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    Clinical Trial Results:
    A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome

    Summary
    EudraCT number
    		 2016-001948-19
    Trial protocol
    		 SE   CZ   FR   IT  
    Global end of trial date
    23 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Oct 2020
    First version publication date
    30 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IM101-603
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to compare the mean change from baseline (Day 1) to Day 169 in ESSDAI of abatacept versus placebo in subjects with moderate to severe primary Sjögrens Syndrome (pSS).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Dec 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 16
    Country: Number of subjects enrolled
    Australia: 33
    Country: Number of subjects enrolled
    Brazil: 49
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Japan: 37
    Country: Number of subjects enrolled
    Korea, Republic of: 10
    Country: Number of subjects enrolled
    Mexico: 16
    Country: Number of subjects enrolled
    Puerto Rico: 2
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    United States: 46
    Worldwide total number of subjects
    249
    EEA total number of subjects
    40
    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)
    201
    From 65 to 84 years
    47
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 250 enrolled; 188 Randomized, 62 not Randomized:Reasons Not randomized: 6 withdrew consent, 1 lost to follow-up, 49 no longer meet study criteria, 6 screening failures

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Abatacept - Double Blind Treatment Period
    Arm description
    		 Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abatacept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    125 mg/mL IV syringe

    Arm title
    		 Placebo - Double Blind Treatment Period
    Arm description
    		 Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    1 mL pre-filled syringes

    Number of subjects in period 1 [1]
    		Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Started
    92
    95
    Completed
    81
    87
    Not completed
    11
    8
         poor/non-compliance
    1
    -
         Participant withdrew consent
    5
    1
         Adverse event, non-fatal
    2
    2
         Request to discontinue treatment
    1
    2
         Participant no longer meets criteria
    2
    -
         Lack of efficacy
    -
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 250 enrolled; 188 Randomized, 62 not Randomized:Reasons Not randomized: 6 withdrew consent, 1 lost to follow-up, 49 no longer meet study criteria, 6 screening failures

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Abatacept - Double Blind Treatment Period
    Reporting group description
    		 Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe

    Reporting group title
    Placebo - Double Blind Treatment Period
    Reporting group description
    		 Double Blind Treatment Period SC injection in 1 mL pre-filled syringe

    Reporting group values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period Total
    Number of subjects
    		 92 95 187
    Age Categorical
    Categorical Age Dispersion
    Units: Participants
        < 65 years
    		 80 73 153
        ≥ 65 years
    		 12 22 34
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 51.2 ± 12.3 52.9 ± 13.5 -
    Sex: Female, Male
    Units: Participants
        Female
    		 85 92 177
        Male
    		 7 3 10
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 21 23 44
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 10 9 19
        White
    		 60 60 120
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 1 3 4
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 5 7
        Not Hispanic or Latino
    		 10 13 23
        Unknown or Not Reported
    		 80 77 157

    End points

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    End points reporting groups
    Reporting group title
    Abatacept - Double Blind Treatment Period
    Reporting group description
    		 Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe

    Reporting group title
    Placebo - Double Blind Treatment Period
    Reporting group description
    		 Double Blind Treatment Period SC injection in 1 mL pre-filled syringe

    Subject analysis set title
    Abatacept - Open Label Treatment Period
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Open Label Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe

    Subject analysis set title
    Abatacept - Open Label Treatment Period
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe

    Primary: Change from Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

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    End point title
    		 Change from Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
    End point description
    The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm. Domain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2) (No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA) Overall score, which can range from 0 to 123, a higher score indicates more disease activity
    End point type
    Primary
    End point timeframe
    Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Score on a Scale
        arithmetic mean (confidence interval 95%)
    -3.2 (-4.6 to -1.9)
    -3.7 (-5.0 to -2.4)
    Statistical analysis title
    		 Change from baseline in EULAR
    Comparison groups
    Abatacept - Double Blind Treatment Period v Placebo - Double Blind Treatment Period
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4421
    Method
    		 longitudinal repeated measures analysis
    Confidence interval

    Secondary: Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)

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    End point title
    		 Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)
    End point description
    The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components. Total Score Range (0 = Best outcome and 10 = Worst Outcome) The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren’s syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Score on a Scale
        arithmetic mean (confidence interval 95%)
    -1.26 (-1.88 to -0.64)
    -1.52 (-2.12 to -0.93)
    Statistical analysis title
    		 Change from baseline in EULAR
    Comparison groups
    Abatacept - Double Blind Treatment Period v Placebo - Double Blind Treatment Period
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3367
    Method
    		 longitudinal repeated measures analysis
    Confidence interval

    Secondary: Change from Baseline in the Stimulated Whole Salivary Flow

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    End point title
    		 Change from Baseline in the Stimulated Whole Salivary Flow
    End point description
    The mean change from baseline in the stimulated whole salivary flow at Day 169
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    88
    88
    Units: mL/min
        arithmetic mean (confidence interval 95%)
    0.057 (-0.115 to 0.230)
    0.108 (-0.060 to 0.276)
    Statistical analysis title
    		 Change from baseline
    Comparison groups
    Abatacept - Double Blind Treatment Period v Placebo - Double Blind Treatment Period
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5841
    Method
    		 longitudinal repeated measures analysis
    Confidence interval

    Secondary: Change from Baseline of DAS28-C-reactive peptide (CRP): In The Full Population

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    End point title
    		 Change from Baseline of DAS28-C-reactive peptide (CRP): In The Full Population
    End point description
    The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(hsCRP+1) + 0.014 * VAS + 0.96. (sqrt = Square root, ln = natural log) Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Scores on a scale
    arithmetic mean (confidence interval 95%)
        Day 29
    -0.4 (-0.6 to -0.2)
    -0.4 (-0.6 to -0.2)
        Day 57
    -0.6 (-0.8 to -0.4)
    -0.7 (-0.9 to -0.4)
        Day 85
    -0.8 (-1.0 to -0.6)
    -0.8 (-1.1 to -0.6)
        Day 113
    -0.8 (-1.0 to -0.5)
    -1.0 (-1.2 to -0.7)
        Day 141
    -0.8 (-1.0 to -0.5)
    -1.0 (-1.3 to -0.8)
        Day 169
    -0.9 (-1.1 to -0.6)
    -1.1 (-1.4 to -0.9)
    No statistical analyses for this end point

    Secondary: Change from Baseline of DAS28-CRP: Tender Swollen joint count of at least 3

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    End point title
    		 Change from Baseline of DAS28-CRP: Tender Swollen joint count of at least 3
    End point description
    The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(hsCRP+1) + 0.014 * VAS + 0.96. (sqrt = Square root, ln = natural log) Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    57
    63
    Units: Scores on a scale
    arithmetic mean (confidence interval 95%)
        Day 29
    -0.5 (-0.8 to -0.2)
    -0.6 (-0.9 to -0.3)
        Day 57
    -0.9 (-1.2 to -0.5)
    -1.0 (-1.3 to -0.6)
        Day 85
    -1.1 (-1.5 to -0.7)
    -1.2 (-1.5 to -0.8)
        Day 113
    -1.1 (-1.4 to -0.7)
    -1.4 (-1.7 to -1.0)
        Day 141
    -1.2 (-1.5 to -0.8)
    -1.5 (-1.8 to -1.1)
        Day 169
    -1.3 (-1.7 to -0.9)
    -1.5 (-1.9 to -1.2)
    No statistical analyses for this end point

    Secondary: Change from Baseline of DAS28-CRP: Tender Swollen Joints count less than 3

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    End point title
    		 Change from Baseline of DAS28-CRP: Tender Swollen Joints count less than 3
    End point description
    The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(hsCRP+1) + 0.014 * VAS + 0.96. (sqrt = Square root, ln = natural log) Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    35
    31
    Units: Scores on a scale
    arithmetic mean (confidence interval 95%)
        Day 29
    -0.3 (-0.6 to 0.0)
    -0.2 (-0.6 to 0.1)
        Day 57
    -0.2 (-0.5 to 0.1)
    -0.2 (-0.5 to 0.1)
        Day 85
    -0.4 (-0.6 to -0.1)
    -0.4 (-0.7 to -0.1)
        Day 113
    -0.3 (-0.6 to -0.0)
    -0.3 (-0.6 to -0.1)
        Day 141
    -0.2 (-0.5 to 0.1)
    -0.4 (-0.7 to -0.0)
        Day 169
    -0.3 (-0.5 to -0.0)
    -0.5 (-0.7 to -0.2)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Joint component of DAS28-CRP: In the full population

