Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects with Active Psoriatic Arthritis Who Have an Inadequate Response to Methotrexate

    Summary
    EudraCT number
    		 2014-003558-15
    Trial protocol
    		 DE   LV   HU   CZ   ES   BG  
    Global end of trial date
    04 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2017
    First version publication date
    13 Jul 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M14-197
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02349451
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Abbvie Deutschland GmbH & Co.KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Nannette Englehardt, BS, AbbVie, nannette.englehardt@abbvie.com
    Scientific contact
    Paul Peloso, MD, AbbVie, paul.peloso@abbvie.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
    04 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is a Phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in subjects with active psoriatic arthiritis (PsA) who are inadequately responding to methotrexate (MTX) treatment.
    Protection of trial subjects
    Participant and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Apr 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Bulgaria: 38
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Latvia: 26
    Country: Number of subjects enrolled
    New Zealand: 5
    Country: Number of subjects enrolled
    Poland: 103
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    United States: 42
    Worldwide total number of subjects
    240
    EEA total number of subjects
    191
    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)
    207
    From 65 to 84 years
    33
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study included a 30-day screening period conducted within 30 days of the first dose of study drug.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo EW
    Arm description
    		 Double-blind placebo administered every week (EW) for 12 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for ABT-122 lyophilized powder for solution for injection administered EW

    Arm title
    		 Adalimumab 40 mg EOW
    Arm description
    		 Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab, solution for injection 50 mg/mL (0.8 mL) pre-filled syringe (PFS) 40 mg administered EOW

    Investigational medicinal product name
    placebo for adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for adalimumab solution for injection, 0.8 mL pre-filled syringe EOW

    Arm title
    		 ABT-122 120 mg EW
    Arm description
    		 Double-blind ABT-122 120 mg administered EW for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-122
    Investigational medicinal product code
    ABT-122
    Other name
    remtolumab
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ABT-122 lyophilized powder for solution for injection, 100 mg, 1.0 mL, vial 120 mg administered EW

    Arm title
    		 ABT-122 240 mg EW
    Arm description
    		 Double-blind ABT-122 240 mg administered EW for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-122
    Investigational medicinal product code
    ABT-122
    Other name
    remtolumab
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ABT-122 lyophilized powder for solution for injection, 100 mg, 1.0 mL, vial 240 mg administered EW

    Number of subjects in period 1
    		Placebo EW Adalimumab 40 mg EOW ABT-122 120 mg EW ABT-122 240 mg EW
    Started
    24
    72
    71
    73
    Completed
    24
    71
    69
    72
    Not completed
    0
    1
    2
    1
         Consent withdrawn by subject
    -
    1
    2
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo EW
    Reporting group description
    		 Double-blind placebo administered every week (EW) for 12 weeks

    Reporting group title
    Adalimumab 40 mg EOW
    Reporting group description
    		 Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks

    Reporting group title
    ABT-122 120 mg EW
    Reporting group description
    		 Double-blind ABT-122 120 mg administered EW for 12 weeks

    Reporting group title
    ABT-122 240 mg EW
    Reporting group description
    		 Double-blind ABT-122 240 mg administered EW for 12 weeks

    Reporting group values
    		 Placebo EW Adalimumab 40 mg EOW ABT-122 120 mg EW ABT-122 240 mg EW Total
    Number of subjects
    		 24 72 71 73 240
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.7 ( 13.67 ) 50.5 ( 12.03 ) 51 ( 12.39 ) 47.4 ( 13.77 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 33 37 37 119
        Male
    		 12 39 34 36 121
    Sex: Female, Male
    Units: Subjects
        Female
    		 12 33 37 37 119
        Male
    		 12 39 34 36 121

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo EW
    Reporting group description
    		 Double-blind placebo administered every week (EW) for 12 weeks

    Reporting group title
    Adalimumab 40 mg EOW
    Reporting group description
    		 Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks

    Reporting group title
    ABT-122 120 mg EW
    Reporting group description
    		 Double-blind ABT-122 120 mg administered EW for 12 weeks

