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    Clinical Trial Results:
    A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects with Active Ankylosing Spondylitis

    Summary
    EudraCT number
    		 2014-004532-18
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Jan 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Apr 2016
    First version publication date
    13 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M10-239
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00667355
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    1 North Waukegan Road, North Chicago, IL, United States, 60064
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    Hideyuki Hashiba, AbbVie, Hideyuki.Hashiba@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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Jan 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active ankylosing spondylitis
    Protection of trial subjects
    Subject and/or legal guardian read and understood information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Mar 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    0
    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)
    2
    Adults (18-64 years)
    39
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study included a 2-week screening period.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Adalimumab
    Arm description
    		 Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    ABT-D2E7, Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg or 80 mg every other week, subcutaneous

    Number of subjects in period 1
    		Adalimumab
    Started
    41
    Completed
    30
    Not completed
    11
         Other reason was not specified
    5
         Adverse event, non-fatal
    5
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.

    Reporting group values
    		 Adalimumab Total
    Number of subjects
    		 41 41
    Age categorical
    Units: Subjects
        <40 years
    		 25 25
        Between 40 and 65 years
    		 16 16
        >65 years
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.2 ( 12.17 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 32 32

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.

    Primary: Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12

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    End point title
    		 Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12 [1]
    End point description
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = at least 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0 - 100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain. For all non-responder imputation (NRI) analyses, subjects with a missing value at a visit were imputed as a non-responder for that visit. Observed cases is based on a total of 40 subjects analyzed (vs. 41 subjects for the study and all other analysis sets) due to 1 subject who discontinued prior to Week 12.
    End point type
    Primary
    End point timeframe
    Week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were summarize for this end point per protocol.
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: Subjects
    number (not applicable)
        Non-responder imputation (NRI), N = 41
    30
        Last Observation Carried Forward (LOCF), N = 41
    30
        Observed Cases, N = 40
    30
    No statistical analyses for this end point

    Secondary: Number of Subjects Achieving ASAS 20

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    End point title
    		 Number of Subjects Achieving ASAS 20
    End point description
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain. Analysis is based on non-responder imputation (NRI), for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: Subjects
    number (not applicable)
        Week 12
    30
        Week 24
    30
        Week 48
    32
        Week 72
    32
        Week 96
    27
        Week 120
    21
        Final Visit
    32
    No statistical analyses for this end point

    Secondary: Number of Subjects Achieving ASAS 50

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    End point title
    		 Number of Subjects Achieving ASAS 50
    End point description
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = at least 50% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain. Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: Subjects
    number (not applicable)
        Week 12
    23
        Week 24
    26
        Week 48
    26
        Week 72
    25
        Week 96
    19
        Week 120
    17
        Final Visit
    27
    No statistical analyses for this end point

    Secondary: Number of Subjects Achieving ASAS 70

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    End point title
    		 Number of Subjects Achieving ASAS 70
    End point description
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = at least 70% improvement (vs. baseline) and an absolute improvement ≥ 30 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain. Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: Subjects
    number (not applicable)
        Week 12
    13
        Week 24
    16
        Week 48
    18
        Week 72
    17
        Week 96
    15
        Week 120
    13
        Final Visit
    19
    No statistical analyses for this end point

    Secondary: Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)

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    End point title
    		 Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)
    End point description
    BASDAI is a validated self assessment tool used to determine disease activity in subjects with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) subjects answered 6 questions measuring discomfort, pain, fatigue, and morning stiffness. BASDAI 50 = at least 50% improvement (vs. baseline) in BASDAI. Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: Subjects
    number (not applicable)
        Week 12
    27
        Week 24
    26
        Week 48
    25
        Week 72
    28
        Week 96
    22
        Week 120
    18
        Final Visit
    29
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Patient's Global Assessment of Disease Activity

