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    Clinical Trial Results:
    A PHASE 3 RANDOMIZED PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ABATACEPT SUBCUTANEOUS INJECTION IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS

    Summary
    EudraCT number
    		 2012-002798-80
    Trial protocol
    		 ES   DE   GR   IT   CZ   PL   FR  
    Global end of trial date
    30 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2021
    First version publication date
    16 Jul 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IM101-332
    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
    16 Nov 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of abatacept to placebo as assessed by the ACR20 response at Day 169
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and incompliance 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
    05 Jun 2013
    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: 44
    Country: Number of subjects enrolled
    Brazil: 16
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Chile: 39
    Country: Number of subjects enrolled
    Colombia: 14
    Country: Number of subjects enrolled
    Czechia: 14
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Greece: 6
    Country: Number of subjects enrolled
    Israel: 18
    Country: Number of subjects enrolled
    Italy: 23
    Country: Number of subjects enrolled
    Mexico: 66
    Country: Number of subjects enrolled
    Peru: 15
    Country: Number of subjects enrolled
    Poland: 18
    Country: Number of subjects enrolled
    South Africa: 39
    Country: Number of subjects enrolled
    Spain: 31
    Country: Number of subjects enrolled
    United States: 100
    Worldwide total number of subjects
    489
    EEA total number of subjects
    133
    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)
    439
    From 65 to 84 years
    50
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 424 Were Randomized and Treated

    Period 1
    Period 1 title
    Blinded Treatment
    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
    Arm description
    		 Abatacept 125mg, self-administered subcutaneously, once weekly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abatacept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    125 mg/mL

    Arm title
    		 Placebo
    Arm description
    		 Placebo, self-administered subcutaneously, once weekly.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    125mg/syringe

    Number of subjects in period 1 [1]
    		Abatacept Placebo
    Started
    213
    211
    Completed
    125
    98
    Not completed
    88
    113
         Subject request to discontinue treatment
    2
    3
         Consent withdrawn by subject
    3
    5
         Adverse event, non-fatal
    1
    3
         Early Escape: Transitioned to OL period
    76
    89
         Entered Open-Label in error
    -
    1
         Subject no longer met criteria
    1
    -
         Lack of efficacy
    5
    12
    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: 424 participants were randomized and treated
    Period 2
    Period 2 title
    Open-Label
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Abatacept
    Arm description
    		 Abatacept 125mg, self-administered subcutaneously, once weekly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abatacept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    125mg/mL

    Arm title
    		 Placebo
    Arm description
    		 Placebo, self-administered subcutaneously, once weekly.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    125mg/syringe

    Number of subjects in period 2
    		Abatacept Placebo
    Started
    197
    185
    Completed
    123
    121
    Not completed
    74
    64
         Consent withdrawn by subject
    4
    1
         Adverse event, non-fatal
    2
    4
         Other Reasons
    1
    1
         Subject request discontinue treatment
    4
    3
         Lost to follow-up
    1
    2
         Ongoing OL treatment at time of analysis
    46
    45
         Lack of efficacy
    16
    8
    Period 3
    Period 3 title
    Long Term Extension
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Abatacept
    Arm description
    		 Abatacept 125mg, self-administered subcutaneously, once weekly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abatacept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    125mg/mL

    Arm title
    		 Placebo
    Arm description
    		 Placebo, self-administered subcutaneously, once weekly.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    125mg/syringe

    Number of subjects in period 3
    		Abatacept Placebo
    Started
    113
    115
    Completed
    0
    8
    Not completed
    113
    107
         Subject request to discontinue treatment
    2
    -
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    -
         Ongoing treatment at time of analysis
    106
    100
         Lack of efficacy
    3
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Abatacept
    Reporting group description
    		 Abatacept 125mg, self-administered subcutaneously, once weekly

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, self-administered subcutaneously, once weekly.

    Reporting group values
    		 Abatacept Placebo Total
    Number of subjects
    		 213 211 424
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.0 ± 10.67 49.8 ± 11.26 -
    Sex: Female, Male
    Units:
        Female
    		 121 112 233
        Male
    		 92 99 191
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 195 198 393
        More than one race
    		 18 11 29
        Unknown or Not Reported
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Abatacept
    Reporting group description
    		 Abatacept 125mg, self-administered subcutaneously, once weekly

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, self-administered subcutaneously, once weekly.
    Reporting group title
    Abatacept
    Reporting group description
    		 Abatacept 125mg, self-administered subcutaneously, once weekly

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, self-administered subcutaneously, once weekly.
    Reporting group title
    Abatacept
    Reporting group description
    		 Abatacept 125mg, self-administered subcutaneously, once weekly

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, self-administered subcutaneously, once weekly.