    Reporting group title
    ABT-122 240 mg EW
    Reporting group description
    		 Double-blind ABT-122 240 mg administered EW for 12 weeks

    Primary: American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo

    		 Close Top of page
    End point title
    		 American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo [1]
    End point description
    Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein [hsCRP]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
    End point type
    Primary
    End point timeframe
    Week 12
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The primary endpoint was a comparison between ABT-122 and placebo only.
    End point values
    		 Placebo EW ABT-122 120 mg EW ABT-122 240 mg EW
    Number of subjects analysed
    24
    71
    73
    Units: percentage of participants
        number (confidence interval 95%)
    25 (11.7 to 45.2)
    64.8 (53.2 to 74.9)
    75.3 (64.3 to 83.9)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo EW v ABT-122 120 mg EW
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 Fisher exact
    Parameter type
    		 response rate difference
    Point estimate
    39.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.2
         upper limit
    		 57.7
    Notes
    [2] - P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo EW v ABT-122 240 mg EW
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Fisher exact
    Parameter type
    		 response rate difference
    Point estimate
    50.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28.1
         upper limit
    		 67.4
    Notes
    [3] - P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.

    Secondary: ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab

    		 Close Top of page
    End point title
    		 ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab [4]
    End point description
    Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This secondary endpoint was a comparison between ABT-122 and adalimumab only.
    End point values
    		 Adalimumab 40 mg EOW ABT-122 120 mg EW ABT-122 240 mg EW
    Number of subjects analysed
    72
    71
    73
    Units: percentage of participants
        number (confidence interval 95%)
    68.1 (56.6 to 77.7)
    64.8 (53.2 to 74.9)
    75.3 (64.3 to 83.9)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 120 mg EW
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.723 [5]
    Method
    		 Fisher exact
    Parameter type
    		 response rate difference
    Point estimate
    -3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.5
         upper limit
    		 12.1
    Notes
    [5] - P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 240 mg EW
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.215 [6]
    Method
    		 Fisher exact
    Parameter type
    		 response rate difference
    Point estimate
    7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 21.6
    Notes
    [6] - P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.

    Secondary: ACR50 Response Rate at Week 12

    		 Close Top of page
    End point title
    		 ACR50 Response Rate at Week 12
    End point description
    Percentage of participants with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo EW Adalimumab 40 mg EOW ABT-122 120 mg EW ABT-122 240 mg EW
    Number of subjects analysed
    24
    72
    71
    73
    Units: percentage of participants
        number (confidence interval 95%)
    12.5 (3.5 to 31.8)
    37.5 (27.2 to 49.1)
    36.6 (26.3 to 48.3)
    53.4 (42.1 to 64.4)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo EW v ABT-122 120 mg EW
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021 [7]
    Method
    		 Fisher exact
    Parameter type
    		 response rate difference
    Point estimate
    24.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.9
         upper limit
    		 39.3
    Notes
    [7] - P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 120 mg EW
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.611 [8]
    Method
    		 Fisher exact
    Parameter type
    		 response rate difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.5
         upper limit
    		 14.8
    Notes
    [8] - P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo EW v ABT-122 240 mg EW
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [9]
    Method
    		 Fisher exact
    Parameter type
    		 response rate difference
    Point estimate
    40.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.1
         upper limit
    		 55.8
    Notes
    [9] - P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 240 mg EW
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039 [10]
    Method
    		 Fisher exact
    Parameter type
    		 response rate difference
    Point estimate
    15.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 31.3
    Notes
    [10] - P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.

