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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy

    Summary
    EudraCT number
    		 2013-002358-57
    Trial protocol
    		 ES   CZ   HU   NL   BE  
    Global end of trial date
    27 Jul 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    12 Jul 2018
    First version publication date
    06 Aug 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of the number of subjects affected in 1 column of the Adverse Events data table.

    Trial information

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    Trial identification
    Sponsor protocol code
    M13-550
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01960855
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4XE
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    Steven Jungerwirth, MD, AbbVie, steven.jungerwirth@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
    27 Jul 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to anti-TNF biologic therapy.
    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
    31 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 33
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Hungary: 20
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    New Zealand: 4
    Country: Number of subjects enrolled
    Puerto Rico: 11
    Country: Number of subjects enrolled
    United States: 176
    Worldwide total number of subjects
    276
    EEA total number of subjects
    83
    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)
    196
    From 65 to 84 years
    78
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study included a screening period of 30 days.

    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, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo BID
    Arm description
    		 Placebo twice daily (BID) for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for ABT-494 capsule administered orally twice daily (BID).

    Arm title
    		 ABT-494 3 mg BID
    Arm description
    		 ABT-494 3 mg twice daily (BID) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-494
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-494 capsule administered orally twice daily (BID).

    Arm title
    		 ABT-494 6 mg BID
    Arm description
    		 ABT-494 6 mg twice daily (BID) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-494
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-494 capsule administered orally twice daily (BID).

    Arm title
    		 ABT-494 12 mg BID
    Arm description
    		 ABT-494 12 mg twice daily (BID) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-494
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-494 capsule administered orally twice daily (BID).

    Arm title
    		 ABT-494 18 mg BID
    Arm description
    		 ABT-494 18 mg twice daily (BID) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-494
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-494 capsule administered orally twice daily (BID).

    Number of subjects in period 1
    		Placebo BID ABT-494 3 mg BID ABT-494 6 mg BID ABT-494 12 mg BID ABT-494 18 mg BID
    Started
    56
    55
    55
    55
    55
    Completed
    45
    51
    46
    51
    50
    Not completed
    11
    4
    9
    4
    5
         Consent withdrawn by subject
    3
    1
    2
    1
    1
         Not specified
    2
    1
    1
    1
    -
         Adverse event
    2
    -
    6
    2
    2
         Lost to follow-up
    2
    1
    -
    -
    2
         Subject noncompliant
    1
    -
    -
    -
    -
         Lack of efficacy
    1
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo BID
    Reporting group description
    		 Placebo twice daily (BID) for 12 weeks.

    Reporting group title
    ABT-494 3 mg BID
    Reporting group description
    		 ABT-494 3 mg twice daily (BID) for 12 weeks.

    Reporting group title
    ABT-494 6 mg BID
    Reporting group description
    		 ABT-494 6 mg twice daily (BID) for 12 weeks.

    Reporting group title
    ABT-494 12 mg BID
    Reporting group description
    		 ABT-494 12 mg twice daily (BID) for 12 weeks.

    Reporting group title
    ABT-494 18 mg BID
    Reporting group description
    		 ABT-494 18 mg twice daily (BID) for 12 weeks.

    Reporting group values
    		 Placebo BID ABT-494 3 mg BID ABT-494 6 mg BID ABT-494 12 mg BID ABT-494 18 mg BID Total
    Number of subjects
    		 56 55 55 55 55 276
    Age categorical
    Units: Subjects
    Age continuous
    Modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least 1 dose of study drug.
    Units: years
        arithmetic mean (standard deviation)
    		 57.5 ± 12.04 57 ± 13.06 56.3 ± 11.71 59.1 ± 11.4 56.7 ± 12.39 -
    Gender categorical
    mITT population.
    Units: Subjects
        Female
    		 48 43 43 45 42 221
        Male
    		 8 12 12 10 13 55

    End points

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    End points reporting groups
    Reporting group title
    Placebo BID
    Reporting group description
    		 Placebo twice daily (BID) for 12 weeks.

    Reporting group title
    ABT-494 3 mg BID
    Reporting group description
    		 ABT-494 3 mg twice daily (BID) for 12 weeks.