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    End point title
    		 Change from Baseline in the Joint component of DAS28-CRP: In the full population
    End point description
    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. Tender Joint: Count 1-28 Swollen Joint: Count 1-28 Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Joint Count
    arithmetic mean (confidence interval 95%)
        Day 29 - Tender Joint
    -1.7 (-2.8 to -0.7)
    -1.9 (-2.9 to -0.8)
        Day 29 - Swollen Joint
    -0.5 (-1.0 to 0.1)
    -0.6 (-1.1 to -0.1)
        Day 57 - Tender Joint
    -2.6 (-3.7 to -1.5)
    -2.9 (-4.0 to -1.9)
        Day 57 - Swollen Joint
    -1.0 (-1.6 to -0.3)
    -1.0 (-1.6 to -0.4)
        Day 85 - Tender Joint
    -2.9 (-4.1 to -1.7)
    -3.4 (-4.6 to -2.2)
        Day 85 - Swollen Joint
    -1.4 (-2.0 to -0.8)
    -1.4 (-2.0 to -0.9)
        Day 113 - Tender Joint
    -3.1 (-4.2 to -2.0)
    -3.9 (-5.0 to -2.8)
        Day 113 - Swollen Joint
    -1.5 (-2.0 to -1.1)
    -1.9 (-2.3 to -1.4)
        Day 141 - Tender Joint
    -3.6 (-4.7 to -2.5)
    -4.1 (-5.2 to -3.0)
        Day 141 - Swollen Joint
    -1.4 (-1.9 to -0.8)
    -1.8 (-2.4 to -1.3)
        Day 169 - Tender Joint
    -2.9 (-4.0 to -1.7)
    -4.4 (-5.6 to -3.3)
        Day 169 - Swollen Joint
    -1.4 (-1.9 to -0.8)
    -2.0 (-2.6 to -1.5)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the CRP component of DAS28-CRP: In the full population

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    End point title
    		 Change from Baseline in the CRP component of DAS28-CRP: In the full population
    End point description
    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. CRP: measured lab value Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: mg/L
    arithmetic mean (confidence interval 95%)
        Day 29 - CRP
    0.3 (-1.4 to 2.0)
    0.6 (-1.0 to 2.3)
        Day 57 - CRP
    -0.1 (-2.1 to 1.8)
    1.8 (-0.1 to 3.6)
        Day 85 - CRP
    -0.2 (-5.0 to 4.5)
    3.0 (-1.6 to 7.6)
        Day 113 - CRP
    1.6 (-0.8 to 4.1)
    0.3 (-2.1 to 2.6)
        Day 141 - CRP
    3.5 (-1.7 to 8.8)
    -0.2 (-5.2 to 4.7)
        Day 169 - CRP
    -0.2 (-1.8 to 1.3)
    0.0 (-1.5 to 1.5)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Assessment of Disease Activity component of DAS28-CRP: In the full population

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    End point title
    		 Change from Baseline in the Assessment of Disease Activity component of DAS28-CRP: In the full population
    End point description
    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. Assesment of Disease Activity: 0-100 scale [100=Most severe] Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Scores on a Scale
    arithmetic mean (confidence interval 95%)
        Day 29 - Assessment of Disease Activity
    -4.0 (-9.8 to 1.7)
    -7.1 (-12.7 to -1.4)
        Day 57 - Assessment of Disease Activity
    -7.5 (-13.4 to -1.7)
    -6.3 (-11.9 to -0.6)
        Day 85 - Assessment of Disease Activity
    -10.4 (-16.3 to -4.4)
    -10.2 (-16.0 to -4.4)
        Day 113 - Assessment of Disease Activity
    -8.0 (-14.0 to -2.0)
    -9.7 (-15.5 to -3.9)
        Day 141 - Assessment of Disease Activity
    -5.1 (-11.0 to 0.8)
    -11.0 (-16.7 to -5.3)
        Day 169 - Assessment of Disease Activity
    -10.1 (-16.1 to -4.0)
    -9.0 (-14.8 to -3.1)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Joint Component of DAS28-CRP: Tender Swollen joints of at least 3

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    End point title
    		 Change from Baseline in the Joint Component of DAS28-CRP: Tender Swollen joints of at least 3
    End point description
    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. Tender Joint: Count 1-28 Swollen Joint: Count 1-28 Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    57
    63
    Units: Joint Count
    arithmetic mean (confidence interval 95%)
        Day 29 - Tender Joint
    -2.8 (-4.5 to -1.0)
    -3.0 (-4.7 to -1.3)
        Day 29 - Swollen Joint
    -0.7 (-1.5 to 0.2)
    -0.9 (-1.7 to -0.1)
        Day 57 - Tender Joint
    -4.1 (-5.9 to -2.3)
    -4.8 (-6.5 to -3.0)
        Day 57 - Swollen Joint
    -1.5 (-2.6 to -0.5)
    -1.6 (-2.6 to -0.5)
        Day 85 - Tender Joint
    -4.4 (-6.3 to -2.4)
    -5.4 (-7.2 to -3.6)
        Day 85 - Swollen Joint
    -2.1 (-3.1 to -1.1)
    -2.2 (-3.2 to -1.3)
        Day 113 - Tender Joint
    -4.8 (-6.6 to -2.9)
    -6.0 (-7.7 to -4.2)
        Day 113 - Swollen Joint
    -2.3 (-3.2 to -1.5)
    -2.9 (-3.7 to -2.2)
        Day 141 - Tender Joint
    -5.7 (-7.5 to -3.8)
    -6.4 (-8.2 to -4.7)
        Day 141 - Swollen Joint
    -2.2 (-3.1 to -1.3)
    -3.0 (-3.8 to -2.1)
        Day 169 - Tender Joint
    -4.6 (-6.5 to -2.7)
    -6.7 (-8.5 to -4.9)
        Day 169 - Swollen Joint
    -2.2 (-3.1 to -1.3)
    -3.1 (-4.0 to -2.3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the CRP component of DAS28-CRP: Tender Swollen joints of at least 3

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    End point title
    		 Change from Baseline in the CRP component of DAS28-CRP: Tender Swollen joints of at least 3
    End point description
    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. CRP: measured lab value Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    57
    63
    Units: mg/L
    arithmetic mean (confidence interval 95%)
        Day 29 - CRP
    -1.5 (-3.7 to 0.7)
    -0.7 (-2.8 to 1.4)
        Day 57 - CRP
    -1.3 (-4.3 to 1.7)
    1.3 (-1.5 to 4.0)
        Day 85 - CRP
    -2.2 (-9.8 to 5.5)
    3.8 (-3.4 to 11.0)
        Day 113 - CRP
    1.2 (-2.7 to 5.1)
    -0.4 (-4.0 to 3.2)
        Day 141 - CRP
    4.5 (-4.0 to 12.9)
    -1.4 (-9.0 to 6.3)
        Day 169 - CRP
    -1.4 (-3.9 to 1.1)
    -0.7 (-3.0 to 1.6)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Assessment of Disease Activity component of DAS28-CRP: Tender Swollen joints of at least 3

