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    Clinical Trial Results:
    A Phase 2a, multicenter, randomized, double-blind, placebo-controlled study comparing the safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis

    Summary
    EudraCT number
    		 2014-001096-31
    Trial protocol
    		 DK   BE   NL  
    Global end of trial date
    13 Jul 2016

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

    Trial information

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    Trial identification
    Sponsor protocol code
    M14-171
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02384538
    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
    Global Medical Services, Abbvie, 001 800-633-9110,
    Scientific contact
    Marc C. Levesque, MD, PhD, Abbvie, marc.levesque@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
    13 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a multicenter, randomized, double-blind, placebo-controlled study to compare the safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis.
    Protection of trial subjects
    Subject read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 2015
    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
    Netherlands: 4
    Country: Number of subjects enrolled
    Belgium: 20
    Country: Number of subjects enrolled
    Denmark: 27
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    United States: 76
    Worldwide total number of subjects
    132
    EEA total number of subjects
    54
    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)
    56
    From 65 to 84 years
    76
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 132 subjects were randomized and included in the intent-to-treat (ITT) population; 1 subject who was randomized to the ABT-981 treatment group did not receive a dose of study drug and was excluded from the analyses, for a total of 131 subjects in the modified intent-to-treat population (mITT).

    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, Assessor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for ABT-981
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for ABT-981 administered by subcutaneous injection.

    Arm title
    		 ABT-981
    Arm description
    		 ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-981
    Investigational medicinal product code
    Other name
    lutikizumab
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ABT-981 administered by subcutaneous injection.

    Number of subjects in period 1 [1]
    		Placebo ABT-981
    Started
    67
    64
    Completed
    61
    49
    Not completed
    6
    15
         Not specified
    1
    3
         Adverse event
    1
    4
         Withdrew consent
    -
    4
         Lack of efficacy
    4
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 132 subjects were randomized; 1 subject who was randomized to the ABT-981 treatment group did not receive a dose of study drug and was excluded from the analyses, for a total of 131 subjects in the modified intent-to-treat population (mITT).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.

    Reporting group title
    ABT-981
    Reporting group description
    		 ABT-981 200 mg every two weeks (Q2W) for 24 weeks.

    Reporting group values
    		 Placebo ABT-981 Total
    Number of subjects
    		 67 64 131
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.8 ( 7.325 ) 65.7 ( 8.132 ) -
    Gender categorical
    Units: Subjects
        Female
    		 58 53 111
        Male
    		 9 11 20

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.

    Reporting group title
    ABT-981
    Reporting group description
    		 ABT-981 200 mg every two weeks (Q2W) for 24 weeks.

    Primary: Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16

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    End point title
    		 Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16
    End point description
    The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.
    End point type
    Primary
    End point timeframe
    Week 0 (Baseline), Week 16
    End point values
    		 Placebo ABT-981
    Number of subjects analysed
    65 [1]
    64 [2]
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -10.74 (-15.433 to -6.045)
    -9.22 (-13.798 to -4.645)
    Notes
    [1] - mITT population: all randomized subjects who received at least 1 dose of study drug.
    [2] - mITT population: all randomized subjects who received at least 1 dose of study drug.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v ABT-981
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.386 [3]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.944
         upper limit
    		 4.99
    Notes
    [3] - P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.

    Secondary: Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit

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    End point title
    		 Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit
    End point description
    The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values. n=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
    End point values
    		 Placebo ABT-981
    Number of subjects analysed
    67 [4]
    64 [5]
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 2 (n=65,62)
    -3.25 (-7.058 to 0.55)
    -3.27 (-6.983 to 0.438)
        Week 4 (n=65,64)
    -5.01 (-9.144 to -0.885)
    -4.26 (-8.28 to -0.237)
        Week 8 (n=65,64)
    -8.9 (-13.065 to -4.744)
    -6.44 (-10.488 to -2.384)
        Week 12 (n=65,64)
    -8.31 (-12.593 to -4.03)
    -5.64 (-9.809 to -1.469)
        Week 16 (n=65,64)
    -10.74 (-15.443 to -6.045)
    -9.22 (-13.798 to -4.645)
        Week 20 (n=65,64)
    -7.28 (-11.969 to -2.591)
    -8.37 (-12.941 to -3.807)
        Week 26 (n=65,64)
    -8.76 (-13.782 to -3.737)
    -10.37 (-15.264 to -5.481)
    Notes
    [4] - All subjects in the mITT population.
    [5] - All subjects in the mITT population.
    No statistical analyses for this end point