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    End point title
    		 Mean Change from Baseline in Patient's Global Assessment of Disease Activity
    End point description
    Subject's assessment of disease activity using a Visual Analog Scale (VAS) of 0 – 100 mm (0 = none and 100 = severe). Analysis is based on LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: mm on scale
    arithmetic mean (confidence interval 95%)
        Week 12
    -34.6 (-42.8 to -26.33)
        Week 24
    -37.3 (-45.99 to -28.69)
        Week 48
    -39.5 (-47.52 to -31.51)
        Week 72
    -39.7 (-48.14 to -31.32)
        Week 96
    -37.1 (-45.96 to -28.34)
        Week 120
    -40.1 (-48.61 to -31.53)
        Final Visit
    -40.6 (-48.81 to -32.32)
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Total Back Pain

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    End point title
    		 Mean Change from Baseline in Total Back Pain
    End point description
    Subject assessed his/her back pain by using a Visual Analog Scale (VAS) of 0 – 100 mm (0 = no pain and 100 = most severe pain). Analysis is based on LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: mm on scale
    arithmetic mean (confidence interval 95%)
        Week 12
    -35.6 (-43.68 to -27.59)
        Week 24
    -37 (-45.05 to -28.85)
        Week 48
    -38.6 (-46.68 to -30.53)
        Week 72
    -39.3 (-47.53 to -31.01)
        Week 96
    -36.4 (-44.33 to -28.4)
        Week 120
    -39.2 (-46.98 to -31.36)
        Final Visit
    -40.2 (-47.8 to -32.64)
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

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    End point title
    		 Mean Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
    End point description
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS subjects. Utilizing a VAS of 0–100 mm (0=easy, 100=impossible), subjects answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions. Analysis is based on last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: mm on scale
    arithmetic mean (confidence interval 95%)
        Week 12
    -19.4 (-24.49 to -14.34)
        Week 24
    -20.5 (-25.84 to -15.08)
        Week 48
    -21.9 (-28.39 to -15.51)
        Week 72
    -22.2 (-29.44 to -14.89)
        Week 96
    -22.1 (-28.72 to -15.54)
        Week 120
    -21.8 (-28.07 to -15.51)
        Final Visit
    -21.6 (-27.65 to -15.49)
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in C-Reactive Protein (CRP)

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    End point title
    		 Mean Change from Baseline in C-Reactive Protein (CRP)
    End point description
    CRP is a marker of inflammation and measured in mg/dL. A higher level is consistent with inflammation. Analysis is based on LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: mg/dL
    arithmetic mean (confidence interval 95%)
        Week 12
    -1.2 (-1.6 to -0.83)
        Week 24
    -1.3 (-1.76 to -0.89)
        Week 48
    -1.4 (-1.78 to -0.95)
        Week 72
    -1.3 (-1.74 to -0.83)
        Week 96
    -1.4 (-1.84 to -0.94)
        Week 120
    -1.3 (-1.76 to -0.76)
        Final Visit
    -1.2 (-1.67 to -0.64)
    No statistical analyses for this end point

    Secondary: Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.

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    End point title
    		 Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.
    End point description
    ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains (each domain measured on a 0 - 100 scale [0 = no disease activity; 100 = high disease activity]). Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: Subjects
    number (not applicable)
        Week 12
    28
        Week 24
    29
        Week 48
    31
        Week 72
    28
        Week 96
    25
        Week 120
    20
        Final Visit
    29
    No statistical analyses for this end point

    Secondary: Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)

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    End point title
    		 Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)
    End point description
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = at least 40% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain. Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: Subjects
    number (not applicable)
        Week 12
    26
        Week 24
    26
        Week 48
    27
        Week 72
    28
        Week 96
    24
        Week 120
    18
        Final Visit
    26
    No statistical analyses for this end point