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    End point title
    		 Change from Baseline in the Assessment of Disease Activity component of DAS28-CRP: Tender Swollen joints of at least 3
    End point description
    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. Assesment of Disease Activity: 0-100 scale [100=Most severe] Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    57
    63
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Day 29 - Assessment of Disease Activity
    0.6 (-6.9 to 8.1)
    -3.5 (-10.7 to 3.7)
        Day 57 - Assessment of Disease Activity
    -3.5 (-11.5 to 4.5)
    -6.5 (-14.0 to 1.1)
        Day 85 - Assessment of Disease Activity
    -7.5 (-15.5 to 0.4)
    -7.7 (-15.3 to -0.1)
        Day 113 - Assessment of Disease Activity
    -6.6 (-14.4 to 1.3)
    -9.1 (-16.5 to -1.6)
        Day 141 - Assessment of Disease Activity
    -1.2 (-9.0 to 6.7)
    -8.1 (-15.5 to -0.7)
        Day 169 - Assessment of Disease Activity
    -6.7 (-14.9 to 1.5)
    -7.8 (-15.5 to -0.0)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Joint component of DAS28-CRP: Tender Swollen joint count less than 3

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    End point title
    		 Change from Baseline in the Joint component of DAS28-CRP: Tender Swollen joint count less than 3
    End point description
    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. Tender Joint: Count 1-28 Swollen Joint: Count 1-28 Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    35
    31
    Units: Joint Count
    arithmetic mean (confidence interval 95%)
        Day 29 - Tender Joint
    -0.1 (-0.9 to 0.6)
    -0.2 (-0.9 to 0.6)
        Day 29 - Swollen Joint
    0.1 (-0.2 to 0.3)
    0.1 (-0.2 to 0.4)
        Day 57 - Tender Joint
    -0.2 (-0.9 to 0.6)
    0.1 (-0.6 to 0.9)
        Day 57 - Swollen Joint
    0.2 (-0.1 to 0.4)
    0.0 (-0.2 to 0.3)
        Day 85 - Tender Joint
    -0.5 (-1.3 to 0.2)
    0.1 (-0.7 to 0.8)
        Day 85 - Swollen Joint
    -0.0 (-0.3 to 0.2)
    0.1 (-0.2 to 0.4)
        Day 113 - Tender Joint
    -0.4 (-1.2 to 0.3)
    -0.5 (-1.3 to 0.3)
        Day 113 - Swollen Joint
    0.0 (-0.3 to 0.3)
    0.1 (-0.2 to 0.4)
        Day 141 - Tender Joint
    -0.2 (-1.0 to 0.6)
    -0.2 (-1.0 to 0.6)
        Day 141 - Swollen Joint
    0.2 (-0.1 to 0.5)
    0.3 (0.0 to 0.6)
        Day 169 - Tender Joint
    -0.1 (-0.9 to 0.7)
    -0.7 (-1.4 to 0.1)
        Day 169 - Swollen Joint
    0.2 (-0.1 to 0.5)
    -0.0 (-0.3 to 0.2)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the CRP component of DAS28-CRP: Tender Swollen joint count less than 3

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    End point title
    		 Change from Baseline in the CRP component of DAS28-CRP: Tender Swollen joint count less than 3
    End point description
    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. CRP: measured lab value Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    35
    31
    Units: mg/L
    arithmetic mean (confidence interval 95%)
        Day 29 - CRP
    2.1 (-0.8 to 4.9)
    1.8 (-1.2 to 4.7)
        Day 57 - CRP
    0.5 (-2.3 to 3.4)
    1.0 (-1.9 to 3.9)
        Day 85 - CRP
    1.4 (-1.5 to 4.3)
    0.1 (-2.8 to 3.1)
        Day 113 - CRP
    1.3 (-1.6 to 4.1)
    0.1 (-2.8 to 3.1)
        Day 141 - CRP
    0.7 (-2.2 to 3.6)
    0.8 (-2.1 to 3.8)
        Day 169 - CRP
    0.2 (-2.7 to 3.1)
    0.2 (-2.8 to 3.1)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Assessment of Disease Activity component of DAS28-CRP: Tender Swollen joint count less than 3

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    End point title
    		 Change from Baseline in the Assessment of Disease Activity component of DAS28-CRP: Tender Swollen joint count less than 3
    End point description
    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. Assesment of Disease Activity: 0-100 scale [100=Most severe] Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    35
    31
    Units: Scores on a Scale
    arithmetic mean (confidence interval 95%)
        Day 29 - Assessment of Disease Activity
    -10.3 (-19.3 to -1.4)
    -11.8 (-21.3 to -2.3)
        Day 57 - Assessment of Disease Activity
    -12.4 (-21.4 to -3.4)
    -4.8 (-14.3 to 4.7)
        Day 85 - Assessment of Disease Activity
    -14.0 (-23.0 to -5.0)
    -13.5 (-23.0 to -4.0)
        Day 113 - Assessment of Disease Activity
    -9.1 (-18.1 to -0.0)
    -11.1 (-20.6 to -1.5)
        Day 141 - Assessment of Disease Activity
    -10.6 (-19.8 to -1.5)
    -15.3 (-24.8 to -5.7)
        Day 169 - Assessment of Disease Activity
    -13.8 (-23.0 to -4.6)
    -10.9 (-20.5 to -1.4)
    No statistical analyses for this end point

    Secondary: Participants who achieve minimally clinically important change in ESSDAI in at least 3 points

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    End point title
    		 Participants who achieve minimally clinically important change in ESSDAI in at least 3 points
    End point description
    Proportion of participants who achieve a minimally clinically important change (of at least 3 points) in the ESSDAI at all measured time points up to Day 169.
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Percentage
    number (confidence interval 95%)
        Day 29
    37 (27.1 to 47.7)
    34.7 (25.3 to 45.2)
        Day 57
    37 (27.1 to 47.7)
    44.2 (34.0 to 54.8)
        Day 85
    48.9 (38.3 to 59.6)
    50.5 (40.1 to 60.9)
        Day 113
    55.4 (44.7 to 65.8)
    50.5 (40.1 to 60.9)
        Day 141
    51.1 (40.4 to 61.7)
    56.8 (46.3 to 67.0)
        Day 169
    55.4 (44.7 to 65.8)
    57.9 (47.3 to 68.0)
    No statistical analyses for this end point

    Secondary: Participants who achieve minimally clinically important change in ESSDAI in at least 5 points

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    End point title
    		 Participants who achieve minimally clinically important change in ESSDAI in at least 5 points
    End point description
    Proportion of participants who achieve a minimally clinically important change (of at least 5 points) in the ESSDAI at all measured time points up to Day 169.
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Percentage
    number (confidence interval 95%)
        Day 29
    19.6 (12.0 to 29.1)
    13.7 (7.5 to 22.3)
        Day 57
    26.1 (17.5 to 36.3)
    24.2 (16.0 to 34.1)
        Day 85
    34.8 (25.1 to 45.4)
    32.6 (23.4 to 43.0)
        Day 113
    37.0 (27.1 to 47.7)
    36.8 (27.2 to 47.4)
        Day 141
    37.0 (27.1 to 47.7)
    36.8 (31.1 to 51.6)
        Day 169
    35.9 (26.1 to 46.5)
    46.3 (36.0 to 56.8)
    No statistical analyses for this end point

    Secondary: Participants who achieve minimally clinically important change in ESSPRI in at least 1 point

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    End point title
    		 Participants who achieve minimally clinically important change in ESSPRI in at least 1 point
    End point description
    Proportion of participants who achieve a minimally clinically important change (of at least 1 point) in the ESSPRI at all measured time points up to Day 169.
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Percentage
    number (confidence interval 95%)
        Day 29
    31.5 (22.2 to 42.0)
    38.9 (29.1 to 49.5)
        Day 57
    42.4 (32.1 to 53.1)
    47.4 (37.0 to 57.9)
        Day 85
    44.6 (34.2 to 55.3)
    55.8 (45.2 to 66.0)
        Day 113
    42.4 (32.1 to 53.1)
    52.6 (42.1 to 63.0)
        Day 141
    40.2 (30.1 to 51.0)
    54.7 (44.2 to 65.0)
        Day 169
    41.3 (31.1 to 52.1)
    52.6 (42.1 to 63.0)
    No statistical analyses for this end point