    Secondary: ACR70 Response Rate at Week 12

    		 Close Top of page
    End point title
    		 ACR70 Response Rate at Week 12
    End point description
    Percentage of participants with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo EW Adalimumab 40 mg EOW ABT-122 120 mg EW ABT-122 240 mg EW
    Number of subjects analysed
    24
    72
    71
    73
    Units: percentage of participants
        number (confidence interval 95%)
    4.2 (0 to 21.9)
    15.3 (8.6 to 25.5)
    22.5 (14.3 to 33.6)
    31.5 (22 to 42.9)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo EW v ABT-122 120 mg EW
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.034 [11]
    Method
    		 Fisher exact
    Parameter type
    		 response rate difference
    Point estimate
    18.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 29.7
    Notes
    [11] - P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 120 mg EW
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.185 [12]
    Method
    		 Fisher exact
    Parameter type
    		 response rate difference
    Point estimate
    7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 19.9
    Notes
    [12] - P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo EW v ABT-122 240 mg EW
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004 [13]
    Method
    		 Fisher exact
    Parameter type
    		 response rate difference
    Point estimate
    27.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.6
         upper limit
    		 39
    Notes
    [13] - P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 240 mg EW
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017 [14]
    Method
    		 Fisher exact
    Parameter type
    		 response rate difference
    Point estimate
    16.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.3
         upper limit
    		 29.3
    Notes
    [14] - P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.

    Secondary: ACRn at Week 12

    		 Close Top of page
    End point title
    		 ACRn at Week 12
    End point description
    ACR measures percentage improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACRn is a continuous variable based on the ACR criteria. Improvement from baseline in a component of the ACR composite variable was computed as the difference between the baseline value and the value at a given post-baseline visit. A positive value for improvement from baseline for an individual component indicates lesser severity of disease. The 95% confidence interval for mean is constructed using T-statistic with significance level alpha=5%.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Placebo EW Adalimumab 40 mg EOW ABT-122 120 mg EW ABT-122 240 mg EW
    Number of subjects analysed
    24
    72
    71
    73
    Units: percentage improvement
        arithmetic mean (confidence interval 95%)
    -20.3 (-59.6 to 19.1)
    38.2 (29.2 to 47.2)
    34.7 (25.5 to 44)
    48.6 (41.1 to 56.1)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo EW v ABT-122 120 mg EW
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [15]
    Method
    		 Kolmogorov-Smirnov test
    Confidence interval
    Notes
    [15] - Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 120 mg EW
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.561 [16]
    Method
    		 Kolmogorov-Smirnov test
    Confidence interval
    Notes
    [16] - Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo EW v ABT-122 240 mg EW
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [17]
    Method
    		 Kolmogorov-Smirnov test
    Confidence interval
    Notes
    [17] - Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 240 mg EW
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.106 [18]
    Method
    		 Kolmogorov-Smirnov test
    Confidence interval
    Notes
    [18] - Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.

    Secondary: Change from Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12

    		 Close Top of page
    End point title
    		 Change from Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12
    End point description
    The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo EW Adalimumab 40 mg EOW ABT-122 120 mg EW ABT-122 240 mg EW
    Number of subjects analysed
    24
    72
    71
    73
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -0.89 (-1.32 to -0.45)
    -1.83 (-2.08 to -1.58)
    -1.96 (-2.21 to -1.7)
    -2.28 (-2.53 to -2.03)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo EW v ABT-122 120 mg EW
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [19]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.58
         upper limit
    		 -0.57
    Notes
    [19] - Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 120 mg EW
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.479 [20]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 0.23
    Notes
    [20] - Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo EW v ABT-122 240 mg EW
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [21]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 -0.89
    Notes
    [21] - Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 240 mg EW
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012 [22]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.81
         upper limit
    		 -0.1
    Notes
    [22] - Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.

    Secondary: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12

    		 Close Top of page
    End point title
    		 Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12
    End point description
    PASDAS is a continuous compound disease activity state score determined by the combined values of tender or swollen joint counts, subject-reported outcome and hsCRP lab test. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo EW Adalimumab 40 mg EOW ABT-122 120 mg EW ABT-122 240 mg EW
    Number of subjects analysed
    24
    72
    71
    73
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -1.46 (-2.01 to -0.9)
    -2.53 (-2.85 to -2.22)
    -2.62 (-2.94 to -2.31)
    -2.86 (-3.18 to -2.55)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo EW v ABT-122 120 mg EW
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [23]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.81
         upper limit
    		 -0.53
    Notes
    [23] - Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 120 mg EW
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.696 [24]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 0.36
    Notes
    [24] - Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo EW v ABT-122 240 mg EW
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [25]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.04
         upper limit
    		 -0.77
    Notes
    [25] - Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 240 mg EW
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.151 [26]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.77
         upper limit
    		 0.12
    Notes
    [26] - Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.

