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    Clinical Trial Results:
    A Phase-IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of Golimumab (MK-8259 [SCH900259]) After Treatment Withdrawal, Compared With Continued Treatment (Either Full- or Reduced-Treatment Regimen), In Subjects With Non-Radiographic Axial Spondyloarthritis

    Summary
    EudraCT number
    		 2015-004020-65
    Trial protocol
    		 DE   CZ   ES   NL   PL   RO  
    Global end of trial date
    17 Mar 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    12 Jun 2022
    First version publication date
    30 Mar 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    8259-038
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03253796
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 GO-BACK: Merck study name
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 E. Lincoln Avenue, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, 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
    17 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the effect of treatment withdrawal vs continued treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. The primary hypothesis is that continued treatment with golimumab is superior to treatment withdrawal, based on the percentage of participants without a "flare" during up to 12 months of blinded therapy.
    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
    07 Nov 2017
    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
    Czechia: 80
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 75
    Country: Number of subjects enrolled
    Romania: 24
    Country: Number of subjects enrolled
    Russian Federation: 30
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Ukraine: 67
    Country: Number of subjects enrolled
    Turkey: 20
    Worldwide total number of subjects
    323
    EEA total number of subjects
    206
    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)
    323
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adult subjects with active non-radiographic axial spondyloarthritis (nr-AxSpA), who had objective signs of inflammation and intolerance or inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs), were enrolled in this trial.

    Period 1
    Period 1 title
    Period 1: Run-In
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Open-Label Run-In Golimumab QM
    Arm description
    		 Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.
    Arm type
    		 Experimental

    Investigational medicinal product name
    golimumab
    Investigational medicinal product code
    Other name
    MK-8259 Simponi®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.

    Number of subjects in period 1
    		Open-Label Run-In Golimumab QM
    Started
    323
    Completed
    207
    Not completed
    116
         Consent withdrawn by subject
    8
         Adverse event, non-fatal
    4
         Lack of Qualifying Event
    98
         Lack of efficacy
    1
         Protocol deviation
    5
    Period 2
    Period 2 title
    Period 2: Withdrawal vs Continued Tx
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Golimumab QM (Full Treatment Regimen)
    Arm description
    		 Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    golimumab
    Investigational medicinal product code
    Other name
    MK-8259 Simponi®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Arm title
    		 Golimumab Q2M (Reduced Treatment Regimen)
    Arm description
    		 Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    golimumab
    Investigational medicinal product code
    Other name
    MK-8259 Simponi®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Double-blinded SC injections of 50 mg golimumab every other month (Q2M) for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Double-blinded SC injections of placebo to golimumab every other month (Q2M) for up to 12 months.

    Arm title
    		 Placebo (Treatment Withdrawal Regimen)
    Arm description
    		 Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Double-blinded SC injections of placebo to golimumab once a month (QM) for up to 12 months.

    Number of subjects in period 2 [1]
    		Golimumab QM (Full Treatment Regimen) Golimumab Q2M (Reduced Treatment Regimen) Placebo (Treatment Withdrawal Regimen)
    Started
    63
    64
    62
    Completed
    53
    43
    21
    Not completed
    10
    21
    41
         Disease Flare, moved to Open-label retreatment
    10
    15
    38
         Consent withdrawn by subject
    -
    2
    3
         Physician decision
    -
    1
    -
         Adverse event, non-fatal
    -
    2
    -
         Did not attain inactive disease in Period 1
    -
    1
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participants who experienced disease flare discontinued double-blind treatment and entered open-label retreatment
    Period 3
    Period 3 title
    Period 2: Open-Label Retreatment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Open-Label Retreatment
    Arm description
    		 Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    golimumab
    Investigational medicinal product code
    Other name
    Simponi®
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Number of subjects in period 3 [2]
    		Open-Label Retreatment
    Started
    63
    Completed
    58
    Not completed
    5
         Consent withdrawn by subject
    5
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 18 participants did not continue into Period 2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-Label Run-In Golimumab QM
    Reporting group description
    		 Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.