    Secondary: Change from baseline at all measured time points in the ESSDAI

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    End point title
    		 Change from baseline at all measured time points in the ESSDAI
    End point description
    The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm. Domain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2) (No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA) Overall score, which can range from 0 to 123, a higher score indicates more disease activity
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Percent Change from Baseline
    arithmetic mean (confidence interval 95%)
        Day 29
    -10.9 (-22.3 to 0.54)
    -12.6 (-23.71 to -1.39)
        Day 57
    -24.1 (-36.10 to -12.08)
    -18.9 (-30.52 to -7.32)
        Day 85
    -26.0 (-38.81 to -13.17)
    -25.4 (-37.76 to -13.01)
        Day 113
    -34.1 (-46.8 to -21.34)
    -32.1 (-44.35 to -19.83)
        Day 141
    -29.7 (-43.02 to -16.31)
    -37.0 (-49.81 to -24.12)
        Day 169
    -33.4 (-46.54 to -20.24)
    -37.6 (-50.24 to -25.02)
    No statistical analyses for this end point

    Secondary: Change from baseline at all measured time points in the ESSPRI

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    End point title
    		 Change from baseline at all measured time points in the ESSPRI
    End point description
    The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components. Total Score Range (0 = Best outcome and 10 = Worst Outcome) The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren’s syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Day 29
    -0.32 (-0.79 to 0.16)
    -0.54 (-1.00 to -0.08)
        Day 57
    -0.81 (-1.32 to -0.31)
    -0.82 (-1.31 to -0.33)
        Day 85
    -0.83 (-1.34 to -0.32)
    -1.20 (-1.70 to -0.70)
        Day 113
    -0.79 (-1.32 to -0.26)
    -1.37 (-1.88 to -0.86)
        Day 141
    -0.87 (-1.40 to -0.35)
    -1.32 (-1.83 to -0.81)
        Day 169
    -1.03 (-1.55 to -0.50)
    -1.30 (-1.80 to -0.79)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Components of ESSDAI

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    End point title
    		 Change from Baseline in Components of ESSDAI
    End point description
    The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm. Domain: (Score for activity level) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2) (No = No Disease Activity, Low = Low Disease Activity, Moderate = Moderate Disease Activity, High = High Disease Activity)
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Day 29: Constitutional
    -0.3 (-0.4 to -0.1)
    -0.4 (-0.5 to -0.2)
        Day 29: Lymphadenopathy
    -0.6 (-1.0 to -0.2)
    -0.5 (-0.9 to -0.2)
        Day 29: Glandular
    -0.2 (-0.4 to 0.0)
    -0.2 (-0.4 to 0.0)
        Day 29: Articular
    -0.4 (-0.8 to 0.0)
    -0.3 (-0.7 to 0.1)
        Day 29: Cutaneous
    -0.3 (-0.6 to -0.0)
    -0.2 (-0.5 to 0.1)
        Day 29: Pulmonary
    0.0 (-0.3 to 0.3)
    0.1 (-0.2 to 0.4)
        Day 29: Renal
    -0.0 (-0.2 to 0.2)
    -0.2 (-0.3 to 0.0)
        Day 29: Muscular
    -0.0 (-0.1 to 0.1)
    -0.0 (-0.1 to 0.1)
        Day 29: Peripheral Nervous System
    -0.0 (-0.2 to 0.2)
    0.0 (-0.2 to 0.20)
        Day 29: Haematogical
    0.2 (-0.0 to 0.4)
    0.1 (-0.1 to 0.4)
        Day 29: Biological
    0.1 (-0.1 to 0.2)
    0.1 (-0.0 to 0.3)
        Day 57: Constitutional
    -0.2 (-0.4 to -0.0)
    -0.3 (-0.5 to -0.1)
        Day 57: Lymphadenopathy
    -0.7 (-1.1 to -0.2)
    -0.6 (-1.0 to -0.2)
        Day 57: Glandular
    -0.4 (-0.7 to -0.2)
    -0.4 (-0.6 to -0.1)
        Day 57: Articular
    -0.7 (-1.1 to -0.3)
    -0.8 (-1.2 to -0.4)
        Day 57: Cutaneous
    -0.3 (-0.6 to -0.0)
    -0.2 (-0.5 to 0.1)
        Day 57: Pulmonary
    -0.0 (-0.3 to 0.3)
    0.2 (-0.1 to 0.5)
        Day 57: Renal
    -0.0 (-0.2 to 0.2)
    -0.1 (-0.3 to 0.1)
        Day 57: Muscular
    -0.0 (-0.1 to 0.1)
    -0.1 (-0.2 to -0.0)
        Day 57: Peripheral Nervous System
    -0.0 (-0.2 to 0.2)
    0.0 (-0.2 to 0.2)
        Day 57: Haematological
    0.1 (-0.1 to 0.4)
    0.2 (-0.0 to 0.4)
        Day 57: Biological
    -0.1 (-0.2 to 0.1)
    0.0 (-0.1 to 0.2)
        Day 85: Constitutional
    -0.3 (-0.5 to -0.1)
    -0.4 (-0.6 to -0.2)
        Day 85: Lymphadenopathy
    -0.7 (-1.1 to -0.3)
    -0.8 (-1.2 to -0.4)
        Day 85: Glandular
    -0.4 (-0.6 to -0.1)
    -0.5 (-0.7 to -0.2)
        Day 85: Articular
    -1.0 (-1.5 to -0.6)
    -1.1 (-1.6 to -0.7)
        Day 85: Cutaneous
    -0.4 (-0.7 to -0.0)
    -0.2 (-0.5 to 0.1)
        Day 85: Pulmonary
    0.0 (-0.3 to 0.4)
    0.2 (-0.1 to 0.5)
        Day 85: Renal
    -0.1 (-0.3 to 0.1)
    -0.1 (-0.3 to 0.1)
        Day 85: Muscular
    -0.1 (-0.2 to 0.0)
    -0.0 (-0.1 to 0.1)
        Day 85: Peripheral Nervous System
    -0.0 (-0.2 to 0.2)
    0.0 (-0.2 to 0.2)
        Day 85: Haematological
    0.1 (-0.1 to 0.3)
    0.2 (-0.1 to 0.4)
        Day 85: Biological
    0.0 (-0.1 to 0.2)
    0.2 (0.0 to 0.3)
        Day 113: Constitutional
    -0.3 (-0.5 to -0.0)
    -0.3 (-0.5 to -0.1)
        Day 113: Lymphadenopathy
    -0.8 (-1.2 to -0.4)
    -0.9 (-1.3 to -0.5)
        Day 113: Glandular
    -0.5 (-0.7 to -0.3)
    -0.5 (-0.8 to -0.3)
        Day 113: Articular
    -1.3 (-1.8 to -0.8)
    -1.3 (-1.7 to -0.8)
        Day 113: Cutaneous
    -0.4 (-0.7 to -0.1)
    -0.4 (-0.7 to -0.1)
        Day 113: Pulmonary
    0.0 (-0.3 to 0.4)
    0.1 (-0.2 to 0.5)
        Day 113: Renal
    -0.1 (-0.3 to 0.1)
    0.0 (-0.2 to 0.2)
        Day 113: Muscular
    -0.0 (-0.1 to 0.1)
    -0.1 (-0.2 to 0.0)
        Day 113: Peripheral Nervous System
    -0.0 (-0.2 to 0.2)
    -0.0 (-0.2 to 0.1)
        Day 113: Haematological
    0.1 (-0.2 to 0.3)
    0.2 (-0.0 to 0.4)
        Day 113: Biological
    -0.0 (-0.2 to 0.1)
    0.1 (-0.0 to 0.3)
        Day 141: Constitutional
    -0.2 (-0.4 to 0.0)
    -0.4 (-0.6 to -0.2)
        Day 141: Lymphadenopathy
    -0.6 (-1.1 to -0.2)
    -0.9 (-1.4 to -0.5)
        Day 141: Glandular
    -0.5 (-0.7 to -0.2)
    -0.6 (-0.8 to -0.4)
        Day 141: Articular
    -1.2 (-1.7 to -0.8)
    -1.4 (-1.9 to -1.0)
        Day 141: Cutaneous
    -0.4 (-0.7 to -0.1)
    -0.5 (-0.8 to -0.3)
        Day 141: Pulmonary
    -0.0 (-0.4 to 0.3)
    0.1 (-0.2 to 0.4)
        Day 141: Renal
    -0.0 (-0.2 to 0.2)
    -0.1 (-0.3 to 0.1)
        Day 141: Muscular
    -0.1 (-0.2 to 0.0)
    -0.1 (-0.2 to 0.0)
        Day 141: Peripheral Nervous System
    -0.1 (-0.3 to 0.1)
    -0.0 (-0.2 to 0.1)
        Day 141: Haematological
    0.1 (-0.1 to 0.4)
    0.1 (-0.1 to 0.4)
        Day 141: Biological
    -0.0 (-0.2 to 0.1)
    0.1 (-0.0 to 0.2)
        Day 169: Constitutional
    -0.3 (-0.5 to -0.1)
    -0.4 (-0.6 to -0.2)
        Day 169: Lymphadenopathy
    -0.9 (-1.3 to -0.5)
    -1.1 (-1.4 to -0.7)
        Day 169: Glandular
    -0.4 (-0.6 to -0.1)
    -0.5 (-0.8 to -0.3)
        Day 169: Articular
    -1.4 (-1.8 to -0.9)
    -1.8 (-2.2 to -1.4)
        Day 169: Cutaneous
    -0.3 (-0.7 to 0.0)
    -0.5 (-0.9 to -0.2)
        Day 169: Pulmonary
    -0.0 (-0.4 to 0.3)
    0.1 (-0.2 to 0.4)
        Day 169: Renal
    -0.0 (-0.2 to 0.2)
    0.0 (-0.2 to 0.2)
        Day 169: Muscular
    -0.0 (-0.1 to 0.1)
    -0.1 (-0.2 to 0.0)
        Day 169: Peripheral Nervous
    -0.1 (-0.3 to 0.1)
    -0.0 (-0.2 to 0.2)
        Day 169: Haematological
    0.1 (-0.2 to 0.3)
    0.3 (0.1 to 0.5)
        Day 169: Biological
    0.0 (-0.1 to 0.2)
    0.2 (0.0 to 0.3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in ESSPRI Components

