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    Clinical Trial Results:
    A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFα agents (CAIN457F2309) and A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis (CAIN457F2309E1) Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.

    Summary
    EudraCT number
    		 2012-002760-27
    Trial protocol
    		 CZ   HU   DE   SK   IT   BG   ES  
    Global end of trial date
    14 May 2015

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457F2309 and CAIN457F2309E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01350804
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 May 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Core: To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to placebo in patients with active RA based on the proportion of patients achieving an ACR20 response. Extension:To evaluate the long-term efficacy of secukinumab 75 and 150 mg (provided as prefilled syringes) with respect to ACR20, ACR50 and ACR70 response over time up to Month 60 in patients with active rheumatoid arthritis who had previously experienced an inadequate or intolerant response to anti-TNF-α therapy and who completed the core study CAIN457F2309.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Sep 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 37
    Country: Number of subjects enrolled
    Bulgaria: 35
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Colombia: 35
    Country: Number of subjects enrolled
    Czech Republic: 30
    Country: Number of subjects enrolled
    France: 15
    Country: Number of subjects enrolled
    Germany: 122
    Country: Number of subjects enrolled
    Hungary: 14
    Country: Number of subjects enrolled
    Italy: 17
    Country: Number of subjects enrolled
    Mexico: 62
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Russian Federation: 22
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    Spain: 27
    Country: Number of subjects enrolled
    United States: 129
    Worldwide total number of subjects
    551
    EEA total number of subjects
    263
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    435
    From 65 to 84 years
    115
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 At week 16, placebo responders and non-responders were re-randomized to AIN457 75mg or AIN457 150mg. Abatacept responders at Week 16 continued on abatacept. Abatacept non-responders at Week 16 were re-randomized to AIN457 75mg or AIN457 150mg.

    Pre-assignment
    Screening details
    		 One patient was randomized to AIN457 75mg but instead received placebo up to week 16 and was re-categorized to placebo in the Safety Set for the first 16 weeks. Past week 16, this patient received secukinumab and was included in the "Any AIN457 75mg" for long term safety analyses.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIN457 10mg/kg - 75 mg
    Arm description
    		 Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Secukinumab
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.

    Arm title
    		 AIN457 10mg/kg - 150 mg
    Arm description
    		 Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Secukinumab
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status treatment at week 16. Responders were switched to active treatment at week 24.

    Arm title
    		 Abatacept
    Arm description
    		 Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Abatacept
    Investigational medicinal product code
    Other name
    Orencia
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received abatacept (from 500 to 1000 mg i.v. based on weight) up until week 16. At week 16, participants who responded to abatacept maintained treatment with abatacept for the duration of the study. Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).

    Number of subjects in period 1
    		AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept
    Started
    138
    137
    138
    138
    Safety set
    137
    136
    138
    137
    Tratment switch to AIN457 at week 16
    0 [1]
    0 [2]
    78 [3]
    0 [4]
    Treatment switch to AIN457 at week 24
    0 [5]
    0 [6]
    45 [7]
    37 [8]
    Full Analysis Set
    138
    137
    138
    138
    Completed
    97
    90
    91
    112
    Not completed
    41
    47
    47
    26
         Adverse event, serious fatal
    1
    1
    1
    -
         Consent withdrawn by subject
    11
    17
    16
    7
         Physician decision
    1
    -
    1
    3
         Study terminated by Sponsor
    -
    -
    -
    2
         Adverse event, non-fatal
    8
    10
    8
    8
         Protocol deviation
    1
    -
    1
    -
         Lost to follow-up
    3
    -
    2
    1
         Lack of efficacy
    16
    19
    18
    5
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Crossover of placebo non responders arm to active treatment arms in a 1:1 randomized manner
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Crossover of placebo non responders arm to active treatment arms in a 1:1 randomized manner
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Crossover of placebo non responders arm to active treatment arms in a 1:1 randomized manner
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Crossover of placebo non responders arm to active treatment arms in a 1:1 randomized manner
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Crossover of placebo non responders arm to active treatment arms in a 1:1 randomized manner
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Crossover of placebo non responders arm to active treatment arms in a 1:1 randomized manner
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Crossover of placebo non responders arm to active treatment arms in a 1:1 randomized manner
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Crossover of placebo non responders arm to active treatment arms in a 1:1 randomized manner
    Period 2
    Period 2 title
    Extension Study, weeks 52 - 260
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIN457 10mg/kg - 75 mg
    Arm description
    		 Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Secukinumab
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.

    Arm title
    		 AIN457 10mg/kg - 150 mg
    Arm description
    		 Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Secukinumab
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.

    Arm title
    		 Abatacept
    Arm description
    		 Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Abatacept
    Investigational medicinal product code
    Other name
    Orencia
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received abatacept (from 500 to 1000 mg i.v. based on weight) up until week 16. At week 16, participants who responded to abatacept maintained treatment with abatacept for the duration of the study. Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).

    Number of subjects in period 2 [9]
    		AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept
    Started
    80
    79
    72
    23
    Completed
    0
    0
    0
    0
    Not completed
    80
    79
    72
    23
         Consent withdrawn by subject
    5
    6
    4
    3
         Physician decision
    1
    -
    2
    -
         Study terminated by Sponsor
    67
    67
    64
    16
         Adverse event, non-fatal
    3
    1
    2
    3
         Lost to follow-up
    -
    1
    -
    -
         Lack of efficacy
    4
    4
    -
    1
    Notes
    [9] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all patients completing the previous milestone continued on in the extension study

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AIN457 10mg/kg - 75 mg
    Reporting group description
    		 Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.

    Reporting group title
    AIN457 10mg/kg - 150 mg
    Reporting group description
    		 Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.

    Reporting group title
    Abatacept
    Reporting group description
    		 Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).

    Reporting group values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept Total
    Number of subjects
    		 138 137 138 138 551
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0 0 0
        Between 18 and 65 years
    		 111 103 106 115 435
        >=65 years
    		 27 34 32 23 116
    Age continuous
    Units:
        
    		54.9 ± 11.32 55.9 ± 12.27 55.5 ± 12.05 51.6 ± 12.39 -
    Gender, Male/Female
    Units: Participants
        Female
    		 119 109 115 107 450
        Male
    		 19 28 23 31 101

    End points

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    End points reporting groups
    Reporting group title
    AIN457 10mg/kg - 75 mg
    Reporting group description
    		 Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.

    Reporting group title
    AIN457 10mg/kg - 150 mg
    Reporting group description
    		 Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.

    Reporting group title
    Abatacept
    Reporting group description
    		 Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
    Reporting group title
    AIN457 10mg/kg - 75 mg
    Reporting group description
    		 Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.

    Reporting group title
    AIN457 10mg/kg - 150 mg
    Reporting group description
    		 Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.

    Reporting group title
    Abatacept
    Reporting group description
    		 Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).

    Subject analysis set title
    Placebo non-responder - AIN457 75mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants switched from placebo to AIN457 75 mg starting at week 16.

    Subject analysis set title
    Placebo non-responder - AIN457 150mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants switched from placebo to AIN457 150 mg starting at week 16.

    Subject analysis set title
    Placebo responder - AIN457 75mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants switched from placebo to AIN457 75 mg starting at week 24.

    Subject analysis set title
    Placebo responder - AIN457 150mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants switched from placebo to AIN457 150 mg starting at week 24.

    Subject analysis set title
    Abatacept responders
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).

    Subject analysis set title
    Abatacept non-responders - AIN457 75mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants switched from abatacept to AIN457 75 mg starting at week 24.

    Subject analysis set title
    Abatacept non-responders - AIN457 150mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants switched from abatacept to AIN457 150 mg starting at week 24.

    Primary: Percentage of participants achieving an American College of Rheumatology Response 20 (ACR20).