    Reporting group values
    		 Open-Label Run-In Golimumab QM Total
    Number of subjects
    		 323 323
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.5 ± 7.2 -
    Sex: Female, Male
    Units: Participants
        Female
    		 109 109
        Male
    		 214 214
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 323 323
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 2
        Not Hispanic or Latino
    		 321 321
        Unknown or Not Reported
    		 0 0
    C-Reactive Protein (CRP) Category at Enrollment
    Units: Subjects
        > 6 mg/L
    		 196 196
        ≤ 6 mg/L
    		 127 127
    Subject analysis sets

    Subject analysis set title
    Golimumab QM (Full Treatment Regimen) - baseline reporting
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Subject analysis set title
    Golimumab Q2M (Reduced Treatment Regimen) - baseline reporting
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Double-blinded SC injections of 50 mg golimumab every other month (Q2M) for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Subject analysis set title
    Placebo (Treatment Withdrawal Regimen) - baseline reporting
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Double-blinded SC injections of placebo to golimumab once a month (QM) for up to 12 months.

    Subject analysis set title
    Open-Label Retreatment - baseline reporting
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Subject analysis set title
    Golimumab Q2M and Placebo (Withdrawal Regimens)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants were treated with double-blinded SC injections of 50 mg golimumab Q2M alternating with matching placebo to golimumab every other month or with placebo for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Subject analysis sets values
    		 Golimumab QM (Full Treatment Regimen) - baseline reporting Golimumab Q2M (Reduced Treatment Regimen) - baseline reporting Placebo (Treatment Withdrawal Regimen) - baseline reporting Open-Label Retreatment - baseline reporting Golimumab Q2M and Placebo (Withdrawal Regimens)
    Number of subjects
    63
    64
    62
    63
    125
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    31.4 ± 8.0
    30.8 ± 6.7
    32.9 ± 6.8
    33.4 ± 6.7
    ±
    Sex: Female, Male
    Units: Participants
        Female
    19
    21
    16
    20
        Male
    44
    43
    46
    43
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
    0
    0
    0
        Asian
    0
    0
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
    0
    0
        Black or African American
    0
    0
    0
    0
        White
    63
    64
    62
    63
        More than one race
    0
    0
    0
    0
        Unknown or Not Reported
    0
    0
    0
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0
    0
    0
    0
        Not Hispanic or Latino
    63
    64
    62
    63
        Unknown or Not Reported
    0
    0
    0
    0
    C-Reactive Protein (CRP) Category at Enrollment
    Units: Subjects
        > 6 mg/L
    40
    40
    39
    38
        ≤ 6 mg/L
    23
    24
    23
    25

    End points

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    End points reporting groups
    Reporting group title
    Open-Label Run-In Golimumab QM
    Reporting group description
    		 Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.
    Reporting group title
    Golimumab QM (Full Treatment Regimen)
    Reporting group description
    		 Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.

    Reporting group title
    Golimumab Q2M (Reduced Treatment Regimen)
    Reporting group description
    		 Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.

    Reporting group title
    Placebo (Treatment Withdrawal Regimen)
    Reporting group description
    		 Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.
    Reporting group title
    Open-Label Retreatment
    Reporting group description
    		 Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Subject analysis set title
    Golimumab QM (Full Treatment Regimen) - baseline reporting
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Subject analysis set title
    Golimumab Q2M (Reduced Treatment Regimen) - baseline reporting
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Double-blinded SC injections of 50 mg golimumab every other month (Q2M) for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Subject analysis set title
    Placebo (Treatment Withdrawal Regimen) - baseline reporting
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Double-blinded SC injections of placebo to golimumab once a month (QM) for up to 12 months.

