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    Clinical Trial Results:
    A MULTICENTRE, 12- WEEK DOUBLE BLIND PLACEBO CONTROLLED RANDOMIZED STUDY OF ETANERCEPT ON A BACKGROUND NSAID IN THE TREATMENT OF ADULT SUBJECTS WITH NON RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WITH A 92-WEEK OPEN LABEL EXTENSION

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2010-020077-16
    Trial protocol
    		 ES   HU   DE   BE   GB   DK   NL   FI   CZ  
    Global end of trial date
    03 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Mar 2016
    First version publication date
    05 Mar 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B1801031
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01258738
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 East 42nd Street,, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrial.gov Call Center, Pfizer, Inc., +1 800 718 1021,
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., +1 800 718 1021,, ClinicalTrials.gov_Inquiries@pfizer.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 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Nov 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to compare the efficacy of etanercept (ETN) against placebo in improving symptoms of early non-radiographic axial spondyloarthritis (nr-AxSpA) at 12 weeks when added to a background nonsteroidal anti-inflammatory drugs (NSAID) at the optimal anti-inflammatory dose. The secondary objectives were to assess the efficacy and safety of ETN and background NSAID over 104 weeks, to compare the effect of ETN 50 milligram (mg) once weekly versus placebo on inflammation seen in magnetic resonance imaging (MRI) of the spine at 12 weeks when added to a background NSAID at the optimal inflammatory dose and to compare the quality of life between those participants treated with ETN 50mg once weekly versus placebo over 12 weeks when added to a background NSAID at the optimal anti-inflammatory dose.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines (ICH 1996). In addition, all local regulatory requirements, as well as the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Feb 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 21 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hungary: 42
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 20
    Country: Number of subjects enrolled
    Netherlands: 12
    Country: Number of subjects enrolled
    Russian Federation: 6
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Taiwan: 29
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    Argentina: 3
    Country: Number of subjects enrolled
    Belgium: 26
    Country: Number of subjects enrolled
    Colombia: 14
    Country: Number of subjects enrolled
    Czech Republic: 23
    Country: Number of subjects enrolled
    Finland: 5
    Country: Number of subjects enrolled
    France: 12
    Worldwide total number of subjects
    224
    EEA total number of subjects
    152
    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)
    224
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a multicenter study conducted at 48 centers in 14 countries.

    Pre-assignment
    Screening details
    		 Eligible participants were randomized to receive etanercept or placebo for 12 week controlled (double-blind) period. Participants completing 12 week period entered a 92 week open-label period.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The study was subject, investigator and Sponsor-blinded in the double-blind period. At the initiation of the study, the study site was instructed on the method for breaking the blind. The method was either a manual or electronic process. Blinding codes were only to be broken in emergency situations for reasons of participant safety.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Etanercept
    Arm description
    		 Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    Other name
    Enbrel
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were treated with etanercept subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.

    Arm title
    		 Placebo
    Arm description
    		 Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period were eligible to enter into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period who were eligible to enter into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.

    Number of subjects in period 1
    		Etanercept Placebo
    Started
    111
    113
    Completed
    83
    86
    Not completed
    28
    27
         Did not meet inclusion criteria
    3
    3
         Adverse event not related to study drug
    3
    1
         Pregnancy
    1
    1
         No longer willing to participate in the study
    7
    8
         Lost to follow-up
    2
    2
         Other unspecified reasons
    -
    1
         Adverse event related to study drug
    4
    5
         Insufficient clinical response
    5
    3
         Protocol deviation
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    		 Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period were eligible to enter into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.

    Reporting group values
    		 Etanercept Placebo Total
    Number of subjects
    		 111 113 224
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 111 113 224
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 31.7 ( 7.8 ) 32 ( 7.8 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 41 50 91
        Male
    		 70 63 133

    End points

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    End points reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    		 Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period were eligible to enter into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.

    Primary: Percentage of participants achieving Ankylosing Spondylitis (ASAS) 40 response at Week 12

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    End point title
    		 Percentage of participants achieving Ankylosing Spondylitis (ASAS) 40 response at Week 12
    End point description
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    105
    108
    Units: Percentage of participants
        number (not applicable)
    32.38
    15.74
    Statistical analysis title
    		 Statistical analysis 1 at Week 12
    Statistical analysis description
    The null hypothesis was that the efficacy of etanercept was not different from placebo as measured by the proportion of subjects achieving an ASAS 40 response after 12 weeks of treatment. The alternative hypothesis was that the efficacy of etanercept was different from placebo. The primary endpoint was tested at 2-sided alpha = 0.05 significance level. Comparative analysis was carried out for Week 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0062 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    16.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.36
         upper limit
    		 27.92
    Notes
    [1] - P-value <0.05 was required to declare statistical significance. Stratified by positive or negative sacroilitis MRI and geographic region.

    Secondary: Percentage of participants achieving ASAS 40 response at time points

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    End point title
    		 Percentage of participants achieving ASAS 40 response at time points
    End point description
    ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    105
    108
    Units: Percentage of participants
    number (not applicable)
        Week 2 (N=105, 106)
    15.24
    3.77
        Week 4 (N=105, 108)
    20
    14.81
        Week 8 (N=105, 108)
    28.57
    15.74
        Week 12 (N= 105, 108)
    33.33
    14.81
        Week 16 (N= 100, 105)
    42
    38.1
        Week 24 (N= 100, 105)
    44
    51.43
        Week 32 (N= 100, 105)
    47
    52.38
        Week 40 (N= 100, 105)
    55
    53.33
        Week 48 (N= 100, 105)
    52
    53.33
        Week 56 (N= 100, 105)
    52
    59.05
        Week 68 (N= 100, 105)
    54
    58.1
        Week 80 (N= 100, 105)
    49
    58.1
        Week 92 (N= 100, 105)
    57
    61.9
        Week 104 (N= 100, 105)
    56
    61.9
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0059
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    11.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.69
         upper limit
    		 19.24
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3786
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.98
         upper limit
    		 15.35
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0304
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.79
         upper limit
    		 23.87
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0023
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    18.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.29
         upper limit
    		 29.75

    Secondary: Percentage of participants achieving ASAS 20 response at time points

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    End point title
    		 Percentage of participants achieving ASAS 20 response at time points
    End point description
    ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    105
    109
    Units: Percentage of participants
    number (not applicable)
        Week 2 (N = 105, 106)
    30.48
    16.04
        Week 4 (N = 105, 108)
    37.14
    26.85
        Week 8 (N = 105, 108)
    48.57
    37.96
        Week 12 (N = 105, 109)
    52.38
    36.7
        Week 16 (N= 100, 105)
    64
    65.71
        Week 24 (N = 100, 105)
    65
    71.43
        Week 32 (N = 100, 105)
    64
    71.43
        Week 40 (N = 100, 105)
    73
    73.33
        Week 48 (N = 100, 105)
    71
    72.38
        Week 56 (N = 100, 105)
    70
    76.19
        Week 68 (N = 100, 105)
    69
    76.19
        Week 80 (N = 100, 105)
    65
    70.48
        Week 92 (N = 100, 105)
    71
    74.29
        Week 104 (N = 100, 105)
    70
    79.05
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0189
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.2
         upper limit
    		 25.68
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0867
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.63
         upper limit
    		 23.84
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0983
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.17
         upper limit
    		 22.75
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0195
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    16.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 29.43

    Secondary: Percentage of participants achieving ASAS 5/6 response at time points

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    End point title
    		 Percentage of participants achieving ASAS 5/6 response at time points
    End point description
    ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100 = high disease activity) 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 and no worsening in the remaining domain.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    105
    109
    Units: Percentage of participants
    number (not applicable)
        Week 2 (N = 102, 105)
    15.69
    2.86
        Week 4 (N = 103, 107)
    23.3
    8.41
        Week 8 (N = 103, 107)
    33.01
    11.21
        Week 12 (N = 105, 109)
    33.01
    10.38
        Week 16 (N = 100, 105)
    37
    34.29
        Week 24 (N = 100, 105)
    41
    42.86
        Week 32 (N = 100, 105)
    40
    40.95
        Week 40 (N = 100, 105)
    45
    40.95
        Week 48 (N = 100, 105)
    49
    45.71
        Week 56 (N = 100, 105)
    42
    45.71
        Week 68 (N = 100, 105)
    42
    43.81
        Week 80 (N = 100, 105)
    39
    37.14
        Week 92 (N = 100, 105)
    46
    47.62
        Week 104 (N = 100, 105)
    43
    40.95
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    22.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.85
         upper limit
    		 33.41
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0021
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.09
         upper limit
    		 20.57
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.18
         upper limit
    		 24.6
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    21.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.92
         upper limit
    		 32.67

    Secondary: Mean change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) high sensitivity CRP (hsCRP) score at time points

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    End point title
    		 Mean change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) high sensitivity CRP (hsCRP) score at time points
    End point description
    ASDAS includes CRP (mg/L) or ESR (mm/hr); Apart from the value of CRP or ESR, the four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are then calculated as follows: ASDAS_CRP = (0.121 x total back pain) + (0.110 x subject global) + (0.073 x peripheral pain/swelling) + (0.058 x duration of morning stiffness) + (0.579 x Ln(CRP+1)). And ASDAS_ESR: (0.079 x total back pain) + (0.113 x subject global) + (0.086 x peripheral pain/swelling) + (0.069 x duration of morning stiffness) + (0.293 x √ESR). In addition, the proportion of participants who achieve inactive disease based on the ASDAS will be determined for each group. Inactive disease is defined as an ASDAS score <1.3.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    105
    108
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N = 104, 106)
    -0.74 ( 0.1 )
    -0.2 ( 0.1 )
        Week 4 (N = 104, 108)
    -0.92 ( 0.11 )
    -0.3 ( 0.1 )
        Week 8 (N = 104, 108)
    -1.09 ( 0.13 )
    -0.48 ( 0.12 )
        Week 12 (N= 104, 108)
    -1.27 ( 0.11 )
    -0.63 ( 0.08 )
        Week 16 (N= 99, 104)
    -1.41 ( 0.11 )
    -1.35 ( 0.11 )
        Week 24 (N= 99, 104)
    -1.48 ( 0.11 )
    -1.55 ( 0.11 )
        Week 32 (N= 99, 104)
    -1.44 ( 0.11 )
    -1.52 ( 0.11 )
        Week 40 (N= 99, 104)
    -1.64 ( 0.11 )
    -1.6 ( 0.12 )
        Week 48 (N= 99, 104)
    -1.62 ( 0.11 )
    -1.63 ( 0.12 )
        Week 56 (N= 99, 104)
    -1.61 ( 0.12 )
    -1.65 ( 0.11 )
        Week 68 (N= 99, 104)
    -1.6 ( 0.11 )
    -1.65 ( 0.11 )
        Week 80 (N= 99, 104)
    -1.53 ( 0.12 )
    -1.61 ( 0.12 )
        Week 92 (N= 99, 104)
    -1.63 ( 0.12 )
    -1.7 ( 0.12 )
        Week 104 (N= 99, 104)
    -1.59 ( 0.12 )
    -1.68 ( 0.12 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.74
         upper limit
    		 -0.34
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.81
         upper limit
    		 -0.41
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.85
         upper limit
    		 -0.37

    Secondary: Percentage of participants achieving ASAS partial remission at time points

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    End point title
    		 Percentage of participants achieving ASAS partial remission at time points
    End point description
    Partial remission defined as a score of 20 units or less (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100 = high disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    105
    109
    Units: Percentage of participants
    number (not applicable)
        Week 2 (N = 105, 108)
    11.43
    2.78
        Week 4 (N = 105, 109)
    10.48
    3.67
        Week 8 (N = 105, 109)
    21.9
    9.17
        Week 12 (N = 105, 109)
    24.76
    11.93
        Week 16 (N = 100, 105)
    29
    28.57
        Week 24 (N = 100, 105)
    32
    42.86
        Week 32 (N = 100, 105)
    28
    41.9
        Week 40 (N = 100, 105)
    40
    45.71
        Week 48 (N = 100, 105)
    38
    37.14
        Week 56 (N = 100, 105)
    40
    43.81
        Week 68 (N = 100, 105)
    37
    48.57
        Week 80 (N = 100, 105)
    34
    49.52
        Week 92 (N = 100, 105)
    39
    49.52
        Week 104 (N = 100, 105)
    40
    57.14
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0209
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.58
         upper limit
    		 23.09
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0179
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.82
         upper limit
    		 15.48
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0611
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 13.65
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0141
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.14
         upper limit
    		 22.32
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Time to ASAS partial remission

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    End point title
    		 Time to ASAS partial remission
    End point description
    The median time to partial remission was not reached at Week 12. Hence, we report an estimate of the percentage of participants, estimated using Kaplan-Meier approach.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    105
    109
    Units: percentage of participants
        number (confidence interval)
    43.3 (30.4 to 59)
    22.3 (12.5 to 38.1)
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0022
    Method
    		 Logrank
    Confidence interval

    Secondary: Mean Change from Baseline in Visual Analogue Scale (VAS) Physician Global Assessments at time points

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    End point title
    		 Mean Change from Baseline in Visual Analogue Scale (VAS) Physician Global Assessments at time points
    End point description
    The Investigator estimated the participant’s overall disease activity over the previous 48 hours (this was independent of the Subject Assessment of Disease Activity) using a scale between 0 mm (none) and 100 mm (severe).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    102
    105
    Units: cm
    arithmetic mean (standard error)
        Week 2 (N = 101, 104)
    -1.4 ( 0.24 )
    -0.8 ( 0.23 )
        Week 4 (N = 101, 105)
    -1.91 ( 0.25 )
    -1.49 ( 0.24 )
        Week 8 (N = 101, 105)
    -2.39 ( 0.27 )
    -2.1 ( 0.25 )
        Week 12 (N = 100, 105)
    -2.74 ( 0.29 )
    -2.04 ( 0.28 )
        Week 16 (N = 96, 101)
    -3.36 ( 0.23 )
    -2.78 ( 0.23 )
        Week 24 (N = 96, 101)
    -3.66 ( 0.2 )
    -3.25 ( 0.23 )
        Week 32 (N = 96, 101)
    -3.66 ( 0.21 )
    -3.38 ( 0.22 )
        Week 40 (N = 96, 101)
    -3.83 ( 0.21 )
    -3.44 ( 0.21 )
        Week 48 (N = 96, 101)
    -3.93 ( 0.23 )
    -3.53 ( 0.21 )
        Week 56 (N = 96, 101)
    -3.98 ( 0.24 )
    -3.67 ( 0.22 )
        Week 68 (N = 96, 101)
    -3.98 ( 0.22 )
    -3.6 ( 0.22 )
        Week 80 (N = 96, 101)
    -4.03 ( 0.22 )
    -3.54 ( 0.24 )
        Week 92 (N = 96, 101)
    -4 ( 0.22 )
    -3.43 ( 0.24 )
        Week 104 (N = 96, 101)
    -4.12 ( 0.23 )
    -3.78 ( 0.22 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0156
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.26
         upper limit
    		 -0.13
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0111
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 -0.14
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0936
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.91
         upper limit
    		 0.07
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2678
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.81
         upper limit
    		 0.23