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    End point title
    		 Percentage of participants achieving an American College of Rheumatology Response 20 (ACR20).
    End point description
    ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.
    End point type
    Primary
    End point timeframe
    week 24
    End point values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept
    Number of subjects analysed
    138
    137
    138
    138
    Units: Percentage of participants
        number (not applicable)
    28.3
    30.7
    18.1
    42.8
    Statistical analysis title
    		 ACR20 in AIN457 10mg/kg - 75 mg versus placebo
    Comparison groups
    AIN457 10mg/kg - 75 mg v Placebo
    Number of subjects included in analysis
    276
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0458
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 3.2
    Statistical analysis title
    		 ACR20 in AIN457 10mg/kg - 150 mg versus placebo
    Comparison groups
    AIN457 10mg/kg - 150 mg v Placebo
    Number of subjects included in analysis
    275
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0152
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 3.5

    Secondary: Change from baseline in Disease Activity Score utilizing CRP (DAS28-CRP)

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    End point title
    		 Change from baseline in Disease Activity Score utilizing CRP (DAS28-CRP)
    End point description
    The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline, week 24
    End point values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept
    Number of subjects analysed
    116
    108
    44
    84
    Units: score on a scale
        least squares mean (standard error)
    -1.47 ± 0.115
    -1.47 ± 0.119
    -1.02 ± 0.163
    -2.07 ± 0.128
    No statistical analyses for this end point

    Secondary: Change from baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)

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    End point title
    		 Change from baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)
    End point description
    The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline, week 24
    End point values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept
    Number of subjects analysed
    117
    110
    44
    86
    Units: score on a scale
        least squares mean (standard error)
    -0.3 ± 0.049
    -0.39 ± 0.051
    -0.26 ± 0.065
    -0.61 ± 0.053
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving ACR50

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    End point title
    		 Percentage of participants achieving ACR50
    End point description
    ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR50 response results at week 24 used non-responder imputation.
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept
    Number of subjects analysed
    138
    137
    138
    138
    Units: Percentage of participants
        number (not applicable)
    11.6
    16.8
    9.4
    27.5
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving ACR20, ACR 50 and ACR 70 - using non-responder imputation

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    End point title
    		 Percentage of participants achieving ACR20, ACR 50 and ACR 70 - using non-responder imputation
    End point description
    ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).
    End point type
    Secondary
    End point timeframe
    baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24
    End point values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept
    Number of subjects analysed
    138
    137
    138
    138
    Units: Percentage of participants
    number (not applicable)
        ACR20, week 1
    21
    17.5
    7.2
    10.9
        ACR20, week 2
    24.6
    21.2
    12.3
    23.9
        ACR20, week 4
    34.1
    27
    21.7
    31.2
        ACR20, week 8
    35.5
    41.6
    21
    49.3
        ACR20, week 12
    28.3
    33.6
    24.6
    47.1
        ACR20, week 16
    34.1
    39.4
    23.2
    51.4
        ACR20, week 20
    26.8
    38
    18.1
    47.8
        ACR20, week 24
    28.3
    30.7
    18.1
    42.8
        ACR50, week 1
    6.5
    2.9
    0.7
    1.4
        ACR50, week 2
    5.1
    8.8
    2.9
    2.9
        ACR50, week 4
    9.4
    10.2
    2.9
    7.2
        ACR50, week 8
    7.2
    15.3
    10.1
    18.8
        ACR50, week 12
    8.7
    13.1
    10.1
    22.5
        ACR50, week 16
    13.8
    20.4
    9.4
    23.9
        ACR50, week 20
    12.3
    18.2
    8
    26.8
        ACR50, week 24
    11.6
    16.8
    9.4
    27.5
        ACR70, week 1
    0.7
    0.7
    0
    0.7
        ACR70, week 2
    1.4
    0.7
    1.4
    0.7
        ACR70, week 4
    4.3
    2.9
    1.4
    1.4
        ACR70, week 8
    1.4
    4.4
    2.9
    5.8
        ACR70, week 12
    2.2
    2.9
    2.9
    9.4
        ACR70, week 16
    5.1
    8
    2.9
    9.4
        ACR70, week 20
    4.3
    7.3
    5.8
    10.1
        ACR70, week 24
    5.1
    10.2
    5.1
    12.3
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving ACR20, ACR 50 and ACR 70 - observed data