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    End point title
    		 Change from Baseline in ESSPRI Components
    End point description
    The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components. Total Score Range (0 = Best outcome and 10 = Worst Outcome) The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren’s syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.
    End point type
    Secondary
    End point timeframe
    Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Day 29: Dryness Score
    -0.21 (-0.76 to 0.34)
    -0.26 (-0.80 to 0.28)
        Day 29: Fatigue Score
    -0.57 (-1.18 to 0.03)
    -1.01 (-1.60 to -0.42)
        Day 29: Pain Score
    -0.34 (-0.96 to 0.27)
    -0.53 (-1.13 to 0.07)
        Day 57: Dryness Score
    -0.92 (-1.51 to -0.33)
    -0.52 (-1.09 to 0.05)
        Day 57: Fatigue Score
    -1.09 (-1.70 to -0.48)
    -1.22 (-1.81 to -0.63)
        Day 57: Pain Score
    -0.60 (-1.24 to 0.05)
    -0.90 (-1.52 to -0.27)
        Day 85: Dryness Score
    -0.68 (-1.25 to -0.11)
    -0.91 (-1.46 to -0.36)
        Day 85: Fatigue Score
    -1.27 (-1.91 to -0.63)
    -1.56 (-2.18 to -0.94)
        Day 85: Pain Score
    -0.70 (-1.35 to -0.05)
    -1.31 (-1.93 to -0.68)
        Day 113: Dryness Score
    -0.74 (-1.36 to -0.12)
    -1.19 (-1.79 to -0.60)
        Day 113: Fatigue Score
    -1.02 (-1.65 to -0.39)
    -1.76 (-2.37 to -1.15)
        Day 113: Pain Score
    -0.76 (-1.40 to -0.11)
    -1.37 (-1.99 to -0.74)
        Day 141: Dryness Score
    -0.89 (-1.49 to -0.28)
    -1.05 (-1.63 to -0.46)
        Day 141: Fatigue Score
    -1.18 (-1.83 to -0.53)
    -1.73 (-2.36 to -1.11)
        Day 141: Pain Score
    -0.70 (-1.34 to -0.07)
    -1.39 (-2.00 to -0.78)
        Day 169: Dryness Score
    -0.84 (-1.46 to -0.23)
    -1.04 (-1.63 to -0.44)
        Day 169: Fatigue Score
    -1.28 (-1.93 to -0.64)
    -1.57 (-2.19 to -0.95)
        Day 169: Pain Score
    -1.11 (-1.75 to -0.47)
    -1.45 (-2.06 to -0.83)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Schirmer's test

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    End point title
    		 Change from Baseline in Schirmer's test
    End point description
    The Mean change from baseline in Schirmer's Test at all measured time points up to day 169 The length in millimeters that the strip wets during the 5 minute test period for each eye. Collection is done separately for each eye.
    End point type
    Secondary
    End point timeframe
    Day 85, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: millimeters
    arithmetic mean (confidence interval 95%)
        Day 85: Study Eye
    1.9 (-0.0 to 3.9)
    1.5 (-0.5 to 3.5)
        Day 85: Non-Study Eye
    0.1 (-2.0 to 2.2)
    0.8 (-1.2 to 2.9)
        Day 85: Average of Both Eyes
    1.10 (-0.75 to 2.96)
    1.41 (-0.43 to 3.24)
        Day 169: Study Eye
    1.7 (-0.4 to 3.9)
    1.0 (-1.1 to 3.2)
        Day 169: Non-Study Eye
    0.6 (-1.3 to 2.4)
    0.2 (-1.7 to 2.1)
        Day 169: Average of Both Eyes
    1.21 (-0.59 to 3.00)
    0.82 (-0.97 to 2.61)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Ocular Staining Score (OSS)

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    End point title
    		 Change from Baseline in the Ocular Staining Score (OSS)
    End point description
    The Mean change from baseline in OSS at all measured time points up to day 169 Score of 0 = No Staining Score of 12 = diffuse staining The total score will be calculated as the sum of the score for these parameters for each eye. Medial Nasal Bulbar Conjunctiva (MNBC) [score scale: 0 - 3], Corneal (CORN) Staining of Punctate Epithelial Erosions (PEE) [score scale: 0 - 3], Lateral Temporal Bulbar Conjunctiva (LTBC) [score scale: 0 - 3], Patches of Confluent Staining (CONF) [score scale: 0 - 1], PEE observed in the pupil region, i.e. central 4mm diameter portion of the cornea (PUPL) [score scale: 0 - 1], one of more filaments seen anywhere on the cornea (FILA) [score scale: 0 - 1]
    End point type
    Secondary
    End point timeframe
    Day 85, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Day 85: Study Eye
    -1.7 (-2.5 to -0.9)
    -0.5 (-1.3 to 0.3)
        Day 85: Non-Study Eye
    -0.6 (-1.4 to 0.2)
    0.4 (-0.4 to 1.2)
        Day 85: Average of Both Eyes
    -1.15 (-1.91 to -0.39)
    -0.06 (-0.81 to 0.68)
        Day 169: Study Eye
    -1.5 (-2.3 to -0.6)
    -0.7 (-1.6 to 0.1)
        Day 169: Non-Study Eye
    -0.5 (-1.3 to 0.3)
    0.3 (-0.5 to 1.2)
        Day 169: Average of Both Eyes
    -0.99 (-1.79 to -0.19)
    -0.19 (-0.98 to 0.60)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Tear Break-up Time