    Subject analysis set title
    Open-Label Retreatment - baseline reporting
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Subject analysis set title
    Golimumab Q2M and Placebo (Withdrawal Regimens)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants were treated with double-blinded SC injections of 50 mg golimumab Q2M alternating with matching placebo to golimumab every other month or with placebo for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Primary: Percentage of Participants Without a Disease Activity Flare During Period 2

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    End point title
    		 Percentage of Participants Without a Disease Activity Flare During Period 2
    End point description
    Disease flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS) at 2 consecutive visits that both show either score ≥2.1 or a post-withdrawal increase of ≥1.1 relative to baseline prior to the first dose in Period 2. ASDAS is a composite index assessing disease activity in axial spondyloarthropathies consisting of 4 self-assessed parameters and 1 laboratory parameter. The parameters of back pain, duration of morning stiffness, Patient Global Disease Assessment (PGDn), and peripheral pain/swelling are scored on a numeric scale of 0 (low activity/impact) to 10 (high activity/impact). The self-assessed criteria and the laboratory value of CRP are combined to provide the total ASDAS score, which has a lower limit of 0.6 and no defined upper limit. A higher score indicates greater disease activity. The analysis population is all participants who had inactive disease in Period 1, were randomized in Period 2, and received ≥1 dose of double-blind study intervention.
    End point type
    Primary
    End point timeframe
    Up to 12 months
    End point values
    		 Golimumab QM (Full Treatment Regimen) Golimumab Q2M (Reduced Treatment Regimen) Placebo (Treatment Withdrawal Regimen)
    Number of subjects analysed
    63
    63
    62
    Units: Percentage of participants
        number (not applicable)
    84.1
    68.3
    33.9
    Statistical analysis title
    		 Full Treatment Regimen vs Placebo
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab QM (Full Treatment Regimen) v Placebo (Treatment Withdrawal Regimen)
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in percentage
    Point estimate
    50.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 34.1
         upper limit
    		 63.6
    Statistical analysis title
    		 Reduced Treatment Regimen vs Placebo
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab Q2M (Reduced Treatment Regimen) v Placebo (Treatment Withdrawal Regimen)
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in percentage
    Point estimate
    34.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17
         upper limit
    		 49.7

    Secondary: Percentage of Participants with a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment

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    End point title
    		 Percentage of Participants with a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment
    End point description
    Clinical response is defined as BASDAI (Bath Ankylosing Spondylitis Disease Assessment Index) score improvement of ≥2.0 or ≥50% improvement within 3 months of the start of retreatment, relative to the mean of the 2 consecutive BASDAI scores that defined the flare. Sustained clinical response is clinical response and maintenance of BASDAI criteria during 3-month retreatment period. BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness [0 (0 hours) to 10 (2 or more hours)]. BASDAI score is the mean of responses to the 6 questions (range of 0 to 10). A higher score indicates greater disease activity. The population is all participants who had inactive disease in Period 1, were randomized to reduced-treatment regimen or placebo in Period 2, received ≥1 dose of double-blind study intervention, and had disease flare in Period 2.
    End point type
    Secondary
    End point timeframe
    Up to 3 months following start of retreatment
    End point values
    		 Open-Label Retreatment
    Number of subjects analysed
    53
    Units: Percentage of participants
    number (confidence interval 95%)
        Within 1 month of retreatment
    90.6 (79.3 to 96.9)
        Within 2 months of retreatment
    96.2 (87.0 to 99.5)
        Within 3 months of retreatment
    96.2 (87.0 to 99.5)
        Sustained clinical response
    71.7 (57.7 to 83.2)
    No statistical analyses for this end point