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    End point title
    		 Percentage of participants achieving ACR20, ACR 50 and ACR 70 - observed data
    End point description
    ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20, ACR50 and ACR70 response results from baseline up to week 52 were based on observed data, i.e. without imputation.
    End point type
    Secondary
    End point timeframe
    baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept Placebo non-responder - AIN457 75mg Placebo non-responder - AIN457 150mg Placebo responder - AIN457 75mg Placebo responder - AIN457 150mg Abatacept responders Abatacept non-responders - AIN457 75mg Abatacept non-responders - AIN457 150mg
    Number of subjects analysed
    138
    137
    138
    138
    39
    39
    23
    22
    101
    18
    19
    Units: Percentage of participants
    number (not applicable)
        ACR20,wk 1,n=132,129,130,130,39,35,21,22,96,17,17
    22.7
    18.6
    7.7
    11.5
    5.1
    5.7
    14.3
    13.6
    14.6
    0
    5.9
        ACR20,wk 2,n=131,130,134,134,39,36,23,22,99,17,18
    26.7
    22.3
    12.7
    25.4
    2.6
    11.1
    34.8
    13.6
    29.3
    11.8
    16.7
        ACR20,wk 4,n=133,132,131,129,39,39,23,21,93,17,19
    36.1
    28
    22.9
    34.1
    15.4
    12.8
    43.5
    42.9
    41.9
    17.6
    10.5
        ACR20,wk 8,n=132,127,131,131,39,39,23,22,95,17,19
    38.6
    44.9
    22.1
    52.7
    17.9
    12.8
    39.1
    31.8
    61.1
    29.4
    31.6
        ACR20,wk 12,n=130,115,123,129,39,37,23,21,94,17,18
    30.8
    40
    27.6
    51.2
    15.4
    16.2
    47.8
    52.4
    62.8
    17.6
    22.2
        ACR20,wk 16,n=126,118,116,129,36,37,21,22,94,16,19
    38.1
    45.8
    27.6
    55.8
    2.8
    2.7
    76.2
    63.6
    76.6
    0
    0
        ACR20,wk 20,n=122,114,119,126,38,37,23,21,91,16,19
    39.3
    51.8
    42.9
    57.9
    42.1
    29.7
    60.9
    47.6
    73.6
    6.3
    26.3
        ACR20,wk 24,n=117,110,117,121,38,36,21,22,87,16,18
    45.3
    48.2
    40.2
    57.9
    26.3
    33.3
    57.1
    59.1
    69
    31.3
    27.8
        ACR20,wk28,n=115,103,na,na,33,35,21,21,86,17,19
    47.8
    65
    9999
    9999
    33.3
    37.1
    71.4
    90.5
    74.4
    41.2
    42.1
        ACR20,wk32,n=104,97,na,na,33,30,21,19,87,17,17
    56.7
    61.9
    9999
    9999
    51.5
    36.7
    81
    68.4
    74.7
    23.5
    47.1
        ACR20,wk36,n=102,93,na,na,30,30,21,20,85,18,16
    56.9
    53.8
    9999
    9999
    46.7
    56.7
    85.7
    65
    77.6
    27.8
    56.3
        ACR20,wk40,n=96,90,na,na,28,28,21,19,85,15,17
    53.1
    61.1
    9999
    9999
    53.6
    53.6
    85.7
    73.7
    71.8
    40
    58.8
        ACR20,wk44,n=97,90,na,na,28,27,20,18,84,15,16
    56.7
    61.1
    9999
    9999
    50
    55.6
    85
    77.8
    77.4
    33.3
    31.3
        ACR20,wk48,n=94,89,na,na,28,26,18,19,77,12,14
    57.4
    68.5
    9999
    9999
    53.6
    61.5
    72.2
    57.9
    71.4
    25
    50
        ACR20,wk52,n=92,88,na,na,28,26,20,18,79,15,15
    56.5
    62.5
    9999
    9999
    39.3
    57.7
    75
    88.9
    74.7
    40
    33.3
        ACR50,wk1,n=132,129,130,130,39,35,21,22,96,17,17
    6.8
    3.1
    0.8
    1.5
    0
    0
    4.8
    0
    1
    0
    5.9
        ACR50,wk2,n=131,130,134,134,39,36,23,22,99,17,18
    5.3
    9.2
    3
    3
    0
    0
    13
    4.5
    3
    0
    5.6
        ACR50,wk4,n=133,132,131,129,39,39,23,21,93,17,19
    9.8
    10.6
    3.1
    7.8
    0
    0
    8.7
    9.5
    10.8
    0
    0
        ACR50,wk8,n=132,127,131,131,39,39,23,22,95,17,19
    9.1
    16.5
    10.7
    20.6
    5.1
    5.1
    34.8
    9.1
    25.3
    11.8
    5.3
        ACR50,wk12,n=130,115,123,129,39,37,23,21,94,17,18
    10
    15.7
    11.4
    24.8
    2.6
    8.1
    21.7
    23.8
    30.9
    5.9
    11.1
        ACR50,wk16,n=126,118,116,129,36,37,21,22,94,16,19
    15.9
    23.7
    11.2
    26.4
    0
    0
    38.1
    22.7
    36.2
    0
    0
        ACR50,wk20,n=122,114,119,126,38,37,23,21,91,16,19
    15.6
    21.9
    12.6
    31.7
    7.9
    2.7
    34.8
    14.3
    40.7
    0
    15.8
        ACR50,wk24,n=117,110,117,121,38,36,21,22,87,16,18
    14.5
    22.7
    14.5
    33.1
    0
    11.1
    38.1
    22.7
    44.8
    0
    5.6
        ACR50,wk28,n=115,103,na,na,33,35,21,21,86,17,19
    13.9
    31.1
    9999
    9999
    6.1
    8.6
    33.3
    33.3
    41.9
    23.5
    0
        ACR50,wk32,n=104,97,na,na,33,30,21,19,87,17,17
    21.2
    32
    9999
    9999
    6.1
    13.3
    42.9
    31.6
    47.1
    5.9
    0
        ACR50,wk36,n=102,93,na,na,30,30,21,20,85,18,16
    23.5
    24.7
    9999
    9999
    16.7
    16.7
    28.6
    20
    47.1
    16.7
    18.8
        ACR50,wk40,n=96,90,na,na,28,28,21,19,85,15,17
    25
    25.6
    9999
    9999
    14.3
    28.6
    38.1
    26.3
    45.9
    20
    5.9
        ACR50,wk44,n=97,90,na,na,28,27,20,18,84,15,16
    27.8
    30
    9999
    9999
    7.1
    29.6
    35
    33.3
    50
    13.3
    6.3
        ACR50,wk48,n=94,89,na,na,28,26,18,19,77,12,14
    25.5
    42.7
    9999
    9999
    14.3
    23.1
    38.9
    26.3
    48.1
    0
    0
        ACR50,wk52,n=92,88,na,na,28,26,20,18,79,15,15
    26.1
    45.5
    9999
    9999
    10.7
    26.9
    40
    44.4
    51.9
    20
    13.3
        ACR70,wk1,n=132,129,130,130,39,35,21,22,96,17,17
    0.8
    0.8
    0
    0.8
    0
    0
    0
    0
    1
    0
    0
        ACR70,wk2,n=131,130,134,134,39,36,23,22,99,17,18
    1.5
    0.8
    1.5
    0.7
    0
    0
    4.3
    4.5
    1
    0
    0
        ACR70,wk4,n=133,132,131,129,39,39,23,21,93,17,19
    4.5
    3
    1.5
    1.6
    0
    0
    4.3
    4.8
    2.2
    0
    0
        ACR70,wk8,n=132,127,131,131,39,39,23,22,95,17,19
    1.5
    4.7
    3.1
    6.1
    0
    2.6
    13
    0
    7.4
    5.9
    0
        ACR70,wk12,n=130,115,123,129,39,37,23,21,94,17,18
    3.1
    3.5
    3.3
    10.9
    0
    0
    13
    4.8
    14.9
    0
    0
        ACR70,wk16,n=126,118,116,129,36,37,21,22,94,16,19
    6.3
    9.3
    3.4
    10
    0
    0
    14.3
    4.5
    13.8
    0
    0
        ACR70,wk20,n=122,114,119,126,38,37,23,21,91,16,19
    6.6
    8.8
    6.7
    11.1
    0
    0
    21.7
    14.3
    15.4
    0
    0
        ACR70,wk24,n=117,110,117,121,38,36,21,22,87,16,18
    6
    12.7
    8.5
    14.9
    0
    8.3
    23.8
    9.1
    19.5
    0
    5.6
        ACR70,wk28,n=115,103,na,na,33,35,21,21,86,17,19
    6.1
    17.5
    9999
    9999
    0
    2.9
    14.3
    14.3
    17.4
    5.9
    0
        ACR70,wk32,n=104,97,na,na,33,30,21,19,87,17,17
    4.8
    10
    9999
    9999
    0
    3.3
    19
    0
    21.8
    0
    0
        ACR70,wk36,n=102,93,na,na,30,30,21,20,85,18,16
    5.9
    11.8
    9999
    9999
    3.3
    0
    23.8
    0
    23.5
    11.1
    0
        ACR70,wk40,n=96,90,na,na,28,28,21,19,85,15,17
    8.3
    11.1
    9999
    9999
    7.1
    10.7
    19
    10.5
    21.2
    13.3
    0
        ACR70,wk44,n=97,90,na,na,28,27,20,18,84,15,16
    12.4
    18.9
    9999
    9999
    0
    11.1
    25
    11.1
    26.2
    6.7
    0
        ACR70,wk48,n=94,89,na,na,28,26,18,19,77,12,14
    9.6
    20.2
    9999
    9999
    3.6
    15.4
    33.3
    10.5
    27.3
    0
    0
        ACR70,wk52,n=92,88,na,na,28,26,20,18,79,15,15
    6.5
    19.3
    9999
    9999
    0
    7.7
    30
    16.7
    22.8
    13.3
    0
    No statistical analyses for this end point

    Secondary: Change from baseline in HAQ-DI - using mixed model repeated measures (MMRM)

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    End point title
    		 Change from baseline in HAQ-DI - using mixed model repeated measures (MMRM)
    End point description
    The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24
    End point values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept
    Number of subjects analysed
    138
    137
    138
    138
    Units: score on a scale
    least squares mean (standard error)
        week 1, n=132,129,130,129
    -0.22 ± 0.032
    -0.21 ± 0.032
    -0.08 ± 0.032
    -0.19 ± 0.032
        week 2, n=131,130,134,133
    -0.22 ± 0.036
    -0.25 ± 0.036
    -0.16 ± 0.036
    -0.26 ± 0.036
        week 4, n=133,133,131,130
    -0.3 ± 0.039
    -0.31 ± 0.04
    -0.17 ± 0.04
    -0.36 ± 0.04
        week 8, n=132,127,131,130
    -0.29 ± 0.042
    -0.32 ± 0.043
    -0.17 ± 0.043
    -0.46 ± 0.043
        week 12, n=130,114,123,129
    -0.31 ± 0.046
    -0.33 ± 0.047
    -0.18 ± 0.047
    -0.51 ± 0.046
        week 16, n=127,118,116,129
    -0.3 ± 0.048
    -0.37 ± 0.049
    -0.22 ± 0.049
    -0.52 ± 0.048
        week 20, n=122,114,47,92
    -0.36 ± 0.051
    -0.42 ± 0.052
    -0.21 ± 0.066
    -0.57 ± 0.054
        week 24, n=117,110,44,86
    -0.3 ± 0.049
    -0.39 ± 0.051
    -0.26 ± 0.065
    -0.61 ± 0.053
    No statistical analyses for this end point

