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

    Summary
    EudraCT number
    		 2013-004019-37
    Trial protocol
    		 DE   HU   BG   CZ   DK   RO  
    Global end of trial date
    01 Oct 2015

    Results information
    Results version number
    		 v1
    This version publication date
    26 Nov 2016
    First version publication date
    26 Nov 2016
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    M12-963
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02141997
    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 4UB
    Public contact
    Global Medical Information, AbbVie, 001 00-633-9110,
    Scientific contact
    Heikki Mansikka, MD, AbbVie, heikki.mansikka@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
    01 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2015
    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, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT 122 in subjects with active rheumatoid arthritis (RA) who are inadequately responding to methotrexate (MTX) treatment.
    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
    14 Jul 2014
    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
    Bulgaria: 17
    Country: Number of subjects enrolled
    Czech Republic: 17
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 11
    Country: Number of subjects enrolled
    New Zealand: 9
    Country: Number of subjects enrolled
    Poland: 112
    Country: Number of subjects enrolled
    Romania: 6
    Country: Number of subjects enrolled
    United States: 49
    Worldwide total number of subjects
    222
    EEA total number of subjects
    164
    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)
    169
    From 65 to 84 years
    53
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

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

    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, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adalimumab 40 mg EOW
    Arm description
    		 Adalimumab 40 mg every other week (EOW) for 11 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    adalimumab administered as subcutaneous injection every other week (EOW)

    Arm title
    		 ABT-122 60 mg EOW
    Arm description
    		 ABT-122 60 mg every other week (EOW) for 11 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-122
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ABT-122 administered as subcutaneous injection every other week (EOW)

    Arm title
    		 ABT-122 120 mg EOW
    Arm description
    		 ABT-122 120 mg every other week (EOW) for 11 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-122
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ABT-122 administered as subcutaneous injection every other week (EOW)

    Arm title
    		 ABT-122 120 mg EW
    Arm description
    		 ABT-122 120 mg every week (EW) for 11 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-122
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ABT-122 administered as subcutaneous injection every other week (EOW)

    Number of subjects in period 1
    		Adalimumab 40 mg EOW ABT-122 60 mg EOW ABT-122 120 mg EOW ABT-122 120 mg EW
    Started
    56
    55
    56
    55
    Completed
    53
    49
    53
    54
    Not completed
    3
    6
    3
    1
         Adverse event, non-fatal
    -
    2
    -
    1
         Not specified
    1
    4
    -
    -
         Withdrew consent
    1
    -
    3
    -
         Participant noncompliance
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab 40 mg EOW
    Reporting group description
    		 Adalimumab 40 mg every other week (EOW) for 11 weeks.

    Reporting group title
    ABT-122 60 mg EOW
    Reporting group description
    		 ABT-122 60 mg every other week (EOW) for 11 weeks.

    Reporting group title
    ABT-122 120 mg EOW
    Reporting group description
    		 ABT-122 120 mg every other week (EOW) for 11 weeks.

    Reporting group title
    ABT-122 120 mg EW
    Reporting group description
    		 ABT-122 120 mg every week (EW) for 11 weeks.

    Reporting group values
    		 Adalimumab 40 mg EOW ABT-122 60 mg EOW ABT-122 120 mg EOW ABT-122 120 mg EW Total
    Number of subjects
    		 56 55 56 55 222
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.6 ( 12.36 ) 55.2 ( 11.81 ) 53.5 ( 13 ) 55.6 ( 12.34 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 42 45 49 45 181
        Male
    		 14 10 7 10 41

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab 40 mg EOW
    Reporting group description
    		 Adalimumab 40 mg every other week (EOW) for 11 weeks.

    Reporting group title
    ABT-122 60 mg EOW
    Reporting group description
    		 ABT-122 60 mg every other week (EOW) for 11 weeks.

    Reporting group title
    ABT-122 120 mg EOW
    Reporting group description
    		 ABT-122 120 mg every other week (EOW) for 11 weeks.

    Reporting group title
    ABT-122 120 mg EW
    Reporting group description
    		 ABT-122 120 mg every week (EW) for 11 weeks.