    Secondary: Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission

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    End point title
    		 Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission
    End point description
    Partial remission is defined as a score of less than 20 units (on a scale of 0–100; 0=no disease activity and 100=high disease activity) in each of the 4 Assessments in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation. Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: Subjects
    number (not applicable)
        Week 12
    15
        Week 24
    16
        Week 48
    17
        Week 72
    20
        Week 96
    15
        Week 120
    13
        Final Visit
    19
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)

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    End point title
    		 Mean Change from Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
    End point description
    BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total score ranging from 0 to 10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS. Analysis is based on LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: units on scale
    arithmetic mean (confidence interval 95%)
        Week 12
    -0.4 (-0.79 to -0.02)
        Week 24
    -0.5 (-0.9 to -0.17)
        Week 48
    -0.6 (-1.07 to -0.23)
        Week 72
    -0.5 (-0.95 to -0.06)
        Week 96
    -0.6 (-1.03 to -0.13)
        Week 120
    -0.7 (-1.09 to -0.22)
        Final Visit
    -0.6 (-1 to -0.21)
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Chest Expansion

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    End point title
    		 Mean Change from Baseline in Chest Expansion
    End point description
    Chest expansion is the difference in centimeters between full expiration and full inspiration, measured at the 4th inter-costal space. An increase in chest expansion represents improvement. Analysis is based on LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: cm
    arithmetic mean (confidence interval 95%)
        Week 12
    0.7 (0.3 to 1.03)
        Week 24
    0.4 (0.16 to 0.66)
        Week 48
    0.8 (0.4 to 1.17)
        Week 72
    1 (0.56 to 1.46)
        Week 96
    0.6 (0.19 to 1.11)
        Week 120
    1.1 (0.55 to 1.72)
        Final Visit
    1.2 (0.54 to 1.8)
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

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    End point title
    		 Mean Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
    End point description
    Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness). Analysis is based on LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: units on a scale
    arithmetic mean (confidence interval 95%)
        Week 12
    -1 (-1.71 to -0.39)
        Week 24
    -1.1 (-1.76 to -0.53)
        Week 48
    -1.3 (-1.9 to -0.74)
        Week 72
    -1.1 (-1.72 to -0.48)
        Week 96
    -1.4 (-1.98 to -0.85)
        Week 120
    -1.4 (-1.96 to -0.77)
        Final Visit
    -1.4 (-1.96 to -0.77)
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Nocturnal Pain

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    End point title
    		 Mean Change from Baseline in Nocturnal Pain
    End point description
    Nocturnal pain assessed by subjects using a Visual Analog Scale (VAS) of 0 – 100 mm (0 = no pain and 100 = worst possible pain). Analysis is based on LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: mm on scale
    arithmetic mean (confidence interval 95%)
        Week 12
    -30 (-39.71 to -20.29)
        Week 24
    -31.7 (-41.92 to -21.54)
        Week 48
    -35.8 (-45.04 to -26.61)
        Week 72
    -34.6 (-43.45 to -25.77)
        Week 96
    -33.4 (-43.14 to -23.69)
        Week 120
    -35 (-44.1 to -25.85)
        Final Visit
    -35.3 (-44.52 to -26.07)
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Swollen Joint Count for 44 Joints (SJC 44)

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    End point title
    		 Mean Change from Baseline in Swollen Joint Count for 44 Joints (SJC 44)
    End point description
    The number of swollen joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a swollen joint was scored as 1 and absence as 0. The total SJC was derived by the sum of the scores for a range of SJC from 0 (best possible score; no swollen joints) to 44 (worse possible score; all joints swollen). Analysis is based on LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: SJC
    arithmetic mean (confidence interval 95%)
        Week 12
    -1.1 (-1.91 to -0.38)
        Week 24
    -1.1 (-1.81 to -0.34)
        Week 48
    -1.1 (-1.97 to -0.32)
        Week 72
    -1.3 (-2.17 to -0.37)
        Week 96
    -1.2 (-1.99 to -0.44)
        Week 120
    -1.2 (-2.01 to -0.43)
        Final Visit
    -1.2 (-1.94 to -0.4)
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Tender Joint Count for 46 Joints (TJC 46)