    Secondary: Time to First Disease Flare

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    End point title
    		 Time to First Disease Flare
    End point description
    The Kaplan-Meier analysis of time to first "flare" in Period 2 is represented by the percentage of participants who experienced a disease flare relative to baseline prior to the first dose of double-blind treatment in Period 2. Disease flare is defined as ASDAS at two consecutive visits that both show either absolute score ≥2.1 or a post-withdrawal increase of ≥1.1. The analysis population is all participants who had inactive disease in Period 1, were randomized in Period 2, and received ≥1 dose of double-blind study intervention.
    End point type
    Secondary
    End point timeframe
    Month 3, Month 6, Month 9, and Month 12
    End point values
    		 Golimumab QM (Full Treatment Regimen) Golimumab Q2M (Reduced Treatment Regimen) Placebo (Treatment Withdrawal Regimen)
    Number of subjects analysed
    63
    63
    62
    Units: Percentage of participants
    number (not applicable)
        Month 3
    14.3
    7.9
    41.9
        Month 6
    14.3
    17.5
    58.1
        Month 9
    14.3
    20.6
    61.3
        Month 12
    15.9
    23.8
    61.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis international Society) Response (Double-blind treatment)

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    End point title
    		 Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis international Society) Response (Double-blind treatment)
    End point description
    ASAS20 is 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) meeting 2 criteria: 1) improvement of ≥20% from Baseline and an improvement from Baseline of ≥1.0 in at least 3 of 4 domains, and 2) absence of deterioration from Baseline (defined as a ≥20% worsening and an absolute worsening of ≥1.0) in the potential remaining domain. Baseline is defined as the last ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: the PGDn, total back pain, Bath Ankylosing Spondylitis Functional Index (BASFI), and morning stiffness (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 10-point scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact. A higher score indicates more severe impairment. The analysis population is all participants who had inactive disease in Period 1, were randomized in Period 2, and received ≥1 dose of double-blind study intervention.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Golimumab QM (Full Treatment Regimen) Golimumab Q2M (Reduced Treatment Regimen) Placebo (Treatment Withdrawal Regimen)
    Number of subjects analysed
    63
    63
    62
    Units: Percentage of participants
        number (not applicable)
    9.5
    3.2
    0.0
    Statistical analysis title
    		 Reduced Treatment Regimen vs Placebo
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab Q2M (Reduced Treatment Regimen) v Placebo (Treatment Withdrawal Regimen)
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 10.9
    Statistical analysis title
    		 Full Treatment Regimen vs Placebo
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab QM (Full Treatment Regimen) v Placebo (Treatment Withdrawal Regimen)
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 19.4

    Secondary: Percentage of Participants Achieving ASAS20 Response (Open-label retreatment)

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    End point title
    		 Percentage of Participants Achieving ASAS20 Response (Open-label retreatment)
    End point description
    ASAS20 is 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) meeting 2 criteria: 1) improvement of ≥20% from Baseline and an improvement from Baseline of ≥1.0 in at least 3 of 4 domains, and 2) absence of deterioration from Baseline (defined as a ≥20% worsening and an absolute worsening of ≥1.0) in the potential remaining domain. Baseline is defined as the last ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: the PGDn, total back pain, BASFI, and morning stiffness (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 10-point scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact. A higher score indicates more severe impairment. The analysis population is all participants who had inactive disease in Period 1, were randomized in Period 2, and received ≥1 dose of double-blind study intervention.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Open-Label Retreatment
    Number of subjects analysed
    53
    Units: Percentage of participants
        number (confidence interval 95%)
    94.3 (84.3 to 98.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ASAS40 Response (Double-blind treatment)

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    End point title
    		 Percentage of Participants Achieving ASAS40 Response (Double-blind treatment)
    End point description
    ASAS40 is 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) meeting 2 criteria: 1) improvement of ≥40% from Baseline and an improvement from Baseline of ≥2.0 in at least 3 of 4 domains, and 2) no deterioration from in the potential remaining domain. Baseline is defined as the last ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: the PGDn, total back pain, BASFI, and morning stiffness (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 10-point scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact. A higher score indicates more severe impairment. The analysis population is all participants who had inactive disease in Period 1, were randomized in Period 2, and received ≥1 dose of double-blind study intervention.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Golimumab QM (Full Treatment Regimen) Golimumab Q2M (Reduced Treatment Regimen) Placebo (Treatment Withdrawal Regimen)
    Number of subjects analysed
    63
    63
    62
    Units: Percentage of participants
    0
    0
    0
    Statistical analysis title
    		 Reduced Treatment Regimen vs Placebo
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab Q2M (Reduced Treatment Regimen) v Placebo (Treatment Withdrawal Regimen)
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.9
         upper limit
    		 5.8
    Statistical analysis title
    		 Full Treatment Regimen vs Placebo
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab QM (Full Treatment Regimen) v Placebo (Treatment Withdrawal Regimen)
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.9
         upper limit
    		 5.8