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    End point title
    		 Change from Baseline in Tear Break-up Time
    End point description
    The Mean change from baseline in Tear Break-up Time at all measured time points up to day 169 The CRF collects the time in seconds to first appearance of a random dry spot on the corneal surface for 3 repetitions in each eye. The average time will calculated for each eye averaging the 3 measurements for each eye separately. In case only 2 measurements are available, the average of the 2 measurements will be calculated. In case there is only 1 measurement, that measurement will be used for the analysis.
    End point type
    Secondary
    End point timeframe
    Day 85, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Seconds
    arithmetic mean (confidence interval 95%)
        Day 85: Study Eye
    -0.13 (-0.99 to 0.73)
    0.18 (-0.67 to 1.04)
        Day 85: Non-Study Eye
    -0.70 (-1.59 to 0.18)
    -0.12 (-1.01 to 0.76)
        Day 85: Average of Both Eyes
    -0.41 (-1.24 to 0.43)
    0.09 (-0.74 to 0.92)
        Day 169: Study Eye
    -0.23 (-1.11 to 0.64)
    -0.32 (-1.19 to 0.56)
        Day 169: Non-Study Eye
    -0.79 (-1.62 to 0.03)
    -0.62 (-1.46 to 0.21)
        Day 169: Average of Both Eyes
    -0.50 (-1.32 to 0.31)
    -0.43 (-1.25 to 0.39)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Unstimulated Salivary Flow

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    End point title
    		 Change from Baseline in Unstimulated Salivary Flow
    End point description
    The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Day 169.
    End point type
    Secondary
    End point timeframe
    Day 85, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: mL/min
    arithmetic mean (confidence interval 95%)
        Day 85
    0.106 (-0.037 to 0.249)
    0.158 (0.022 to 0295)
        Day 169
    0.051 (-0.100 to 0.203)
    0.105 (-0.042 to 0.251)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Stimulated Salivary Flow

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    End point title
    		 Change from Baseline in Stimulated Salivary Flow
    End point description
    The mean change from baseline in Stimulated whole salivary flow at all measured time points up to Day 169.
    End point type
    Secondary
    End point timeframe
    Day 85, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    88
    88
    Units: mL/min
    arithmetic mean (confidence interval 95%)
        Day 85
    0.11 (-0.039 to 0.262)
    0.169 (0.024 to 0.314)
        Day 169
    0.056 (-0.104 to 0.216)
    0.108 (-0.048 to 0.263)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Numeric Rating Scale for Mouth Dryness

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    End point title
    		 Change from Baseline in Numeric Rating Scale for Mouth Dryness
    End point description
    The mean change from baseline in participant symptoms using the Numeric Rating Scale (NRS) for mouth dryness at all measured time points up to Day 169. The oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness
    End point type
    Secondary
    End point timeframe
    Day 1, 29, 57, 85, 113, 141, 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Score on a Scale
    arithmetic mean (full range (min-max))
        Day 29
    -0.8 (-8 to 3)
    -0.5 (-7 to 6)
        Day 57
    -1.3 (-8 to 5)
    -0.9 (-7 to 6)
        Day 85
    -1.3 (-9 to 4)
    -1.1 (-6 to 8)
        Day 113
    -1.2 (-9 to 3)
    -1.3 (-8 to 4)
        Day 141
    -1.3 (-8 to 5)
    -1.1 (-6 to 6)
        Day 169
    -1.3 (-8 to 3)
    -1.2 (-6 to 8)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Numeric Rating Scale for Eye Dryness

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    End point title
    		 Change from Baseline in Numeric Rating Scale for Eye Dryness
    End point description
    The mean change from baseline in patient symptoms using the Numeric Rating Scale (NRS) for eye dryness at all measured time points up to Day 169. The oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness
    End point type
    Secondary
    End point timeframe
    Day 1, 29, 57, 85, 113, 141, 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Score on a Scale
    arithmetic mean (full range (min-max))
        Day 29
    -0.4 (-8 to 5)
    -0.3 (-6 to 5)
        Day 57
    -0.9 (-7 to 5)
    -0.6 (-6 to 5)
        Day 85
    -0.9 (-7 to 6)
    -0.8 (-7 to 8)
        Day 113
    -1.0 (-7 to 7)
    -1.1 (-8 to 4)
        Day 141
    -0.8 (-7 to 7)
    -1.0 (-7 to 4)
        Day 169
    -0.9 (-5 to 6)
    -1.0 (-7 to 5)
    No statistical analyses for this end point

    Secondary: Change from Baseline in participant assessment of disease activity

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    End point title
    		 Change from Baseline in participant assessment of disease activity
    End point description
    The participant global assessment of disease activity are assessed with visual analog scales. The participant marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters. In cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below: Rescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) * 100mm A negative score = participant assessment of disease activity has improved A positive score = participant assessment of disease activity has worsened
    End point type
    Secondary
    End point timeframe
    Day 29, 57, 85, 113, 141, 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Score on VAS 0-100mm scale
    arithmetic mean (confidence interval 95%)
        Day 29
    -4.0 (-9.8 to 1.7)
    -7.1 (-12.7 to -1.4)
        Day 57
    -7.5 (-13.4 to -1.7)
    -6.3 (-11.9 to -0.6)
        Day 85
    -10.4 (-16.3 to -4.4)
    -10.2 (-16.0 to -4.4)
        Day 113
    -8.0 (-14.0 to -2.0)
    -9.7 (-15.5 to -3.9)
        Day 141
    -5.1 (-11.0 to 0.8)
    -11.0 (-16.7 to -5.3)
        Day 169
    -10.1 (-16.1 to -4.0)
    -9.0 (-14.8 to -3.1)
    No statistical analyses for this end point

    Secondary: Change from Baseline in physician global assessment of disease activity

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    End point title
    		 Change from Baseline in physician global assessment of disease activity
    End point description
    The physician global assessment of disease activity are assessed with visual analog scales. The physician marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters. In cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below: Rescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) * 100mm A negative score = physician assessment of disease activity has improved A positive score = physician assessment of disease activity has worsened
    End point type
    Secondary
    End point timeframe
    Day 29, 57, 85, 113, 141, 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Score on VAS 0-100mm Scale
    arithmetic mean (confidence interval 95%)
        Day 29
    -10.3 (-14.8 to -5.8)
    -10.5 (-14.9 to -6.1)
        Day 57
    -16.2 (-20.8 to -11.7)
    -16.7 (-21.1 to -12.3)
        Day 85
    -20.8 (-25.6 to -16.0)
    -19.4 (-24.0 to -14.7)
        Day 113
    -22.8 (-27.9 to -17.8)
    -19.8 (-24.6 to -14.9)
        Day 141
    -23.7 (-28.6 to -18.8)
    -21.7 (-26.5 to -17.0)
        Day 169
    -23.0 (-27.8 to -18.2)
    -23.7 (-28.3 to -19.0)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Patient Fatigue

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    End point title
    		 Change from Baseline in Patient Fatigue
    End point description
    The mean change from baseline in patient fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue assessment of disease activity at all measured time points up to Day 169. PROMIS Fatigue instruments 10 Questions ranging from a score 0 to 40. Sum of the values gives you the raw sum. The raw is inputted into this formula to give you the raw score: Raw Score = (Raw sum*number of items on the short form)/(Number of items that were actually answered) Raw score is translated to a T-Score using a table. T-Score is used as the final score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. The standardized T-score is reported as the final score for each participant. A negative T Score = Better Prognosis A positive T Score = Worse prognosis
    End point type
    Secondary
    End point timeframe
    Day 29, 57, 85, 113, 141, 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: T-Score
    arithmetic mean (confidence interval 95%)
        Day 29
    -3.08 (-5.22 to -0.95)
    -3.99 (-6.09 to -1.88)
        Day 57
    -4.12 (-6.27 to -1.97)
    -4.02 (-6.12 to -1.91)
        Day 85
    -4.85 (-7.05 to -2.64)
    -5.48 (-7.64 to -3.32)
        Day 113
    -4.17 (-6.37 to -1.97)
    -5.32 (-7.48 to -3.17)
        Day 141
    -4.84 (-7.06 to -2.62)
    -5.68 (-7.85 to -3.52)
        Day 169
    -5.56 (-7.83 to -3.28)
    -5.59 (-7.82 to -3.37)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Female Sexual Function using the Female Sexual Function Index (FSFI)