    Secondary: Mean change from Baseline in VAS score for subject assessment of disease activity at time points

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    End point title
    		 Mean change from Baseline in VAS score for subject assessment of disease activity at time points
    End point description
    Participants to assess their overall disease activity over the last 48 hours using a pain scale between 0 mm (none) and 100 mm (severe), which corresponded to the magnitude of their pain.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: cm
    arithmetic mean (standard error)
        Week 2 (N = 105, 108)
    -1 ( 0.27 )
    -0.08 ( 0.26 )
        Week 4 (N = 105, 109)
    -1.34 ( 0.29 )
    -0.55 ( 0.27 )
        Week 8 (N = 105, 109)
    -1.85 ( 0.32 )
    -1.02 ( 0.3 )
        Week 12 (N = 105, 109)
    -2.06 ( 0.31 )
    -1.26 ( 0.3 )
        Week 16 (N = 100, 105)
    -2.81 ( 0.27 )
    -2.65 ( 0.24 )
        Week 24 (N = 100, 105)
    -2.92 ( 0.28 )
    -3.21 ( 0.23 )
        Week 32 (N = 100, 105)
    -2.99 ( 0.27 )
    -3.23 ( 0.27 )
        Week 40 (N = 100, 105)
    -3.38 ( 0.27 )
    -3.33 ( 0.25 )
        Week 48 (N = 100, 105)
    -3.24 ( 0.28 )
    -3.36 ( 0.27 )
        Week 56 (N = 100, 105)
    -3.3 ( 0.28 )
    -3.45 ( 0.25 )
        Week 68 (N = 100, 105)
    -3.31 ( 0.28 )
    -3.57 ( 0.25 )
        Week 80 (N = 100, 105)
    -3.1 ( 0.27 )
    -3.49 ( 0.25 )
        Week 92 (N = 100, 105)
    -3.34 ( 0.28 )
    -3.65 ( 0.25 )
        Week 104 (N = 100, 105)
    -3.33 ( 0.3 )
    -3.75 ( 0.24 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results included unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0102
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.19
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0007
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.44
         upper limit
    		 -0.39
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0057
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.35
         upper limit
    		 -0.23
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0077
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.44
         upper limit
    		 -0.22

    Secondary: Changes from Baseline in VAS score for nocturnal back pain at time points

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    End point title
    		 Changes from Baseline in VAS score for nocturnal back pain at time points
    End point description
    The VAS scale was used to assess the level of nocturnal pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for “No pain ” to 100 mm for “Most Severe Pain.”
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: cm
    arithmetic mean (standard error)
        Week 2 (N = 105, 107)
    -1.1 ( 0.31 )
    -0.31 ( 0.29 )
        Week 4 (N = 105, 109)
    -1.54 ( 0.33 )
    -0.71 ( 0.31 )
        Week 8 (N = 105, 109)
    -2.31 ( 0.33 )
    -1.34 ( 0.31 )
        Week 12 (N = 105, 109)
    -1.96 ( 0.36 )
    -1.03 ( 0.34 )
        Week 16 (N = 100, 105)
    -2.97 ( 0.31 )
    -2.63 ( 0.26 )
        Week 24 (N = 100, 105)
    -2.79 ( 0.3 )
    -3.25 ( 0.26 )
        Week 32 (N = 100, 105)
    -2.69 ( 0.31 )
    -3.11 ( 0.29 )
        Week 40 (N = 100, 105)
    -3.34 ( 0.31 )
    -3.3 ( 0.26 )
        Week 48 (N = 100, 105)
    -3.22 ( 0.31 )
    -3.21 ( 0.27 )
        Week 56 (N = 100, 105)
    -3.15 ( 0.33 )
    -3.4 ( 0.27 )
        Week 68 (N = 100, 105)
    -3.07 ( 0.33 )
    -3.27 ( 0.26 )
        Week 80 (N = 100, 105)
    -3.01 ( 0.31 )
    -3.32 ( 0.27 )
        Week 92 (N = 100, 105)
    -3.26 ( 0.32 )
    -3.43 ( 0.27 )
        Week 104 (N = 100, 105)
    -3.28 ( 0.34 )
    -3.59 ( 0.27 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0091
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.62
         upper limit
    		 -0.23
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0097
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.38
         upper limit
    		 -0.19
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0101
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.45
         upper limit
    		 -0.2
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0031
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.61
         upper limit
    		 -0.33

    Secondary: Changes from Baseline in VAS score for total back pain at time points

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    End point title
    		 Changes from Baseline in VAS score for total back pain at time points
    End point description
    The VAS scale was used to assess the level of total back pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for “No pain ” to 100 mm for “Most Severe Pain.”
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: cm
    arithmetic mean (standard error)
        Week 2 (N = 105, 107)
    -0.95 ( 0.29 )
    -0.37 ( 0.27 )
        Week 4 (N = 105, 109)
    -1.52 ( 0.31 )
    -0.88 ( 0.29 )
        Week 8 (N = 105, 109)
    -2.19 ( 0.33 )
    -1.18 ( 0.31 )
        Week 12 (n = 105, 109)
    -2.32 ( 0.28 )
    -1.39 ( 0.21 )
        Week 16 (n = 100, 105)
    -2.73 ( 0.29 )
    -2.64 ( 0.25 )
        Week 24 (n = 100, 105)
    -2.76 ( 0.28 )
    -2.92 ( 0.24 )
        Week 32 (n = 100, 105)
    -2.58 ( 0.29 )
    -2.87 ( 0.26 )
        Week 40 (n = 100, 105)
    -3.3 ( 0.28 )
    -3.2 ( 0.24 )
        Week 48 (n = 100, 105)
    -3.09 ( 0.29 )
    -3.14 ( 0.25 )
        Week 56 (n = 100, 105)
    -3.1 ( 0.29 )
    -3.17 ( 0.26 )
        Week 68 (n = 100, 105)
    -3.02 ( 0.31 )
    -3.23 ( 0.26 )
        Week 80 (n = 100, 105)
    -2.95 ( 0.29 )
    -3.17 ( 0.26 )
        Week 92 (n = 100, 105)
    -3.3 ( 0.29 )
    -3.33 ( 0.27 )
        Week 104 (n = 100, 105)
    -3.22 ( 0.32 )
    -3.47 ( 0.26 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0064
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.49
         upper limit
    		 -0.25
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0407
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.12
         upper limit
    		 -0.02
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0349
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.24
         upper limit
    		 -0.05
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0021
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.65
         upper limit
    		 -0.37

    Secondary: Changes from Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at time points

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    End point title
    		 Changes from Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at time points
    End point description
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N = 105, 107)
    -0.82 ( 0.21 )
    -0.27 ( 0.2 )
        Week 4 (N = 105, 108)
    -0.99 ( 0.22 )
    -0.44 ( 0.21 )
        Week 8 (N = 105, 108)
    -1.28 ( 0.23 )
    -0.73 ( 0.22 )
        Week 12 (N = 105, 109)
    -1.41 ( 0.24 )
    -0.84 ( 0.23 )
        Week 16 (N = 100, 105)
    -1.78 ( 0.23 )
    -1.75 ( 0.19 )
        Week 24 (N = 100, 105)
    -1.89 ( 0.22 )
    -1.85 ( 0.2 )
        Week 32 (N = 100, 105)
    -1.81 ( 0.22 )
    -1.98 ( 0.21 )
        Week 40 (N = 100, 105)
    -2.19 ( 0.23 )
    -2.13 ( 0.21 )
        Week 48 (N = 100, 105)
    -2.19 ( 0.23 )
    -2.1 ( 0.22 )
        Week 56 (N = 100, 105)
    -2.15 ( 0.22 )
    -2.3 ( 0.21 )
        Week 68 (N = 100, 105)
    -2.21 ( 0.21 )
    -2.31 ( 0.22 )
        Week 80 (N = 100, 105)
    -2.23 ( 0.21 )
    -2.19 ( 0.22 )
        Week 92 (N = 100, 105)
    -2.31 ( 0.23 )
    -2.35 ( 0.22 )
        Week 104 (N = 100, 105)
    -2.4 ( 0.23 )
    -2.36 ( 0.23 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0164
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.04
         upper limit
    		 -0.11
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0095
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 -0.13
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0127
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 -0.12
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0166
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 -0.1

    Secondary: Mean change from Baseline in BASFI full day activities at time points

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    End point title
    		 Mean change from Baseline in BASFI full day activities at time points
    End point description
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 104, 107)
    -0.99 ( 0.26 )
    -0.21 ( 0.25 )
        Week 4 (N= 104, 108)
    -1.37 ( 0.28 )
    -0.7 ( 0.26 )
        Week 8 (N= 104, 108)
    -1.8 ( 0.27 )
    -1.05 ( 0.26 )
        Week 12 (N = 104, 108)
    -2.11 ( 0.29 )
    -1.16 ( 0.27 )
        Week 16 (N = 99, 105)
    -2.37 ( 0.25 )
    -2.03 ( 0.24 )
        Week 24 (N = 99, 105)
    -2.42 ( 0.25 )
    -2.13 ( 0.25 )
        Week 32 (N = 99, 105)
    -2.43 ( 0.23 )
    -2.38 ( 0.25 )
        Week 40 (N = 99, 105)
    -2.93 ( 0.26 )
    -2.3 ( 0.25 )
        Week 48 (N = 99, 105)
    -2.73 ( 0.25 )
    -2.34 ( 0.27 )
        Week 56 (N = 99, 105)
    -2.66 ( 0.25 )
    -2.59 ( 0.26 )
        Week 68 (N = 99, 105)
    -2.82 ( 0.25 )
    -2.71 ( 0.27 )
        Week 80 (N = 99, 105)
    -2.75 ( 0.25 )
    -2.58 ( 0.27 )
        Week 92 (N = 99, 105)
    -2.93 ( 0.27 )
    -2.7 ( 0.27 )
        Week 104 (N = 99, 105)
    -3.04 ( 0.27 )
    -2.66 ( 0.27 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0029
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.28
         upper limit
    		 -0.27
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0147
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.21
         upper limit
    		 -0.13
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0056
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.28
         upper limit
    		 -0.22
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.52
         upper limit
    		 -0.39

    Secondary: Mean change from Baseline in BASFI bending forward at time points

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    End point title
    		 Mean change from Baseline in BASFI bending forward at time points
    End point description
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 107)
    -1.05 ( 0.28 )
    -0.4 ( 0.26 )
        Week 4 (N= 105, 108)
    -0.96 ( 0.29 )
    -0.56 ( 0.28 )
        Week 8 (N= 105, 108)
    -1.34 ( 0.29 )
    -0.65 ( 0.27 )
        Week 12 (N = 105, 109)
    -1.34 ( 0.29 )
    -0.85 ( 0.27 )
        Week 16 (N = 100, 105)
    -1.76 ( 0.28 )
    -1.57 ( 0.21 )
        Week 24 (N = 100, 105)
    -2 ( 0.29 )
    -1.64 ( 0.23 )
        Week 32 (N = 100, 105)
    -1.78 ( 0.28 )
    -1.69 ( 0.23 )
        Week 40 (N = 100, 105)
    -2.12 ( 0.29 )
    -1.82 ( 0.24 )
        Week 48 (N = 100, 105)
    -2.17 ( 0.29 )
    -1.83 ( 0.25 )
        Week 56 (N = 100, 105)
    -2.13 ( 0.28 )
    -2.09 ( 0.25 )
        Week 68 (N = 100, 105)
    -2.15 ( 0.27 )
    -1.92 ( 0.25 )
        Week 80 (N = 100, 105)
    -2.18 ( 0.28 )
    -1.99 ( 0.26 )
        Week 92 (N = 100, 105)
    -2.33 ( 0.3 )
    -2.04 ( 0.26 )
        Week 104 (N = 100, 105)
    -2.37 ( 0.31 )
    -2.16 ( 0.27 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0173
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.19
         upper limit
    		 -0.12
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1618
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.97
         upper limit
    		 0.16
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0153
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.25
         upper limit
    		 -0.13
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0866
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 0.07

    Secondary: Mean change from Baseline in BASFI getting out of an arm-less chair at time points

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    End point title
    		 Mean change from Baseline in BASFI getting out of an arm-less chair at time points
    End point description
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 107)
    -0.94 ( 0.28 )
    -0.53 ( 0.27 )
        Week 4 (N= 105, 108)
    -1.44 ( 0.28 )
    -0.84 ( 0.27 )
        Week 8 (N= 105, 108)
    -1.54 ( 0.29 )
    -1.02 ( 0.27 )
        Week 12 (N = 105, 108)
    -1.79 ( 0.28 )
    -1.07 ( 0.27 )
        Week 16 (N = 100, 105)
    -2.04 ( 0.29 )
    -1.9 ( 0.23 )
        Week 24 (N = 100, 105)
    -2.2 ( 0.29 )
    -2.12 ( 0.23 )
        Week 32 (N = 100, 105)
    -2.04 ( 0.29 )
    -2.18 ( 0.25 )
        Week 40 (N = 100, 105)
    -2.4 ( 0.3 )
    -2.38 ( 0.25 )
        Week 48 (N = 100, 105)
    -2.4 ( 0.29 )
    -2.25 ( 0.26 )
        Week 56 (N = 100, 105)
    -2.27 ( 0.28 )
    -2.47 ( 0.25 )
        Week 68 (N = 100, 105)
    -2.45 ( 0.28 )
    -2.46 ( 0.25 )
        Week 80 (N = 100, 105)
    -2.52 ( 0.28 )
    -2.33 ( 0.25 )
        Week 92 (N = 100, 105)
    -2.6 ( 0.29 )
    -2.48 ( 0.25 )
        Week 104 (N = 100, 105)
    -2.65 ( 0.29 )
    -2.48 ( 0.25 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistcal analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1413
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 0.14
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0284
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.14
         upper limit
    		 -0.06
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0659
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.07
         upper limit
    		 0.03
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0098
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.26
         upper limit
    		 -0.18

    Secondary: Mean change from Baseline in BASFI physically demanding activities at time points