    Secondary: Percentage of Participants Achieving ASAS40 Response (Open-label retreatment)

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    End point title
    		 Percentage of Participants Achieving ASAS40 Response (Open-label retreatment)
    End point description
    ASAS40 is 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) meeting 2 criteria: 1) improvement of ≥40% from Baseline and an improvement from Baseline of ≥2.0 in at least 3 of 4 domains, and 2) no deterioration from in the potential remaining domain. Baseline is defined as the last ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: the PGDn, total back pain, BASFI, and morning stiffness (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 10-point scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact. A higher score indicates more severe impairment. The analysis population is all participants who had inactive disease in Period 1, were randomized in Period 2, and received ≥1 dose of double-blind study intervention.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Open-Label Retreatment
    Number of subjects analysed
    53
    Units: Percentage of participants
        number (confidence interval 95%)
    90.6 (79.3 to 96.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ASAS Partial Remission (Double-blind treatment)

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    End point title
    		 Percentage of Participants Achieving ASAS Partial Remission (Double-blind treatment)
    End point description
    ASAS partial remission is defined as a score of ≤2 in all 4 ASAS domains. Baseline for this analysis is defined as the ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. The analysis population is all participants who had inactive disease in Period 1, were randomized in Period 2, and received ≥1 dose of double-blind study intervention.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Golimumab QM (Full Treatment Regimen) Golimumab Q2M (Reduced Treatment Regimen) Placebo (Treatment Withdrawal Regimen)
    Number of subjects analysed
    63
    63
    62
    Units: Percentage of participants
        number (not applicable)
    85.7
    85.7
    71.0
    Statistical analysis title
    		 Full Treatment Regimen vs Placebo
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab QM (Full Treatment Regimen) v Placebo (Treatment Withdrawal Regimen)
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    14.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 29
    Statistical analysis title
    		 Reduced Treatment Regimen vs Placebo
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab Q2M (Reduced Treatment Regimen) v Placebo (Treatment Withdrawal Regimen)
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    14.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 29.1

    Secondary: Percentage of Participants Achieving ASAS Partial Remission (Open-label retreatment)

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    End point title
    		 Percentage of Participants Achieving ASAS Partial Remission (Open-label retreatment)
    End point description
    ASAS partial remission is defined as a score of ≤2 in all 4 ASAS domains. Baseline for this analysis is defined as the ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment. The population is all participants who had inactive disease in Period 1, were randomized to reduced-treatment regimen or placebo in Period 2, received ≥1 dose of double-blind study intervention, and experienced disease flare in Period 2.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Open-Label Retreatment
    Number of subjects analysed
    53
    Units: Percentage of participants
        number (confidence interval 95%)
    92.5 (81.8 to 97.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving BASDAI50 Response (Double-blind Treatment)