    Primary: Proportion of ACR 20 Responders at Day 169

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    End point title
    		 Proportion of ACR 20 Responders at Day 169
    End point description
    The American College of Rheumatology (ACR) 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
    End point type
    Primary
    End point timeframe
    Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    213
    211
    Units: Percentage of participants
        number (confidence interval 95%)
    39.4 (32.9 to 46.0)
    22.3 (16.7 to 27.9)
    Statistical analysis title
    		 SA of Proportion of ACR 20 Responders at day 169
    Comparison groups
    Abatacept v Placebo
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Estimate of Difference
    Point estimate
    17.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.7
         upper limit
    		 25.6

    Secondary: Proportion of Health Assessment Questionnaire (HAQ) responders at Day 169

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    End point title
    		 Proportion of Health Assessment Questionnaire (HAQ) responders at Day 169
    End point description
    Participants were considered responders if their HAQ score decreased at least 0.35 from baseline. The number of HAQ responders was divided by the number of treated participants and expressed as a percentage. Scoring conventions are based on the Standard Disability Index of HAQ/HAQ-DI using the 20 response items. For each of the 8 disability categories there is an “aids/devices” companion variable that is used to record the type of assistance, if any, a participant uses for his/her usual activities. If either “aids/devices” and/or “assistance from another person” are checked for a disability category, the score for this category is set to “2” (much difficulty), if the original score was “0” (no difficulty) or “1” (some difficulty). The HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    213
    211
    Units: percentage of participants
        number (confidence interval 95%)
    31.0 (24.8 to 37.2)
    23.7 (18.0 to 29.4)
    No statistical analyses for this end point

    Secondary: Proportion of ACR 20 responders at Day 169 in the TNFi-naïve subpopulation

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    End point title
    		 Proportion of ACR 20 responders at Day 169 in the TNFi-naïve subpopulation
    End point description
    The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated, TNFi-naive participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    84
    81
    Units: Percentage of participants
        number (confidence interval 95%)
    44.0 (33.4 to 54.7)
    22.2 (13.2 to 31.3)
    No statistical analyses for this end point

    Secondary: Proportion of ACR 20 responders at Day 169 in the TNFi-exposed subpopulation

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    End point title
    		 Proportion of ACR 20 responders at Day 169 in the TNFi-exposed subpopulation
    End point description
    The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated, TNFi-exposed participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    129
    130
    Units: Percentage of participants
        number (confidence interval 95%)
    36.4 (28.1 to 44.7)
    22.3 (15.2 to 29.5)
    No statistical analyses for this end point

    Secondary: Proportion of non-progressors in total PsA-modified SHS at Day 169

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    End point title
    		 Proportion of non-progressors in total PsA-modified SHS at Day 169
    End point description
    The number of radiographic non-progressors in total PsA-Modified Sharp van der Heijde score (SHS) at Day 169 was divided by the number of treated participants and expressed as a percentage. Non-progression was defined as a change from baseline in total PsA modified SHS ≤0. Early escape participants, and participants with missing data at day 169 were imputed as non-progressors.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    213
    211
    Units: Percentage of participants
        number (confidence interval 95%)
    42.7 (36.1 to 49.4)
    32.7 (26.4 to 39.0)
    No statistical analyses for this end point

    Secondary: Proportion of participants achieving a PASI 50 at Day 169 in participants with baseline BSA >= 3%

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    End point title
    		 Proportion of participants achieving a PASI 50 at Day 169 in participants with baseline BSA >= 3%
    End point description
    The number of participants who achieved at least 50% improvement from baseline in Psoriasis Area and Severity Index Arthritis (PASI 50) at Day 169 was divided by the number of treated participants with BSA >= 3% and expressed as a percentage. Only participants with >= 3% body surface area (BSA) of psoriatic skin involvement at randomization were included in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    146
    148
    Units: Percentage of participants
        number (confidence interval 95%)
    26.7 (19.5 to 33.9)
    19.6 (13.2 to 26.0)
    No statistical analyses for this end point

    Secondary: Proportions of ACR 50 and ACR 70 responders at Day 169

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    End point title
    		 Proportions of ACR 50 and ACR 70 responders at Day 169
    End point description
    The ACR 50 and ACR 70 definition of improvement is a 50% or 70% improvement, respectively, over baseline in tender and swollen joint counts and a 50% or 70% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 50 and ACR 70 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    213
    211
    Units: Percentage of participants
    number (confidence interval 95%)
        ACR 50
    19.2 (14.0 to 24.5)
    12.3 (7.9 to 16.8)
        ACR 70
    10.3 (6.2 to 14.4)
    6.6 (3.3 to 10.0)
    No statistical analyses for this end point