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    End point title
    		 Mean change from Baseline in BASFI physically demanding activities at time points
    End point description
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 104, 107)
    -0.88 ( 0.26 )
    -0.13 ( 0.25 )
        Week 4 (N= 104, 108)
    -1.06 ( 0.28 )
    -0.26 ( 0.27 )
        Week 8 (N= 104, 108)
    -1.51 ( 0.28 )
    -0.8 ( 0.26 )
        Week 12 (N = 104, 109)
    -1.69 ( 0.29 )
    -0.91 ( 0.27 )
        Week 16 (N = 99, 105)
    -2.12 ( 0.26 )
    -1.79 ( 0.25 )
        Week 24 (N = 99, 105)
    -2.23 ( 0.26 )
    -2.05 ( 0.26 )
        Week 32 (N = 99, 105)
    -2.2 ( 0.25 )
    -2.19 ( 0.24 )
        Week 40 (N = 99, 105)
    -2.79 ( 0.26 )
    -2.24 ( 0.27 )
        Week 48 (N = 99, 105)
    -2.71 ( 0.27 )
    -2.25 ( 0.26 )
        Week 56 (N = 99, 105)
    -2.66 ( 0.27 )
    -2.37 ( 0.28 )
        Week 68 (N = 99, 105)
    -2.67 ( 0.26 )
    -2.6 ( 0.29 )
        Week 80 (N = 99, 105)
    -2.7 ( 0.26 )
    -2.39 ( 0.28 )
        Week 92 (N = 99, 105)
    -2.91 ( 0.27 )
    -2.59 ( 0.28 )
        Week 104 (N = 99, 105)
    -3.02 ( 0.27 )
    -2.59 ( 0.3 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0037
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.26
         upper limit
    		 -0.25
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0044
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.35
         upper limit
    		 -0.25
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0104
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.26
         upper limit
    		 -0.17
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.33
         upper limit
    		 -0.22

    Secondary: Mean change from Baseline in BASFI reaching up high at time points

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    End point title
    		 Mean change from Baseline in BASFI reaching up high at time points
    End point description
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 107)
    -0.33 ( 0.26 )
    -0.02 ( 0.24 )
        Week 4 (N= 105, 108)
    -0.63 ( 0.27 )
    -0.21 ( 0.26 )
        Week 8 (N= 105, 108)
    -0.81 ( 0.26 )
    -0.31 ( 0.25 )
        Week 12 (N = 105, 109)
    -0.7 ( 0.27 )
    -0.2 ( 0.25 )
        Week 16 (N = 100, 105)
    -1.09 ( 0.26 )
    -1.34 ( 0.22 )
        Week 24 (N = 100, 105)
    -1.26 ( 0.26 )
    -1.46 ( 0.22 )
        Week 32 (N = 100, 105)
    -1 ( 0.27 )
    -1.46 ( 0.23 )
        Week 40 (N = 100, 105)
    -1.3 ( 0.25 )
    -1.66 ( 0.24 )
        Week 48 (N = 100, 105)
    -1.38 ( 0.26 )
    -1.67 ( 0.25 )
        Week 56 (N = 100, 105)
    -1.34 ( 0.25 )
    -1.76 ( 0.24 )
        Week 68 (N = 100, 105)
    -1.42 ( 0.24 )
    -1.77 ( 0.24 )
        Week 80 (N = 100, 105)
    -1.37 ( 0.24 )
    -1.63 ( 0.24 )
        Week 92 (N = 100, 105)
    -1.55 ( 0.25 )
    -1.83 ( 0.24 )
        Week 104 (N = 100, 105)
    -1.62 ( 0.25 )
    -1.76 ( 0.24 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2268
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.19
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1145
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.93
         upper limit
    		 0.1
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0512
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0509
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.02
         upper limit
    		 0

    Secondary: Mean change from Baseline in BASFI climbing steps without aid at time points

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    End point title
    		 Mean change from Baseline in BASFI climbing steps without aid at time points
    End point description
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 107)
    -0.46 ( 0.26 )
    -0.16 ( 0.24 )
        Week 4 (N= 105, 108)
    -0.65 ( 0.28 )
    -0.09 ( 0.26 )
        Week 8 (N= 105, 108)
    -0.92 ( 0.28 )
    -0.44 ( 0.27 )
        Week 12 (N = 105, 109)
    -0.93 ( 0.29 )
    -0.58 ( 0.27 )
        Week 16 (N = 100, 105)
    -1.48 ( 0.28 )
    -1.64 ( 0.24 )
        Week 24 (N = 100, 105)
    -1.54 ( 0.27 )
    -1.65 ( 0.25 )
        Week 32 (N = 100, 105)
    -1.57 ( 0.28 )
    -1.97 ( 0.25 )
        Week 40 (N = 100, 105)
    -1.84 ( 0.28 )
    -2.19 ( 0.26 )
        Week 48 (N = 100, 105)
    -1.78 ( 0.28 )
    -2.05 ( 0.28 )
        Week 56 (N = 100, 105)
    -1.81 ( 0.27 )
    -2.26 ( 0.26 )
        Week 68 (N = 100, 105)
    -1.88 ( 0.28 )
    -2.34 ( 0.28 )
        Week 80 (N = 100, 105)
    -1.89 ( 0.28 )
    -2.16 ( 0.26 )
        Week 92 (N = 100, 105)
    -1.91 ( 0.29 )
    -2.38 ( 0.28 )
        Week 104 (N = 100, 105)
    -2.01 ( 0.29 )
    -2.42 ( 0.28 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.243
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.79
         upper limit
    		 0.2
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0384
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.09
         upper limit
    		 -0.03
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0797
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.03
         upper limit
    		 0.06
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2186
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.21

    Secondary: Mean change from Baseline in BASFI getting-up off-floor from back at time points

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    End point title
    		 Mean change from Baseline in BASFI getting-up off-floor from back at time points
    End point description
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 107)
    -0.95 ( 0.28 )
    -0.53 ( 0.27 )
        Week 8 (N= 105, 108)
    -1.1 ( 0.28 )
    -0.77 ( 0.27 )
        Week 12 (N = 105, 109)
    -1.58 ( 0.31 )
    -1.18 ( 0.29 )
        Week 12 (N= 105, 108)
    -1.34 ( 0.3 )
    -1.05 ( 0.28 )
        Week 16 (N = 100, 105)
    -1.97 ( 0.28 )
    -2.18 ( 0.26 )
        Week 24 (N = 100, 105)
    -2.07 ( 0.26 )
    -2.18 ( 0.25 )
        Week 32 (N = 100, 105)
    -2.05 ( 0.27 )
    -2.31 ( 0.27 )
        Week 40 (N = 100, 105)
    -2.52 ( 0.27 )
    -2.59 ( 0.27 )
        Week 48 (N = 100, 105)
    -2.4 ( 0.28 )
    -2.51 ( 0.27 )
        Week 56 (N = 100, 105)
    -2.48 ( 0.27 )
    -2.81 ( 0.27 )
        Week 68 (N = 100, 105)
    -2.5 ( 0.27 )
    -2.75 ( 0.28 )
        Week 80 (N = 100, 105)
    -2.5 ( 0.26 )
    -2.63 ( 0.27 )
        Week 92 (N = 100, 105)
    -2.55 ( 0.29 )
    -2.84 ( 0.28 )
        Week 104 (N = 100, 105)
    -2.71 ( 0.29 )
    -2.9 ( 0.27 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.141
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.96
         upper limit
    		 0.14
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2299
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.88
         upper limit
    		 0.21
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3221
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.87
         upper limit
    		 0.29
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1891
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 0.2

    Secondary: Mean change from Baseline in BASFI standing unsupported for 10 minutes at time points

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    End point title
    		 Mean change from Baseline in BASFI standing unsupported for 10 minutes at time points
    End point description
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 107)
    -0.58 ( 0.26 )
    -0.17 ( 0.24 )
        Week 4 (N= 105, 108)
    -0.8 ( 0.27 )
    -0.25 ( 0.25 )
        Week 8 (N= 105, 108)
    -1.03 ( 0.28 )
    -0.6 ( 0.27 )
        Week 12 (N = 105, 109)
    -1.33 ( 0.3 )
    -0.97 ( 0.29 )
        Week 16 (N = 100, 105)
    -1.88 ( 0.26 )
    -1.93 ( 0.23 )
        Week 24 (N = 100, 105)
    -1.96 ( 0.26 )
    -1.98 ( 0.25 )
        Week 32 (N = 100, 105)
    -1.84 ( 0.26 )
    -2.19 ( 0.25 )
        Week 40 (N = 100, 105)
    -2.17 ( 0.27 )
    -2.44 ( 0.26 )
        Week 48 (N = 100, 105)
    -2.3 ( 0.28 )
    -2.41 ( 0.28 )
        Week 56 (N = 100, 105)
    -2.26 ( 0.25 )
    -2.63 ( 0.26 )
        Week 68 (N = 100, 105)
    -2.37 ( 0.27 )
    -2.64 ( 0.27 )
        Week 80 (N = 100, 105)
    -2.41 ( 0.26 )
    -2.56 ( 0.26 )
        Week 92 (N = 100, 105)
    -2.42 ( 0.27 )
    -2.72 ( 0.28 )
        Week 104 (N = 100, 105)
    -2.53 ( 0.27 )
    -2.74 ( 0.27 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.108
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.09
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0389
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 -0.03
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1181
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.98
         upper limit
    		 0.11
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2271
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.94
         upper limit
    		 0.22

    Secondary: Mean change from Baseline in BASFI looking over shoulder at time points

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    End point title
    		 Mean change from Baseline in BASFI looking over shoulder at time points
    End point description
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 8 (N= 105, 108)
    -1.21 ( 0.28 )
    -0.84 ( 0.26 )
        Week 12 (N = 105, 108)
    -1.4 ( 0.28 )
    -0.82 ( 0.27 )
        Week 16 (N = 100, 105)
    -1.63 ( 0.28 )
    -1.69 ( 0.26 )
        Week 24 (N = 100, 105)
    -1.59 ( 0.28 )
    -1.84 ( 0.27 )
        Week 32 (N = 100, 105)
    -1.61 ( 0.29 )
    -1.92 ( 0.26 )
        Week 40 (N = 100, 105)
    -1.91 ( 0.28 )
    -2.03 ( 0.27 )
        Week 48 (N = 100, 105)
    -1.97 ( 0.28 )
    -2.08 ( 0.27 )
        Week 56 (N = 100, 105)
    -1.99 ( 0.27 )
    -2.27 ( 0.26 )
        Week 68 (N = 100, 105)
    -2.05 ( 0.27 )
    -2.25 ( 0.27 )
        Week 80 (N = 100, 105)
    -2.03 ( 0.27 )
    -1.94 ( 0.29 )
        Week 92 (N = 100, 105)
    -1.97 ( 0.28 )
    -2.19 ( 0.27 )
        Week 104 (N = 100, 105)
    -2.14 ( 0.27 )
    -2.16 ( 0.28 )
        Week 2 (N= 105, 107)
    -0.83 ( 0.27 )
    -0.07 ( 0.25 )
        Week 4 (N= 105, 108)
    -0.88 ( 0.28 )
    -0.33 ( 0.27 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0044
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.27
         upper limit
    		 -0.24
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0455
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.09
         upper limit
    		 -0.01
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.175
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.91
         upper limit
    		 0.17
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0379
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.12
         upper limit
    		 -0.03

    Secondary: Mean change from Baseline in BASFI putting on socks at time points

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    End point title
    		 Mean change from Baseline in BASFI putting on socks at time points
    End point description
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants 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.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 107)
    -0.94 ( 0.27 )
    -0.47 ( 0.26 )
        Week 4 (N= 105, 108)
    -0.74 ( 0.29 )
    -0.34 ( 0.27 )
        Week 8 (N= 105, 108)
    -1.04 ( 0.28 )
    -0.54 ( 0.27 )
        Week 12 (N = 105, 108)
    -1.02 ( 0.28 )
    -0.57 ( 0.26 )
        Week 16 (N = 100, 105)
    -1.52 ( 0.29 )
    -1.36 ( 0.21 )
        Week 24 (N = 100, 105)
    -1.65 ( 0.29 )
    -1.44 ( 0.21 )
        Week 32 (N = 100, 105)
    -1.55 ( 0.29 )
    -1.49 ( 0.21 )
        Week 40 (N = 100, 105)
    -1.92 ( 0.28 )
    -1.64 ( 0.23 )
        Week 48 (N = 100, 105)
    -1.95 ( 0.28 )
    -1.6 ( 0.23 )
        Week 56 (N = 100, 105)
    -1.85 ( 0.29 )
    -1.75 ( 0.21 )
        Week 68 (N = 100, 105)
    -1.8 ( 0.27 )
    -1.62 ( 0.22 )
        Week 80 (N = 100, 105)
    -1.92 ( 0.29 )
    -1.66 ( 0.22 )
        Week 92 (N = 100, 105)
    -1.93 ( 0.29 )
    -1.7 ( 0.22 )
        Week 104 (N = 100, 105)
    -1.95 ( 0.29 )
    -1.71 ( 0.23 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0826
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.98
         upper limit
    		 0.06
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1538
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.96
         upper limit
    		 0.15
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0728
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.04
         upper limit
    		 0.05
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0975
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 0.08

    Secondary: Changes from Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at time points

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    End point title
    		 Changes from Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at time points
    End point description
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N = 105, 108)
    -0.96 ( 0.23 )
    -0.39 ( 0.22 )
        Week 4 (N = 105, 109)
    -1.63 ( 0.24 )
    -0.97 ( 0.22 )
        Week 8 (N = 105, 109)
    -2.05 ( 0.26 )
    -1.24 ( 0.25 )
        Week 12 (N = 105, 109)
    -1.96 ( 0.28 )
    -1.31 ( 0.27 )
        Week 16 (N = 100, 105)
    -2.7 ( 0.21 )
    -2.98 ( 0.2 )
        Week 24 (N = 100, 105)
    -2.86 ( 0.22 )
    -3.26 ( 0.19 )
        Week 32 (N = 100, 105)
    -2.72 ( 0.22 )
    -3.24 ( 0.22 )
        Week 40 (N = 100, 105)
    -3.22 ( 0.22 )
    -3.41 ( 0.21 )
        Week 48 (N = 100, 105)
    -3.18 ( 0.23 )
    -3.47 ( 0.22 )
        Week 56 (N = 100, 105)
    -3.21 ( 0.24 )
    -3.5 ( 0.21 )
        Week 68 (N = 100, 105)
    -3.17 ( 0.23 )
    -3.69 ( 0.22 )
        Week 80 (N = 100, 105)
    -3.12 ( 0.24 )
    -3.59 ( 0.22 )
        Week 92 (N = 100, 105)
    -3.35 ( 0.25 )
    -3.77 ( 0.23 )
        Week 104 (N = 100, 105)
    -3.41 ( 0.24 )
    -3.87 ( 0.23 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0186
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.18
         upper limit
    		 -0.11
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0106
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.01
         upper limit
    		 -0.13
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0048
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.11
         upper limit
    		 -0.2
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0016
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.31
         upper limit
    		 -0.31

    Secondary: Mean change from Baseline in BASDAI level of morning stiffness at time points