    Secondary: Change from baseline in HAQ-DI - observed data

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    End point title
    		 Change from baseline in HAQ-DI - observed data
    End point description
    The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement. The HAQ-DI results from baseline up to week 52 were based on observed data, i.e. without imputation.
    End point type
    Secondary
    End point timeframe
    baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept Placebo non-responder - AIN457 75mg Placebo non-responder - AIN457 150mg Placebo responder - AIN457 75mg Placebo responder - AIN457 150mg Abatacept responders Abatacept non-responders - AIN457 75mg Abatacept non-responders - AIN457 150mg
    Number of subjects analysed
    138
    137
    138
    138
    39
    39
    23
    22
    101
    18
    19
    Units: score on a scale
    arithmetic mean (standard deviation)
        wk1,n=132,129,130,129,39,35,21,22,95,17,17
    -0.225 ± 0.3766
    -0.215 ± 0.4095
    -0.101 ± 0.3186
    -0.194 ± 0.429
    -0.119 ± 0.2896
    -0.079 ± 0.3093
    -0.125 ± 0.4257
    -0.153 ± 0.2468
    -0.232 ± 0.4551
    -0.081 ± 0.3616
    -0.096 ± 0.3047
        Wk2,n=131,130,134,133,39,36,23,22,133,98,17,18
    -0.215 ± 0.3877
    -0.239 ± 0.4885
    -0.191 ± 0.434
    -0.254 ± 0.452
    -0.122 ± 0.2605
    -0.176 ± 0.4631
    -0.38 ± 0.5063
    -0.25 ± 0.5015
    -0.3 ± 0.4693
    -0.132 ± 0.363
    -0.118 ± 0.3987
        Wk4,n=133,133,131,130,39,39,23,21,94,17,19
    -0.299 ± 0.4551
    -0.3 ± 0.5184
    -0.214 ± 0.4492
    -0.368 ± 0.513
    -0.077 ± 0.3634
    -0.224 ± 0.4968
    -0.364 ± 0.5627
    -0.31 ± 0.3103
    -0.445 ± 0.5245
    -0.11 ± 0.3505
    -0.217 ± 0.4874
        Wk8,n=132,127,131,130,39,39,23,22,94,17,19
    -0.277 ± 0.5062
    -0.309 ± 0.5175
    -0.217 ± 0.5457
    -0.463 ± 0.5182
    -0.186 ± 0.5097
    -0.128 ± 0.5077
    -0.543 ± 0.6313
    -0.176 ± 0.4782
    -0.543 ± 0.5289
    -0.206 ± 0.49
    -0.303 ± 0.378
        wk12,n=130,114,123,129,39,37,23,21,94,17,18
    -0.287 ± 0.5384
    -0.307 ± 0.5488
    -0.241 ± 0.5152
    -0.508 ± 0.6369
    -0.109 ± 0.4783
    -0.179 ± 0.5133
    -0.451 ± 0.6167
    -0.381 ± 0.3982
    -0.622 ± 0.652
    -0.221 ± 0.4274
    -0.181 ± 0.5376
        Wk16,n=127,118,116,129,36,37,21,22,94,16,19
    -0.294 ± 0.5236
    -0.355 ± 0.6217
    -0.279 ± 0.5493
    -0.535 ± 0.6418
    -0.167 ± 0.5295
    -0.111 ± 0.4591
    -0.565 ± 0.5356
    -0.472 ± 0.5988
    -0.66 ± 0.659
    -0.195 ± 0.4281
    -0.204 ± 0.4827
        Wk20,n=122,114,119,125,38,37,23,21,90,16,19
    -0.333 ± 0.5111
    -0.402 ± 0.6429
    -0.319 ± 0.5637
    -0.583 ± 0.6654
    -0.237 ± 0.4756
    -0.179 ± 0.5158
    -0.543 ± 0.5325
    -0.47 ± 0.7309
    -0.699 ± 0.6849
    -0.086 ± 0.3972
    -0.454 ± 0.5436
        Wk24,n=117,110,117,120,38,36,21,22,86,16,18
    -0.268 ± 0.493
    -0.405 ± 0.5767
    0.346 ± 0.5941
    -0.59 ± 0.6872
    -0.257 ± 0.473
    -0.253 ± 0.6502
    -0.589 ± 0.5648
    -0.42 ± 0.6732
    -0.744 ± 0.6787
    -0.18 ± 0.4257
    -0.215 ± 0.6443
        Wk28,n=115,102,na,na,33,35,21,21,86,17,19
    -0.304 ± 0.5342
    -0.439 ± 0.578
    9999 ± 9999
    9999 ± 9999
    -0.345 ± 0.588
    -0.336 ± 0.5846
    -0.625 ± 0.4809
    -0.601 ± 0.5571
    -0.689 ± 0.6428
    -0.309 ± 0.5522
    -0.303 ± 0.5882
        Wk32,n=104,97,na,na,33,30,21,19,87,17,17
    -0.358 ± 0.4964
    -0.505 ± 0.5759
    9999 ± 9999
    9999 ± 9999
    -0.284 ± 0.4627
    -0.3 ± 0.5039
    -0.679 ± 0.5414
    -0.546 ± 0.5998
    -0.741 ± 0.6909
    -0.228 ± 0.5612
    -0.375 ± 0.7315
        Wk36,n=102,93,na,na,30,30,21,19,84,18,16,
    -0.339 ± 0.5687
    -0.43 ± 0.5573
    9999 ± 9999
    9999 ± 9999
    -0.368 ± 0.5397
    -0.383 ± 0.45
    -0.607 ± 0.5538
    -0.474 ± 0.6032
    -0.756 ± 0.6844
    -0.285 ± 0.5891
    -0.43 ± 0.6723
        Wk40,n=96,89,na,na,28,28,21,19,84,15,17
    -0.424 ± 0.5967
    -0.44 ± 0.5416
    9999 ± 9999
    9999 ± 9999
    -0.522 ± 0.6805
    -0.391 ± 0.5446
    -0.571 ± 0.5736
    -0.539 ± 0.6998
    -0.763 ± 0.675
    -0.242 ± 0.6312
    -0.39 ± 0.6523
        Wk44,n=97,90,na,na,28,27,20,18,84,15,16
    -0.331 ± 0.5871
    -0.449 ± 0.5427
    9999 ± 9999
    9999 ± 9999
    -0.277 ± 0.6377
    -0.523 ± 0.6587
    -0.638 ± 0.5144
    -0.514 ± 0.7752
    -0.781 ± 0.7252
    -0.308 ± 0.6319
    -0.203 ± 0.7917
        Wk48,n-94,89,na,na,28,26,19,19,76,12,14
    -0.303 ± 0.5062
    -0.483 ± 0.5459
    9999 ± 9999
    9999 ± 9999
    -0.348 ± 0.5886
    -0.413 ± 0.5698
    -0.605 ± 0.6113
    -0.454 ± 0.5547
    -0.798 ± 0.6481
    -0.229 ± 0.6546
    -0.286 ± 0.7618
        Wk52,n=92,87,na,na,28,26,20,18,79,15,15
    -0.341 ± 0.5428
    -0.516 ± 0.6036
    9999 ± 9999
    9999 ± 9999
    -0.402 ± 0.5436
    -0.351 ± 0.6335
    -0.606 ± 0.6492
    -0.569 ± 0.7126
    -0.788 ± 0.6853
    -0.392 ± 0.5216
    -0.258 ± 0.8298
    No statistical analyses for this end point

    Secondary: Change from baseline in Disease Activity Score utilizing CRP (DAS28-CRP) - using MMRM

