjects enrolled
    Peru: 10
    Country: Number of subjects enrolled
    Russian Federation: 5
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    South Africa: 19
    Country: Number of subjects enrolled
    United States: 26
    Country: Number of subjects enrolled
    Argentina: 26
    Worldwide total number of subjects
    234
    EEA total number of subjects
    117
    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)
    128
    Adolescents (12-17 years)
    106
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Total 234 participants were enrolled, 220 randomized as 14 participants were screen failures. 219 participants were treated as one participant discontinued prior to being dosed, hence not included in analysis.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SC Abatacept Ages 6 to 17
    Arm description
    Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (<) 25 kilogram (kg) (50 milligram [mg] in 0.4 milliliter [mL] PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
    Arm type
    Experimental

    Investigational medicinal product name
    Abatacept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Abatacept was administered once weekly according to the following weight-tiered dosing regimen: 10 to l< 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).

    Arm title
    SC Abatacept Ages 2 to 5
    Arm description
    All weight-tiered dosing groups receiving SC abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
    Arm type
    Experimental

    Investigational medicinal product name
    Abatacept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Abatacept was administered once weekly according to the following weight-tiered dosing regimen: 10 to l< 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).

    Number of subjects in period 1 [1]
    SC Abatacept Ages 6 to 17 SC Abatacept Ages 2 to 5
    Started
    173
    46
    Completed
    132
    39
    Not completed
    41
    7
         Poor/Non-Compliance
    1
    -
         Withdrawal of Consent
    9
    -
         Lack of efficacy
    17
    5
         Pregnancy
    1
    -
         No Longer Met Study Criteria
    2
    -
         Participant requested to discontinue
    4
    1
         Adverse event, non-fatal
    7
    1
    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: A total of 234 participants were enrolled, of whom 220 were randomized as 14 participants were screen failures. Of these, 219 participants were treated as one participant discontinued prior to being dosed and was not included in analysis.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SC Abatacept Ages 6 to 17
    Reporting group description
    Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (<) 25 kilogram (kg) (50 milligram [mg] in 0.4 milliliter [mL] PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).

    Reporting group title
    SC Abatacept Ages 2 to 5
    Reporting group description
    All weight-tiered dosing groups receiving SC abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).

    Reporting group values
    SC Abatacept Ages 6 to 17 SC Abatacept Ages 2 to 5 Total
    Number of subjects
    173 46 219
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    74 46 120
        Adolescents (12-17 years)
    99 0 99
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Gender, Male/Female
    Units: Subjects
        Female
    136 28 164
        Male
    37 18 55
    Race (NIH/OMB)
    Units: Subjects
        Black or African American
    14 1 15
        White
    144 44 188
        Other
    15 1 16

    End points

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    End points reporting groups
    Reporting group title
    SC Abatacept Ages 6 to 17
    Reporting group description
    Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (<) 25 kilogram (kg) (50 milligram [mg] in 0.4 milliliter [mL] PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).

    Reporting group title
    SC Abatacept Ages 2 to 5
    Reporting group description
    All weight-tiered dosing groups receiving SC abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).

    Subject analysis set title
    10 to <25 kg Dosing Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Weight-tiered dosing group received 50 mg SC abatacept administered to 6 to 17 year old participants by PFS once weekly.

    Subject analysis set title
    25 to <50 kg Dosing Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Weight-tiered dosing group received 87.5 mg SC abatacept administered to 6 to 17 year old participants by PFS once weekly.

    Subject analysis set title
    >=50 kg Dosing Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Weight-tiered dosing group received 125 mg SC abatacept administered to 6 to 17 year old participants by PFS once weekly.