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    End point title
    		 Percentage of Participants Achieving BASDAI50 Response (Double-blind Treatment)
    End point description
    BASDAI50 is defined as ≥50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score. Baseline for BASDAI50 analysis is defined as the last BASDAI score prior to the first dose of double-blind treatment in Period 2. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness [0 (zero) to 10 (2 or more hours)]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a maximum of 10. A higher score indicates greater disease activity. The analysis population is all participants who had inactive disease in Period 1, were randomized in Period 2, and received ≥1 dose of double-blind study intervention.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Golimumab QM (Full Treatment Regimen) Golimumab Q2M (Reduced Treatment Regimen) Placebo (Treatment Withdrawal Regimen)
    Number of subjects analysed
    63
    63
    62
    Units: Percentage of participants
        number (not applicable)
    49.2
    30.2
    24.2
    Statistical analysis title
    		 Reduced Treatment Regimen vs Placebo
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab Q2M (Reduced Treatment Regimen) v Placebo (Treatment Withdrawal Regimen)
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.9
         upper limit
    		 21.3
    Statistical analysis title
    		 Full Treatment Regimen vs Placebo
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab QM (Full Treatment Regimen) v Placebo (Treatment Withdrawal Regimen)
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    24.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.5
         upper limit
    		 40.3

    Secondary: Percentage of Participants Achieving BASDAI50 Response (Open-label Retreatment)

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    End point title
    		 Percentage of Participants Achieving BASDAI50 Response (Open-label Retreatment)
    End point description
    BASDAI50 is defined as ≥50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score. Baseline for BASDAI50 analysis is defined as the last BASDAI score prior to the first dose of open-label retreatment in Period 2. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness [0 (zero) to 10 (2 or more hours)]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a maximum of 10. A higher score indicates greater disease activity. The population is all participants who had inactive disease in Period 1, were randomized to reduced-treatment regimen or placebo in Period 2, received ≥1 dose of double-blind study intervention, and experienced disease flare in Period 2.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Open-Label Retreatment
    Number of subjects analysed
    53
    Units: Percentage of participants
        number (confidence interval 95%)
    98.1 (89.9 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Inactive Disease Status (Double-Blind Treatment)

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    End point title
    		 Percentage of Participants Achieving Inactive Disease Status (Double-Blind Treatment)
    End point description
    Inactive disease status is defined as an ASDAS score <1.3. The ASDAS is a composite index assessing disease activity in axial spondyloarthropathies that consists of 4 self-assessed parameters and 1 laboratory parameter. The self-assessed parameters of back pain, duration of morning stiffness, Patient Global Disease Assessment (PGDn), and peripheral pain/swelling are individually scored on a numeric scale of 0 to 10, with 0 being low activity/impact and 10 being high activity/impact. The self-assessed criteria and the laboratory value of CRP are combined to provide the total ASDAS score, which has a lower limit of 0.6 and no defined upper limit. A higher score indicates greater disease activity. The analysis population is all participants who had inactive disease in Period 1, were randomized in Period 2, and received ≥1 dose of double-blind study intervention.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Golimumab QM (Full Treatment Regimen) Golimumab Q2M (Reduced Treatment Regimen) Placebo (Treatment Withdrawal Regimen)
    Number of subjects analysed
    63
    63
    62
    Units: Percentage of participants
        number (not applicable)
    85.7
    84.1
    61.3
    Statistical analysis title
    		 Full Treatment Regimen vs Placebo
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab QM (Full Treatment Regimen) v Placebo (Treatment Withdrawal Regimen)
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    24.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.1
         upper limit
    		 39
    Statistical analysis title
    		 Reduced Treatment Regimen vs Placebo
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab Q2M (Reduced Treatment Regimen) v Placebo (Treatment Withdrawal Regimen)
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    22.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.3
         upper limit
    		 37.7

    Secondary: Percentage of Participants Achieving Inactive Disease Status (Open-label retreatment)