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    End point title
    		 Change from Baseline in Female Sexual Function using the Female Sexual Function Index (FSFI)
    End point description
    For the FSFI, is a 19 item instrument used for assessing key dimensions of female sexual function over the past 4 weeks with 6 domains being analyzed. The specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI are scored on a scale ranging from 0 to 5, with higher scores indicating better performance. Domain scores are calculated by summing the scores of the individual questions that make up the domain and multiplying the sum by the factor in the table below. The full scale score is the sum of the six domain scores. Full Scale Score range: 2.0(minimum score) - 36.0 (maximum score) Negative Score = Reduced functioning Positive Score = Improved functioning
    End point type
    Secondary
    End point timeframe
    Day 85, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    88
    88
    Units: Scores on a Scale
    arithmetic mean (confidence interval 95%)
        Day 85
    -2.44 (-5.67 to 0.78)
    -1.56 (-4.90 to 1.77)
        Day 169
    -2.32 (-5.73 to 1.09)
    -1.87 (-5.42 to 1.68)
    No statistical analyses for this end point

    Secondary: Change from Baseline in 36-item Short Form Health Survey (SF-36)

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    End point title
    		 Change from Baseline in 36-item Short Form Health Survey (SF-36)
    End point description
    The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement
    End point type
    Secondary
    End point timeframe
    Day 85, Day 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Day 85: Physical Function
    1.908 (-0.240 to 4.056)
    1.523 (-0.568 to 3.614)
        Day 85: Role Physical
    5.248 (3.112 to 7.383)
    4.416 (2.321 to 6.511)
        Day 85: Bodily Pain
    3.200 (0.910 to 5.490)
    3.721 (1.464 to 5.978)
        Day 85: General Health
    4.042 (1.938 to 6.146)
    3.409 (1.363 to 5.456)
        Day 85: Vitality
    3.827 (1.269 to 6.384)
    3.859 (1.335 to 6.382)
        Day 85: Social Functioning
    3.020 (0.296 to 5.744)
    4.771 (2.117 to 7.426)
        Day 85: Role-Emotional
    3.024 (0.214 to 5.834)
    4.834 (2.093 to 7.576)
        Day 85: Mental Health
    2.942 (0.458 to 5.425)
    2.287 (-0.135 to 4.709)
        Day 85: Physical component Summary
    3.430 (1.615 to 5.244)
    2.686 (0.904 to 4.468)
        Day 85: Mental component Summary
    2.693 (0.160 to 5.226)
    3.672 (1.208 to 6.136)
        Day 169: Physical Function
    2.927 (0.593 to 5.261)
    1.742 (-0.505 to 3.989)
        Day 169: Role-Physical
    5.853 (3.756 to 7.949)
    4.626 (2.604 to 6.649)
        Day 169: Bodily Pain
    3.842 (1.432 to 6.252)
    3.458 (1.114 to 5.801)
        Day 169: General Health
    3.880 (1.700 to 6.060)
    3.764 (1.665 to 5.862)
        Day 169: Vitality
    3.742 (1.160 to 6.324)
    4.523 (2.005 to 7.041)
        Day 169: Social functioning
    4.125 (1.320 to 6.929)
    4.471 (1.773 to 7.169)
        Day 169: Role-Emotional
    4.653 (1.943 to 7.364)
    4.930 (2.334 to 7.526)
        Day 169: Mental Health
    2.375 (-0.116 to 4.866)
    2.972 (0.581 to 5.363)
        Day 169: Physical Component Summary
    3.998 (2.045 to 5.951)
    2.650 (0.756 to 4.543)
        Day 169: Mental Component Summary
    2.940 (0.368 to 5.512)
    4.112 (1.648 to 6.577)
    No statistical analyses for this end point

    Secondary: Geometric mean of trough concentration (Cmin) of Abatacept

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    End point title
    		 Geometric mean of trough concentration (Cmin) of Abatacept
    End point description
    Geometric mean of trough concentration (Cmin) of abatacept at all measured time points.
    End point type
    Secondary
    End point timeframe
    Day 29, 85, 113, 141, 169
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    0 [1]
    Units: µg/mL
    geometric mean (geometric coefficient of variation)
        Day 29
    21.401 ± 36
    ±
        Day 85
    27.543 ± 38.4
    ±
        Day 113
    25.567 ± 42.1
    ±
        Day 141
    25.870 ± 40.8
    ±
        Day 169
    24.522 ± 42.7
    ±
    Notes
    [1] - Data is only applicable for study drug
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a Positive Antibody Response

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    End point title
    		 Percentage of Participants with a Positive Antibody Response
    End point description
    Percentage of participants with at least one positive immunogenicity response up to Day 169 and during 3 months follow up (for participants who discontinue during the 6-months double-blind).
    End point type
    Secondary
    End point timeframe
    Day 85 db, day 169 db, post treatment day 85
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    90
    0 [2]
    Units: Percentage
    number (not applicable)
        Study Day 169
    1.2
        Post Treatment Day 85 (DB)
    0
        Post Treatment Day 169 (DB)
    0
    Notes
    [2] - data only applicable for study drug
    No statistical analyses for this end point

    Secondary: Summary of Adverse Events: Double Blind Period

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    End point title
    		 Summary of Adverse Events: Double Blind Period
    End point description
    Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation
    End point type
    Secondary
    End point timeframe
    Day 1 up to first dose of Open Label Treatment Period (OLTP) abatacept or up to 56 post last dose in double -blind for those not in OL.
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    92
    95
    Units: Percentage
    number (not applicable)
        Adverse Events (AEs)
    85.9
    71.6
        Deaths
    0
    1.1
        Serious Adverse Events
    9.8
    3.2
        Discontinuation due to AEs
    3.3
    2.1
    No statistical analyses for this end point

    Secondary: Laboratory Marked Abnormalities: Double Blind Period

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    End point title
    		 Laboratory Marked Abnormalities: Double Blind Period
    End point description
    Laboratory values meeting the marked abnormality criteria 9999 = not available
    End point type
    Secondary
    End point timeframe
    Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.
    End point values
    		 Abatacept - Double Blind Treatment Period Placebo - Double Blind Treatment Period
    Number of subjects analysed
    91
    95
    Units: Percentage
    number (not applicable)
        Hematocrit High
    9999
    9999
        Hematocrit Low
    0
    0
        Hemoglobin High
    9999
    9999
        Hemoglobin Low
    0
    0
        Platelet count High
    0
    0
        Platelet count low
    0
    0
        Leukocytes high
    1.1
    0
        Leukocytes low
    12.1
    8.4
        Basophils high
    0
    0
        Basophils Low
    9999
    9999
        Eosinophils High
    4.4
    1.1
        Eosinophils Low
    9999
    9999
        lymphocytes high
    0
    0
        lymphocytes low
    9.9
    14.7
        Monocytes high
    0
    0
        Monocytes Low
    9999
    9999
        Neutrophils+Bands High
    9999
    9999
        Neutrophils+Bands Low
    6.6
    1.1
        Alanine Aminotransferase High
    1.1
    2.1
        Alkaline Phosphatase HIgh
    0
    0
        Aspartate Aminotransferase High
    1.1
    3.2
        Bilirubin, Total High
    0
    0
        G-Glutamyl Transferase High
    6.6
    1.1
        Blood Urea Nitrogen High
    1.1
    1.1
        Creatinine High
    0
    0
        Calcium High
    0
    0
        Calcium Low
    1.1
    0
        Chloride High
    0
    0
        Chloride Low
    1.1
    0
        Phosphorus High
    0
    0
        Phosphorus Low
    0
    1.1
        Potassium High
    0
    0
        Potassium Low
    1.1
    0
        Sodium High
    0
    1.1
        Sodium Low
    2.2
    0
        Glucose, Serum High
    0
    1.1
        Glucose, Serum Low
    2.2
    5.3
        Albumin High
    9999
    9999
        Albumin Low
    2.2
    1.1
        Protein, Total High
    2.2
    3.2
        Protein, Total Low
    1.1
    0
        Creatine Kinase High
    0
    4.2
        Blood, Urine High
    14.3
    9.5
        Blood, Urine Low
    9999
    9999
        Glucose, Urine High
    0
    0
        Glucose, Urine Low
    9999
    9999
        Protein, Urine High
    2.2
    3.2
    No statistical analyses for this end point