    Secondary: Change From Baseline in Psoriasis Target Lesion Score at Week 12

    		 Close Top of page
    End point title
    		 Change From Baseline in Psoriasis Target Lesion Score at Week 12
    End point description
    Target lesion score for psoriasis in participants with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque thickness) to 10 (severe erythema and evidence of plaque thickness).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo EW Adalimumab 40 mg EOW ABT-122 120 mg EW ABT-122 240 mg EW
    Number of subjects analysed
    24
    72
    71
    73
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -1.81 (-2.65 to -0.96)
    -4.16 (-4.65 to -3.67)
    -4.98 (-5.47 to -4.49)
    -4.53 (-5.02 to -4.05)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo EW v ABT-122 120 mg EW
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [27]
    Method
    		 ANOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -3.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.14
         upper limit
    		 -2.19
    Notes
    [27] - Two-sided p-value is calculated from ANOVA model with treatment group as the fixed factor and baseline value as the covariate.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 120 mg EW
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021 [28]
    Method
    		 ANOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.51
         upper limit
    		 -0.12
    Notes
    [28] - Two-sided p-value is calculated from ANOVA model with treatment group as the fixed factor and baseline value as the covariate.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo EW v ABT-122 240 mg EW
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [29]
    Method
    		 ANOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -2.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 -1.75
    Notes
    [29] - Two-sided p-value is calculated from ANOVA model with treatment group as the fixed factor and baseline value as the covariate.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 240 mg EW
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.288 [30]
    Method
    		 ANOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 0.32
    Notes
    [30] - Two-sided p-value is calculated from ANOVA model with treatment group as the fixed factor and baseline value as the covariate.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks).
    Adverse event reporting additional description
    A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo EW
    Reporting group description
    		 Double-blind placebo administered EW for 12 weeks

    Reporting group title
    Adalimumab 40 mg EOW
    Reporting group description
    		 Double-blind adalimumab 40 mg administered EOW for 12 weeks

    Reporting group title
    ABT-122 120 mg EW
    Reporting group description
    		 Double-blind ABT-122 120 mg administered EW for 12 weeks

    Reporting group title
    ABT-122 240 mg EW
    Reporting group description
    		 Double-blind ABT-122 240 mg administered EW for 12 weeks