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    End point title
    		 Change from baseline in Disease Activity Score utilizing CRP (DAS28-CRP) - using MMRM
    End point description
    The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24
    End point values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept
    Number of subjects analysed
    138
    137
    138
    39
    Units: score on a scale
    least squares mean (standard error)
        week 1, n=131,129,130,129
    -0.89 ± 0.069
    -0.73 ± 0.069
    -0.22 ± 0.069
    -0.5 ± 0.069
        week 2, n=131,127,132,133
    -0.96 ± 0.08
    -0.9 ± 0.081
    -0.35 ± 0.08
    -0.78 ± 0.08
        week 4, n=130,131,138,138
    -1.2 ± 0.09
    -1.11 ± 0.09
    -0.48 ± 0.09
    -1.11 ± 0.091
        week 8, n=130,126,130,130
    -1.21 ± 0.093
    -1.23 ± 0.094
    -0.61 ± 0.093
    -1.55 ± 0.093
        week 12, n=130,114,123,128
    -1.23 ± 0.097
    -1.36 ± 0.102
    -0.73 ± 0.1
    -1.78 ± 0.098
        week 16, n=126,116,114,127
    -1.23 ± 0.108
    -1.4 ± 0.112
    -0.57 ± 0.112
    -1.71 ± 0.108
        week 20, n=121,114,47,92
    -1.44 ± 0.108
    -1.49 ± 0.111
    -0.89 ± 0.146
    -1.96 ± 0.117
        week 24, n=116,108,44,84
    -1.47 ± 0.115
    -1.47 ± 0.119
    -1.02 ± 0.163
    -2.07 ± 0.128
    No statistical analyses for this end point

    Secondary: Change from baseline in Disease Activity Score utilizing CRP (DAS28-CRP) - observed data

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    End point title
    		 Change from baseline in Disease Activity Score utilizing CRP (DAS28-CRP) - observed data
    End point description
    The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement. The DAS28-CRP results from baseline up to week 52 were based on observed data, i.e. without imputation.
    End point type
    Secondary
    End point timeframe
    baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept Placebo non-responder - AIN457 75mg Placebo non-responder - AIN457 150mg Placebo responder - AIN457 75mg Placebo responder - AIN457 150mg Abatacept responders Abatacept non-responders - AIN457 75mg Abatacept non-responders - AIN457 150mg
    Number of subjects analysed
    138
    137
    138
    138
    39
    39
    23
    22
    101
    18
    19
    Units: score on a scale
    arithmetic mean (standard deviation)
        Wk1,n=131,129,130,129,39,35,21,22, 95,17,17
    -0.886 ± 0.9784
    -0.759 ± 0.8654
    -0.211 ± 0.6877
    -0.502 ± 0.7539
    -0.147 ± 0.5527
    -0.141 ± 0.7095
    -0.572 ± 0.7856
    -0.235 ± 0.7699
    -0.577 ± 0.7924
    -0.361 ± 0.3578
    -0.222 ± 0.7695
        Wk2,n=131,127,132,133,39,36,23,21,98,17,18
    -0.909 ± 1.0331
    -0.9 ± 1.0284
    -0.363 ± 0.8388
    -0.755 ± 0.9234
    -0.191 ± 0.7331
    -0.368 ± 0.717
    -0.835 ± 0.9466
    -0.292 ± 0.7448
    -0.755 ± 0.9234
    -0.882 ± 0.9526
    -0.359 ± 0.898
        Wk4,n=130,131,129,128,39,38,23,21,92,17,19
    -1.163 ± 1.1656
    -1.15 ± 1.1942
    -0.492 ± 0.8876
    -1.095 ± 1.0483
    -0.252 ± 0.8116
    -0.352 ± 0.7471
    -1.034 ± 0.9119
    -0.767 ± 0.9661
    -1.268 ± 1.0533
    -0.595 ± 1.116
    -0.706 ± 0.6999
        Wk8,n=130,126,130,130,39,39,23,22,94,17,19
    -1.181 ± 1.1821
    -1.283 ± 1.1678
    -0.644 ± 1.1356
    -1.541 ± 1.1172
    -0.546 ± 1.1597
    -0.312 ± 0.9151
    -1.403 ± 1.206
    -0.613 ± 0.9772
    -1.816 ± 1.0708
    -0.834 ± 1.1469
    -0.808 ± 0.6444
        Wk12,n=130,114,123,128,39,37,23,21,93,17,18
    -1.229 ± 1.1782
    -1.402 ± 1.2182
    -0.742 ± 1.233
    -1.79 ± 1.2356
    -0.311 ± 0.9514
    -0.383 ± 1.1765
    -1.588 ± 0.9714
    -1.33 ± 1.4721
    -2.144 ± 1.1028
    -0.749 ± 1.0757
    -0.945 ± 1.1008
        Wk16,n=126,116,114,128,36,36,21,21,94,15,19
    -1.225 ± 1.2866
    -1.455 ± 1.3489
    -0.592 ± 1.2557
    -1.691 ± 1.2979
    0.128 ± 0.8579
    0.045 ± 0.9145
    -2.008 ± 0.8675
    -1.503 ± 0.8746
    -2.159 ± 1.0767
    -0.49 ± 0.817
    -0.322 ± 1.0262
        Wk20,n=121,114,,119,125,38,37,23,21,90,16,19
    -1.427 ± 1.3266
    -1.569 ± 1.2361
    -1.164 ± 1.2087
    -1.84 ± 1.4144
    -0.683 ± 1.1231
    -0.937 ± 1.0966
    -2.108 ± 1.0368
    -1.399 ± 1.1487
    -2.317 ± 1.2549
    -0.402 ± 0.982
    -0.792 ± 1.0272
        Wk24,n=116,108,116,117,37,36,21,22,84,15,18
    -1.467 ± 1.3116
    -1.579 ± 1.3221
    -1.248 ± 1.2915
    -1.989 ± 1.4717
    -0.666 ± 0.9983
    -1.14 ± 1.1954
    -2.343 ± 1.2649
    -1.362 ± 1.2999
    -2.435 ± 1.3266
    -0.772 ± 1.1656
    -0.923 ± 1.256
        Wk28,n=115,103,na,na,33,35,21,21,86,17,18
    -1.484 ± 1.3216
    -1.819 ± 1.3434
    9999 ± 9999
    9999 ± 9999
    -1.172 ± 1.1602
    -1.244 ± 1.2433
    -2.117 ± 0.8573
    -1.782 ± 1.0655
    -2.47 ± 1.2153
    -1.137 ± 1.205
    -0.973 ± 1.1034
        Wk32,n=103,97,na,na,33,39,23,22,87,17,16
    -1.738 ± 1.2783
    -1.966 ± 1.177
    9999 ± 9999
    9999 ± 9999
    -1.408 ± 1.3855
    -1.475 ± 1.1846
    -2.363 ± 1.0711
    -1.875 ± 0.9807
    -2.629 ± 1.3104
    -0.961 ± 1.0043
    -1.464 ± 1.2025
        Wk36,n=101,92,na,na,30,30,21,20,84,18,15
    -1.737 ± 1.4592
    -1.82 ± 1.25
    9999 ± 9999
    9999 ± 9999
    -1.271 ± 1.4949
    -1.444 ± 1.1949
    -2.269 ± 1.0688
    -1.784 ± 0.9029
    -2.642 ± 1.4305
    -1.2 ± 1.3228
    -1.425 ± 0.9247
        Wk40,n=96,90,na,na,28,28,21,19,84,15,17
    -1.742 ± 1.3259
    -1.788 ± 1.1333
    9999 ± 9999
    9999 ± 9999
    -1.354 ± 1.359
    -1.494 ± 1.3243
    -2.315 ± 1.0773
    -2.134 ± 1.0405
    -2.549 ± 1.3305
    -1.201 ± 1.5293
    -1.612 ± 1.1839
        Wk44,n=96,88,na,na,28,27,20,18,84,15,16
    -1.764 ± 1.3227
    -1.932 ± 1.285
    9999 ± 9999
    9999 ± 9999
    -1.168 ± 1.2638
    -1.858 ± 1.2373
    -2.155 ± 0.9488
    -2.121 ± 1.1347
    -2.697 ± 1.2117
    -0.881 ± 1.3337
    -1.528 ± 1.2973
        Wk48,n=94,88,na,na,28,26,18,19,76,12,14
    -1.761 ± 1.3152
    -2.2 ± 1.3293
    9999 ± 9999
    9999 ± 9999
    -1.516 ± 1.0635
    -1.66 ± 1.1805
    -2.259 ± 1.1813
    -1.964 ± 1.3404
    -2.634 ± 1.2189
    -1.013 ± 1.1738
    -1.4 ± 1.1985
        Wk52,n=92,86,na,na,28,26,20,18,79,15,15
    -1.839 ± 1.3755
    -2.109 ± 1.4
    9999 ± 9999
    9999 ± 9999
    -1.487 ± 1.0729
    -1.69 ± 1.2093
    -2.07 ± 0.9984
    -2.334 ± 1.1428
    -2.676 ± 1.3593
    -1.39 ± 1.1884
    -0.982 ± 1.1943
    No statistical analyses for this end point