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    End point title
    		 Percentage of Participants Achieving Inactive Disease Status (Open-label retreatment)
    End point description
    Inactive disease status is defined as an ASDAS score <1.3. The ASDAS is a composite index assessing disease activity in axial spondyloarthropathies that consists of 4 self-assessed parameters and 1 laboratory parameter. The self-assessed parameters of back pain, duration of morning stiffness, Patient Global Disease Assessment (PGDn), and peripheral pain/swelling are individually scored on a numeric scale of 0 to 10, with 0 being low activity/impact and 10 being high activity/impact. The self-assessed criteria and the laboratory value of CRP are combined to provide the total ASDAS score, which has a lower limit of 0.6 and no defined upper limit. A higher score indicates greater disease activity. The population is all participants who had inactive disease in Period 1, were randomized to reduced-treatment regimen or placebo in Period 2, received ≥1 dose of double-blind study intervention, and experienced disease flare in Period 2.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Open-Label Retreatment
    Number of subjects analysed
    53
    Units: Percentage of participants
        number (confidence interval 95%)
    90.6 (79.3 to 96.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Experienced an Adverse Event (AE) in Period 2

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    End point title
    		 Percentage of Participants Who Experienced an Adverse Event (AE) in Period 2
    End point description
    This endpoint evaluated the safety and tolerability of withdrawing from or continuing treatment with golimumab in Period 2. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE. The analysis includes AEs that occurred through 90 days after the last dose of study treatment. The analysis population consists of all participants who received at least one dose of study intervention in Period 2.
    End point type
    Secondary
    End point timeframe
    Up to approximately 15 months
    End point values
    		 Golimumab QM (Full Treatment Regimen) Open-Label Retreatment Golimumab Q2M (Reduced Treatment Regimen) Placebo (Treatment Withdrawal Regimen)
    Number of subjects analysed
    63
    63
    64
    62
    Units: Percentage of participants
        number (not applicable)
    46.0
    41.3
    46.9
    32.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2

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    End point title
    		 Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2
    End point description
    This endpoint evaluated the safety and tolerability of withdrawing from or continuing treatment with golimumab in Period 2. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE. The analysis population consists of all participants who received at least one dose of study intervention in Period 2.
    End point type
    Secondary
    End point timeframe
    Up to approximately 12 months
    End point values
    		 Golimumab QM (Full Treatment Regimen) Open-Label Retreatment Golimumab Q2M (Reduced Treatment Regimen) Placebo (Treatment Withdrawal Regimen)
    Number of subjects analysed
    63
    63
    64
    62
    Units: Percentage of participants
        number (not applicable)
    0.0
    0.0
    4.7
    1.6
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen versus Withdrawal Regimens)

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    End point title
    		 Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen versus Withdrawal Regimens)
    End point description
    Disease flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS) at 2 consecutive visits that both show either score ≥2.1 or a post-withdrawal increase of ≥1.1 relative to baseline prior to the first dose in Period 2. ASDAS is a composite index assessing disease activity in axial spondyloarthropathies consisting of 4 self-assessed parameters and 1 laboratory parameter. The parameters of back pain, duration of morning stiffness, Patient Global Disease Assessment (PGDn), and peripheral pain/swelling are scored on a numeric scale of 0 (low activity/impact) to 10 (high activity/impact). The self-assessed criteria and the laboratory value of CRP are combined to provide the total ASDAS score, which has a lower limit of 0.6 and no defined upper limit. A higher score indicates greater disease activity. The analysis population is all participants who had inactive disease in Period 1, were randomized in Period 2, and received ≥1 dose of double-blind study intervention.
    End point type
    Other pre-specified
    End point timeframe
    Up to 12 months
    End point values
    		 Golimumab QM (Full Treatment Regimen) Golimumab Q2M and Placebo (Withdrawal Regimens)
    Number of subjects analysed
    63
    125
    Units: Percentage of participants
        number (not applicable)
    84.1
    51.2
    Statistical analysis title
    		 Full Treatment Regimen vs Withdrawal Regimens
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab QM (Full Treatment Regimen) v Golimumab Q2M and Placebo (Withdrawal Regimens)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in percentage
    Point estimate
    32.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.2
         upper limit
    		 44.5

    Other pre-specified: Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen versus Reduced Treatment Regimen)