    Primary: Abatacept Trough Concentration (Cmin) in Subjects Ages 6 to 17

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    End point title
    Abatacept Trough Concentration (Cmin) in Subjects Ages 6 to 17 [1] [2]
    End point description
    Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable subjects. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be >= 10 µg/mL. Evaluable pharmacokinetic (PK) analysis population at Day 113 included all the subjects whose PK measurements were collected in the 4 to 10 day window after the previous SC dose and prior to Day 113 dose and if 7 consecutive weekly SC abatacept injections of the same dose were administrated prior to Day 113. Here 'N' 'number of subjects analyzed' signifies subjects who were evaluable for this time point. As per planned analysis results were reported for this arm only.
    End point type
    Primary
    End point timeframe
    Day 113
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only summary statistics were planned for this endpoint.
    End point values
    SC Abatacept Ages 6 to 17
    Number of subjects analysed
    131
    Units: µg/mL
    geometric mean (geometric coefficient of variation)
        Cmin
    39.7 ± 35
    No statistical analyses for this end point

    Secondary: Percentage of Subjects (ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)

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    End point title
    Percentage of Subjects (ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30) [3]
    End point description
    ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables [number of active joints, number of joints with limitation of motion (LOM), physician global assessment of disease activity, parent global assessment of patient overall well-being, functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ) and C-reactive protein (CRP)] and ≥30% worsening in not more than 1 of the remaining 6 JIA core set variables. All treated population included all participants who received at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    Day 113
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only summary statistics were planned for this endpoint.
    End point values
    SC Abatacept Ages 6 to 17
    Number of subjects analysed
    173
    Units: Percentage of subjects
    number (confidence interval 95%)
        ACRp30
    80.9 (75.1 to 86.8)
    No statistical analyses for this end point

    Secondary: Abatacept Trough Concentration (Cmin) in Subjects Ages 6 to 17 by Weight Tier Dose

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    End point title
    Abatacept Trough Concentration (Cmin) in Subjects Ages 6 to 17 by Weight Tier Dose
    End point description
    Evaluation of the trough concentration of abatacept (reported as geometric mean of Cmin) in all pk-evaluable subjects at Days 57, 85 and 113 during a 4-month treatment period. Weight-tiered dosing groups are based on the first dose the subject received. Cmin is reported in microgram per milliliter (µg/mL). Evaluable PK analysis population at Days 57 or 85 included all the subjects whose PK measurements were collected in the 4 to 10 day window after the previous SC dose and prior to the Day 57 dose or Day 85 dose, respectively; and for Day 113 included all the subjects whose PK measurements were collected in the 4 to 10 day window after the previous SC dose and prior to Day 113 dose and if 7 consecutive weekly SC abatacept injections of the same dose were administrated prior to Day 113. Here 'n' 'number analyzed' signifies subjects who were evaluable for each time point. As per planned analysis results were reported for this arm only.
    End point type
    Secondary
    End point timeframe
    Days 57, 85 and 113
    End point values
    10 to <25 kg Dosing Group 25 to <50 kg Dosing Group >=50 kg Dosing Group
    Number of subjects analysed
    18
    74
    81
    Units: µg/mL
    geometric mean (geometric coefficient of variation)
        Day 57 (n =14, 69, 75)
    29.5 ± 32
    36.2 ± 35
    33.3 ± 33
        Day 85 (n= 17, 64, 65)
    27.7 ± 38
    42.5 ± 32
    36.0 ± 40
        Day 113 (n= 14, 62, 59)
    34.3 ± 39
    44.2 ± 34
    36.3 ± 31
    No statistical analyses for this end point

    Secondary: Number of Subjects (ages 6 to 17) with Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short Term Period

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    End point title
    Number of Subjects (ages 6 to 17) with Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short Term Period [4]
    End point description
    An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which results in death, is life threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect. All treated population included all subjects who received at least one dose of study medication. As per planned analysis results were reported for this arm only.
    End point type
    Secondary
    End point timeframe
    Day 1 up to 56 days post last dose in short-term period or first dose in long-term period whichever is first
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only summary statistics were planned for this endpoint.
    End point values
    SC Abatacept Ages 6 to 17
    Number of subjects analysed
    173
    Units: Subjects
        Deaths
    0
        SAEs
    5
        Drug-Related SAEs
    1
        Discontinuation due to SAEs
    2
        Drug-Related AEs
    36
        Discontinuation due to AEs
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period