    Secondary: Change from baseline in hsCRP - observed data

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    End point title
    		 Change from baseline in hsCRP - observed data
    End point description
    Blood samples were obtained to identify the presence of inflammation, to determine its severity and to monitor response to treatment. A negative change from baseline indicates improvement. The hsCRP results from baseline up to week 52 were based on observed data, i.e. without imputation.
    End point type
    Secondary
    End point timeframe
    baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept Placebo non-responder - AIN457 75mg Placebo non-responder - AIN457 150mg Placebo responder - AIN457 75mg Placebo responder - AIN457 150mg Abatacept responders Abatacept non-responders - AIN457 75mg Abatacept non-responders - AIN457 150mg
    Number of subjects analysed
    138
    137
    138
    138
    39
    39
    23
    22
    101
    18
    19
    Units: mg/L
    arithmetic mean (standard deviation)
        Wk1,n=134,130,131,131,39,36,21,22,97,17,17
    -10.91 ± 30.815
    -10.31 ± 27.754
    -0.69 ± 15.521
    -5.64 ± 18.55
    -0.33 ± 10.43
    -0.84 ± 24.777
    -0.4 ± 12.244
    -1.5 ± 7.541
    -6.4 ± 20.458
    -2.92 ± 12.405
    -4.07 ± 10.811
        Wk2,n=133,129,133,135,39,36,23,21,100,17,18
    -10.24 ± 33.209
    -11.51 ± 32.139
    -2.21 ± 14.501
    -6.36 ± 19.416
    0.43 ± 15.333
    -5.48 ± 17.301
    -1.7 ± 11.17
    -4.78 ± 10.515
    -7.52 ± 20.301
    -3.84 ± 13.737
    -2.3 ± 19.035
        Wk4,n=131,134,129,133,39,38,23,21,97,17,19
    -9.1 ± 20.514
    -10.76 ± 33.376
    -1.53 ± 19.311
    -6.7 ± 20.732
    2.23 ± 23.317
    -1.94 ± 21.927
    -6.47 ± 12.458
    -1.95 ± 12.09
    -7.53 ± 22.982
    -4.42 ± 14.991
    -4.5 ± 11.029
        Wk8,n=134,128,130,132,39,39,23,22,96,17,19
    -10.18 ± 33.4
    -12.94 ± 30.854
    -2.94 ± 20.601
    -8.48 ± 21.134
    -4.72 ± 18.766
    -3.28 ± 25.501
    0.13 ± 18.061
    -1.5 ± 12.839
    -10.13 ± 22.724
    -0.54 ± 14.849
    -4.59 ± 16.603
        Wk12,n=133,119,128,131,39,39,23,22,96,17,18
    -9.41 ± 31.859
    -9.66 ± 24.298
    -0.69 ± 18.908
    -9.72 ± 25.787
    2.11 ± 18.312
    -2.89 ± 20.763
    -2.74 ± 12.899
    2.1 ± 22.545
    -12.17 ± 25.813
    -4.18 ± 16.024
    -1.94 ± 31.483
        Wk16,n=129,120,121,131,36,38,21,21,96,16,19
    -9.97 ± 33.291
    -5.78 ± 25.418
    -1.82 ± 20.849
    -8.37 ± 22.571
    3.92 ± 23.403
    -2.13 ± 24.422
    -5.67 ± 9.583
    -4.29 ± 13.497
    -11.25 ± 23.692
    -1.41 ± 8.81
    0.32 ± 22.024
        Wk20,n=124,116,120,127,38,37,23,21,91,17,19
    -9.19 ± 32.876
    -8.05 ± 22.394
    -3.75 ± 29.301
    -9.43 ± 23.212
    -5.33 ± 20.645
    -7.77 ± 27.581
    3.23 ± 48.634
    -1.06 ± 15.737
    -11.59 ± 24.271
    -3.94 ± 15.716
    -3.99 ± 32.871
        Wk24,n=121,113,116,120,37,36,21,22,86,16,18
    -6.9 ± 22.098
    -4.92 ± 23.075
    -6.88 ± 21.014
    -8.66 ± 21.574
    -7.06 ± 20.298
    -11.46 ± 26.373
    -6.4 ± 11.562
    0.45 ± 18.244
    -11.72 ± 22.198
    -4.94 ± 13.605
    2.63 ± 20.875
        Wk28,n=119,110,na,na,34,35,21,21,89,17,18
    -4.94 ± 23.155
    -5.87 ± 25.885
    9999 ± 9999
    9999 ± 9999
    -4.43 ± 21.777
    -11.1 ± 27.186
    -7.97 ± 18.018
    0.09 ± 24.933
    -12.08 ± 22.791
    -4.51 ± 14.144
    -1.7 ± 22.671
        Wk32,n=107,101,na,na,34,32,20,21,87,17,16
    -8.57 ± 20.826
    7.37 ± 24.564
    9999 ± 9999
    9999 ± 9999
    -4.34 ± 23.742
    -9.08 ± 25.867
    -5.02 ± 10.3
    -5.51 ± 14.279
    -12.83 ± 23.33
    -4.26 ± 15.329
    -7.14 ± 17.446
        Wk36,n=107,98,na,na,32,31,21,20,85,18,15
    -6.6 ± 25.895
    -6.36 ± 22.571
    9999 ± 9999
    9999 ± 9999
    -4.21 ± 27.424
    -2.35 ± 37.226
    -2.73 ± 21.272
    -6.78 ± 13.94
    -12.19 ± 24.535
    -4.38 ± 14.479
    -0.47 ± 27.932
        WK40,n=101,96,na,na,29,29,22,20,86,15,17
    -8.74 ± 22.257
    -7.09 ± 24.325
    9999 ± 9999
    9999 ± 9999
    -7.07 ± 26.156
    2.39 ± 32.966
    -4.46 ± 22.808
    -4.73 ± 13.502
    -12.63 ± 23.788
    -2.75 ± 17.297
    -7.95 ± 18.343
        Wk44,n=97,92,na,na,,28,28,20,19,85,15,16
    -6.59 ± 20.975
    -7.25 ± 24.681
    9999 ± 9999
    9999 ± 9999
    -6.66 ± 23.396
    -8.53 ± 19.97
    -6.5 ± 19.968
    -7.27 ± 13.887
    -12.32 ± 25.47
    -1.33 ± 4.846
    -3.69 ± 24.389
        Wk48,n=97,91,na,na,28,29,20,19,79,13,14
    -6.19 ± 18.912
    -7.63 ± 21.682
    9999 ± 9999
    9999 ± 9999
    -10.49 ± 25.564
    -4.76 ± 15.784
    -1.43 ± 33.122
    -6.97 ± 13.68
    -13.9 ± 25.636
    -3.5 ± 21.343
    -4.48 ± 16.918
        Wk52,n=95,92,na,na,29,28,20,18,83,16,16
    -6.68 ± 26.24
    -8.14 ± 22.149
    9999 ± 9999
    9999 ± 9999
    -4.63 ± 25.795
    -4.79 ± 22.882
    2.95 ± 9.88
    -4.88 ± 11.707
    -11.19 ± 27.768
    -6.73 ± 14.972
    -5.78 ± 18.534
    No statistical analyses for this end point