    Secondary: Summary of Adverse Events: Open Label Cumulative Abatacept Period

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    End point title
    		 Summary of Adverse Events: Open Label Cumulative Abatacept Period
    End point description
    Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation
    End point type
    Secondary
    End point timeframe
    Day 1 up to first dose of Open Label Treatment Period (OLTP) abatacept or up to 56 post last dose in double -blind for those not in OL.
    End point values
    		 Abatacept - Open Label Treatment Period
    Number of subjects analysed
    178
    Units: Percentage
    number (not applicable)
        Adverse Events (AEs)
    78.7
        Deaths
    0.6
        Serious Adverse Events (SAEs)
    14.6
        Discontinuation due to AEs
    5.6
        Related Serious Adverse Events
    3.4
        Discontinued due to SAEs
    3.4
        Related AEs
    40.4
    No statistical analyses for this end point

    Secondary: Laboratory Marked Abnormalities: Open Label Cumulative Abatacept Period

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    End point title
    		 Laboratory Marked Abnormalities: Open Label Cumulative Abatacept Period
    End point description
    Laboratory values meeting the marked abnormality criteria
    End point type
    Secondary
    End point timeframe
    Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.
    End point values
    		 Abatacept - Open Label Treatment Period
    Number of subjects analysed
    177
    Units: Percentage
    number (not applicable)
        Hematocrit High
    9999
        Hematocrit Low
    0
        Hemoglobin High
    9999
        Hemoglobin Low
    0.6
        Platelet count High
    0
        Platelet count low
    0.6
        Leukocytes high
    0.6
        Leukocytes low
    18.6
        Basophils high
    0.6
        Basophils Low
    9999
        Eosinophils High
    5.6
        Eosinophils Low
    9999
        lymphocytes high
    0
        lymphocytes low
    12.4
        Monocytes high
    0
        Monocytes Low
    9999
        Neutrophils+Bands High
    9999
        Neutrophils+Bands Low
    7.3
        Alanine Aminotransferase High
    1.7
        Alkaline Phosphatase HIgh
    0.6
        Aspartate Aminotransferase High
    1.1
        Bilirubin, Total High
    0
        G-Glutamyl Transferase High
    5.6
        Blood Urea Nitrogen High
    1.7
        Creatinine High
    0.6
        Calcium High
    0
        Calcium Low
    1.1
        Chloride High
    0
        Chloride Low
    1.1
        Phosphorus High
    0.6
        Phosphorus Low
    1.1
        Potassium High
    0.6
        Potassium Low
    0.6
        Sodium High
    0.6
        Sodium Low
    1.7
        Glucose, Serum High
    0.6
        Glucose, Serum Low
    5.1
        Albumin High
    9999
        Albumin Low
    1.7
        Protein, Total High
    4.0
        Protein, Total Low
    0.6
        Creatine Kinase High
    2.3
        Blood, Urine High
    14.7
        Blood, Urine Low
    9999
        Glucose, Urine High
    0
        Glucose, Urine Low
    9999
        Protein, Urine High
    5.6
        WBC, Urine High
    100.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were reported from start treatment up to 56 days post last treatment of double blind period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were subcutaneously administered with matching placebo of Abatacept in 1 mL pre-filled syringe once a week.

    Reporting group title
    Abatacept
    Reporting group description
    		 Subjects were subcutaneously administered with 125 milligrams per millilitre of Abatacept in 1 mL pre-filled syringe once a week.

    Serious adverse events
    		 Placebo Abatacept
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 95 (3.16%)
    9 / 92 (9.78%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasma cell myeloma
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactoid reaction
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic cyst ruptured
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthropathy
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia bacterial
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Abatacept
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 95 (42.11%)
    47 / 92 (51.09%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 95 (9.47%)
    10 / 92 (10.87%)
         occurrences all number
    9
    21
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 95 (0.00%)
    5 / 92 (5.43%)
         occurrences all number
    0
    5
    Diarrhoea
         subjects affected / exposed
    4 / 95 (4.21%)
    11 / 92 (11.96%)
         occurrences all number
    4
    24
    Nausea
         subjects affected / exposed
    4 / 95 (4.21%)
    9 / 92 (9.78%)
         occurrences all number
    4
    21
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 95 (4.21%)
    5 / 92 (5.43%)
         occurrences all number
    4
    5
    Oropharyngeal pain
         subjects affected / exposed
    1 / 95 (1.05%)
    6 / 92 (6.52%)
         occurrences all number
    1
    6
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 95 (1.05%)
    5 / 92 (5.43%)
         occurrences all number
    1
    5
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    2 / 95 (2.11%)
    5 / 92 (5.43%)
         occurrences all number
    2
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    18 / 95 (18.95%)
    11 / 92 (11.96%)
         occurrences all number
    22
    13
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 95 (7.37%)
    9 / 92 (9.78%)
         occurrences all number
    7
    9
    Urinary tract infection
         subjects affected / exposed
    8 / 95 (8.42%)
    6 / 92 (6.52%)
         occurrences all number
    9
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Aug 2016
     To provide clear differentiate between discontinuation of study treatment from discontinuation from the study. o Subjects who discontinue investigational product during the Double-Blind Treatment Period should continue to comply with all protocol specified procedures during the Double-Blind Treatment Period. o Define the assessments required for the collection of follow-up data.  To clarify inclusion/exclusion criteria  To clarify testing for stimulated salivary flow  Add allowable window for obtaining the optional biopsy samples.  Modify laboratory testing to limit to the most critical tests and to adjust for feasibility issues.  Add additional secondary and exploratory endpoints.  Increase the total number of subjects targeted for enrollment in order to increase statistical power and the overall size of the safety database.  Revise appendices to include most current versions.  Corrections to minor typographical errors
    22 Nov 2016
     Updated ACR EULAR Classification Criteria for Primary Sjögren’s syndrome from proposed 2015 criteria to 2016 criteria.  Corrected typographical error for stimulated salivary flow procedure  Corrected Appendix 11 with correct example of PROMIS Fatigue questionnaire
    17 Mar 2017
     Update contact information for the Medical Monitor, add Study Director and contact information.  Update the Study Design Section and Schematic to include Day 169.  Add stratification criteria for Japan.  Clarify potential reason for extended screening visit.  Clarify exclusion criteria for DMARDs and eye surgeries and clarify restrictions for corticosteroids  Allow for the use of glaucoma eye drops and autologous serum eye drops.  Clarify criteria for discontinuation of study therapy.  Update Study Assessments and procedure clarifications  Update the statistical section with stratification for Japan and HA request from Germany.  Add Appendix 14 for Topical corticosteroids (low potency/Class VI and VII)  Corrections to typographical errors and reconcile inconsistencies.
    06 Jun 2017
     Clarify exclusion criterion for severe renal involvement.  Add exclusion criterion for herbal supplements and remedies.  Add restriction for use of contact lenses  Clarify corticosteroid use  Add restriction for use of hyaluronate eye drops  Add domain by domain guidance and/or clarification to non-protocol specified procedures and tests.  Add lab testing for serum protein electrophoresis and cryoglobulins to all visits at which the ESSDAI is assessed.  Corrections to typographical errors and reconcile inconsistencies.
    23 Jul 2018
     Correct description of ESSDAI change 5  Update definition for Serious Breach  Align language for the post dose follow-up visits  Modify use of anti-histamines  Provide guidance for concomitant medication use for subjects continuing beyond Day 365 or Day 533 in Japan.  Clarify number of missed consecutive doses resulting in discontinuation.  Correct section text for collection of weight to align with Time and Events table  Modify footnote to Table 5.6.1-1 to align with Time and Events schedule.  Minor formatting and typographical corrections

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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