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    End point title
    		 Mean change from Baseline in BASDAI level of morning stiffness at time points
    End point description
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 108)
    -1.26 ( 0.29 )
    -0.45 ( 0.28 )
        Week 4 (N= 105, 108)
    -1.83 ( 0.31 )
    -1 ( 0.29 )
        Week 8 (N= 101, 106)
    -2.46 ( 0.33 )
    -1.24 ( 0.31 )
        Week 12 (N = 101, 106)
    -2.26 ( 0.34 )
    -1.43 ( 0.32 )
        Week 16 (N = 100, 105)
    -3.5 ( 0.29 )
    -3.4 ( 0.25 )
        Week 24 (N = 100, 105)
    -3.71 ( 0.28 )
    -4 ( 0.25 )
        Week 32 (N = 100, 105)
    -3.45 ( 0.28 )
    -3.84 ( 0.26 )
        Week 40 (N = 100, 105)
    -3.93 ( 0.28 )
    -4.23 ( 0.24 )
        Week 48 (N = 100, 105)
    -3.91 ( 0.3 )
    -4.06 ( 0.25 )
        Week 56 (N = 100, 105)
    -3.89 ( 0.31 )
    -4.28 ( 0.25 )
        Week 68 (N = 100, 105)
    -3.99 ( 0.28 )
    -4.41 ( 0.26 )
        Week 80 (N = 100, 105)
    -3.74 ( 0.29 )
    -4.3 ( 0.26 )
        Week 92 (N = 100, 105)
    -3.99 ( 0.31 )
    -4.42 ( 0.25 )
        Week 104 (N = 100, 105)
    -4.09 ( 0.3 )
    -4.66 ( 0.24 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0058
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.37
         upper limit
    		 -0.24
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0064
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.42
         upper limit
    		 -0.24
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.85
         upper limit
    		 -0.6
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0134
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.49
         upper limit
    		 -0.17

    Secondary: Mean change from Baseline in BASDAI level of fatigue/tiredness at time points

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    End point title
    		 Mean change from Baseline in BASDAI level of fatigue/tiredness at time points
    End point description
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 108)
    -0.8 ( 0.27 )
    -0.23 ( 0.26 )
        Week 4 (N= 105, 109)
    -1.71 ( 0.28 )
    -1.26 ( 0.26 )
        Week 8 (N= 105, 109)
    -1.98 ( 0.3 )
    -1.29 ( 0.29 )
        Week 12 (N = 105, 109)
    -1.7 ( 0.34 )
    -1.32 ( 0.32 )
        Week 16 (N = 100, 105)
    -2.29 ( 0.24 )
    -2.89 ( 0.25 )
        Week 24 (N = 100, 105)
    -2.48 ( 0.27 )
    -2.95 ( 0.23 )
        Week 32 (N = 100, 105)
    -2.22 ( 0.26 )
    -2.74 ( 0.26 )
        Week 40 (N = 100, 105)
    -2.82 ( 0.26 )
    -2.93 ( 0.26 )
        Week 48 (N = 100, 105)
    -2.86 ( 0.25 )
    -3.19 ( 0.26 )
        Week 56 (N = 100, 105)
    -3.03 ( 0.26 )
    -3.2 ( 0.26 )
        Week 68 (N = 100, 105)
    -2.92 ( 0.27 )
    -3.48 ( 0.24 )
        Week 80 (N = 100, 105)
    -3.15 ( 0.28 )
    -3.36 ( 0.26 )
        Week 92 (N = 100, 105)
    -3.2 ( 0.27 )
    -3.68 ( 0.25 )
        Week 104 (N = 100, 105)
    -3.18 ( 0.27 )
    -3.63 ( 0.28 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0316
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.09
         upper limit
    		 -0.05
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0973
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 0.08
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0216
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.27
         upper limit
    		 -0.1
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2425
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.03
         upper limit
    		 0.26

    Secondary: Mean change from Baseline in BASDAI level of discomfort at time points

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    End point title
    		 Mean change from Baseline in BASDAI level of discomfort at time points
    End point description
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 108)
    -0.81 ( 0.31 )
    -0.48 ( 0.29 )
        Week 8 (N= 105, 109)
    -1.31 ( 0.33 )
    -0.77 ( 0.31 )
        Week 12 (N= 105, 109)
    -1.91 ( 0.33 )
    -1.2 ( 0.31 )
        Week 12 (N = 105, 109)
    -1.68 ( 0.34 )
    -1.29 ( 0.32 )
        Week 16 (N = 100, 105)
    -2.65 ( 0.3 )
    -2.82 ( 0.25 )
        Week 24 (N = 100, 105)
    -2.71 ( 0.31 )
    -3.07 ( 0.26 )
        Week 32 (N = 100, 105)
    -2.64 ( 0.31 )
    -3.25 ( 0.27 )
        Week 40 (N = 100, 105)
    -3.09 ( 0.3 )
    -3.25 ( 0.27 )
        Week 48 (N = 100, 105)
    -2.97 ( 0.33 )
    -3.27 ( 0.29 )
        Week 56 (N = 100, 105)
    -3.13 ( 0.34 )
    -3.24 ( 0.29 )
        Week 68 (N = 100, 105)
    -3.01 ( 0.32 )
    -3.49 ( 0.31 )
        Week 80 (N = 100, 105)
    -2.87 ( 0.33 )
    -3.5 ( 0.28 )
        Week 92 (N = 100, 105)
    -3.21 ( 0.33 )
    -3.57 ( 0.3 )
        Week 104 (N = 100, 105)
    -3.31 ( 0.34 )
    -3.72 ( 0.29 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2688
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.92
         upper limit
    		 0.26
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0866
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.17
         upper limit
    		 0.08
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0277
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.34
         upper limit
    		 -0.08
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.239
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.04
         upper limit
    		 0.26

    Secondary: Mean change from Baseline in BASDAI level of how long stiffness lasts at time points

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    End point title
    		 Mean change from Baseline in BASDAI level of how long stiffness lasts at time points
    End point description
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 108)
    -0.61 ( 0.28 )
    -0.15 ( 0.26 )
        Week 4 (N= 105, 109)
    -1.33 ( 0.29 )
    -0.62 ( 0.28 )
        Week 8 (N= 105, 109)
    -1.62 ( 0.3 )
    -0.68 ( 0.29 )
        Week 12 (N = 105, 109)
    -1.98 ( 0.31 )
    -0.97 ( 0.29 )
        Week 16 (N = 100, 105)
    -2.63 ( 0.27 )
    -2.6 ( 0.26 )
        Week 24 (N = 100, 105)
    -2.84 ( 0.29 )
    -3.04 ( 0.29 )
        Week 32 (N = 100, 105)
    -2.54 ( 0.29 )
    -3.06 ( 0.3 )
        Week 40 (N = 100, 105)
    -2.94 ( 0.3 )
    -3.28 ( 0.3 )
        Week 48 (N = 100, 105)
    -2.9 ( 0.3 )
    -3.09 ( 0.32 )
        Week 56 (N = 100, 105)
    -2.92 ( 0.33 )
    -3.17 ( 0.3 )
        Week 68 (N = 100, 105)
    -2.91 ( 0.32 )
    -3.5 ( 0.32 )
        Week 80 (N = 100, 105)
    -2.77 ( 0.3 )
    -3.24 ( 0.31 )
        Week 92 (N = 100, 105)
    -2.89 ( 0.33 )
    -3.36 ( 0.31 )
        Week 104 (N = 100, 105)
    -2.95 ( 0.32 )
    -3.38 ( 0.31 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0928
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0.08
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0139
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.27
         upper limit
    		 -0.15
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0017
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.53
         upper limit
    		 -0.36
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0008
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.61
         upper limit
    		 -0.43

    Secondary: Mean change from Baseline in BASDAI level of pain/swelling at time points

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    End point title
    		 Mean change from Baseline in BASDAI level of pain/swelling at time points
    End point description
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 107)
    -0.64 ( 0.32 )
    -0.41 ( 0.3 )
        Week 4 (N= 105, 109)
    -1.35 ( 0.32 )
    -0.68 ( 0.31 )
        Week 8 (N= 105, 109)
    -1.69 ( 0.33 )
    -1.01 ( 0.31 )
        Week 12 (N = 105, 109)
    -1.47 ( 0.33 )
    -0.87 ( 0.32 )
        Week 16 (N = 100, 105)
    -2.38 ( 0.28 )
    -2.66 ( 0.28 )
        Week 24 (N = 100, 105)
    -2.49 ( 0.29 )
    -2.92 ( 0.28 )
        Week 32 (N = 100, 105)
    -2.47 ( 0.3 )
    -3.1 ( 0.29 )
        Week 40 (N = 100, 105)
    2.91 ( 0.27 )
    -3.21 ( 0.28 )
        Week 48 (N = 100, 105)
    -2.8 ( 0.3 )
    -3.21 ( 0.3 )
        Week 56 (N = 100, 105)
    -2.66 ( 0.31 )
    -3.13 ( 0.29 )
        Week 68 (N = 100, 105)
    -2.6 ( 0.32 )
    -3.24 ( 0.32 )
        Week 80 (N = 100, 105)
    -2.67 ( 0.32 )
    -3.19 ( 0.31 )
        Week 92 (N = 100, 105)
    -2.96 ( 0.31 )
    -3.4 ( 0.32 )
        Week 104 (N = 100, 105)
    -3.07 ( 0.31 )
    -3.51 ( 0.31 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4559
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.84
         upper limit
    		 0.38
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0345
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.28
         upper limit
    		 -0.05
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.034
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.05
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0634
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.24
         upper limit
    		 0.03

    Secondary: Mean change from Baseline in BASDAI level of neck/back/hip pain at time points

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    End point title
    		 Mean change from Baseline in BASDAI level of neck/back/hip pain at time points
    End point description
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 108)
    -1.34 ( 0.29 )
    -0.34 ( 0.28 )
        Week 4 (N= 105, 109)
    -1.91 ( 0.31 )
    -1.1 ( 0.29 )
        Week 8 (N= 105, 109)
    -2.32 ( 0.33 )
    -1.48 ( 0.31 )
        Week 12 (N = 105, 109)
    -2.44 ( 0.35 )
    -1.58 ( 0.33 )
        Week 16 (N = 100, 105)
    -3.13 ( 0.28 )
    -3.55 ( 0.28 )
        Week 24 (N = 100, 105)
    -3.32 ( 0.27 )
    -3.82 ( 0.26 )
        Week 32 (N = 100, 105)
    -3.27 ( 0.26 )
    -3.65 ( 0.27 )
        Week 40 (N = 100, 105)
    -3.81 ( 0.27 )
    -3.92 ( 0.27 )
        Week 48 (N = 100, 105)
    -3.85 ( 0.27 )
    -4.1 ( 0.26 )
        Week 56 (N = 100, 105)
    -3.82 ( 0.27 )
    -4.22 ( 0.27 )
        Week 68 (N = 100, 105)
    -3.83 ( 0.26 )
    -4.28 ( 0.27 )
        Week 80 (N = 100, 105)
    -3.6 ( 0.28 )
    -4.11 ( 0.28 )
        Week 92 (N = 100, 105)
    -3.88 ( 0.29 )
    -4.29 ( 0.28 )
        Week 104 (N = 100, 105)
    -3.96 ( 0.29 )
    -4.48 ( 0.27 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0007
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.56
         upper limit
    		 -0.43
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0073
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.39
         upper limit
    		 -0.22
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0094
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.48
         upper limit
    		 -0.21
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.54
         upper limit
    		 -0.19

    Secondary: Percentage of participants with BASDAI 50 at time points

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    End point title
    		 Percentage of participants with BASDAI 50 at time points
    End point description
    Response was defined as a 50% improvement of the Baseline BASDAI to 104 weeks of study treatment, respectively. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    105
    109
    Units: Percentage of participants
    number (not applicable)
        Week 2 (N = 105, 108)
    17.14
    5.56
        Week 4 (N = 105, 109)
    24.76
    11.01
        Week 8 (N = 105, 109)
    37.14
    22.02
        Week 12 (N = 105, 109)
    43.81
    23.85
        Week 16 (N = 100, 105)
    45
    59.05
        Week 24 (N = 100, 105)
    50
    62.86
        Week 32 (N = 100, 105)
    49
    59.05
        Week 40 (N = 100, 105)
    58
    61.9
        Week 48 (N = 100, 105)
    60
    64.76
        Week 56 (N = 100, 105)
    59
    65.71
        Week 68 (N = 100, 105)
    61
    66.67
        Week 80 (N = 100, 105)
    56
    66.67
        Week 92 (N = 100, 105)
    62
    71.43
        Week 104 (N = 100, 105)
    64
    70.48
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0029
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    19.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.54
         upper limit
    		 32.37
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    11.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.18
         upper limit
    		 19.99
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    13.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.62
         upper limit
    		 23.89
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0213
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.04
         upper limit
    		 27.2

    Secondary: Percentage of participants with BASDAI 20 at time points

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    End point title
    		 Percentage of participants with BASDAI 20 at time points
    End point description
    Response was defined as a 20% improvement of the Baseline BASDAI to 104 weeks of study treatment. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    105
    109
    Units: Percentage of participants
    number (not applicable)
        Week 2 (N = 105, 108)
    41.9
    33.33
        Week 4 (N = 105, 109)
    56.19
    42.2
        Week 8 (N = 105, 109)
    66.67
    51.38
        Week 12 (N = 105, 109)
    64.76
    56.88
        Week 16 (N = 100, 105)
    73
    82.86
        Week 24 (N = 100, 105)
    77
    86.67
        Week 32 (N = 100, 105)
    77
    84.76
        Week 40 (N = 100, 105)
    86
    87.62
        Week 48 (N = 100, 105)
    81
    87.62
        Week 56 (N = 100, 105)
    81
    85.71
        Week 68 (N = 100, 105)
    80
    90.48
        Week 80 (N = 100, 105)
    81
    88.57
        Week 92 (N = 100, 105)
    82
    88.57
        Week 104 (N = 100, 105)
    84
    90.48
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2755
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.15
         upper limit
    		 20.92
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.195
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.39
         upper limit
    		 21.54
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0278
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    13.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 27.26
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0174
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.28
         upper limit
    		 28.3

    Secondary: Change from Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Total Score at time points

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    End point title
    		 Change from Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Total Score at time points
    End point description
    The BAS-G was a 2 question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. The 2 questions were: How have you been over the last week? and How have you been over the last six months?. Each question is scored by the participant on a 100 mm scale ranging from 0 (Very Good) to 100 (Very Bad). The two values are averaged to obtain the BAS-G score.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 4 (N = 105, 109)
    -1.29 ( 0.24 )
    -0.75 ( 0.22 )
        Week 12 (N = 105, 109)
    -1.85 ( 0.27 )
    -1.35 ( 0.25 )
        Week 24 (N = 100, 105)
    -2.8 ( 0.24 )
    -2.87 ( 0.19 )
        Week 48 (N = 105, 109)
    -3.2 ( 0.25 )
    -3.51 ( 0.22 )
        Week 68 (N = 105, 109)
    -3.28 ( 0.25 )
    -3.77 ( 0.23 )
        Week 92 (N = 105, 109)
    -3.55 ( 0.25 )
    -3.81 ( 0.23 )
        Week 104 (N = 105, 109)
    -3.59 ( 0.26 )
    -3.92 ( 0.24 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0558
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.02
         upper limit
    		 0.01
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0201
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 -0.09

    Secondary: Mean change from Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at time points

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    End point title
    		 Mean change from Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at time points
    End point description
    BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    104
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N = 103, 108)
    -0.08 ( 0.12 )
    -0.13 ( 0.11 )
        Week 4 (N = 103, 109)
    -0.3 ( 0.12 )
    -0.2 ( 0.11 )
        Week 8 (N = 103, 109)
    -0.36 ( 0.14 )
    -0.41 ( 0.13 )
        Week 12 (N = 103, 109)
    -0.34 ( 0.14 )
    -0.19 ( 0.1 )
        Week 16 (N = 98, 105)
    -0.44 ( 0.14 )
    -0.35 ( 0.1 )
        Week 24 (N = 98, 105)
    -0.48 ( 0.13 )
    -0.34 ( 0.1 )
        Week 40 (N = 98, 105)
    -0.49 ( 0.14 )
    -0.49 ( 0.11 )
        Week 32 (N = 98, 105)
    -0.55 ( 0.14 )
    -0.47 ( 0.11 )
        Week 48 (N = 98, 105)
    -0.54 ( 0.13 )
    -0.44 ( 0.11 )
        Week 56 (N = 98, 105)
    -0.56 ( 0.13 )
    -0.49 ( 0.11 )
        Week 68 (N = 98, 105)
    -0.6 ( 0.13 )
    -0.58 ( 0.11 )
        Week 80 (N = 98, 105)
    -0.64 ( 0.14 )
    -0.62 ( 0.11 )
        Week 92 (N = 98, 105)
    -0.61 ( 0.13 )
    -0.62 ( 0.11 )
        Week 104 (N = 98, 105)
    -0.61 ( 0.14 )
    -0.55 ( 0.11 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6741
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.28
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3896
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 0.13
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7468
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.31
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6871
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 0.23

    Secondary: Mean change from Baseline in BASMI lateral side flexion score by time point

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    End point title
    		 Mean change from Baseline in BASMI lateral side flexion score by time point
    End point description
    BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    104
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 100, 105)
    1.06 ( 0.49 )
    0.69 ( 0.46 )
        Week 4 (N= 100, 106)
    1.49 ( 0.51 )
    1.49 ( 0.48 )
        Week 8 (N= 100, 106)
    1.64 ( 0.53 )
    0.91 ( 0.5 )
        Week 12 (N = 100, 106)
    1.64 ( 0.62 )
    0.43 ( 0.58 )
        Week 16 (N = 98, 105)
    1.35 ( 0.55 )
    1.02 ( 0.32 )
        Week 24 (N = 98, 105)
    1.97 ( 0.66 )
    1.29 ( 0.34 )
        Week 32 (N = 98, 105)
    2.03 ( 0.57 )
    1.62 ( 0.35 )
        Week 40 (N = 98, 105)
    1.86 ( 0.59 )
    1.57 ( 0.38 )
        Week 48 (N = 98, 105)
    2.2 ( 0.55 )
    1.36 ( 0.34 )
        Week 56 (N = 98, 105)
    1.82 ( 0.54 )
    1.43 ( 0.36 )
        Week 68 (N = 98, 105)
    2.24 ( 0.58 )
    1.54 ( 0.41 )
        Week 80 (N = 98, 105)
    1.96 ( 0.59 )
    1.52 ( 0.4 )
        Week 92 (N = 98, 105)
    2.14 ( 0.6 )
    1.5 ( 0.38 )
        Week 104 (N = 98, 105)
    1.97 ( 0.59 )
    1.65 ( 0.37 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4332
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 1.32
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9947
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.98
         upper limit
    		 0.98
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1558
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 1.75
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0488
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 2.39

    Secondary: Mean change from Baseline in BASMI cervical rotation degree by time point

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    End point title
    		 Mean change from Baseline in BASMI cervical rotation degree by time point
    End point description
    BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 108)
    1.35 ( 1.26 )
    0.98 ( 1.19 )
        Week 4 (N= 105, 109)
    3.52 ( 1.31 )
    2.49 ( 1.23 )
        Week 8 (N= 105, 109)
    4.92 ( 1.42 )
    3.86 ( 1.34 )
        Week 12 (N = 105, 109)
    4.46 ( 1.52 )
    2.07 ( 1.44 )
        Week 16 (N = 100, 105)
    5.13 ( 1.37 )
    4.73 ( 1.09 )
        Week 24 (N = 100, 105)
    5 ( 1.35 )
    5.1 ( 1.18 )
        Week 32 (N = 100, 105)
    5.32 ( 1.43 )
    6 ( 1.25 )
        Week 40 (N = 100, 105)
    5.56 ( 1.51 )
    5.61 ( 1.19 )
        Week 48 (N = 100, 105)
    5.04 ( 1.48 )
    6.9 ( 1.19 )
        Week 56 (N = 100, 105)
    5.7 ( 1.44 )
    6.92 ( 1.31 )
        Week 68 (N = 100, 105)
    6.47 ( 1.43 )
    8.1 ( 1.23 )
        Week 80 (N = 100, 105)
    6.14 ( 1.45 )
    7.96 ( 1.23 )
        Week 92 (N = 100, 105)
    6.26 ( 1.5 )
    8.25 ( 1.24 )
        Week 104 (N = 100, 105)
    5.92 ( 1.57 )
    8.55 ( 1.22 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7645
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.06
         upper limit
    		 2.8
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4178
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.48
         upper limit
    		 3.55
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.443
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.67
         upper limit
    		 3.79
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1095
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 5.31

    Secondary: Mean change from Baseline in BASMI modified schobers test score by time point

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    End point title
    		 Mean change from Baseline in BASMI modified schobers test score by time point
    End point description
    BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    104
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 89, 90)
    0.17 ( 0.24 )
    0.16 ( 0.23 )
        Week 4 (N= 89, 90)
    0.02 ( 0.26 )
    0.2 ( 0.25 )
        Week 8 (N= 89, 90)
    0.15 ( 0.26 )
    0.12 ( 0.25 )
        Week 12 (N = 89, 90)
    0.05 ( 0.31 )
    0.04 ( 0.3 )
        Week 16 (N = 86, 86)
    0.71 ( 0.23 )
    0.37 ( 0.24 )
        Week 24 (N = 86, 86)
    0.98 ( 0.27 )
    0.54 ( 0.25 )
        Week 32 (N = 86, 86)
    0.73 ( 0.3 )
    0.54 ( 0.28 )
        Week 40 (N = 86, 86)
    0.68 ( 0.24 )
    0.77 ( 0.25 )
        Week 48 (N = 86, 86)
    0.75 ( 0.26 )
    0.63 ( 0.26 )
        Week 56 (N = 86, 86)
    1.16 ( 0.36 )
    0.79 ( 0.32 )
        Week 68 (N = 86, 86)
    1.34 ( 0.35 )
    0.89 ( 0.31 )
        Week 80 (N = 86, 86)
    1.38 ( 0.38 )
    0.97 ( 0.31 )
        Week 92 (N = 86, 86)
    1.03 ( 0.35 )
    0.88 ( 0.29 )
        Week 104 (N = 86, 86)
    0.99 ( 0.36 )
    0.92 ( 0.33 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9504
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 0.49
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4971
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.34
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8999
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 0.54
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9712
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.62

    Secondary: Mean change from Baseline in BASMI intermalleolar distance score by time point

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    End point title
    		 Mean change from Baseline in BASMI intermalleolar distance score by time point
    End point description
    BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    104
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 108)
    0.75 ( 1.22 )
    -0.15 ( 1.15 )
        Week 4 (N= 105, 109)
    4.02 ( 1.5 )
    1.17 ( 1.42 )
        Week 8 (N= 105, 109)
    4.25 ( 1.7 )
    1.99 ( 1.61 )
        Week 12 (N = 105, 109)
    3.25 ( 1.75 )
    1.81 ( 1.66 )
        Week 16 (N = 100, 105)
    6.28 ( 1.44 )
    3.73 ( 1.27 )
        Week 24 (N = 100, 105)
    7.48 ( 1.41 )
    4.76 ( 1.3 )
        Week 32 (N = 100, 105)
    8.09 ( 1.38 )
    5.01 ( 1.35 )
        Week 40 (N = 100, 105)
    8.38 ( 1.38 )
    5.61 ( 1.34 )
        Week 48 (N = 100, 105)
    8.35 ( 1.5 )
    6.32 ( 1.33 )
        Week 56 (N = 100, 105)
    9.31 ( 1.48 )
    7.42 ( 1.38 )
        Week 68 (N = 100, 105)
    9.26 ( 1.55 )
    7.92 ( 1.37 )
        Week 80 (N = 100, 105)
    9.17 ( 1.55 )
    8.73 ( 1.32 )
        Week 92 (N = 100, 105)
    9.8 ( 1.55 )
    9.05 ( 1.34 )
        Week 104 (N = 100, 105)
    8.91 ( 1.57 )
    8.72 ( 1.35 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4556
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.46
         upper limit
    		 3.24
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0543
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 5.75
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1754
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.02
         upper limit
    		 5.53
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3985
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.93
         upper limit
    		 4.82

    Secondary: Mean change from Baseline in BASMI tragus to wall score by time point

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    End point title
    		 Mean change from Baseline in BASMI tragus to wall score by time point
    End point description
    BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    104
    109
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N= 105, 108)
    0.02 ( 0.21 )
    -0.2 ( 0.2 )
        Week 4 (N= 105, 109)
    -0.2 ( 0.21 )
    -0.37 ( 0.2 )
        Week 8 (N= 105, 109)
    -0.31 ( 0.2 )
    -0.44 ( 0.19 )
        Week 12 (N = 105, 109)
    -0.29 ( 0.23 )
    -0.41 ( 0.22 )
        Week 16 (N = 100, 105)
    0.14 ( 0.22 )
    -0.02 ( 0.16 )
        Week 24 (N = 100, 105)
    0.28 ( 0.24 )
    0.01 ( 0.17 )
        Week 32 (N = 100, 105)
    0.02 ( 0.27 )
    0.01 ( 0.16 )
        Week 40 (N = 100, 105)
    -0.07 ( 0.25 )
    -0.08 ( 0.21 )
        Week 48 (N = 100, 105)
    -0.16 ( 0.27 )
    0.03 ( 0.16 )
        Week 68 (N = 100, 105)
    -0.28 ( 0.27 )
    0.08 ( 0.18 )
        Week 56 (N = 100, 105)
    0.01 ( 0.26 )
    0 ( 0.17 )
        Week 80 (N = 100, 105)
    -0.24 ( 0.26 )
    0 ( 0.16 )
        Week 92 (N = 100, 105)
    -0.17 ( 0.27 )
    -0.02 ( 0.18 )
        Week 104 (N = 100, 105)
    -0.39 ( 0.25 )
    -0.15 ( 0.18 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2823
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.62
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4029
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 0.58
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.511
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.51
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5844
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.32
         upper limit
    		 0.56

    Secondary: Change from Baseline in Chest Expansion at time points

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    End point title
    		 Change from Baseline in Chest Expansion at time points
    End point description
    Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). At maximal inspiration, the chest circumference was measured at nipple line or at the 4th intercostal space (in cm to the nearest 0.1 cm).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    105
    108
    Units: cm
    arithmetic mean (standard error)
        Week 2 (N = 104, 105)
    0.16 ( 0.22 )
    0.69 ( 0.2 )
        Week 4 (N = 104, 108)
    0.31 ( 0.25 )
    0.44 ( 0.23 )
        Week 8 (N = 104, 108)
    0.2 ( 0.25 )
    0.61 ( 0.23 )
        Week 12 (N = 104, 108)
    0.12 ( 0.25 )
    0.37 ( 0.24 )
        Week 16 (N = 99, 104)
    0.43 ( 0.19 )
    0.68 ( 0.19 )
        Week 24 (N = 99, 104)
    0.38 ( 0.17 )
    0.69 ( 0.19 )
        Week 32 (N = 99, 104)
    0.49 ( 0.18 )
    0.62 ( 0.18 )
        Week 40 (N = 99, 104)
    0.55 ( 0.17 )
    0.71 ( 0.17 )
        Week 48 (N = 99, 104)
    0.63 ( 0.17 )
    0.8 ( 0.21 )
        Week 56 (N = 99, 104)
    0.49 ( 0.18 )
    0.72 ( 0.19 )
        Week 68 (N = 99, 104)
    0.61 ( 0.17 )
    0.56 ( 0.18 )
        Week 80 (N = 99, 104)
    0.32 ( 0.18 )
    0.74 ( 0.2 )
        Week 92 (N = 99, 104)
    0.52 ( 0.18 )
    0.56 ( 0.2 )
        Week 104 (N = 99, 104)
    0.67 ( 0.18 )
    0.63 ( 0.2 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Most within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0129
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 -0.11
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6003
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.61
         upper limit
    		 0.35
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0911
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.89
         upper limit
    		 0.07
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3144
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.73
         upper limit
    		 0.24

    Secondary: Mean change from Baseline in Occiput-to-wall test at time points

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    End point title
    		 Mean change from Baseline in Occiput-to-wall test at time points
    End point description
    Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    105
    108
    Units: cm
    arithmetic mean (standard error)
        Week 2 (N = 104, 106)
    -0.21 ( 0.19 )
    -0.12 ( 0.19 )
        Week 4 (N = 104, 108)
    -0.37 ( 0.2 )
    -0.36 ( 0.19 )
        Week 8 (N = 104, 108)
    -0.09 ( 0.24 )
    -0.27 ( 0.23 )
        Week 12 (N = 104, 108)
    -0.28 ( 0.24 )
    -0.41 ( 0.23 )
        Week 16 (N = 99, 104)
    -0.24 ( 0.25 )
    -0.29 ( 0.11 )
        Week 24 (N = 99, 104)
    -0.11 ( 0.25 )
    -0.38 ( 0.18 )
        Week 32 (N = 99, 104)
    -0.2 ( 0.25 )
    -0.31 ( 0.16 )
        Week 40 (N = 99, 104)
    -0.34 ( 0.22 )
    -0.24 ( 0.17 )
        Week 48 (N = 99, 104)
    -0.25 ( 0.24 )
    -0.42 ( 0.13 )
        Week 56 (N = 99, 104)
    -0.42 ( 0.22 )
    -0.26 ( 0.14 )
        Week 68 (N = 99, 104)
    -0.42 ( 0.23 )
    -0.21 ( 0.16 )
        Week 80 (N = 99, 104)
    -0.34 ( 0.24 )
    -0.55 ( 0.17 )
        Week 92 (N = 99, 104)
    -0.29 ( 0.24 )
    -0.49 ( 0.15 )
        Week 104 (N = 99, 104)
    -0.73 ( 0.26 )
    -0.52 ( 0.19 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Most within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 2
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6476
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 0.29
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9777
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.39
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4453
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.65
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5782
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 0.6

    Secondary: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) - Spine 6 discovertebral units (DVU) Total Score at 12 weeks

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    End point title
    		 Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) - Spine 6 discovertebral units (DVU) Total Score at 12 weeks
    End point description
    The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    95
    105
    Units: units on a scale
        arithmetic mean (standard error)
    -2.12 ( 0.72 )
    -2.12 ( 0.43 )
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0414
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.88
         upper limit
    		 -0.04

    Secondary: Mean change from Baseline in SPARCC Score for the Sacroiliac Joint at time points

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    End point title
    		 Mean change from Baseline in SPARCC Score for the Sacroiliac Joint at time points
    End point description
    The change from baseline in the MRI score of sacroiliac joints was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion/1 = increased signal. For each slice, the score is increased by 1 for each joint that exhibits an intense signal in any quadrant. Also, for each slice, an additional score of 1 will be given for each joint that includes a lesion demonstrating continuous increased signal of a depth ≥1 cm from the articular surface. The maximum possible score is 72.
    End point type
    Secondary
    End point timeframe
    Weeks 12 and 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    95
    105
    Units: units on a scale
    arithmetic mean (standard error)
        Week 12 (N = 97, 105)
    -3.99 ( 0.72 )
    -0.86 ( 0.43 )
        Week 104 (N = 74, 79)
    -6 ( 1.15 )
    -3.36 ( 0.84 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.16
         upper limit
    		 -1.7

    Secondary: Mean Change from Baseline in SPARCC - Spine 6 discovertebral units (DVU) Total Score at time points

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    End point title
    		 Mean Change from Baseline in SPARCC - Spine 6 discovertebral units (DVU) Total Score at time points
    End point description
    The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.
    End point type
    Secondary
    End point timeframe
    Weeks 12 and 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    95
    105
    Units: units on a scale
    arithmetic mean (standard error)
        Week 12 (N= 95, 105)
    -2.12 ( 0.49 )
    -1.16 ( 0.47 )
        Week 104 (N= 74, 80)
    -2.08 ( 0.91 )
    -0.78 ( 0.49 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0414
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.88
         upper limit
    		 -0.04

    Secondary: Mean change from Baseline in Ankylosing Spondylitis Spine Magnetic Resonance Imaging-Activity (ASspiMRI-a) Total Score

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    End point title
    		 Mean change from Baseline in Ankylosing Spondylitis Spine Magnetic Resonance Imaging-Activity (ASspiMRI-a) Total Score
    End point description
    ASspiMRI-a measures acute lesion scores as determined by short-tau inversion recovery (STIR) and gadolinium-enhanced T1 (Gd-DTPA). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, are scored in a single dimension, which is representing the highest level of inflammation in that particular DVU. Enhancement and bone marrow edema are graded (0-3) for each DVU, with 3 more grades (4-6) if, in addition to the signs of acute inflammation defined for grades 1-3, erosions are visualized, leading to a maximum score of 138 for the entire spine. Acute spinal changes were assessed by using STIR sagittal views of the cervical, thoracic and lumbar spine. The total score ranges from 0 (no inflammation) to 138 (high inflammation).
    End point type
    Secondary
    End point timeframe
    Weeks 12 and 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    95
    105
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 12 (N= 95 105)
    -0.73 ( 0.17 )
    -0.33 ( 0.16 )
        Week 104 (N= 73, 80)
    -0.79 ( 0.29 )
    -0.28 ( 0.16 )
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0132
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 -0.08

    Secondary: Mean change from Baseline in number of swollen joints at time points

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    End point title
    		 Mean change from Baseline in number of swollen joints at time points
    End point description
    Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered swollen (artificial joints were not assessed). The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done. The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    102
    105
    Units: Number of joints
    arithmetic mean (standard error)
        Week 2 (N = 100, 102)
    -0.27 ( 0.17 )
    -0.08 ( 0.16 )
        Week 4 (N = 100, 105)
    -0.62 ( 0.13 )
    -0.45 ( 0.13 )
        Week 8 (N = 101, 105)
    -0.71 ( 0.14 )
    -0.52 ( 0.13 )
        Week 12 (N = 101, 105)
    -0.6 ( 0.12 )
    -0.29 ( 0.11 )
        Week 16 (N = 96, 102)
    -0.76 ( 0.17 )
    -0.59 ( 0.19 )
        Week 24 (N = 96, 102)
    -0.8 ( 0.2 )
    -0.68 ( 0.22 )
        Week 32 (N= 96, 102)
    -0.75 ( 0.23 )
    -0.64 ( 0.2 )
        Week 40 (N= 96, 102)
    -0.8 ( 0.21 )
    -0.71 ( 0.2 )
        Week 48 (N= 96, 102)
    -0.83 ( 0.21 )
    -0.83 ( 0.22 )
        Week 56 (N= 96, 102)
    -0.86 ( 0.21 )
    -0.76 ( 0.21 )
        Week 68 (N= 96, 102)
    -0.86 ( 0.21 )
    -0.82 ( 0.22 )
        Week 80 (N= 96, 102)
    -0.85 ( 0.21 )
    -0.79 ( 0.22 )
        Week 92 (N= 96, 102)
    -0.83 ( 0.21 )
    -0.76 ( 0.23 )
        Week 104 (N= 96, 102)
    -0.89 ( 0.21 )
    -0.84 ( 0.22 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2438
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 0.13
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1958
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 0.09
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1624
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 0.08
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0091
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 -0.08

    Secondary: Mean change from Baseline in number of tender joints at time points

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    End point title
    		 Mean change from Baseline in number of tender joints at time points
    End point description
    Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Aplicable (to be considered for artificial joints). The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    102
    105
    Units: Number of joints
    arithmetic mean (standard error)
        Week 2 (N = 100, 102)
    -1.99 ( 0.36 )
    -1.38 ( 0.35 )
        Week 4 (N = 100, 105)
    1.52 ( 0.41 )
    -1.27 ( 0.39 )
        Week 8 (N = 101, 105)
    -1.93 ( 0.41 )
    -2.02 ( 0.39 )
        Week 12 (N = 101, 105)
    -1.55 ( 0.38 )
    -1.56 ( 0.36 )
        Week 16 (N = 96, 102)
    -1.93 ( 0.39 )
    -2.35 ( 0.49 )
        Week 24 (N = 96, 102)
    -2.46 ( 0.43 )
    -2.83 ( 0.57 )
        Week 32 (N = 96, 102)
    -1.96 ( 0.42 )
    -3.09 ( 0.55 )
        Week 40 (N = 96, 102)
    -2.42 ( 0.42 )
    -3.16 ( 0.53 )
        Week 48 (N = 96, 102)
    -2.65 ( 0.42 )
    -2.95 ( 0.55 )
        Week 56 (N = 96, 102)
    -2.44 ( 0.43 )
    -3.25 ( 0.58 )
        Week 68 (N = 96, 102)
    -2.43 ( 0.4 )
    -3.3 ( 0.61 )
        Week 80 (N = 96, 102)
    -2.6 ( 0.43 )
    -3.07 ( 0.6 )
        Week 92 (N = 96, 102)
    -2.45 ( 0.37 )
    -3.29 ( 0.58 )
        Week 104 (N = 96, 102)
    -2.72 ( 0.42 )
    -3.48 ( 0.58 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0836
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.32
         upper limit
    		 0.08
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5402
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.02
         upper limit
    		 0.54
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8167
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.69
         upper limit
    		 0.87
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9891
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 0.73

    Secondary: Mean change from Baseline in dactylitis score at time points

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    End point title
    		 Mean change from Baseline in dactylitis score at time points
    End point description
    Each of the 10 fingers and 10 toes is evaluated for dactylitis. A score of 0, 1, 2 or 3 (where 0 = none, 1= mild, 2 = moderate, 3 = severe) is assigned to each. A total score which can range from 0 to 60 is obtained by adding the scores for the 20 digits
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    108
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N = 105, 107)
    0 ( 0.03 )
    0.02 ( 0.03 )
        Week 4 (N = 105, 108)
    -0.09 ( 0.03 )
    -0.05 ( 0.03 )
        Week 8 (N = 105, 108)
    -0.19 ( 0.02 )
    -0.16 ( 0.02 )
        Week 12 (N = 105, 108)
    -0.19 ( 0.08 )
    -0.21 ( 0.07 )
        Week 16 (N = 100, 104)
    -0.21 ( 0.13 )
    -0.2 ( 0.1 )
        Week 24 (N = 100, 104)
    -0.23 ( 0.13 )
    -0.2 ( 0.1 )
        Week 32 (N = 100, 104)
    -0.23 ( 0.13 )
    -0.21 ( 0.1 )
        Week 40 (N = 100, 104)
    -0.22 ( 0.13 )
    -0.23 ( 0.1 )
        Week 48 (N = 100, 104)
    -0.22 ( 0.13 )
    -0.22 ( 0.09 )
        Week 56 (N = 100, 104)
    -0.23 ( 0.13 )
    -0.22 ( 0.1 )
        Week 68 (N = 100, 104)
    -0.2 ( 0.11 )
    -0.23 ( 0.1 )
        Week 80 (N = 100, 104)
    -0.23 ( 0.13 )
    -0.23 ( 0.1 )
        Week 92 (N = 100, 104)
    -0.17 ( 0.1 )
    -0.23 ( 0.1 )
        Week 104 (N = 100, 104)
    -0.23 ( 0.13 )
    -0.23 ( 0.1 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6148
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.05
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2547
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.03
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1208
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.01
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8291
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.17

    Secondary: Changes from Baseline in Maastricht Ankylosing Spondylitis Enthesis Score (MASES) at time points

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    End point title
    		 Changes from Baseline in Maastricht Ankylosing Spondylitis Enthesis Score (MASES) at time points
    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).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    105
    108
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N = 104, 107)
    -0.94 ( 0.23 )
    -0.74 ( 0.22 )
        Week 4 (N = 104, 108)
    -1.11 ( 0.27 )
    -0.65 ( 0.25 )
        Week 8 (N = 104, 108)
    -1.39 ( 0.27 )
    -1.2 ( 0.25 )
        Week 12 (N = 104, 108)
    -1.4 ( 0.28 )
    -0.74 ( 0.26 )
        Week 16 (N = 99, 104)
    -1.64 ( 0.24 )
    -1.5 ( 0.26 )
        Week 24 (N = 99, 104)
    -1.78 ( 0.25 )
    -1.34 ( 0.27 )
        Week 32 (N = 99, 104)
    -1.59 ( 0.26 )
    -1.66 ( 0.28 )
        Week 40 (N = 99, 104)
    -1.86 ( 0.26 )
    -1.62 ( 0.27 )
        Week 48 (N = 99, 104)
    -1.79 ( 0.27 )
    -1.73 ( 0.28 )
        Week 56 (N = 99, 104)
    -2.01 ( 0.28 )
    -1.63 ( 0.3 )
        Week 68 (N = 99, 104)
    -1.92 ( 0.27 )
    -1.73 ( 0.29 )
        Week 80 (N = 99, 104)
    -1.99 ( 0.28 )
    -1.72 ( 0.32 )
        Week 92 (N = 99, 104)
    -2 ( 0.26 )
    -1.65 ( 0.3 )
        Week 104 (N = 99, 104)
    -1.87 ( 0.28 )
    -1.77 ( 0.29 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3536
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 0.23
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0769
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.97
         upper limit
    		 0.05
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4698
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.33
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0167
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.19
         upper limit
    		 -0.12

    Secondary: Change from Baseline in C-reactive protein (CRP) concentration time points

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    End point title
    		 Change from Baseline in C-reactive protein (CRP) concentration time points
    End point description
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    106
    108
    Units: mg/L
    arithmetic mean (standard error)
        Week 2 (N = 105, 107)
    -4.49 ( 0.71 )
    -1.46 ( 0.67 )
        Week 4 (N = 105, 108)
    -3.61 ( 1.16 )
    0.25 ( 1.1 )
        Week 8 (N = 105, 108)
    -4.07 ( 1.33 )
    -0.97 ( 1.27 )
        Week 12 (N = 105, 108)
    -2.78 ( 1.14 )
    0.65 ( 1.08 )
        Week 16 (N = 100, 104)
    -4.84 ( 1.07 )
    -3.82 ( 1.08 )
        Week 24 (N = 100, 104)
    -4.62 ( 1.1 )
    -4.56 ( 1.04 )
        Week 32 (N = 100, 104)
    -4.97 ( 1.01 )
    -3.88 ( 1.01 )
        Week 40 (N = 100, 104)
    -4.88 ( 1.1 )
    -4.26 ( 1.08 )
        Week 48 (N = 100, 104)
    -4.94 ( 1.08 )
    -4.64 ( 1.06 )
        Week 56 (N = 100, 104)
    -5.2 ( 1.04 )
    -4.59 ( 1.02 )
        Week 68 (N = 100, 104)
    -5.03 ( 1.01 )
    -3.93 ( 1.09 )
        Week 80 (N = 100, 104)
    -4.29 ( 1.17 )
    -4.12 ( 0.99 )
        Week 92 (N = 100, 104)
    -5.1 ( 1.06 )
    -4.44 ( 1.04 )
        Week 104 (N = 100, 104)
    -4.28 ( 1.16 )
    -3.65 ( 1.12 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Most within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.39
         upper limit
    		 -1.66
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0008
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.09
         upper limit
    		 -1.62
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0143
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.47
         upper limit
    		 -0.61
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0038
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.23
         upper limit
    		 -1.02

    Secondary: Change from Baseline in Erythrocyte sedimentation Rate (ESR) at time points

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    End point title
    		 Change from Baseline in Erythrocyte sedimentation Rate (ESR) at time points
    End point description
    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    101
    106
    Units: mm/hr
    arithmetic mean (standard error)
        Week 2 (N = 100, 104)
    -9.02 ( 1.61 )
    -1.3 ( 1.53 )
        Week 4 (N = 100, 106)
    -10 ( 1.57 )
    -3.98 ( 1.48 )
        Week 8 (N = 100, 106)
    -10.79 ( 1.84 )
    -4.81 ( 1.76 )
        Week 12 (N = 100, 106)
    -11.34 ( 1.8 )
    -2.68 ( 1.39 )
        Week 16 (N = 95, 102)
    -12.75 ( 2.03 )
    -9.77 ( 1.62 )
        Week 24 (N = 95, 102)
    -14.22 ( 1.96 )
    -8.82 ( 1.77 )
        Week 32 (N = 95, 102)
    -12.76 ( 2.04 )
    -10.13 ( 1.76 )
        Week 40 (N = 95, 102)
    -11.49 ( 2.22 )
    -10.48 ( 1.74 )
        Week 48 (N = 95, 102)
    -12.2 ( 2.05 )
    -9.91 ( 1.9 )
        Week 56 (N = 95, 102)
    -13.03 ( 2.18 )
    -8.91 ( 1.7 )
        Week 68 (N = 95, 102)
    -10.8 ( 2.17 )
    -9.48 ( 1.74 )
        Week 80 (N = 95, 102)
    -10.74 ( 2.14 )
    -8.15 ( 1.74 )
        Week 92 (N = 95, 102)
    -10.84 ( 2.28 )
    -8.79 ( 1.79 )
        Week 104 (N = 95, 102)
    -10.51 ( 2.15 )
    -5.73 ( 2.05 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.85
         upper limit
    		 -4.58
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.16
         upper limit
    		 -3.09
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0009
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.15
         upper limit
    		 -2.41
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.34
         upper limit
    		 -3.73

    Secondary: Change from Baseline in Euro Quality of Life (EQ)-5D VAS Score time points

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    End point title
    		 Change from Baseline in Euro Quality of Life (EQ)-5D VAS Score time points
    End point description
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    90
    96
    Units: mm
    arithmetic mean (standard error)
        Week 4 (N = 86, 93)
    4.76 ( 2.2 )
    4.77 ( 2.03 )
        Week 8 (N = 85, 93)
    6.66 ( 2.84 )
    3.05 ( 2.65 )
        Week 12 (N = 84, 92)
    9.33 ( 2.97 )
    3.26 ( 2.77 )
        Week 16 (N = 82, 91)
    12.72 ( 2.16 )
    11.56 ( 2.44 )
        Week 24 (N = 82, 90)
    13.21 ( 2.23 )
    16.61 ( 2.26 )
        Week 40 (N = 79, 86)
    16.62 ( 2.13 )
    14.67 ( 2.64 )
        Week 48 (N = 75, 86)
    16.29 ( 2.37 )
    18.72 ( 2.37 )
        Week 68 (N = 72, 82)
    17.26 ( 2.18 )
    17.9 ( 2.6 )
        Week 92 (N = 69, 77)
    16.32 ( 2.33 )
    21.08 ( 2.73 )
        Week 104 (N = 64, 75)
    19.81 ( 2.45 )
    23.69 ( 2.71 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    With the exception of change from Baseline in the placebo group at Week 12, within group comparisons to baseline for all other treatment groups and time points were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.037
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9965
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.39
         upper limit
    		 4.37
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.197
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.89
         upper limit
    		 9.1
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0394
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 11.84

    Secondary: Change from Baseline in EQ-5D Health State Profile Utility Score at time points

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    End point title
    		 Change from Baseline in EQ-5D Health State Profile Utility Score at time points
    End point description
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    90
    96
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 4 (N = 89, 96)
    0.14 ( 0.03 )
    0.09 ( 0.03 )
        Week 8 (N = 86, 94)
    0.13 ( 0.04 )
    0.08 ( 0.03 )
        Week 12 (N = 85, 93)
    0.19 ( 0.04 )
    0.08 ( 0.03 )
        Week 16 (N = 83, 90)
    0.19 ( 0.04 )
    0.17 ( 0.03 )
        Week 24 (N = 82, 90)
    0.21 ( 0.03 )
    0.2 ( 0.03 )
        Week 40 (N = 79, 86)
    0.24 ( 0.04 )
    0.18 ( 0.03 )
        Week 48 (N= 75, 86)
    0.23 ( 0.03 )
    0.22 ( 0.03 )
        Week 68 (N= 72, 83)
    0.24 ( 0.04 )
    0.22 ( 0.03 )
        Week 92 (N= 69, 78)
    0.24 ( 0.04 )
    0.22 ( 0.03 )
        Week 104 (N= 64, 75)
    0.29 ( 0.04 )
    0.25 ( 0.03 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.01 at Week 12 and <0.001 thereafter, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.01
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1341
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.21
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0447
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.14
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1345
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.13

    Secondary: Change from Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) at time points

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    End point title
    		 Change from Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) at time points
    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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100 = highest level of functioning).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    90
    96
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 4 (N = 89, 96)
    4.04 ( 0.79 )
    2.72 ( 0.74 )
        Week 12 (N = 85, 94)
    6.18 ( 0.97 )
    3.8 ( 0.91 )
        Week 24 (N = 83, 91)
    6.67 ( 0.93 )
    7.29 ( 0.78 )
        Week 48 (N = 77, 86)
    8.03 ( 0.96 )
    8.51 ( 0.85 )
        Week 68 (N = 72, 83)
    8.97 ( 0.98 )
    9.42 ( 0.94 )
        Week 92 (N = 69, 78)
    8.35 ( 1.15 )
    9.28 ( 0.93 )
        Week 104 (N = 65, 75)
    9.98 ( 1.03 )
    10.38 ( 1.01 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1035
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 2.9
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0134
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 4.26

    Secondary: Change from Baseline in SF-36 Mental Component Summary (MCS) at time points

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    End point title
    		 Change from Baseline in SF-36 Mental Component Summary (MCS) at time points
    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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    90
    96
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 4 (N = 89, 96)
    2.65 ( 1.02 )
    1.47 ( 0.94 )
        Week 12 (N = 85, 94)
    2.44 ( 1.29 )
    1.58 ( 1.2 )
        Week 24 (N = 83, 91)
    3.52 ( 1.3 )
    4.36 ( 0.99 )
        Week 48 (N = 77, 86)
    3.47 ( 1.18 )
    3.54 ( 1.07 )
        Week 68 (N = 72, 83)
    3.65 ( 1.23 )
    4.44 ( 1.05 )
        Week 92 (N = 69, 78)
    4.18 ( 1.48 )
    4.77 ( 1.19 )
        Week 104 (N= 65, 75)
    4.9 ( 1.34 )
    3.74 ( 1.06 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.05, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.252
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.84
         upper limit
    		 3.19
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4981
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.63
         upper limit
    		 3.34

    Secondary: Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Depression score at time points

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    End point title
    		 Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Depression score at time points
    End point description
    This outcome measure is describing the HADS subscale of depression. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    90
    96
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 4 (N = 89, 96)
    -0.63 ( 0.33 )
    -0.39 ( 0.31 )
        Week 12 (N = 85, 94)
    -0.45 ( 0.46 )
    -0.05 ( 0.43 )
        Week 24 (N = 83, 91)
    -1.22 ( 0.35 )
    -1.04 ( 0.31 )
        Week 48 (N = 77, 85)
    -1.42 ( 0.38 )
    -1.04 ( 0.36 )
        Week 68 (N = 72, 82)
    -1.61 ( 0.33 )
    -1.35 ( 0.36 )
        Week 92 (N = 69, 78)
    -1.29 ( 0.39 )
    -1.47 ( 0.38 )
        Week 104 (N = 65, 74)
    -1.91 ( 0.4 )
    -1.61 ( 0.35 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4621
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.41
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3842
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.28
         upper limit
    		 0.5

    Secondary: Change from Baseline in HADS Anxiety score at time points

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    End point title
    		 Change from Baseline in HADS Anxiety score at time points
    End point description
    This outcome measure is describing the HADS subscale of anxiety. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    90
    96
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 4 (N = 89, 96)
    -0.73 ( 0.35 )
    -0.89 ( 0.32 )
        Week 12 (N = 85, 94)
    -1.33 ( 0.45 )
    -0.81 ( 0.43 )
        Week 24 (N = 83, 91)
    -0.89 ( 0.4 )
    -1.66 ( 0.33 )
        Week 48 (N = 77, 85)
    -1.03 ( 0.38 )
    -1.4 ( 0.34 )
        Week 68 (N = 72, 82)
    -1.24 ( 0.39 )
    -1.76 ( 0.41 )
        Week 92 (N = 69, 78)
    -0.96 ( 0.46 )
    -2.24 ( 0.35 )
        Week 104 (N = 65, 74)
    -1.8 ( 0.4 )
    -1.74 ( 0.39 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6357
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 0.86
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2439
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.39
         upper limit
    		 0.36

    Secondary: Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) score at time points

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    End point title
    		 Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) score at time points
    End point description
    ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    90
    96
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 12 (N = 88, 94)
    -1.93 ( 0.54 )
    -1.42 ( 0.51 )
        Week 24 (N = 83, 91)
    -3.12 ( 0.47 )
    -3.16 ( 0.41 )
        Week 48 (N = 77, 86)
    -3.74 ( 0.49 )
    -3.67 ( 0.43 )
        Week 68 (N = 72, 83)
    -4.04 ( 0.48 )
    -4.1 ( 0.46 )
        Week 92 (N = 69, 77)
    -4 ( 0.52 )
    -4.1 ( 0.53 )
        Week 104 (N = 65, 73)
    -4.74 ( 0.54 )
    -3.99 ( 0.54 )
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3286
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.55
         upper limit
    		 0.52
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change from Baseline in Ankylosing Spondylitis Work Instability Index (AS-WIS) score at time points

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    End point title
    		 Change from Baseline in Ankylosing Spondylitis Work Instability Index (AS-WIS) score at time points
    End point description
    The AS-WIS is a 20 item questionnaire to assess work disability and risk of unemployment due to AS. Higher scores indicate greater work impairment and instability that results from a mismatch between an individual’s ability levels given their AS and their job. Each question is assigned a score of 1 for a response of “True” and 0 for a response of “Not True”. All item scores are summed to give a total score that can range from 0 to 20. If a subject has ≥ 5 missing responses (ie more than 20%), then a total score is not calculated. For subjects with ≥ 1 but ≤ 4 missing responses, the total score is calculated as follows: T=20x/(20-m) where: T is the total score, x is the total score for the items answered and n is the number of non-missing items.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    87
    91
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 12 (N = 81, 84)
    -2.36 ( 0.58 )
    -1.58 ( 0.55 )
        Week 24 (N = 74, 75)
    -3.16 ( 0.58 )
    -2.71 ( 0.6 )
        Week 48 (N = 66, 75)
    -3.61 ( 0.63 )
    -4.01 ( 0.59 )
        Week 68 (N = 60, 66)
    -4.5 ( 0.64 )
    -5.08 ( 0.71 )
        Week 92 (N = 57, 60)
    -4.35 ( 0.76 )
    -5.27 ( 0.71 )
        Week 104 (N = 55, 62)
    -4.78 ( 0.68 )
    -5.23 ( 0.74 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1829
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.93
         upper limit
    		 0.37

    Secondary: Change from Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed due to Health Problems at time points

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    End point title
    		 Change from Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed due to Health Problems at time points
    End point description
    The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    62
    62
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N = 56, 59)
    2.83 ( 3.64 )
    0.46 ( 3.58 )
        Week 4 (N = 57, 59)
    1.74 ( 3.35 )
    0.12 ( 3.25 )
        Week 8 (N = 53, 53)
    4.19 ( 4.13 )
    0.67 ( 4.15 )
        Week 12 (N = 53, 55)
    -0.19 ( 4.36 )
    -4.93 ( 4.25 )
        Week 16 (N = 53, 52)
    -1.35 ( 3.34 )
    -2.03 ( 4.92 )
        Week 24 (N = 47, 47)
    -0.71 ( 3.4 )
    -7.39 ( 4.61 )
        Week 32 (N = 48, 46)
    -4.06 ( 3.02 )
    -9.76 ( 4.12 )
        Week 40 (N= 50, 50)
    -2.16 ( 4.15 )
    -9.23 ( 3.73 )
        Week 48 (N= 48, 47)
    -5.04 ( 2.33 )
    -6.12 ( 3.6 )
        Week 56 (N= 44, 49)
    -3.99 ( 2.77 )
    -9.11 ( 3.79 )
        Week 68 (N= 44, 44)
    -2.41 ( 3.19 )
    -7.51 ( 3.69 )
        Week 80 (N= 43, 44)
    2.92 ( 2.45 )
    -9.96 ( 4.21 )
        Week 92 (N= 45, 44)
    -1.81 ( 3.31 )
    -8.42 ( 4.29 )
        Week 104 (N= 42, 43)
    -6.35 ( 3.45 )
    -10.44 ( 4.74 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.05, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5226
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.95
         upper limit
    		 9.68
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6232
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 8.14
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3877
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.53
         upper limit
    		 11.57
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2402
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.22
         upper limit
    		 12.69

    Secondary: Change from Baseline in WPAI: Percent Impairment While Working Due to Health Problems at time points

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    End point title
    		 Change from Baseline in WPAI: Percent Impairment While Working Due to Health Problems at time points
    End point description
    The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    59
    58
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N = 53, 56)
    -11.47 ( 3.71 )
    -2.28 ( 3.67 )
        Week 4 (N = 52, 55)
    -8.88 ( 3.66 )
    -3.81 ( 3.54 )
        Week 8 (N = 47, 50)
    -12.74 ( 3.94 )
    -6.48 ( 3.9 )
        Week 12 (N = 48, 50)
    -21.22 ( 4.74 )
    -12.09 ( 4.7 )
        Week 16 (N = 49, 46)
    -16.53 ( 3.69 )
    -16.09 ( 2.97 )
        Week 24 (N = 46, 43)
    -16.52 ( 4.66 )
    -18.84 ( 3.35 )
        Week 32 (N = 46, 43)
    -18.04 ( 3.76 )
    -15.81 ( 3.45 )
        Week 40 (N = 45, 47)
    -22.89 ( 4.04 )
    -19.36 ( 2.92 )
        Week 48 (N = 45, 47)
    -22.22 ( 3.55 )
    -16.6 ( 3.64 )
        Week 56 (N = 42, 46)
    -23.81 ( 3.9 )
    -20.43 ( 3.33 )
        Week 68 (N = 43, 43)
    -22.33 ( 3.96 )
    -22.09 ( 3.39 )
        Week 80 (N = 42, 41)
    -24.29 ( 4.06 )
    -21.95 ( 3.6 )
        Week 92 (N = 42, 41)
    -23.57 ( 3.47 )
    -19.27 ( 3.07 )
        Week 104 (N = 40, 40)
    -25.5 ( 3.69 )
    -22.5 ( 3.54 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.001 at Week 16 and thereafter, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0193
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.85
         upper limit
    		 -1.52
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.173
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.41
         upper limit
    		 2.26
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1224
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.23
         upper limit
    		 1.71
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0461
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.11
         upper limit
    		 -0.16

    Secondary: Changes from Baseline in WPAI - Activity Impairment Due to Health Problems at time points

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    End point title
    		 Changes from Baseline in WPAI - Activity Impairment Due to Health Problems at time points
    End point description
    The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    90
    95
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N = 89, 94)
    -10.7 ( 2.8 )
    -4.73 ( 2.61 )
        Week 4 (N = 89, 95)
    -11.52 ( 2.45 )
    -8.42 ( 2.28 )
        Week 8 (N = 86, 93)
    -18.35 ( 3.15 )
    -11.68 ( 2.96 )
        Week 12 (N = 85, 92)
    -18.92 ( 3.35 )
    -12.07 ( 3.14 )
        Week 16 (N = 82, 90)
    -19.88 ( 2.77 )
    -22.33 ( 2.69 )
        Week 24 (N = 82, 89)
    -20.61 ( 3.14 )
    -23.15 ( 2.31 )
        Week 32 (N = 78, 86)
    -20.26 ( 2.96 )
    -22.09 ( 2.58 )
        Week 40 (N = 77, 85)
    -27.14 ( 2.85 )
    -24 ( 2.36 )
        Week 48 (N = 74, 85)
    -24.46 ( 2.93 )
    -22.12 ( 2.85 )
        Week 56 (N = 74, 84)
    -25 ( 2.8 )
    -25.71 ( 2.44 )
        Week 68 (N = 72, 82)
    -26.53 ( 2.95 )
    -25.73 ( 2.73 )
        Week 80 (N = 69, 77)
    -27.39 ( 3.17 )
    -27.66 ( 2.97 )
        Week 92 (N = 69, 77)
    -26.96 ( 3.32 )
    -25.97 ( 2.81 )
        Week 104 (N = 65, 73)
    -30.77 ( 3.01 )
    -28.36 ( 2.87 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0372
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.58
         upper limit
    		 -0.36
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2126
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.98
         upper limit
    		 1.79
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.033
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.79
         upper limit
    		 -0.54
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0397
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.38
         upper limit
    		 -0.33

    Secondary: Changes from Baseline in WPAI - Overall Work Impairment Due to Health Problems at time points

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    End point title
    		 Changes from Baseline in WPAI - Overall Work Impairment Due to Health Problems at time points
    End point description
    The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    58
    58
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 2 (N = 51, 56)
    -7.43 ( 3.81 )
    0.86 ( 3.74 )
        Week 4 (N = 52, 55)
    -7.07 ( 3.72 )
    -1.82 ( 3.59 )
        Week 8 (N = 47, 49)
    -10.32 ( 4.04 )
    -4.35 ( 4.09 )
        Week 12 (N = 48, 50)
    -20.77 ( 4.94 )
    -12.09 ( 4.89 )
        Week 16 (N = 49, 46)
    -16.3 ( 3.83 )
    -16.39 ( 2.86 )
        Week 24 (N = 45, 43)
    -14.85 ( 4.52 )
    -18.59 ( 3.68 )
        Week 32 (N = 46, 43)
    -17.59 ( 3.79 )
    -16.53 ( 3.33 )
        Week 40 (N = 45, 47)
    -23.74 ( 4.15 )
    -20.52 ( 3.03 )
        Week 48 (N = 45, 45)
    -23.03 ( 3.61 )
    -17.54 ( 3.87 )
        Week 56 (N = 42, 46)
    -23.6 ( 4.1 )
    -21.39 ( 3.43 )
        Week 68 (N = 43, 42)
    -21.9 ( 4.26 )
    -22.27 ( 3.46 )
        Week 80 (N = 42, 41)
    -20.66 ( 4.15 )
    -23.1 ( 3.8 )
        Week 92 (N = 42, 41)
    -24 ( 3.52 )
    -19.39 ( 3.24 )
        Week 104 (N = 40, 40)
    -25.76 ( 3.73 )
    -23.01 ( 3.8 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Within group comparisons to baseline were <0.001 at Week 16 and at Week 32 and thereafter, from paired t test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 2
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0382
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.12
         upper limit
    		 -0.46
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1648
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.69
         upper limit
    		 2.19
    Statistical analysis title
    		 Statistical analysis at Week 8
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1476
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.11
         upper limit
    		 2.15
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0687
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.03
         upper limit
    		 0.68

    Secondary: Change from Baseline in Multidimensional Fatigue Inventory (MFI) score at time points

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    End point title
    		 Change from Baseline in Multidimensional Fatigue Inventory (MFI) score at time points
    End point description
    The MFI is a 20-item questionnaire that evaluates several aspects of fatigue. The General Fatigue Item is disclosed here. The general fatigue item contains four items, two of which are indicative for fatigue and two items contra-indicative for fatigue. Indicative items (eg, "I tire easily") are formulated in such a way that a high score suggests a high degree of fatigue. In case of contra-indicative items (eg, "I feel fit") a high score indicates a low degree of fatigue. Each item is scored on a 5-point numeric rating scale anchored at each end by “Yes, that is true” (scored 1) to “No, that is not true” (scored 5). Scoring for the MFI is done in such a way that higher scores indicate greater fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). For each scale a total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20. MFI-20 scale is copyrighted.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    90
    95
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 4 (N = 89, 95)
    -1.08 ( 0.38 )
    -0.64 ( 0.36 )
        Week 12 (N = 85, 93)
    -1.34 ( 0.42 )
    -1.08 ( 0.39 )
        Week 24 (N = 83, 89)
    -1.67 ( 0.37 )
    -2.69 ( 0.4 )
        Week 48 (N = 77, 85)
    -2.01 ( 0.39 )
    -2.84 ( 0.39 )
        Week 68 (N = 72, 82)
    -1.79 ( 0.42 )
    -3.01 ( 0.45 )
        Week 92 (N = 69, 77)
    -2.74 ( 0.4 )
    -3.18 ( 0.52 )
        Week 104 (N = 65, 73)
    -3.26 ( 0.46 )
    -3.04 ( 0.5 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2578
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.21
         upper limit
    		 0.33
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4334
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.21
         upper limit
    		 0.52

    Secondary: Change from Baseline in Medical Outcomes Study (MOS) Sleep Scale score from Baseline to Week 104

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    End point title
    		 Change from Baseline in Medical Outcomes Study (MOS) Sleep Scale score from Baseline to Week 104
    End point description
    The MOS sleep scale consists of 12 items to measure 6 sleep dimensions: initiation (time to fall asleep), quantity (hours of sleep each night), maintenance, respiratory problems, perceived adequacy, somnolence (the last 4 items reported using a 6-item Likert scale ranging from 1 [all of the time] to 6 [none of the time]). The raw scores ranging from 1 to 6 are transformed to scores ranging from 0 to 100 before the indices are calculated. Therefore the reported scores, consisting of means of converted items, also range from 0 to 100. However, two indexes can be derived: Sleep problems index I (short form) and sleep problems index II (long form). Additional subscales can be derived: sleep disturbance, snoring, awaken shortness of breath or headache, sleep adequacy, sleep somnolence, sleep quantity, and optimal sleep. However, data for two indexes and additional subscales is not reported.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    90
    95
    Units: Units on a scale
    arithmetic mean (standard error)
        Week 4 (N = 89, 94)
    -2.35 ( 1.59 )
    -0.85 ( 1.5 )
        Week 12 (N = 85, 93)
    -6.01 ( 2 )
    -4.1 ( 1.88 )
        Week 24 (N = 83, 89)
    -11.01 ( 2.64 )
    -14.34 ( 2.28 )
        Week 32 (N = 78, 86)
    -13.17 ( 2.3 )
    -17.06 ( 2.42 )
        Week 48 (N = 76, 85)
    -11.97 ( 2.6 )
    -17.57 ( 2.23 )
        Week 68 (N = 71, 82)
    -10.4 ( 2.56 )
    -15.5 ( 2.49 )
        Week 104 (N = 66, 76)
    -17.92 ( 2.78 )
    -15.61 ( 2.66 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    All within group comparisons to baseline were <0.001, from paired t-test.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Statistical analysis at Week 4
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3554
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 1.7
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.335
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.82
         upper limit
    		 1.99

    Secondary: Percentage of participants with Minimally Clinically Important Improvement (MCII) at time points

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    End point title
    		 Percentage of participants with Minimally Clinically Important Improvement (MCII) at time points
    End point description
    The MCII asks participants to rate the level of improvement they have experienced in the 48 hours compared to when they started the study. Response options are “Improved - less pain”, “No change”, and “Worse – more pain.” If the participant indicates that improvement has occurred, then they are asked to indicate how important that improvement is to them from “Not at all important” to “Very important’.
    End point type
    Secondary
    End point timeframe
    Weeks 12 and 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    88
    94
    Units: Percentage of participants
    number (not applicable)
        Week 12 (N = 88, 94)
    59.09
    44.68
        Week 104 (N = 75, 79)
    76
    81.01
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 14.41
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 28.78

    Secondary: Percentage of participants Achieving Patient Acceptable Symptom State (PASS) at time points

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    End point title
    		 Percentage of participants Achieving Patient Acceptable Symptom State (PASS) at time points
    End point description
    PASS is defined as a symptom state that the participants consider acceptable.
    End point type
    Secondary
    End point timeframe
    Weeks 12 and 104
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    88
    94
    Units: Percentage of participants
    number (not applicable)
        Week 12 (N = 88, 94)
    72.73
    61.7
        Week 104 (N = 74, 80)
    79.73
    88.75
    Statistical analysis title
    		 Statistical analysis at Week 12
    Statistical analysis description
    Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1285
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    11.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.51
         upper limit
    		 24.56

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the signing of the informed consent until Week 104 visit.
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).

    Reporting group title
    Etanercept
    Reporting group description
    		 Participants were treated with etanercept subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).

    Serious adverse events
    		 Placebo Etanercept
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 113 (7.08%)
    9 / 111 (8.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocarditis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Multiple sclerosis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Hearing impaired
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoids
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 113 (0.00%)
    3 / 111 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 111 (1.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Etanercept
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    87 / 113 (76.99%)
    86 / 111 (77.48%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 113 (7.08%)
    9 / 111 (8.11%)
         occurrences all number
    21
    9
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    6 / 113 (5.31%)
    8 / 111 (7.21%)
         occurrences all number
    14
    18
    Injection site reaction
         subjects affected / exposed
    6 / 113 (5.31%)
    7 / 111 (6.31%)
         occurrences all number
    9
    7
    Eye disorders
    Uveitis
         subjects affected / exposed
    8 / 113 (7.08%)
    13 / 111 (11.71%)
         occurrences all number
    13
    18
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 113 (7.96%)
    11 / 111 (9.91%)
         occurrences all number
    9
    11
    Nausea
         subjects affected / exposed
    7 / 113 (6.19%)
    2 / 111 (1.80%)
         occurrences all number
    8
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 113 (2.65%)
    9 / 111 (8.11%)
         occurrences all number
    3
    10
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    7 / 113 (6.19%)
    2 / 111 (1.80%)
         occurrences all number
    8
    3
    Myalgia
         subjects affected / exposed
    3 / 113 (2.65%)
    6 / 111 (5.41%)
         occurrences all number
    3
    7
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    7 / 113 (6.19%)
    7 / 111 (6.31%)
         occurrences all number
    7
    8
    Gastroenteritis
         subjects affected / exposed
    7 / 113 (6.19%)
    8 / 111 (7.21%)
         occurrences all number
    8
    11
    Influenza
         subjects affected / exposed
    7 / 113 (6.19%)
    7 / 111 (6.31%)
         occurrences all number
    11
    10
    Nasopharyngitis
         subjects affected / exposed
    23 / 113 (20.35%)
    26 / 111 (23.42%)
         occurrences all number
    38
    51
    Pharyngitis
         subjects affected / exposed
    8 / 113 (7.08%)
    5 / 111 (4.50%)
         occurrences all number
    12
    7
    Sinusitis
         subjects affected / exposed
    4 / 113 (3.54%)
    6 / 111 (5.41%)
         occurrences all number
    6
    9
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 113 (12.39%)
    10 / 111 (9.01%)
         occurrences all number
    20
    17

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Oct 2010
    Throughout the protocol, this amendment allowed for the use of historical x-rays in order to comply with local law (as directed by the German Federation of Radiation Control) to limit the use of radiation exposure among the German population. X-rays obtained within 12 months of screening and found to acceptable as determined by central radiologist were permitted.
    05 Apr 2011
    In this amendment, under section schedule of activities, added assessment for IBD, psoriasis, uveitis; Clarified timing/order of imaging procedures; added fasting glucose at Baseline, Visits(V) 6, 11, and 16; Clarified visit windows ±4 days for V3-7, ±7 days for V8-17; Clarified collection period for AEs/SAEs and Clarified eligibility regarding Baseline lab values. In the introduction, changed single reference safety document from Core Data Sheet to Investigator Brochure. Under section, objectives/endpoints: Clarified secondary objective is inflammation of MRI of the spine at 12 weeks; Changed primary endpoint from proportion of subjects at 12 weeks who meet ASAS 20 to ASAS 40. Adjusted secondary endpoints to measure ASAS 40 at additional time points, deleted proportion of subjects who achieve ASAS 50 and ASAS 70; Clarified secondary endpoint to measure dactylitis, along with enthesitis; Clarified time points for measurement of exploratory endpoints. Under section for eligibility Criteria: Clarified definition of axial spondyloarthritis diagnosis; Clarified BASDAI 4 required at screening visit; Increased upper age of eligible subjects to less than 50 to coincide with ASAS criteria; Clarified use of tumor necrosis factor alpha inhibitors (added immunosuppressants), for IBD and conditions other than IBD; Clarified timeframes regarding IBD and uveitis episodes; Allowed for the use of historical x-rays (obtained within 4 months of screening) with sacroiliitis grade 0 1 unilaterally or grade 0 bilaterally; Clarified eligibility regarding TB; Clarified timing of active infections; Clarified definition of participation in other studies; Added that when required by Health Authorities, local HIV testing must be performed to determine eligibility. Other changes were made to sections such as study treatments, procedures and adverse event reporting and appendices.
    09 May 2011
    In this amendment, the final visit (V17) must be an in person visit instead of a telephone call follow up and clarified withdrawal criteria regarding investigator decision.
    25 Jun 2012
    In this amendment, global amendment for new protocol template which now included Germany specific requirements and the summary of changes were updated list of abbreviations; clarified eligibility criteria, clarified definition of “legal representative”, Added wording to state that medication errors are reportable events and must be documented accordingly in the CRF, Added examples of medication errors, Added language around lack of compliance with protocol, Clarified adverse event information around ongoing safety reviews conducted by the Sponsor, any non-serious adverse event that is determined by the Sponsor to be serious will be reported by the Sponsor as an SAE. Extended investigator reporting SAE requirements to report SAEs if they become aware of them any time after the active reporting period, Added drug abuse and drug dependency to examples of AEs, Added medication error to signs and symptoms of an adverse event, Expanded the bullet in Serious Adverse Event section regarding “results in persistent or significant disability”, Clarified the criteria for laboratory abnormalities that require further evaluation in the context of potential cases of drug induced liver injury; Clarified that generally the facts (evidence) or arguments to suggest a causal relationship should be provided by the investigator. Changes to exposure during pregnancy were made to improve clarity. Editorial changes were made to this section were made to data handling and record keeping section, Clarified informed consent process language (changed legally acceptable representative to legal representative) and clarified the communication of results.

    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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