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    End point title
    		 Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen versus Reduced Treatment Regimen)
    End point description
    Disease flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS) at 2 consecutive visits that both show either score ≥2.1 or a post-withdrawal increase of ≥1.1 relative to baseline prior to the first dose in Period 2. ASDAS is a composite index assessing disease activity in axial spondyloarthropathies consisting of 4 self-assessed parameters and 1 laboratory parameter. The parameters of back pain, duration of morning stiffness, Patient Global Disease Assessment (PGDn), and peripheral pain/swelling are scored on a numeric scale of 0 (low activity/impact) to 10 (high activity/impact). The self-assessed criteria and the laboratory value of CRP are combined to provide the total ASDAS score, which has a lower limit of 0.6 and no defined upper limit. A higher score indicates greater disease activity. The analysis population is all participants who had inactive disease in Period 1, were randomized in Period 2, and received ≥1 dose of double-blind golimumab.
    End point type
    Other pre-specified
    End point timeframe
    Up to 12 months
    End point values
    		 Golimumab QM (Full Treatment Regimen) Golimumab Q2M (Reduced Treatment Regimen)
    Number of subjects analysed
    63
    63
    Units: Percentage of participants
        number (not applicable)
    84.1
    68.3
    Statistical analysis title
    		 Full Treatment vs Reduced Treatment
    Statistical analysis description
    Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
    Comparison groups
    Golimumab QM (Full Treatment Regimen) v Golimumab Q2M (Reduced Treatment Regimen)
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.037
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in percentage
    Point estimate
    15.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 30.5

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months.
    Adverse event reporting additional description
    The safety analysis population includes all participants who received at least one dose of study intervention.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Open-Label Run-In Golimumab QM
    Reporting group description
    		 Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.

    Reporting group title
    Golimumab QM (Full Treatment Regimen)
    Reporting group description
    		 Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.

    Reporting group title
    Open-Label Retreatment
    Reporting group description
    		 Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.

    Reporting group title
    Placebo (Treatment Withdrawal Regimen)
    Reporting group description
    		 Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.

    Reporting group title
    Golimumab Q2M (Reduced Treatment Regimen)
    Reporting group description
    		 Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.

    Serious adverse events
    		 Open-Label Run-In Golimumab QM Golimumab QM (Full Treatment Regimen) Open-Label Retreatment Placebo (Treatment Withdrawal Regimen) Golimumab Q2M (Reduced Treatment Regimen)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 323 (2.17%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    1 / 64 (1.56%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    0 / 323 (0.00%)
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exostosis
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint instability
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pilonidal cyst
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 323 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis bacterial
         subjects affected / exposed
    1 / 323 (0.31%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Open-Label Run-In Golimumab QM Golimumab QM (Full Treatment Regimen) Open-Label Retreatment Placebo (Treatment Withdrawal Regimen) Golimumab Q2M (Reduced Treatment Regimen)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    79 / 323 (24.46%)
    13 / 63 (20.63%)
    11 / 63 (17.46%)
    11 / 62 (17.74%)
    17 / 64 (26.56%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    24 / 323 (7.43%)
    4 / 63 (6.35%)
    1 / 63 (1.59%)
    4 / 62 (6.45%)
    2 / 64 (3.13%)
         occurrences all number
    39
    8
    2
    5
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    36 / 323 (11.15%)
    6 / 63 (9.52%)
    4 / 63 (6.35%)
    3 / 62 (4.84%)
    6 / 64 (9.38%)
         occurrences all number
    39
    7
    4
    4
    6
    Pharyngitis
         subjects affected / exposed
    12 / 323 (3.72%)
    2 / 63 (3.17%)
    1 / 63 (1.59%)
    3 / 62 (4.84%)
    6 / 64 (9.38%)
         occurrences all number
    14
    2
    1
    4
    9
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 323 (4.95%)
    2 / 63 (3.17%)
    5 / 63 (7.94%)
    2 / 62 (3.23%)
    3 / 64 (4.69%)
         occurrences all number
    24
    5
    5
    3
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Apr 2017
    Amendment 1 added language regarding male contraception, pregnancy follow-up, and clarified timing of several study procedures.

    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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