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

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    End point title
    		 Percentage of Participants 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 (hsCRP). Last observation carried forward (LOCF) was used for missing data (only post-baseline values were carried forward).
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and Week 12
    End point values
    		 Adalimumab 40 mg EOW ABT-122 60 mg EOW ABT-122 120 mg EOW ABT-122 120 mg EW
    Number of subjects analysed
    56
    55
    56
    55
    Units: percentage of participants
        number (not applicable)
    73.2
    65.5
    76.8
    81.8
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    P-value calculated using 1-sided Fisher's Exact test.
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 60 mg EOW
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.863
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    P-value calculated using 1-sided Fisher's Exact test.
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 120 mg EOW
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.414
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    P-value calculated using 1-sided Fisher's Exact test.
    Comparison groups
    Adalimumab 40 mg EOW v ABT-122 120 mg EW
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.196
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP])

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    End point title
    		 Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP])
    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: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. A negative change from baseline represents improvement. n=the number of participants with evaluable data at each time point. LOCF was used (only post-baseline values were carried forward).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 8, and 12
    End point values
    		 Adalimumab 40 mg EOW ABT-122 60 mg EOW ABT-122 120 mg EOW ABT-122 120 mg EW
    Number of subjects analysed
    56
    55
    56
    55
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 2 (n=54,53,55,53)
    -1.43 (-1.71 to -1.15)
    -1.26 (-1.54 to -0.97)
    -1.8 (-2.08 to -1.52)
    -1.69 (-1.97 to -1.41)
        Week 4 (n=56,55,56,55)
    -1.86 (-2.17 to -1.55)
    -1.66 (-1.97 to -1.34)
    -2.08 (-2.39 to -1.78)
    -2.15 (-2.46 to -1.84)
        Week 6 (n=56,55,56,55)
    -2.28 (-2.6 to -1.96)
    -1.83 (-2.16 to -1.51)
    -2.39 (-2.71 to -2.07)
    -2.41 (-2.74 to -2.09)
        Week 8 (n=56,55,56,55)
    -2.32 (-2.64 to -2)
    -1.98 (-2.31 to -1.65)
    -2.6 (-2.93 to -2.28)
    -2.58 (-2.91 to -2.25)
        Week 12 (n=56,55,56,55)
    -2.44 (-2.75 to -2.12)
    -2.06 (-2.38 to -1.74)
    -2.64 (-2.95 to -2.33)
    -2.67 (-2.98 to -2.35)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants 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 hsCRP. LOCF was used (only post-baseline values were carried forward).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 12
    End point values
    		 Adalimumab 40 mg EOW ABT-122 60 mg EOW ABT-122 120 mg EOW ABT-122 120 mg EW
    Number of subjects analysed
    56
    55
    56
    54
    Units: percentage of participants
        number (not applicable)
    51.8
    34.5
    48.2
    48.1
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants 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 hsCRP. LOCF was used (only post-baseline values were carried forward).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 12
    End point values
    		 Adalimumab 40 mg EOW ABT-122 60 mg EOW ABT-122 120 mg EOW ABT-122 120 mg EW
    Number of subjects analysed
    56
    55
    56
    55
    Units: percentage of participants
        number (not applicable)
    23.2
    23.6
    19.6
    36.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Low Disease Activity (LDA) or Clinical Remission (CR) Based on DAS28 (hsCRP) at Week 12

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    End point title
    		 Percentage of Participants Achieving Low Disease Activity (LDA) or Clinical Remission (CR) Based on 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: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. LDA is defined as a DAS28 (hsCRP) score from 2.6 to < 3.2 at Week 12. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Adalimumab 40 mg EOW ABT-122 60 mg EOW ABT-122 120 mg EOW ABT-122 120 mg EW
    Number of subjects analysed
    56
    55
    56
    55
    Units: percentage of participants
        number (not applicable)
    50
    34.5
    53.6
    54.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving CR based on DAS28 (hsCRP) at Week 12

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    End point title
    		 Percentage of Participants Achieving CR based on 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: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Adalimumab 40 mg EOW ABT-122 60 mg EOW ABT-122 120 mg EOW ABT-122 120 mg EW
    Number of subjects analysed
    56
    55
    56
    55
    Units: percentage of participants
        number (not applicable)
    32.1
    23.6
    39.3
    41.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving LDA or CR Based on Clinical Disease Activity Index (CDAI) at Week 12

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    End point title
    		 Percentage of Participants Achieving LDA or CR Based on Clinical Disease Activity Index (CDAI) at Week 12
    End point description
    The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score from 2.8 to ≤ 10 at Week 12. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Adalimumab 40 mg EOW ABT-122 60 mg EOW ABT-122 120 mg EOW ABT-122 120 mg EW
    Number of subjects analysed
    56
    55
    56
    55
    Units: percentage of participants
        number (not applicable)
    42.9
    36.4
    44.6
    54.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving CR Based on Clinical Disease Activity Index (CDAI) at Week 12