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    End point title
    Number of Subjects with Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period
    End point description
    An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which results in death, is life threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect. All treated population included all subjects who received at least one dose of study medication. As per planned analysis results were reported for this arm only.
    End point type
    Secondary
    End point timeframe
    Day 1 up to 56 days after last dose ( up to 2 years)
    End point values
    SC Abatacept Ages 6 to 17 SC Abatacept Ages 2 to 5
    Number of subjects analysed
    173
    46
    Units: Subjects
        Deaths
    0
    0
        SAEs
    14
    5
        Drug-Related SAEs
    1
    2
        Discontinuation Due to SAEs
    4
    0
        Treatment-Related AEs
    54
    30
        Discontinuation Due to AEs
    4
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects (ages 6 to 17) with Positive Immunogenicity Response in the Short Term Period

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    End point title
    Number of Subjects (ages 6 to 17) with Positive Immunogenicity Response in the Short Term Period [5]
    End point description
    Overall number of subjects with either a positive immunogenicity response for ‘CTLA4 and possibly Ig’ or ‘Ig and/or Junction Region’ relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose for those subjects who discontinued from the ST period or completed the ST study without continuing abatacept treatment. Immunogenicity analysis population: who received at least one dose of study medication and who had at least 1 immunogenicity result reported after start of study medication. Here 'N' number of participants analyzed signifies participants who were evaluable for this outcome measure. As per planned analysis results were reported for this arm only.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to start of LT (for those continuing in long-term) or up to 168 days after the lost dose of study medication in the ST period (for those not entering in the long-term)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only summary statistics were planned for this endpoint.
    End point values
    SC Abatacept Ages 6 to 17
    Number of subjects analysed
    171
    Units: Subjects
        # of subjects (6-17 yr) with +ve Imm. Resp. in ST
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects with Positive Immunogenicity Response in the Cumulative Period

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    End point title
    Number of Subjects with Positive Immunogenicity Response in the Cumulative Period
    End point description
    Overall number of subjects with either a positive immunogenicity response for ‘CTLA4 and possibly Ig’ or ‘Ig and/or Junction Region’ relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose regardless of whether they discontinued early in the ST or LTE period, elected not to enter the LTE period, or completed both ST and LTE periods. Immunogenicity analysis population included all subjects who received at least one dose of study medication and who had at least 1 immunogenicity result reported after start of study medication.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    SC Abatacept Ages 6 to 17 SC Abatacept Ages 2 to 5
    Number of subjects analysed
    172
    46
    Units: Subjects
        # of Subjects with +ve Imm. Resp in Cum. Period
    8
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to 56 days after last dose ( up to 2 years)
    Adverse event reporting additional description
    Safety population included all treated population who received at least one dose of study medication.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    SC Abatacept Ages 6 to 17
    Reporting group description
    Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (<) 25 kilogram (kg) (50 milligram [mg] in 0.4 milliliter [mL] PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).

    Reporting group title
    SC Abatacept Ages 2 to 5
    Reporting group description
    All weight-tiered dosing groups receiving SC abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).