    Reporting group title
    ABT-494 6 mg BID
    Reporting group description
    		 ABT-494 6 mg twice daily (BID) for 12 weeks.

    Reporting group title
    ABT-494 12 mg BID
    Reporting group description
    		 ABT-494 12 mg twice daily (BID) for 12 weeks.

    Reporting group title
    ABT-494 18 mg BID
    Reporting group description
    		 ABT-494 18 mg twice daily (BID) for 12 weeks.

    Primary: Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

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    End point title
    		 Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
    End point description
    Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient’s assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire – Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hs CRP). Last observation carried forward (LOCF) was used for missing data.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Placebo BID ABT-494 3 mg BID ABT-494 6 mg BID ABT-494 12 mg BID ABT-494 18 mg BID
    Number of subjects analysed
    54 [1]
    54 [2]
    52 [3]
    55 [4]
    55 [5]
    Units: subjects
    19
    30
    33
    40
    39
    Notes
    [1] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [2] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [3] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [4] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [5] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    ABT-494 3 mg BID v Placebo BID
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.033
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo BID v ABT-494 6 mg BID
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo BID v ABT-494 12 mg BID
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo BID v ABT-494 18 mg BID
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Number of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 12

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    End point title
    		 Number of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 12
    End point description
    Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient’s assessment of pain, PtGA; PGA, HAQ-DI, and hs CRP. LOCF was used.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Placebo BID ABT-494 3 mg BID ABT-494 6 mg BID ABT-494 12 mg BID ABT-494 18 mg BID
    Number of subjects analysed
    53 [6]
    54 [7]
    52 [8]
    55 [9]
    55 [10]
    Units: subjects
    9
    13
    20
    24
    22
    Notes
    [6] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [7] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [8] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [9] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [10] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo BID v ABT-494 3 mg BID
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.364
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo BID v ABT-494 6 mg BID
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.014
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo BID v ABT-494 12 mg BID
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo BID v ABT-494 18 mg BID
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.008
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Number of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12

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    End point title
    		 Number of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
    End point description
    Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient’s assessment of pain, PtGA; PGA, HAQ-DI, and hs CRP. LOCF was used.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Placebo BID ABT-494 3 mg BID ABT-494 6 mg BID ABT-494 12 mg BID ABT-494 18 mg BID
    Number of subjects analysed
    55 [11]
    54 [12]
    52 [13]
    55 [14]
    55 [15]
    Units: subjects
    2
    7
    14
    12
    12
    Notes
    [11] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [12] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [13] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [14] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [15] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo BID v ABT-494 3 mg BID
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.093
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    ABT-494 6 mg BID v Placebo BID
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo BID v ABT-494 12 mg BID
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo BID v ABT-494 18 mg BID
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Number of Subjects Achieving Low Disease Activity (LDA) Based on Disease Activity Score (DAS28) or Clinical Remission (CR) based on (DAS28) at Week 12

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    End point title
    		 Number of Subjects Achieving Low Disease Activity (LDA) Based on Disease Activity Score (DAS28) or Clinical Remission (CR) based on (DAS28) at Week 12
    End point description
    LDA is defined as DAS28 from 2.6 to < 3.2 at Week 12. CR is defined as DAS28 (CRP) < 2.6 at Week 12. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hs CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. LOCF was used.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo BID ABT-494 3 mg BID ABT-494 6 mg BID ABT-494 12 mg BID ABT-494 18 mg BID
    Number of subjects analysed
    55 [16]
    54 [17]
    53 [18]
    55 [19]
    55 [20]
    Units: subjects
    14
    18
    20
    29
    25
    Notes
    [16] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [17] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [18] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [19] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [20] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo BID v ABT-494 3 mg BID
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.366
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo BID v ABT-494 6 mg BID
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.17
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo BID v ABT-494 12 mg BID
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo BID v ABT-494 18 mg BID
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.028
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Number of Subjects Achieving CR based on DAS28 at Week 12