    Secondary: Change from baseline in Erythrocyte Sedimentation Rate (ESR) - observed data

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    End point title
    		 Change from baseline in Erythrocyte Sedimentation Rate (ESR) - observed data
    End point description
    Blood samples were obtained to monitor disease activity and response to treatment. A negative change from baseline indicates improvement. The ESR results from baseline up to week 52 were based on observed data, i.e. without imputation.
    End point type
    Secondary
    End point timeframe
    baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    		 AIN457 10mg/kg - 75 mg AIN457 10mg/kg - 150 mg Placebo Abatacept Placebo non-responder - AIN457 75mg Placebo non-responder - AIN457 150mg Placebo responder - AIN457 75mg Placebo responder - AIN457 150mg Abatacept responders Abatacept non-responders - AIN457 75mg Abatacept non-responders - AIN457 150mg
    Number of subjects analysed
    138
    137
    138
    138
    39
    39
    23
    22
    101
    18
    19
    Units: mm/hr
    arithmetic mean (standard deviation)
        Wk1,n=133,130,131,131,39,36,21,22,97,17,17,
    -7.5 ± 18.74
    -8.4 ± 19.2
    -5.7 ± 15.68
    -9.5 ± 16.55
    -8.4 ± 12.65
    -1.1 ± 18.88
    -5.7 ± 14.97
    -7.1 ± 13.22
    -10.2 ± 17.11
    -7.7 ± 13.9
    -7.2 ± 16.3
        Wk2,n=133,130,135,134,39,36,23,22,99,17,18
    -12.2 ± 19.06
    -10.5 ± 19.05
    -5.7 ± 18.22
    -11 ± 19.5
    -4 ± 12.69
    -5.6 ± 26.44
    -9.7 ± 17.86
    -6.6 ± 14.44
    -10.2 ± 20.33
    -12.5 ± 16.71
    -13.6 ± 17.78
        Wk4,n=133,135,131,133,39,39,23,21,97,17,19
    -12.7 ± 22.23
    -12.1 ± 21.88
    -6 ± 18.9
    -12.6 ± 18.14
    -3.7 ± 14.35
    -3.8 ± 20.5
    -9.3 ± 13.81
    -8.2 ± 23.89
    -12.3 ± 18.66
    -15.8 ± 17.49
    -11.3 ± 16.46
        Wk8,n=133,129,131,132,39,39,23,22,96,17,19
    -15.4 ± 20.38
    -15.7 ± 21.62
    -6.4 ± 22.72
    -17.6 ± 20.89
    -9.4 ± 19.24
    -0.9 ± 27.25
    -8.2 ± 24.09
    -8.3 ± 14.29
    -18.3 ± 21.56
    -13.9 ± 23.29
    -17.6 ± 15.03
        Wk12,n=133,118,127,131,39,39,23,21,96,17,18
    -14.7 ± 20.08
    -18.4 ± 21.18
    -5.8 ± 21.02
    -19.4 ± 20.97
    -5.9 ± 17.96
    -1.5 ± 25.62
    -11.2 ± 18.06
    -5.5 ± 20.06
    -19.9 ± 21.08
    -18.4 ± 23.07
    -17.9 ± 19.31
        Wk16,n=129,121,122,130,36,38,21,22,95,16,19
    -16.2 ± 21.22
    -15.6 ± 19.09
    -6.5 ± 23.48
    -18.5 ± 24.32
    -3.1 ± 19.21
    -1.1 ± 25.47
    -17.6 ± 23.03
    -4.9 ± 20.54
    -21.1 ± 24.73
    -14.9 ± 17.78
    -8.8 ± 25.22
        Wk20,n=123,116,120,127,38,37,23,21,91,17,19
    -16.3 ± 20.9
    -17.7 ± 19.9
    -9.1 ± 26.29
    -21.1 ± 23.66
    -21.1 ± 23.66
    -10.5 ± 20.08
    -7.4 ± 29.4
    -11.6 ± 34.23
    -7 ± 22.32
    -22 ± 23.6
    -20.5 ± 22.81
        Wk24,n=122,113,117,123,38,36,21,22,88,17,18
    -13.9 ± 23.65
    -16 ± 20.2
    -12 ± 24.31
    -19.6 ± 24.52
    -10.8 ± 20.33
    -14.7 ± 27.77
    -16.1 ± 21.57
    -5.5 ± 27.07
    -21.1 ± 24.62
    -20.7 ± 20.65
    -11.4 ± 26.96
        Wk28,n=119,110,na,na,34,35,21,21,89,17,19
    -15.4 ± 22.95
    -16.8 ± 23.05
    9999 ± 9999
    9999 ± 9999
    -17.9 ± 24.87
    -12.5 ± 30.87
    -12.3 ± 24.1
    -14.6 ± 17.31
    -22.4 ± 22.9
    -26.1 ± 19.83
    -17.4 ± 24.77
        Wk32,n=108,101,na,na,34,32,21,21,88,17,16
    -18.3 ± 23.51
    -17.4 ± 21.57
    9999 ± 9999
    9999 ± 9999
    -17.2 ± 16.7
    -12.8 ± 26.21
    -16.8 ± 24.37
    -14.1 ± 20.72
    -25.5 ± 24.89
    -25.7 ± 21.14
    -23.1 ± 21.46
        Wk36,n=107,98,na,na,32,31,21,20,87,18,16
    -16.6 ± 25.2
    -18.4 ± 21.51
    9999 ± 9999
    9999 ± 9999
    -17.8 ± 21.72
    -13.4 ± 29.49
    -17.3 ± 22.02
    -16.5 ± 17.95
    -21.7 ± 25.4
    -26 ± 21.21
    -16.6 ± 23.31
        Wk40,n=101,96,na,na,29,29,22,20,85,15,17
    -18.1 ± 21.06
    -17.3 ± 21.05
    9999 ± 9999
    9999 ± 9999
    -20.6 ± 19.66
    -12.3 ± 26.37
    -13.3 ± 18.78
    -16.4 ± 21.79
    -22.2 ± 26.24
    -23.8 ± 22.96
    -22.9 ± 15.57
        Wk44,n=98,93,na,na,28,28,20,19,85,15,16
    -18 ± 21.08
    -16.7 ± 23.87
    9999 ± 9999
    9999 ± 9999
    -20.1 ± 17.61
    -16 ± 25.3
    -12 ± 29.2
    -19.2 ± 22.57
    -24.9 ± 25.66
    -22.3 ± 23.36
    -18.5 ± 21
        Wk48,n=97,92,na,na,28,30,20,19,79,13,14
    -17.8 ± 23.11
    -19.8 ± 20.3
    9999 ± 9999
    9999 ± 9999
    -20.8 ± 18.26
    -7.2 ± 22.58
    -12.2 ± 29.55
    -19.4 ± 20.58
    -23.9 ± 25.56
    -18.9 ± 26.41
    -20.2 ± 18.16
        Wk52,n=94,91,na,na,29,28,20,18,83,16,16
    -17.7 ± 21.08
    -20.6 ± 23.48
    9999 ± 9999
    9999 ± 9999
    -14.9 ± 20.53
    -15.1 ± 21.5
    -14.4 ± 24.54
    -13.6 ± 27.16
    -25.2 ± 27.88
    -27.4 ± 22.71
    -15.4 ± 22.53
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Any AIN457 75 mg
    Reporting group description
    		 Any AIN457 75mg included patients who originally were randomized to this treatment and placebo/abatacept-switchers to this dose.

    Reporting group title
    Any AIN457 150 mg
    Reporting group description
    		 Any AIN457 150mg included patients who originally were randomized to this treatment and placebo/abatacept-switchers to this dose.

    Reporting group title
    Any AIN457
    Reporting group description
    		 Any AIN457 included patients who originally were randomized to AIN457 75 mg or AIN457 150mg and placebo/abatacept-switchers to this dose.