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    End point title
    		 Percentage of Participants Achieving CR Based on Clinical Disease Activity Index (CDAI) at Week 12
    End point description
    The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Adalimumab 40 mg EOW ABT-122 60 mg EOW ABT-122 120 mg EOW ABT-122 120 mg EW
    Number of subjects analysed
    56
    55
    56
    55
    Units: percentage of participants
        number (not applicable)
    8.9
    7.3
    10.7
    10.9
    No statistical analyses for this end point

    Adverse events

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    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 (SAEs) were collected from the time informed consent was obtained (25 weeks).
    Adverse event reporting additional description
    A TEAE is defined as any AE with onset or worsening reported by a subject from the time that the first dose of study drug is administered until 70 days have elapsed following discontinuation of study drug administration. TEAEs were collected whether elicited or spontaneously reported by the subject.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Adalimumab 40 mg EOW
    Reporting group description
    		 Adalimumab 40 mg every other week (EOW) for 11 weeks.

    Reporting group title
    ABT-122 60 mg EOW
    Reporting group description
    		 ABT-122 60 mg every other week (EOW) for 11 weeks.

    Reporting group title
    ABT-122 120 mg EOW
    Reporting group description
    		 ABT-122 120 mg every other week (EOW) for 11 weeks.

    Reporting group title
    ABT-122 120 mg EW
    Reporting group description
    		 ABT-122 120 mg every week (EW) for 11 weeks.

    Serious adverse events
    		 Adalimumab 40 mg EOW ABT-122 60 mg EOW ABT-122 120 mg EOW ABT-122 120 mg EW
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 55 (3.64%)
    0 / 56 (0.00%)
    2 / 55 (3.64%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         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
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Adalimumab 40 mg EOW ABT-122 60 mg EOW ABT-122 120 mg EOW ABT-122 120 mg EW
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 56 (21.43%)
    11 / 55 (20.00%)
    11 / 56 (19.64%)
    10 / 55 (18.18%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    3 / 56 (5.36%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    3 / 56 (5.36%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 55 (1.82%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 55 (5.45%)
    2 / 56 (3.57%)
    1 / 55 (1.82%)
         occurrences all number
    0
    4
    2
    1
    Somnolence
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 55 (3.64%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    2
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 55 (3.64%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 55 (5.45%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    2
    4
    0
    1
    Nausea
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    2 / 56 (3.57%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    2 / 56 (3.57%)
    2 / 55 (3.64%)
         occurrences all number
    0
    0
    2
    2
    Nasopharyngitis
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 55 (3.64%)
    1 / 56 (1.79%)
    3 / 55 (5.45%)
         occurrences all number
    3
    2
    1
    3
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    0 / 56 (0.00%)
    4 / 55 (7.27%)
         occurrences all number
    1
    1
    0
    4
    Urinary tract infection
         subjects affected / exposed
    1 / 56 (1.79%)
    5 / 55 (9.09%)
    1 / 56 (1.79%)
    1 / 55 (1.82%)
         occurrences all number
    1
    7
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Apr 2014
    The purpose of this amendment was to remove Part 2 Open-label Extension (OLE) Period to separate the randomized control trial and the OLE trial into 2 protocols; remove pharmacokinetics sub-study and revise pharmacokinetics analyses; clarify that re-screening was permitted only once per subject; and revise inclusion (remove body mass index) and exclusion criteria (clarify HCV testing and chest x-ray requirements).
    13 Feb 2015
    The purpose of this amendment was to clarify lab retesting requirements and window visits; revise study site numbers to at least 85 sites globally; update female and male reproductive language; and update inclusion (high sensitivity C-reactive protein [hsCRP] criteria or positive rheumatoid factor [RF] and anticyclic citrullinated peptide [anti-CCP] antibody levels) and exclusion criteria (live vaccinations); remove 24-hour methylhistamine laboratory test; clarify chest x-ray assessment; add injection site reaction language; and revise unblinding for interim analysis;
    29 Jul 2015
    The purpose of this amendment was to increase the number of randomized subjects from approximately 160 to approximately 225; add new standard medical and non-medical complaint language; and clarify who could be unblinded for analyses during the trial.

    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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