    Serious adverse events
    SC Abatacept Ages 6 to 17 SC Abatacept Ages 2 to 5
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 173 (8.09%)
    5 / 46 (10.87%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian germ cell teratoma stage iii
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autonomic nervous system imbalance
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Synovitis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon disorder
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypomagnesaemia
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    SC Abatacept Ages 6 to 17 SC Abatacept Ages 2 to 5
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    116 / 173 (67.05%)
    42 / 46 (91.30%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 173 (2.89%)
    3 / 46 (6.52%)
         occurrences all number
    5
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 173 (4.62%)
    9 / 46 (19.57%)
         occurrences all number
    9
    12
    Nervous system disorders
    Headache
         subjects affected / exposed
    24 / 173 (13.87%)
    6 / 46 (13.04%)
         occurrences all number
    35
    11
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    21 / 173 (12.14%)
    15 / 46 (32.61%)
         occurrences all number
    35
    24
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    20 / 173 (11.56%)
    6 / 46 (13.04%)
         occurrences all number
    26
    7
    Vomiting
         subjects affected / exposed
    11 / 173 (6.36%)
    6 / 46 (13.04%)
         occurrences all number
    18
    9
    Constipation
         subjects affected / exposed
    1 / 173 (0.58%)
    3 / 46 (6.52%)
         occurrences all number
    1
    5
    Diarrhoea
         subjects affected / exposed
    5 / 173 (2.89%)
    3 / 46 (6.52%)
         occurrences all number
    5
    3
    Abdominal pain
         subjects affected / exposed
    13 / 173 (7.51%)
    4 / 46 (8.70%)
         occurrences all number
    16
    5
    Aphthous ulcer
         subjects affected / exposed
    3 / 173 (1.73%)
    3 / 46 (6.52%)
         occurrences all number
    7
    3
    Dental caries
         subjects affected / exposed
    7 / 173 (4.05%)
    4 / 46 (8.70%)
         occurrences all number
    11
    9
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    52 / 173 (30.06%)
    17 / 46 (36.96%)
         occurrences all number
    86
    37
    Rhinitis
         subjects affected / exposed
    10 / 173 (5.78%)
    8 / 46 (17.39%)
         occurrences all number
    16
    14
    Pharyngitis
         subjects affected / exposed
    11 / 173 (6.36%)
    6 / 46 (13.04%)
         occurrences all number
    13
    7
    Tonsillitis
         subjects affected / exposed
    6 / 173 (3.47%)
    4 / 46 (8.70%)
         occurrences all number
    9
    7
    Gastroenteritis
         subjects affected / exposed
    15 / 173 (8.67%)
    6 / 46 (13.04%)
         occurrences all number
    17
    6
    Bronchitis
         subjects affected / exposed
    6 / 173 (3.47%)
    4 / 46 (8.70%)
         occurrences all number
    9
    5
    Influenza
         subjects affected / exposed
    10 / 173 (5.78%)
    3 / 46 (6.52%)
         occurrences all number
    18
    4
    Conjunctivitis
         subjects affected / exposed
    7 / 173 (4.05%)
    6 / 46 (13.04%)
         occurrences all number
    8
    6
    Varicella
         subjects affected / exposed
    0 / 173 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    3
    Scarlet fever
         subjects affected / exposed
    0 / 173 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    3
    Molluscum contagiosum
         subjects affected / exposed
    2 / 173 (1.16%)
    3 / 46 (6.52%)
         occurrences all number
    2
    3
    Upper respiratory tract infection
         subjects affected / exposed
    32 / 173 (18.50%)
    10 / 46 (21.74%)
         occurrences all number
    62
    15
    Urinary tract infection
         subjects affected / exposed
    10 / 173 (5.78%)
    1 / 46 (2.17%)
         occurrences all number
    13
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Feb 2013
    The main reason of this amendment was to eliminate two questionnaires, the requirement of varicella vaccination prior to the enrollment in the study, the modification of the acceptable methods of contraception, and additional minor changes to the protocol.
    14 Feb 2014
    The main reason of this amendment was to amend inclusion and exclusion criteria, revise pregnancy testing requirements, and to make additional minor changes to the protocol.
    22 Jan 2015
    The main reason of this amendment was to clarify that the 7 days post dose follow up visit is performed as the early termination/final study completion visit, to update objectives/endpoints to align with the current regulatory view on long-term safety analysis, and to make other minor changes to the protocol.

    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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