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    End point title
    		 Number of Subjects Achieving CR based on DAS28 at Week 12
    End point description
    The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hs CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. LOCF was used.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo BID ABT-494 3 mg BID ABT-494 6 mg BID ABT-494 12 mg BID ABT-494 18 mg BID
    Number of subjects analysed
    55 [21]
    54 [22]
    53 [23]
    55 [24]
    55 [25]
    Units: subjects
    7
    13
    14
    18
    17
    Notes
    [21] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [22] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [23] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [24] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    [25] - Subjects in the mITT population with a baseline value and at least 1 post-baseline value
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo BID v ABT-494 3 mg BID
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.126
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo BID v ABT-494 6 mg BID
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.072
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo BID v ABT-494 12 mg BID
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.012
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo BID v ABT-494 18 mg BID
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.021
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).
    Adverse event reporting additional description
    A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of study drug is administered 30 days have elapsed following discontinuation of study drug administration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo BID
    Reporting group description
    		 Placebo twice daily (BID) for 12 weeks.

    Reporting group title
    ABT-494 3 mg BID
    Reporting group description
    		 ABT-494 3 mg twice daily (BID) for 12 weeks.

    Reporting group title
    ABT-494 6 mg BID
    Reporting group description
    		 ABT-494 6 mg twice daily (BID) for 12 weeks.

    Reporting group title
    ABT-494 12 mg BID
    Reporting group description
    		 ABT-494 12 mg twice daily (BID) for 12 weeks.

    Reporting group title
    ABT-494 18 mg BID
    Reporting group description
    		 ABT-494 18 mg twice daily (BID) for 12 weeks.

    Serious adverse events
    		 Placebo BID ABT-494 3 mg BID ABT-494 6 mg BID ABT-494 12 mg BID ABT-494 18 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 55 (3.64%)
    2 / 55 (3.64%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    1 / 55 (1.82%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo BID ABT-494 3 mg BID ABT-494 6 mg BID ABT-494 12 mg BID ABT-494 18 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 56 (16.07%)
    13 / 55 (23.64%)
    9 / 55 (16.36%)
    14 / 55 (25.45%)
    27 / 55 (49.09%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    5 / 55 (9.09%)
         occurrences all number
    0
    0
    0
    0
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 55 (5.45%)
    3 / 55 (5.45%)
    3 / 55 (5.45%)
    3 / 55 (5.45%)
         occurrences all number
    2
    3
    4
    4
    6
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    3 / 55 (5.45%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    3
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    4 / 55 (7.27%)
         occurrences all number
    0
    1
    0
    0
    5
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    1 / 55 (1.82%)
    0 / 55 (0.00%)
    4 / 55 (7.27%)
         occurrences all number
    0
    1
    1
    0
    7
    Nausea
         subjects affected / exposed
    1 / 56 (1.79%)
    4 / 55 (7.27%)
    1 / 55 (1.82%)
    2 / 55 (3.64%)
    4 / 55 (7.27%)
         occurrences all number
    1
    4
    1
    3
    4
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 55 (5.45%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    1
    3
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 55 (5.45%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    3
    0
    0
    1
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    1
    0
    0
    0
    4
    Sinusitis
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 55 (5.45%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
    1 / 55 (1.82%)
         occurrences all number
    3
    3
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 55 (3.64%)
    1 / 55 (1.82%)
    4 / 55 (7.27%)
    4 / 55 (7.27%)
         occurrences all number
    1
    2
    1
    5
    4
    Urinary tract infection
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 55 (3.64%)
    1 / 55 (1.82%)
    2 / 55 (3.64%)
    7 / 55 (12.73%)
         occurrences all number
    2
    2
    1
    2
    9
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    2 / 55 (3.64%)
    1 / 55 (1.82%)
    3 / 55 (5.45%)
         occurrences all number
    1
    0
    2
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Dec 2013
    The purpose of this amendment is to update inclusion (including RA diagnosis criteria, prior biologic use, hsCRP <ULN criteria, and permitted medications) and exclusion criteria (including live vaccinations, laboratory values, and prohibited medications and therapies), and update study procedures (including chest x-ray permitted at any time per investigator decision, TB tests, and clinical lab tests).
    18 Nov 2014
    The purpose of this amendment was to increase the number of sites expected to participate in the study, add and internal independent safety data review committee, add an interim analysis of efficacy, and clarify inclusion (including prior treatment, prohibited and acceptable concomitant medications), clarify study procedures (including blood samples for pharmacokinetics), and clarify patient rollover into open label extension.

    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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