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    Clinical Trial Results:
    Multicenter, Open-Label Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis Flares in Axial Spondyloarthritis Subjects with a History of Anterior Uveitis (C-VIEW)

    Summary
    EudraCT number
    2016-000343-14
    Trial protocol
    DE   ES   CZ   NL  
    Global end of trial date
    23 Jan 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Feb 2021
    First version publication date
    05 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AS0007
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03020992
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SPRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, B-1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.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
    26 Feb 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the effect of Certolizumab Pegol (CZP) treatment on the reduction of Anterior Uveitis (AU) flares in subjects with active Axial Spondyloarthritis (axSpA) and a documented history of AU.
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Background therapy as permitted in the protocol.
    Evidence for comparator
    Not Applicable
    Actual start date of recruitment
    21 Dec 2016
    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: 35
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Poland: 38
    Country: Number of subjects enrolled
    Spain: 4
    Worldwide total number of subjects
    89
    EEA total number of subjects
    89
    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)
    84
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The first participant was enrolled in December 2016 and the last participant was enrolled in December 2017.

    Pre-assignment
    Screening details
    The study included 3 periods as follows: Period 1 (Screening Period) 1 to 5 weeks before Baseline, Period 2 (Treatment Period) Week 0 to Week 96 and Period 3 (FU Period) 10 weeks from the final dose of investigational medicinal product (IMP) received (Week 104). Participant Flow refers to the Safety Set.

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

    Arms
    Arm title
    Certolizumab Pegol
    Arm description
    Participants received a loading dose of Certolizumab Pegol (CZP) 400 milligrams (mg) subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc every 2 weeks (Q2W) (starting at Week 6 until Week 94).
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab Pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Certolizumab Pegol (CZP) 400 mg or 200 mg was administered as subcutaneous (sc) injections every 2 weeks. Suitable areas for administrations were the lateral abdominal wall and upper outer thigh.

    Number of subjects in period 1
    Certolizumab Pegol
    Started
    89
    Completed
    83
    Not completed
    6
         Adverse event, non-fatal
    5
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Certolizumab Pegol
    Reporting group description
    Participants received a loading dose of Certolizumab Pegol (CZP) 400 milligrams (mg) subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc every 2 weeks (Q2W) (starting at Week 6 until Week 94).

    Reporting group values
    Certolizumab Pegol Total
    Number of subjects
    89 89
    Age categorical
    Units: Subjects
        <=18 years
    0 0
        Between 18 and 65 years
    84 84
        >=65 years
    5 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    46.52 ± 11.24 -
    Gender categorical
    Units: Subjects
        Female
    33 33
        Male
    56 56

    End points

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    End points reporting groups
    Reporting group title
    Certolizumab Pegol
    Reporting group description
    Participants received a loading dose of Certolizumab Pegol (CZP) 400 milligrams (mg) subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc every 2 weeks (Q2W) (starting at Week 6 until Week 94).

    Subject analysis set title
    Certolizumab Pegol (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received a loading dose of Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc Q2W (starting at Week 6 until Week 94).

    Subject analysis set title
    Certolizumab Pegol (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received a loading dose of Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc Q2W (starting at Week 6 until Week 94).

    Subject analysis set title
    Certolizumab Pegol - Pre-study/Historical (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Pre-study was before IMP start and included 2 years (104 weeks) prior to Baseline. This group is used in the primary efficacy analysis, to compare the frequency of AU flares during the pre-study/historical period with that observed while in the study during CZP treatment.

    Subject analysis set title
    Certolizumab Pegol - On-study (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received a loading dose of Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc Q2W (starting at Week 6 until Week 94).