    Secondary: Mean change from baseline in SF-36 physical and mental components at Day 169

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    End point title
    		 Mean change from baseline in SF-36 physical and mental components at Day 169
    End point description
    Adjusted mean change in scores on the Short Form 36 physical and mental function assessment (SF-36) from baseline were analyzed from the physical component summary (PCS) mental component summary (MCS). The SF-36 is a participant questionnaire assessing 8 domains of health status: physical functioning, pain, vitality, social functioning, psychological functioning, general health perception, and role limitations due to physical and emotional problems. The instrument can be divided into two summary scores, physical and mental component score. The scores range from 0 to 100, with a higher score indicating better quality of life. The two summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    213
    211
    Units: SF-36 points
    arithmetic mean (standard error)
        PCS
    5.11 ± 0.637
    3.69 ± 0.707
        MCS
    2.56 ± 0.826
    2.62 ± 0.924
    No statistical analyses for this end point

    Secondary: Proportion of participants with at least one positive immunogenicity response up to Day 169 relative to baseline

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    End point title
    		 Proportion of participants with at least one positive immunogenicity response up to Day 169 relative to baseline
    End point description
    Blood samples were collected at Days 1, 85 and 169 and assayed for the presence of abatacept-specific antibodies. The number of participants with at least one positive immunogenicity response was divided by the number of treated participants and expressed as a percentage.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    203
    198
    Units: Percentage of participants
        number (not applicable)
    3.9
    8.6
    No statistical analyses for this end point

    Secondary: Proportion of participants with AEs at Day 169

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    End point title
    		 Proportion of participants with AEs at Day 169
    End point description
    Proportion of participants with AEs at Day 169
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    213
    211
    Units: Percentage of participants
        number (not applicable)
    54.5
    53.1
    No statistical analyses for this end point

    Secondary: Proportion of participants with SAEs at Day 169

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    End point title
    		 Proportion of participants with SAEs at Day 169
    End point description
    Proportion of participants with SAEs at Day 169
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    213
    211
    Units: Percentage of participants
        number (not applicable)
    2.8
    4.3
    No statistical analyses for this end point

    Secondary: Proportion of participants with AEs leading to discontinuation at Day 169

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    End point title
    		 Proportion of participants with AEs leading to discontinuation at Day 169
    End point description
    Proportion of participants with AEs leading to discontinuation at Day 169
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    213
    211
    Units: Percentage of participants
        number (not applicable)
    1.4
    1.9
    No statistical analyses for this end point

    Secondary: Proportion of participant deaths at Day 169

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    End point title
    		 Proportion of participant deaths at Day 169
    End point description
    Proportion of participant deaths at Day 169
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    213
    211
    Units: Percentage of participants
    0
    0
    No statistical analyses for this end point

    Secondary: Proportion of participants with marked laboratory abnormalities at Day 169

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    End point title
    		 Proportion of participants with marked laboratory abnormalities at Day 169
    End point description
    Proportion of participants with marked laboratory abnormalities at Day 169
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    		 Abatacept Placebo
    Number of subjects analysed
    213
    211
    Units: Percentage of participants
        number (not applicable)
    3.2
    5.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All reported AEs including those that occur more than 56 days after the last dose of study medication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    ABATACEPT DURING DOUBLE-BLIND PERIOD
    Reporting group description
    		 Subject self-administered 125 mg/syringe (125 mg/mL) of Abatacept subcutaneously(SC) once weekly for 24 weeks.

    Reporting group title
    PLACEBO DURING DOUBLE-BLIND PERIOD
    Reporting group description
    		 Subject self-administered 125 mg/syringe Placebo matching Abatacept SC once weekly for 24 weeks.

    Reporting group title
    ABATACEPT DURING OPEN-LABEL PERIOD
    Reporting group description
    		 All subjects transitioned to the Open-label Period and self-administered 125 mg/syringe (125 mg/mL) of Abatacept subcutaneously (SC) once weekly for 28 weeks.

    Reporting group title
    ABATACEPT DURING OPEN-LABEL EXTENSION PERIOD
    Reporting group description
    		 Subjects self-administered 125 mg/syringe (125 mg/mL) of Abatacept subcutaneously (SC) once weekly during the open label extension period.