    Reporting group title
    Abatacept
    Reporting group description
    		 Abatacept

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 Any AIN457 75 mg Any AIN457 150 mg Any AIN457 Abatacept Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 218 (13.76%)
    28 / 215 (13.02%)
    58 / 433 (13.39%)
    9 / 137 (6.57%)
    7 / 139 (5.04%)
         number of deaths (all causes)
    3
    1
    4
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibroadenoma of breast
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 218 (0.46%)
    1 / 215 (0.47%)
    2 / 433 (0.46%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Venous thrombosis limb
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Cyst
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cystocele
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 218 (0.46%)
    1 / 215 (0.47%)
    2 / 433 (0.46%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    0 / 137 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural headache
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    0 / 137 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 218 (0.92%)
    0 / 215 (0.00%)
    2 / 433 (0.46%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    0 / 137 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Formication
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningorrhagia
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perineurial cyst
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    0 / 137 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    2 / 218 (0.92%)
    1 / 215 (0.47%)
    3 / 433 (0.69%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    0 / 137 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Sudden hearing loss
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    0 / 137 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal polyp
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 218 (0.46%)
    1 / 215 (0.47%)
    2 / 433 (0.46%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Acquired claw toe
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 218 (0.46%)
    1 / 215 (0.47%)
    2 / 433 (0.46%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 218 (0.92%)
    1 / 215 (0.47%)
    3 / 433 (0.69%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 218 (0.46%)
    1 / 215 (0.47%)
    2 / 433 (0.46%)
    0 / 137 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    0 / 218 (0.00%)
    2 / 215 (0.93%)
    2 / 433 (0.46%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 218 (0.00%)
    2 / 215 (0.93%)
    2 / 433 (0.46%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    4 / 218 (1.83%)
    2 / 215 (0.93%)
    6 / 433 (1.39%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 7
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 218 (0.00%)
    2 / 215 (0.93%)
    2 / 433 (0.46%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye abscess
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 218 (0.46%)
    1 / 215 (0.47%)
    2 / 433 (0.46%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    0 / 137 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster oticus
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint abscess
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 215 (0.00%)
    0 / 433 (0.00%)
    1 / 137 (0.73%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 215 (0.00%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 215 (0.47%)
    1 / 433 (0.23%)
    0 / 137 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Any AIN457 75 mg Any AIN457 150 mg Any AIN457 Abatacept Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    110 / 218 (50.46%)
    114 / 215 (53.02%)
    224 / 433 (51.73%)
    58 / 137 (42.34%)
    36 / 139 (25.90%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    20 / 218 (9.17%)
    10 / 215 (4.65%)
    30 / 433 (6.93%)
    5 / 137 (3.65%)
    4 / 139 (2.88%)
         occurrences all number
    25
    10
    35
    5
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 218 (8.26%)
    11 / 215 (5.12%)
    29 / 433 (6.70%)
    9 / 137 (6.57%)
    4 / 139 (2.88%)
         occurrences all number
    23
    12
    35
    10
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    10 / 218 (4.59%)
    10 / 215 (4.65%)
    20 / 433 (4.62%)
    6 / 137 (4.38%)
    8 / 139 (5.76%)
         occurrences all number
    12
    10
    22
    6
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    16 / 218 (7.34%)
    12 / 215 (5.58%)
    28 / 433 (6.47%)
    9 / 137 (6.57%)
    0 / 139 (0.00%)
         occurrences all number
    22
    16
    38
    9
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    17 / 218 (7.80%)
    15 / 215 (6.98%)
    32 / 433 (7.39%)
    5 / 137 (3.65%)
    1 / 139 (0.72%)
         occurrences all number
    26
    20
    46
    7
    1
    Back pain
         subjects affected / exposed
    12 / 218 (5.50%)
    10 / 215 (4.65%)
    22 / 433 (5.08%)
    6 / 137 (4.38%)
    2 / 139 (1.44%)
         occurrences all number
    16
    11
    27
    6
    2
    Rheumatoid arthritis
         subjects affected / exposed
    19 / 218 (8.72%)
    22 / 215 (10.23%)
    41 / 433 (9.47%)
    6 / 137 (4.38%)
    6 / 139 (4.32%)
         occurrences all number
    24
    27
    51
    6
    8
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    10 / 218 (4.59%)
    12 / 215 (5.58%)
    22 / 433 (5.08%)
    5 / 137 (3.65%)
    0 / 139 (0.00%)
         occurrences all number
    11
    17
    28
    7
    0
    Influenza
         subjects affected / exposed
    7 / 218 (3.21%)
    13 / 215 (6.05%)
    20 / 433 (4.62%)
    1 / 137 (0.73%)
    1 / 139 (0.72%)
         occurrences all number
    7
    17
    24
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    24 / 218 (11.01%)
    17 / 215 (7.91%)
    41 / 433 (9.47%)
    8 / 137 (5.84%)
    4 / 139 (2.88%)
         occurrences all number
    42
    33
    75
    11
    7
    Rhinitis
         subjects affected / exposed
    8 / 218 (3.67%)
    12 / 215 (5.58%)
    20 / 433 (4.62%)
    3 / 137 (2.19%)
    1 / 139 (0.72%)
         occurrences all number
    10
    15
    25
    3
    1
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 218 (8.26%)
    21 / 215 (9.77%)
    39 / 433 (9.01%)
    6 / 137 (4.38%)
    9 / 139 (6.47%)
         occurrences all number
    28
    34
    62
    7
    9
    Urinary tract infection
         subjects affected / exposed
    16 / 218 (7.34%)
    10 / 215 (4.65%)
    26 / 433 (6.00%)
    8 / 137 (5.84%)
    2 / 139 (1.44%)
         occurrences all number
    19
    10
    29
    8
    3
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    7 / 218 (3.21%)
    7 / 215 (3.26%)
    14 / 433 (3.23%)
    10 / 137 (7.30%)
    6 / 139 (4.32%)
         occurrences all number
    7
    7
    14
    10
    6
    Hyperlipidaemia
         subjects affected / exposed
    6 / 218 (2.75%)
    11 / 215 (5.12%)
    17 / 433 (3.93%)
    1 / 137 (0.73%)
    2 / 139 (1.44%)
         occurrences all number
    6
    11
    17
    1
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Aug 2011
    Amendment 1 introduced the following changes: Wording on the patient number for re-screened patient was removed. Each patient was tracked using a unique patient identifier, that was applied within the database but not visible for the investigator and therefore the sentence was misleading. A serum biomarker sample log was added. Typographic errors were corrected and some sentences clarified. The changes described in this amended protocol were non- substantial and did not requireIRB/IEC approval prior to implementation.
    08 Jan 2014
    Amendment 2 introduced the following change(s): Amending the handling of missing values in the analysis plan in line with guidance received in discussions with FDA. The sequence of the hierarchical testing strategy was aligned with Draft FDA guidance released May 2013 for clinical trials in patients with rheumatoid arthritis. This placed more emphasis on DAS28 and parameters related to physical function, in particular HAQ-DI, and accounted for other data obtained from Phase IIb studies in the RA development program with secukinumab and newly available data from other RA programs. Implementing a full primary analysis after all patients completed 24 weeks replacing a potential futility analysis after 25-50% of patients had completed Week 16. Simplifying the protocol section on study drug preparations and administration, including removing details covered in pharmacist manual. This resulted in improved patient convenience for the remainder of the trial, as patient did not have to stay at site for a mandatory length of time after administration of study drug was completed. Providing investigator with more flexibility to be able to apply own best clinical judgment when study treatment interruptions for safety reasons were indicated, and clarification of the requirements to be observed with regards to live vaccines. Clarification on the restrictions with regards to concomitant medications, mostly to clarify what had to be followed (otherwise considered protocol deviation) as compared to what is only a general guidance (indicated by words like ‘should’). Clarification that any laboratory abnormalities that in the judgment of the investigator were clinically significant and were deemed to place the patient at a safety risk for continuation in the study should result in study treatment discontinuation, and updated general guidance for investigators with regards to notable laboratory abnormalities for the most relevant lab parameters.

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.
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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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