    Serious adverse events
    		 Placebo EW Adalimumab 40 mg EOW ABT-122 120 mg EW ABT-122 240 mg EW
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    HEART RATE DECREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ROAD TRAFFIC ACCIDENT
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SKIN ABRASION
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    UPPER LIMB FRACTURE
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    SYNCOPE
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo EW Adalimumab 40 mg EOW ABT-122 120 mg EW ABT-122 240 mg EW
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 24 (41.67%)
    39 / 72 (54.17%)
    33 / 71 (46.48%)
    33 / 73 (45.21%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 72 (2.78%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    2
    1
    0
    PHLEBITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 72 (2.78%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         occurrences all number
    0
    2
    1
    1
    GAIT DISTURBANCE
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    INJECTION SITE BRUISING
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 72 (4.17%)
    1 / 71 (1.41%)
    2 / 73 (2.74%)
         occurrences all number
    0
    6
    1
    3
    INJECTION SITE HAEMATOMA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    1
    INJECTION SITE INDURATION
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    INJECTION SITE OEDEMA
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    0
    1
    INJECTION SITE PAPULE
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    INJECTION SITE PRURITUS
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    2
    0
    2
    PERIPHERAL SWELLING
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    VESSEL PUNCTURE SITE PHLEBITIS
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Social circumstances
    ECONOMIC PROBLEM
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    CATARRH
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    COUGH
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    DYSPNOEA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    0
    1
    RHINITIS ALLERGIC
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    SINUS PAIN
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    THROAT IRRITATION
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    0
    1
    DEPRESSION
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    INSOMNIA
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    2
    0
    STRESS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 72 (2.78%)
    5 / 71 (7.04%)
    3 / 73 (4.11%)
         occurrences all number
    0
    2
    5
    4
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    3 / 71 (4.23%)
    2 / 73 (2.74%)
         occurrences all number
    0
    1
    3
    2
    BLOOD CALCIUM INCREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    BLOOD CHOLESTEROL INCREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    BLOOD PRESSURE INCREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 72 (2.78%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         occurrences all number
    0
    2
    1
    1
    BLOOD TRIGLYCERIDES INCREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    2 / 71 (2.82%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    2
    1
    BLOOD URIC ACID INCREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    BODY TEMPERATURE INCREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    CRYSTAL URINE PRESENT
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    1
    HAEMOGLOBIN INCREASED
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    0
    0
    LYMPHOCYTE COUNT DECREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 72 (2.78%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    4
    0
    1
    MONOCYTE COUNT INCREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    NEUTROPHIL COUNT DECREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 72 (4.17%)
    2 / 71 (2.82%)
    0 / 73 (0.00%)
         occurrences all number
    0
    3
    2
    0
    TRANSAMINASES ABNORMAL
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    TRANSAMINASES INCREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    2 / 71 (2.82%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    2
    0
    URINE OUTPUT DECREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    WEIGHT INCREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    WHITE BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 72 (4.17%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Injury, poisoning and procedural complications
    ANIMAL SCRATCH
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    CONTUSION
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    FALL
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    FOOT FRACTURE
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    INJURY
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    LIGAMENT RUPTURE
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    ROAD TRAFFIC ACCIDENT
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    SPINAL COMPRESSION FRACTURE
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    SPLINTER
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Congenital, familial and genetic disorders
    HYDROCELE
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    PALPITATIONS
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    SINUS TACHYCARDIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    0
    1
    NEUROPATHY PERIPHERAL
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    SOMNOLENCE
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    2 / 73 (2.74%)
         occurrences all number
    0
    0
    1
    2
    Blood and lymphatic system disorders
    GRANULOCYTOPENIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    LEUKOPENIA
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 72 (2.78%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         occurrences all number
    0
    2
    1
    2
    LYMPHADENOPATHY
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    LYMPHOCYTOSIS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    LYMPHOPENIA
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 72 (2.78%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    2
    0
    0
    NEUTROPENIA
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 72 (2.78%)
    2 / 71 (2.82%)
    1 / 73 (1.37%)
         occurrences all number
    0
    2
    2
    1
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye disorders
    BLEPHARITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    ERYTHEMA OF EYELID
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    MYOPIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    RETINAL VASCULAR DISORDER
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    DIARRHOEA
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 72 (1.39%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    1
    1
    1
    0
    DYSPEPSIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    FOOD POISONING
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    0
    1
    HAEMATOCHEZIA
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    2
    0