    Reporting group title
    ABATACEPT DURING LONG-TERM EXTENSION PERIOD
    Reporting group description
    		 At the end of Open-label Period, subjects entered a one-year, Long-term Extension Period during which only safety data was collected. The protocol was then extended for an additional 3 years in 6 countries in compliance with local regulatory requirements. Subjects self-administered 125 mg/syringe (125 mg/mL) of Abatacept subcutaneously (SC) once weekly.

    Serious adverse events
    		 ABATACEPT DURING DOUBLE-BLIND PERIOD PLACEBO DURING DOUBLE-BLIND PERIOD ABATACEPT DURING OPEN-LABEL PERIOD ABATACEPT DURING OPEN-LABEL EXTENSION PERIOD ABATACEPT DURING LONG-TERM EXTENSION PERIOD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 213 (2.82%)
    9 / 211 (4.27%)
    29 / 382 (7.59%)
    20 / 322 (6.21%)
    17 / 106 (16.04%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 211 (0.47%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 211 (0.47%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         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
    Breast cancer
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         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
    Carcinoma in situ of skin
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         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
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (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
    Prostate cancer
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 211 (0.47%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    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
    Chest pain
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (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
    Incarcerated hernia
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 211 (0.47%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    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
    Polycystic ovaries
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute chest syndrome
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 211 (0.47%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    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
    1 / 213 (0.47%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 211 (0.47%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 211 (0.47%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (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
    Fall
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (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
    Meniscus injury
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         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
    Patella fracture
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         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
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (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
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Demyelination
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         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
    Transient ischaemic attack
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (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
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 211 (0.47%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Meniere's disease
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         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
    Abdominal pain upper
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (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
    Colitis
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric mucosa erythema
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (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
    Inguinal hernia
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (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
    Pancreatitis acute
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         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
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 211 (0.47%)
    1 / 382 (0.26%)
    1 / 322 (0.31%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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 fibrosis
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         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
    Skin and subcutaneous tissue disorders
    Erythrodermic psoriasis
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus bladder
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         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
    Nephrolithiasis
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 211 (0.47%)
    2 / 382 (0.52%)
    3 / 322 (0.93%)
    3 / 106 (2.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondropathy
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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 spinal stenosis
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metatarsalgia
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    4 / 322 (1.24%)
    2 / 106 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    2 / 322 (0.62%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    1 / 322 (0.31%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 211 (0.47%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (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
    Cellulitis
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 211 (0.47%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 213 (0.94%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii infection
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (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
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         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
    Intervertebral discitis
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (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
    Osteomyelitis
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    1 / 322 (0.31%)
    0 / 106 (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
    Pneumonia
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 213 (0.00%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    0 / 322 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 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 / 213 (0.00%)
    0 / 211 (0.00%)
    0 / 382 (0.00%)
    0 / 322 (0.00%)
    1 / 106 (0.94%)
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ABATACEPT DURING DOUBLE-BLIND PERIOD PLACEBO DURING DOUBLE-BLIND PERIOD ABATACEPT DURING OPEN-LABEL PERIOD ABATACEPT DURING OPEN-LABEL EXTENSION PERIOD ABATACEPT DURING LONG-TERM EXTENSION PERIOD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 213 (21.60%)
    47 / 211 (22.27%)
    106 / 382 (27.75%)
    122 / 322 (37.89%)
    90 / 106 (84.91%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 213 (2.35%)
    8 / 211 (3.79%)
    10 / 382 (2.62%)
    7 / 322 (2.17%)
    9 / 106 (8.49%)
         occurrences all number
    5
    8
    11
    8
    10
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 211 (0.00%)
    2 / 382 (0.52%)
    1 / 322 (0.31%)
    6 / 106 (5.66%)
         occurrences all number
    1
    0
    2
    1
    7
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 211 (0.00%)
    1 / 382 (0.26%)
    2 / 322 (0.62%)
    12 / 106 (11.32%)
         occurrences all number
    1
    0
    1
    2
    17
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 213 (1.88%)
    2 / 211 (0.95%)
    10 / 382 (2.62%)
    11 / 322 (3.42%)
    12 / 106 (11.32%)
         occurrences all number
    4
    2
    10
    11
    20
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 213 (4.23%)
    11 / 211 (5.21%)
    17 / 382 (4.45%)
    26 / 322 (8.07%)
    16 / 106 (15.09%)
         occurrences all number
    11
    12
    19
    32
    24
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 213 (2.82%)
    14 / 211 (6.64%)
    23 / 382 (6.02%)
    19 / 322 (5.90%)
    3 / 106 (2.83%)
         occurrences all number
    7
    15
    28
    20
    6
    Bronchitis
         subjects affected / exposed
    7 / 213 (3.29%)
    5 / 211 (2.37%)
    19 / 382 (4.97%)
    17 / 322 (5.28%)
    15 / 106 (14.15%)
         occurrences all number
    8
    5
    20
    19
    18
    Influenza
         subjects affected / exposed
    4 / 213 (1.88%)
    3 / 211 (1.42%)
    9 / 382 (2.36%)
    17 / 322 (5.28%)
    4 / 106 (3.77%)
         occurrences all number
    4
    3
    11
    18
    4
    Pharyngitis
         subjects affected / exposed
    0 / 213 (0.00%)
    2 / 211 (0.95%)
    5 / 382 (1.31%)
    10 / 322 (3.11%)
    6 / 106 (5.66%)
         occurrences all number
    0
    2
    5
    12
    6
    Urinary tract infection
         subjects affected / exposed
    10 / 213 (4.69%)
    2 / 211 (0.95%)
    10 / 382 (2.62%)
    12 / 322 (3.73%)
    8 / 106 (7.55%)
         occurrences all number
    12
    2
    11
    13
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jul 2013
     Changed “entering” to “continue into” when describing how subjects can continue the one year long term extension (Section 3.1.4).  Added azathioprine as a medication which must be discontinued  28 days or five half lives prior to randomization.  Deleted study from the breast cancer screening exclusion.  Added “prior to randomization (Day 1) to exclusions from Medical History Exclusion Criteria n, q, and v [Section 3.3.2, Subsection 2)].  Added an exclusion for treatment with phototherapy within 28 days prior to randomization and hypersensitivity to investigational product excipients.  Added that the target lesion must not be in the axilla, genitals, groins, palms, or soles.  Changed dose reduction to dose limitation in the definition of intolerance for prior use of DMARDs.  Changed information on methods of contraception based on new language currently in discussion (protocol body and Appendix 2).  Clarified criteria for missed doses requiring discontinuation of treatment to be consistent throughout the protocol.  Added that subjects should avoid taking MTX within 48 hours of study drug administration to simplify determination of relatedness of adverse events to the study drug.
    22 Jul 2013
     Added the hyaluronic acid is not permitted in the double-blind and open label periods.  Added storage conditions for investigational drug in the Study Treatment section.  Changed procedure guide to instructions to describe how subjects will be trained in the use of the safety syringe.  Changed caretaker to caregiver in Section 4.3 to be consistent with other language in the protocol.  Added immunogenicity to information for which the BMS Bioanalytical Science Department or designee will be unblinded.  Added note that the Physician and Subject Global Assessments if Disease Activity refers to arthritis as the disease (Table 5.1-2, Table 5.1-3, and Section 5.4.4.)  Added note that subjects should not apply emollients to the skin on the day of their office visits (Table 5.1-2, Table 5.1-3, and Section 5.4.4).  Changed description of OL-1 to correctly refer to “Same day as final day in the Double Blind Period.  Deleted urine pregnancy test in OL-1 since the testing is already done on the last day in the double blind period.  Corrected table note references for Dosing Injectable Study Medication in Table 5.1-3.  Added into table notes regarding provisioning of urine pregnancy
    29 Oct 2013
     Modified definition of menopause to be 12 months amenorrhea rather than 6 months.  Added prior treatment of briakinumab as an exclusion criteria.  Indicated the Target Lesion should be assessed in addition to be identified at screening.  Added window the Day 1 radiograph to be - 3 days.  Corrected PK/PD substudy flow chart to delete information indicating a PK sample is collected at Day 169.  Clarified that the clinical assessor for enthesitis, dactylitis, PASI, target lesion, and physician visual analog scales may be a different person from the joint assessor.  Added a window for the biopsy sample collection to be - 3 days on Days 1 and 169.  Clarified when pregnancy tests are required.  Corrected PK table 5.5.1-1 to add sample collection and testing at Early Termination in the double-blind period.
    19 Aug 2014
     Changed screening period from 7-42 to 7-56 days.  Added permission for rescreening.  Modified inclusion criteria for target lesion to be at screening and randomization/Day 1.  Changed exclusion criteria for subjects who have been exposed to more than 2 TNFi to specify subjects who have failed more than 2 TNFi due to inefficacy.  Changed drug stabilization time for prior use of TNFis.  Deleted exclusion of prior use of apremilast, ustekinumab, and briakinumab.  Added drug stabiliation time for prior use of apremilast, ustekinumab, and briakinumab.  Changed TB testing to allow use of a gamma release assay.

    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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