    Secondary: Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit

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    End point title
    		 Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit
    End point description
    The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The physical function subdomain score ranges from 0 to 90; lower scores indicate better status. A decrease in the physical function subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values. n=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
    End point values
    		 Placebo ABT-981
    Number of subjects analysed
    67 [6]
    64 [7]
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 2 (n=65,62)
    -6.23 (-13.098 to 0.63)
    -4.79 (-11.44 to 1.861)
        Week 4 (n=65,64)
    -8.43 (-15.879 to -0.974)
    -7.04 (-14.249 to 0.177)
        Week 8 (n=65,64)
    -14.25 (-21.729 to -6.763)
    -8.97 (-16.211 to -1.725)
        Week 12 (n=65,64)
    -12.54 (-20.14 to -4.947)
    -8.53 (-15.887 to -1.182)
        Week 16 (n=65,64)
    -17.18 (-24.938 to -9.431)
    -14.64 (-22.142 to -7.133)
        Week 20 (n=65,64)
    -11.5 (-19.415 to -3.584)
    -12.53 (-20.189 to -4.867)
        Week 26 (n=65,64)
    -14.25 (-22.523 to -5.978)
    -16.39 (-24.402 to -8.388)
    Notes
    [6] - All subjects in the mITT population.
    [7] - All subjects in the mITT population.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v ABT-981
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.383 [8]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    2.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.214
         upper limit
    		 8.308
    Notes
    [8] - P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.

    Secondary: Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit

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    End point title
    		 Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit
    End point description
    The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The stiffness subdomain score ranges from 0 to 10; lower scores indicate better status. A decrease in the stiffness subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values. n=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
    End point values
    		 Placebo ABT-981
    Number of subjects analysed
    67 [9]
    64 [10]
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 2 (n=65,62)
    -0.74 (-1.692 to 0.215)
    -0.96 (-1.877 to -0.036)
        Week 4 (n=65,64)
    -0.98 (-1.937 to -0.028)
    -1.24 (-2.163 to -0.321)
        Week 8 (n=65,64)
    -1.51 (-2.535 to -0.493)
    -1.43 (-2.412 to -0.441)
        Week 12 (n=65,64)
    -1.65 (-2.706 to -0.599)
    -1.23 (-2.244 to -0.211)
        Week 16 (n=65,64)
    -1.76 (-2.885 to -0.633)
    -1.61 (-2.695 to -0.522)
        Week 20 (n=65,64)
    -1.34 (-2.515 to -0.169)
    -1.85 (-2.986 to -0.722)
        Week 26 (n=65,64)
    -1.94 (-3.017 to -0.859)
    -2.45 (-3.492 to -1.41)
    Notes
    [9] - All subjects in the mITT population.
    [10] - All subjects in the mITT population.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v ABT-981
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.719 [11]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.677
         upper limit
    		 0.979
    Notes
    [11] - P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.

    Secondary: Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit

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    End point title
    		 Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit
    End point description
    The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The total score ranges from 0 to 150; lower scores indicate better status. A decrease in the total score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values. n=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
    End point values
    		 Placebo ABT-981
    Number of subjects analysed
    67 [12]
    64 [13]
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 2 (n=65,62)
    -10.01 (-21.037 to 1.019)
    -8.85 (-19.545 to 1.835)
        Week 4 (n=65,64)
    -14.06 (-26.185 to -1.93)
    -12.18 (-23.928 to -0.439)
        Week 8 (n=65,64)
    -24.52 (-36.66 to -12.373)
    -16.65 (-28.406 to -4.886)
        Week 12 (n=65,64)
    -22.29 (-34.714 to -9.873)
    -15.15 (-27.181 to -3.124)
        Week 16 (n=65,64)
    -29.37 (-42.469 to -16.264)
    -25.12 (-37.808 to -12.429)
        Week 20 (n=65,64)
    -19.68 (-32.894 to -6.458)
    -22.33 (-35.128 to -9.526)
        Week 26 (n=65,64)
    -24.73 (-38.636 to -10.82)
    -28.99 (-42.461 to -15.523)
    Notes
    [12] - All subjects in the mITT population.
    [13] - All subjects in the mITT population.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v ABT-981
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.387 [14]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    4.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.448
         upper limit
    		 13.945
    Notes
    [14] - P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.

    Secondary: Subject Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit

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    End point title
    		 Subject Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit
    End point description
    Subjects rated the pain intensity of each hand during the previous 48 hours using an 11-point scale (NRS-11). The change from baseline to each visit in NRS-11 in the index hand (the hand with the most disease) are presented. Scores range from 0 to 10 points, with higher scores indicating greater pain intensity. A decrease in the NRS-11 score represents a decrease in pain intensity. n=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
    End point values
    		 Placebo ABT-981
    Number of subjects analysed
    67 [15]
    64 [16]
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 2 (n=65,62)
    -0.62 (-1.55 to 0.32)
    -0.69 (-1.613 to 0.228)
        Week 4 (n=65,63)
    -1.18 (-2.163 to -0.195)
    -1.06 (-2.025 to -0.088)
        Week 8 (n=63,58)
    -2.4 (-3.339 to -1.465)
    -1.74 (-2.66 to -0.814)
        Week 12 (n=61,53)
    -1.65 (-2.434 to -0.875)
    -0.81 (-1.629 to 0.01)
        Week 16 (n=61,51)
    -2.05 (-3.085 to -1.017)
    -1.6 (-2.626 to -0.578)
        Week 20 (n=57,49)
    -1.61 (-2.749 to -0.477)
    -1.75 (-2.892 to -0.612)
        Week 26 (n=60,50)
    -2.02 (-3.132 to -0.901)
    -2.52 (-3.62 to -1.415)
    Notes
    [15] - All subjects in the mITT population.
    [16] - All subjects in the mITT population.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v ABT-981
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.281 [17]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.373
         upper limit
    		 1.272
    Notes
    [17] - P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.