    1
    INGUINAL HERNIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    NAUSEA
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         occurrences all number
    2
    0
    1
    1
    ORAL MUCOSA EROSION
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    STOMATITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    1
    TOOTHACHE
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    1
    1
    VOMITING
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    Hepatobiliary disorders
    BILE DUCT OBSTRUCTION
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    HYPERTRANSAMINASAEMIA
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    ACNE
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    DERMATITIS ALLERGIC
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    1
    ERYTHEMA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    1
    PRURITUS
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    1
    0
    PSORIASIS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    RASH
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    0
    0
    0
    2
    RASH ERYTHEMATOUS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal and urinary disorders
    CRYSTALLURIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    MICTURITION URGENCY
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    POLLAKIURIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    PROTEINURIA
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    2 / 71 (2.82%)
    1 / 73 (1.37%)
         occurrences all number
    0
    1
    2
    2
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    2
    0
    0
    1
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    MYALGIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    OSTEOARTHRITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    OSTEOPOROSIS
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    PSORIATIC ARTHROPATHY
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    1
    1
    0
    1
    ROTATOR CUFF SYNDROME
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    SPINAL PAIN
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    ACUTE SINUSITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 72 (2.78%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    2
    0
    0
    BRONCHITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    1
    0
    CONJUNCTIVITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    FOLLICULITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    FURUNCLE
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    GASTROENTERITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    HORDEOLUM
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    INFLUENZA
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 72 (4.17%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    3
    0
    1
    LARYNGITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    6 / 72 (8.33%)
    4 / 71 (5.63%)
    3 / 73 (4.11%)
         occurrences all number
    0
    6
    4
    4
    ORAL CANDIDIASIS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    1
    ORAL HERPES
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    PARONYCHIA
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    0
    0
    PHARYNGITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    2
    0
    0
    PNEUMONIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    RHINITIS
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    1
    0
    0
    1
    SINUSITIS
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         occurrences all number
    1
    0
    1
    1
    SUBCUTANEOUS ABSCESS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    2 / 71 (2.82%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    2
    0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    2 / 24 (8.33%)
    5 / 72 (6.94%)
    1 / 71 (1.41%)
    7 / 73 (9.59%)
         occurrences all number
    2
    5
    2
    9
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    2 / 71 (2.82%)
    4 / 73 (5.48%)
         occurrences all number
    0
    1
    2
    5
    URINARY TRACT INFECTION BACTERIAL
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    VIRAL PHARYNGITIS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    DIABETES MELLITUS
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    2 / 71 (2.82%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    2
    0
    DYSLIPIDAEMIA
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    HYPERCHOLESTEROLAEMIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    2 / 71 (2.82%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    2
    1
    HYPERLIPIDAEMIA
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 72 (2.78%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    2
    0
    0
    HYPERTRIGLYCERIDAEMIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    0
    HYPERURICAEMIA
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    HYPOGLYCAEMIA
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    3
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Feb 2015
    The substantive change in this amendment was updating Exclusion Criterion 8 and 23 and adding Exclusion Criterion 17 and 22 to ensure the appropriate subject population was enrolled.
    23 Jul 2015
    Substantive changes in this amendment were as follows: ● Revising total number of sites to approximately 110 globally. ● Clarifying rescreening and laboratory retesting requirements to make clear timing of rescreening and the requirements for retesting. ● Adding interim analysis to review the cumulative safety and dose response relationship during the trial. ● Identifying additional personnel who can be unblinded for analysis purposes during the trial. ● Updating female and male reproductive language in Inclusion Criterion 8 and 9 to ensure that only highly effective contraceptive measures were allowed, consistent with the recommendations related to contraception and pregnancy testing in clinical trials by the Clinical Trial Facilitation Group (CTFG) of the Heads of Medicinal Agencies (HMA). ● Updating Exclusion Criterion 1 to facilitate enrollment such that patients exposed to prior TNF inhibitors were allowed to enroll so long as the prior TNF inhibitor excludes prior adalimumab and also if the reason for discontinuation of the prior TNF inhibitor was not related to a lack of efficacy or safety. ● Clarifying chest x-ray (CXR) language to allow the Principal Investigator (PI) or physician delegate to complete the assessment of CXR. ● Removing 24-hour methylhistamine laboratory test and urine drug screen as they were no longer required. ● Updating injection site reaction language to allow sites to further assess and investigate injection site reactions as deemed by the PI. ● Adding Complaint and Product Complaint definition as well as the reporting requirements for Product Complaints to implement a standard process for the collection of Product Quality Complaints in clinical trials. ● Adding Electronic Patient Reported Outcomes (ePRO) language to include information on the use of the ePRO device as a source for collecting data.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 22:02:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA