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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects with Active Axial Spondyloarthritis (Protocol No. P07642, also known as MK-8259-006-02).

    Summary
    EudraCT number
    		 2011-000311-34
    Trial protocol
    		 DE   ES   FI   IT   GR  
    Global end of trial date
    15 Jan 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    P07642
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01453725
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol Number: MK-8259-006
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    15 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (SpA). In Part 1, participants were to receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the identity of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2, the participants were to be told they were receiving active study drug. The primary hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks was superior to placebo as measured by the proportion of participants achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Feb 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 33
    Country: Number of subjects enrolled
    Denmark: 15
    Country: Number of subjects enrolled
    Finland: 5
    Country: Number of subjects enrolled
    Germany: 29
    Country: Number of subjects enrolled
    Greece: 2
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Russian Federation: 45
    Country: Number of subjects enrolled
    Slovakia: 7
    Country: Number of subjects enrolled
    Spain: 17
    Country: Number of subjects enrolled
    Turkey: 18
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    198
    EEA total number of subjects
    125
    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)
    198
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Male and female participants who were 18 to 45 years of age and had active axial SpA with a disease duration of ≤5 years and back pain for ≥3 month duration were recruited fro this study.

    Pre-assignment
    Screening details
    		 These data are for Parts 1 and 2 of the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Golimumab→Golimumab
    Arm description
    		 In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    MK-8259, SCH 900259
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Golimumab 50 mg, subcutaneously (SC) every 4 weeks

    Arm title
    		 Placebo→Golimumab
    Arm description
    		 In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    MK-8259, SCH 900259
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Golimumab 50 mg, SC every 4 weeks

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo, SC every 4 weeks

    Number of subjects in period 1
    		Golimumab→Golimumab Placebo→Golimumab
    Started
    98
    100
    Completed
    85
    89
    Not completed
    13
    11
         Non-compliance With Protocol
    1
    2
         Pregnancy Wish
    -
    2
         Consent withdrawn by subject
    2
    3
         Physician decision
    1
    1
         Adverse event, non-fatal
    3
    3
         Pregnancy
    1
    -
         Lost to follow-up
    4
    -
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Golimumab→Golimumab
    Reporting group description
    		 In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)

    Reporting group title
    Placebo→Golimumab
    Reporting group description
    		 In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)

    Reporting group values
    		 Golimumab→Golimumab Placebo→Golimumab Total
    Number of subjects
    		 98 100 198
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 98 100 198
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 30.7 ± 7.1 31.7 ± 7.2 -
    Gender, Male/Female
    Units: Participants
        Female
    		 37 48 85
        Male
    		 61 52 113

    End points

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    End points reporting groups
    Reporting group title
    Golimumab→Golimumab
    Reporting group description
    		 In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)

    Reporting group title
    Placebo→Golimumab
    Reporting group description
    		 In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)

    Subject analysis set title
    Golimumab→Golimumab
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)

    Subject analysis set title
    Golimumab→Golimumab
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)

    Subject analysis set title
    Golimumab→Golimumab
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)

    Subject analysis set title
    Placebo→Golimumab
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)

    Primary: Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16

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    End point title
    		 Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16
    End point description
    The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=20% from Baseline and an absolute improvement from Baseline of >=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=20% worsening and an absolute worsening of >=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Golimumab→Golimumab Placebo→Golimumab
    Number of subjects analysed
    97
    100
    Units: Percentage of Participants
        number (not applicable)
    71.1
    40
    Statistical analysis title
    		 Difference in Percentages: Golimumab vs. Placebo
    Comparison groups
    Golimumab→Golimumab v Placebo→Golimumab
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Stratified Miettinen and Nurminen Method
    Parameter type
    		 Difference in Percent vs Placebo
    Point estimate
    31.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.5
         upper limit
    		 43.6
    Notes
    [1] - Stratification factors: Baseline evidence of sacroiliitis on magnetic resonance imaging (MRI) and Screening C-reactive protein (CRP) level

    Primary: Percentage of Participants Who Experienced at Least One Adverse Event (AE)

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    End point title
    		 Percentage of Participants Who Experienced at Least One Adverse Event (AE) [2] [3]
    End point description
    An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.
    End point type
    Primary
    End point timeframe
    Up to 16 weeks for Part 1; From Week 16 up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this end point.
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: One participant in the GolimumabGolimumab reporting group did not receive study drug, so a safety subject analysis set was created to reflect this. The PlaceboGolimumab reporting group and the GolimumabGolimumab safety subject analysis set were used to report the data for this end point.
    End point values
    		 Placebo→Golimumab Golimumab→Golimumab
    Number of subjects analysed
    100
    97
    Units: Percentage of Participants
    number (not applicable)
        Part 1 (Up to 16 weeks) (n=100, 97)
    47
    41.2
        Part 2 (Up to 60 weeks) (n=96, 93)
    54.2
    41.9
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Discontinued Study Drug Due to an AE

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    End point title
    		 Percentage of Participants Who Discontinued Study Drug Due to an AE [4] [5]
    End point description
    An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated. Participants may have discontinued study drug without discontinuing from the study. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study.
    End point type
    Primary
    End point timeframe
    Up to 16 weeks for Part 1; From Week 16 up to 48 weeks for Part 2
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this end point.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: One participant in the GolimumabGolimumab reporting group did not receive study drug, so a safety subject analysis set was created to reflect this. The PlaceboGolimumab reporting group and the GolimumabGolimumab safety subject analysis set were used to report the data for this end point.
    End point values
    		 Placebo→Golimumab Golimumab→Golimumab
    Number of subjects analysed
    100
    97
    Units: Percentage of Participants
    number (not applicable)
        Part 1 (Up to 16 weeks) (n= 100, 97)
    1
    2.1
        Part 2 (Up to 52 weeks) (n=96, 93)
    2.1
    1.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16

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    End point title
    		 Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16
    End point description
    The ASAS consists of 4 domains: participant global assessment, total back pain, function (BASFI), and inflammation (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 100-mm VAS from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=40% from Baseline and an absolute improvement from Baseline of >=20 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=0% worsening and an absolute worsening of >=0 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 40 were calculated.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Golimumab→Golimumab Placebo→Golimumab
    Number of subjects analysed
    97
    100
    Units: Percentage of Participants
        number (not applicable)
    56.7
    23
    Statistical analysis title
    		 Difference in Percentages: Golimumab vs. Placebo
    Comparison groups
    Golimumab→Golimumab v Placebo→Golimumab
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [6]
    Method
    		 Stratified Miettinen and Nurminen Method
    Parameter type
    		 Difference in Percent vs Placebo
    Point estimate
    33.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.4
         upper limit
    		 46.1
    Notes
    [6] - Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level

    Secondary: Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16

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    End point title
    		 Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16
    End point description
    The BASDAI is a summary of 6 participant-assessed 100-mm VAS for a) Fatigue, b) Spinal pain (overall), c) Peripheral arthritis, d) Enthesitis, e) Qualitative morning stiffness (intensity) and f) Quantitative morning stiffness (duration). Each VAS is measured as 0=none to 100=very severe, with a higher score indicating more severe symptoms. The BASDAI score is calculated as 0.2 time (a+b+c+d+[0.5 times e+f]) and can range from 0 to 100. The BASDAI 50 is defined as improvement by at least 50% from Baseline in the BASDAI score. The percentages of participants who achieved BASDAI 50 were calculated.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Golimumab→Golimumab Placebo→Golimumab
    Number of subjects analysed
    97
    100
    Units: Percentage of Participants
        number (not applicable)
    57.7
    30
    Statistical analysis title
    		 Difference in Percentages: Golimumab vs. Placebo
    Comparison groups
    Golimumab→Golimumab v Placebo→Golimumab
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [7]
    Method
    		 Stratified Miettinen and Nurminen Method
    Parameter type
    		 Difference in Percent vs Placebo
    Point estimate
    28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.4
         upper limit
    		 40.6
    Notes
    [7] - Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level

    Secondary: Percentage of Participants Achieving ASAS Partial Remission at Week 16

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    End point title
    		 Percentage of Participants Achieving ASAS Partial Remission at Week 16
    End point description
    ASAS partial remission was defined as a VAS score of less than 20 mm in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Golimumab→Golimumab Placebo→Golimumab
    Number of subjects analysed
    97
    100
    Units: Percentage of Participants
        number (not applicable)
    33
    18
    Statistical analysis title
    		 Difference in Percentages: Golimumab vs. Placebo
    Comparison groups
    Golimumab→Golimumab v Placebo→Golimumab
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0136 [8]
    Method
    		 Stratified Miettinen and Nurminen Method
    Parameter type
    		 Difference in Percent vs Placebo
    Point estimate
    15.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.2
         upper limit
    		 27.1
    Notes
    [8] - Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level

    Secondary: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16

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    End point title
    		 Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16
    End point description
    Participants underwent MRI of the SI joints, without contrast, at Screening and Week 16 to assess the presence or absence of active inflammation of the SI joints. Scoring was based on 6 consecutive MRI slices through the SI joint. Each slice was divided into 4 quadrants. Each of the 48 quadrants was scored with respect to the presence of inflammation (0=no, 1=yes), yielding a maximum score of 48. Each slice was also assessed for the presence of a lesion exhibiting either intense signal or a depth >=1 cm anywhere within the SI joint of the 6 slices (0=no, 1=yes), yielding a maximum score of 24. Total SI joint scores could range from 0 to 72, with a higher score indicating more signs of disease.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Golimumab→Golimumab Placebo→Golimumab
    Number of subjects analysed
    74
    87
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Baseline Score
    9.87 ± 11.822
    12.66 ± 15.619
        Change from Baseline at Week 16
    -5.25 ± 7.708
    -0.95 ± 8.533
    Statistical analysis title
    		 Difference in Changes: Golimumab vs. Placebo
    Comparison groups
    Golimumab→Golimumab v Placebo→Golimumab
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mann-Whitney Test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 16 weeks for Part 1; From Week 16 up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
    Adverse event reporting additional description
    The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Part 1: Golimumab→Golimumab
    Reporting group description
    		 In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)

    Reporting group title
    Part 2: Golimumab→Golimumab
    Reporting group description
    		 In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)

    Reporting group title
    Part 2: Placebo→Golimumab
    Reporting group description
    		 In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)

    Reporting group title
    Part 1: Placebo→Golimumab
    Reporting group description
    		 In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)

    Serious adverse events
    		 Part 1: Golimumab→Golimumab Part 2: Golimumab→Golimumab Part 2: Placebo→Golimumab Part 1: Placebo→Golimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 97 (1.03%)
    2 / 93 (2.15%)
    3 / 96 (3.13%)
    2 / 100 (2.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Foetal death
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 93 (0.00%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 93 (0.00%)
    1 / 96 (1.04%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenitis
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 93 (1.08%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine polyp
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 93 (0.00%)
    1 / 96 (1.04%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 93 (0.00%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 93 (0.00%)
    0 / 96 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial infection
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 93 (1.08%)
    0 / 96 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 93 (0.00%)
    1 / 96 (1.04%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part 1: Golimumab→Golimumab Part 2: Golimumab→Golimumab Part 2: Placebo→Golimumab Part 1: Placebo→Golimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 97 (17.53%)
    13 / 93 (13.98%)
    27 / 96 (28.13%)
    21 / 100 (21.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 97 (7.22%)
    6 / 93 (6.45%)
    8 / 96 (8.33%)
    6 / 100 (6.00%)
         occurrences all number
    8
    11
    26
    11
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 97 (0.00%)
    0 / 93 (0.00%)
    0 / 96 (0.00%)
    6 / 100 (6.00%)
         occurrences all number
    0
    0
    0
    8
    Diarrhoea
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 93 (1.08%)
    5 / 96 (5.21%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    5
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    5 / 97 (5.15%)
    0 / 93 (0.00%)
    0 / 96 (0.00%)
    4 / 100 (4.00%)
         occurrences all number
    5
    0
    0
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 97 (9.28%)
    5 / 93 (5.38%)
    10 / 96 (10.42%)
    9 / 100 (9.00%)
         occurrences all number
    11
    5
    12
    11
    Influenza
         subjects affected / exposed
    0 / 97 (0.00%)
    2 / 93 (2.15%)
    7 / 96 (7.29%)
    0 / 100 (0.00%)
         occurrences all number
    0
    3
    7
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 97 (0.00%)
    4 / 93 (4.30%)
    6 / 96 (6.25%)
    0 / 100 (0.00%)
         occurrences all number
    0
    5
    9
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2011
    Amendment 01: Expedited Reporting of Safety Observations process was updated to indicate that events should be reported via the electronic data capture (EDC) system.
    19 Feb 2013
    Amendment 02: Recent data in people with axial SpA treated with an anti-tumor necrosis factor (anti-TNF) agent indicated that a person’s baseline CRP level and radiologic sacroiliitis (as assessed by MRI SPARCC score) were factors that affect the treatment response. To ensure that the study assessed SpA participants with active inflammation, a modification in participant enrollment based on these two already identified inclusion parameters was made. The study now required that >40% of the subjects enrolled have CRP > upper limit of normal; participants with a normal CRP level were limited to 60% of the total enrolled population. Also information regarding malignancy and pre-malignancy follow-up was added to the protocol.

    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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