    Secondary: Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit

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    End point title
    		 Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit
    End point description
    Subjects were asked how much they were affected by hand OA by responding to the question "Considering all the ways your hand OA affects you, how have you been during the last 48 hours?" using an 11-point scale (NRS-11). Scores range from 0 to 10 points, with higher scores indicating greater effect of hand OA on the subject. A decrease in the NRS-11 score represents an improvement the effect of hand OA on the subject. n=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
    End point values
    		 Placebo ABT-981
    Number of subjects analysed
    67 [18]
    64 [19]
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 2 (n=65,62)
    -0.52 (-1.399 to 0.351)
    -0.54 (-1.403 to 0.316)
        Week 4 (n=65,63)
    -1.31 (-2.277 to -0.335)
    -1.13 (-2.083 to -0.176)
        Week 8 (n=63,58)
    -1.85 (-2.74 to -0.952)
    -1.2 (-2.08 to -0.324)
        Week 12 (n=61,53)
    -1.78 (-2.567 to -0.993)
    -1.17 (-1.997 to -0.348)
        Week 16 (n=61,51)
    -2.2 (-3.225 to -1.185)
    -1.69 (-2.697 to -0.677)
        Week 20 (n=57,49)
    -1.73 (-3.225 to -1.185)
    -1.77 (-2.879 to -0.666)
        Week 26 (n=60,50)
    -2 (-3.133 to -0.874)
    -2.35 (-3.465 to -1.236)
    Notes
    [18] - All subjects in the mITT population.
    [19] - All subjects in the mITT population.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo v ABT-981
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.212 [20]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 1.336
    Notes
    [20] - P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
    Adverse event reporting additional description
    TEAEs and TESAEs are defined as any AE or SAE that begins on or after the first dose of study drug, up to 70 days after the last dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.

    Reporting group title
    ABT-981
    Reporting group description
    		 ABT-981 200 mg every two weeks (Q2W) for 24 weeks.

    Serious adverse events
    		 Placebo ABT-981
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 64 (3.13%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive breast carcinoma
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Faeces discoloured
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo ABT-981
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 67 (67.16%)
    49 / 64 (76.56%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 67 (4.48%)
    4 / 64 (6.25%)
         occurrences all number
    3
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 67 (5.97%)
    4 / 64 (6.25%)
         occurrences all number
    10
    9
    Headache
         subjects affected / exposed
    17 / 67 (25.37%)
    10 / 64 (15.63%)
         occurrences all number
    35
    22
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 67 (0.00%)
    6 / 64 (9.38%)
         occurrences all number
    0
    12
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 67 (0.00%)
    4 / 64 (6.25%)
         occurrences all number
    0
    4
    Injection site erythema
         subjects affected / exposed
    0 / 67 (0.00%)
    7 / 64 (10.94%)
         occurrences all number
    0
    10
    Injection site rash
         subjects affected / exposed
    3 / 67 (4.48%)
    7 / 64 (10.94%)
         occurrences all number
    6
    44
    Injection site reaction
         subjects affected / exposed
    3 / 67 (4.48%)
    7 / 64 (10.94%)
         occurrences all number
    3
    18
    Pain
         subjects affected / exposed
    4 / 67 (5.97%)
    0 / 64 (0.00%)
         occurrences all number
    4
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 67 (8.96%)
    4 / 64 (6.25%)
         occurrences all number
    6
    4
    Nausea
         subjects affected / exposed
    2 / 67 (2.99%)
    8 / 64 (12.50%)
         occurrences all number
    2
    11
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    5 / 67 (7.46%)
    4 / 64 (6.25%)
         occurrences all number
    5
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 67 (8.96%)
    4 / 64 (6.25%)
         occurrences all number
    12
    4
    Back pain
         subjects affected / exposed
    11 / 67 (16.42%)
    3 / 64 (4.69%)
         occurrences all number
    16
    5
    Pain in extremity
         subjects affected / exposed
    4 / 67 (5.97%)
    3 / 64 (4.69%)
         occurrences all number
    5
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    17 / 67 (25.37%)
    13 / 64 (20.31%)
         occurrences all number
    23
    18
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 67 (5.97%)
    4 / 64 (6.25%)
         occurrences all number
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Oct 2015
    The main purpose of this amendments was to remove the Patient Global Assessment Questionnaire from Inclusion criteria and clarify patient reported outcome collection method.

    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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    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
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