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    End point title
    		 Mean Change from Baseline in Tender Joint Count for 46 Joints (TJC 46)
    End point description
    The number of tender or painful joints among 23 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a tender or painful joint was scored as 1 and absence as 0. The total TJC was derived by the sum of the scores for a range of TJC from 0 (best possible score; no tender or painful joints) to 46 (worst possible score; all joints tender or painful). Analysis is based on LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: TJC
    arithmetic mean (confidence interval 95%)
        Week 12
    -1.5 (-3.86 to 0.94)
        Week 24
    -1.4 (-3.66 to 0.87)
        Week 48
    -1.3 (-3.6 to 0.96)
        Week 72
    -1.6 (-4 to 0.88)
        Week 96
    -1.6 (-3.63 to 0.46)
        Week 120
    -1.6 (-3.69 to 0.56)
        Final Visit
    -1.6 (-3.69 to 0.56)
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in 36-Item Short Form (SF-36) Questionnaire

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    End point title
    		 Mean Change from Baseline in 36-Item Short Form (SF-36) Questionnaire
    End point description
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These are summarized in a physical component summary (PCS) and mental component summary (MCS) score. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=lowest level of functioning; 100=highest level of functioning). Analysis is based on LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
    End point values
    		 Adalimumab
    Number of subjects analysed
    41
    Units: units on scale
    arithmetic mean (confidence interval 95%)
        PCS Week 12
    9.6 (6.81 to 12.4)
        PCS Week 24
    10.6 (7.51 to 13.67)
        PCS Week 48
    11.4 (8.69 to 14.06)
        PCS Week 72
    11.3 (8.29 to 14.3)
        PCS Week 96
    12.3 (9.25 to 15.37)
        PCS Week 120
    12.1 (9.07 to 15.19)
        PCS Final Visit
    12.6 (9.75 to 15.53)
        MCS Week 12
    7 (3.07 to 10.87)
        MCS Week 24
    7 (3.62 to 10.34)
        MCS Week 48
    6.1 (2.52 to 9.59)
        MCS Week 72
    6.7 (2.94 to 10.53)
        MCS Week 96
    5.8 (2.55 to 9.09)
        MCS Week 120
    6.1 (2.63 to 9.59)
        MCS Final Visit
    5.9 (2.44 to 9.42)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.

    Serious adverse events
    		 Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 41 (14.63%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colon cancer
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Periodontitis
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Intervertebral discitis
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 41 (97.56%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    11
    Pyrexia
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    4
    Malaise
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract inflammation
         subjects affected / exposed
    8 / 41 (19.51%)
         occurrences all number
    11
    Pharyngolaryngeal pain
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    4
    Investigations
    Weight increased
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    5
    C-reactive protein increased
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    6
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 41 (19.51%)
         occurrences all number
    11
    Stomatitis
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    4
    Nausea
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    5
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Hepatic function abnormal
         subjects affected / exposed
    9 / 41 (21.95%)
         occurrences all number
    9
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    11
    Dermatitis contact
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Erythema
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    7
    Back pain
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    4
    Arthralgia
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Myalgia
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    22 / 41 (53.66%)
         occurrences all number
    55
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 41 (17.07%)
         occurrences all number
    12
    Pharyngitis
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    6
    Gastroenteritis
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    4
    Influenza
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    4
    Rhinitis
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Feb 2008
    Added the maximal limited dose of codeine phosphate and dihydrocodeine phosphate for antitussive (prohibited medications); added transdermal NSAIDs preparation to the list of restricted therapy
    19 Mar 2008
    Added the procedure to confirm the reason in the case when a subject was not able to receive the maximal recommended dose of NSAIDs.
    02 Apr 2009
    Changed the procedure for protocol deviation and protocol change due to the change of GCP.

    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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