    Primary: Number of distinct episodes of Anterior Uveitis (AU) flares during the Treatment Period

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    End point title
    Number of distinct episodes of Anterior Uveitis (AU) flares during the Treatment Period
    End point description
    A flare was defined as being a new episode of Anterior Uveitis (AU) that, based on the judgment of an ophthalmologist, required specific treatment. A flare was considered a new episode if a gap of at least 3 months occurred between 2 flares. The Full Analysis Set (FAS) consisted of all study participants in the Safety Set (SS) with nonmissing Baseline values for the primary efficacy variable (AU flare incidence data from the prestudy period).
    End point type
    Primary
    End point timeframe
    During the pre-study period and during the Treatment Period up to 96 weeks
    End point values
    Certolizumab Pegol - Pre-study/Historical (FAS) Certolizumab Pegol - On-study (FAS)
    Number of subjects analysed
    89
    89
    Units: flares
        arithmetic mean (standard deviation)
    1.9 ± 0.9
    0.3 ± 0.7
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The Poisson regression allowed for a comparison of event rates adjusting for differences in time between prestudy/on-study periods. Event rates were based on a Poisson model with generalized estimating equations and a loglink, including an offset term for time interval length, and with period and disease duration of axSpA (<2 years/≥2 years) as covariates. A repeated statement was included for participants and assumed an exchangeable correlation structure between prestudy and on-study flares.
    Comparison groups
    Certolizumab Pegol - Pre-study/Historical (FAS) v Certolizumab Pegol - On-study (FAS)
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Poisson regression
    Parameter type
    Rate ratio
    Point estimate
    0.18
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.116
         upper limit
    0.281

    Secondary: Number of Anterior Uveitis (AU) flares per 100 patient-years in participants with active axial SpondyloArthritis (axSpA) and a history of AU at Week 48

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    End point title
    Number of Anterior Uveitis (AU) flares per 100 patient-years in participants with active axial SpondyloArthritis (axSpA) and a history of AU at Week 48
    End point description
    A flare was defined as being a new episode of Anterior Uveitis (AU) that, based on the judgment of an ophthalmologist, required specific treatment. A flare was considered a new episode if a gap of at least 3 months occurred between 2 flares. The Full Analysis Set (FAS) consisted of all study participants in the Safety Set (SS) with nonmissing Baseline values for the primary efficacy variable (AU flare incidence data from the prestudy period).
    End point type
    Secondary
    End point timeframe
    During the pre-study period and during the Treatment Period up to 48 weeks
    End point values
    Certolizumab Pegol (FAS)
    Number of subjects analysed
    89
    Units: flares
    number (confidence interval 95%)
        Pre-study Historical
    132.72 (109.76 to 159.06)
        On-study CZP
    18.56 (10.39 to 30.61)
    No statistical analyses for this end point

    Secondary: Number of Anterior Uveitis (AU) flares per 100 patient-years in participants with active axial SpondyloArthritis (axSpA) and a history of AU at Week 96

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    End point title
    Number of Anterior Uveitis (AU) flares per 100 patient-years in participants with active axial SpondyloArthritis (axSpA) and a history of AU at Week 96
    End point description
    A flare was defined as being a new episode of Anterior Uveitis (AU) that, based on the judgment of an ophthalmologist, required specific treatment. A flare was considered a new episode if a gap of at least 3 months occurred between 2 flares. The Full Analysis Set (FAS) consisted of all study participants in the Safety Set (SS) with nonmissing Baseline values for the primary efficacy variable (AU flare incidence data from the prestudy period).
    End point type
    Secondary
    End point timeframe
    During the pre-study period and during the Treatment Period up to 96 weeks
    End point values
    Certolizumab Pegol (FAS)
    Number of subjects analysed
    89
    Units: flares
    number (confidence interval 95%)
        Pre-study Historical
    97.51 (83.24 to 113.53)
        On-study CZP
    17.67 (11.74 to 25.53)
    No statistical analyses for this end point

    Secondary: Number of Anterior Uveitis (AU) flares per 100 patient-years in participants with active axial SpondyloArthritis (axSpA) and at least 1 AU episode within 12 months prior Baseline at Week 48

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    End point title
    Number of Anterior Uveitis (AU) flares per 100 patient-years in participants with active axial SpondyloArthritis (axSpA) and at least 1 AU episode within 12 months prior Baseline at Week 48
    End point description
    A flare was defined as being a new episode of Anterior Uveitis (AU) that, based on the judgment of an ophthalmologist, required specific treatment. A flare was considered a new episode if a gap of at least 3 months occurred between 2 flares. The Full Analysis Set (FAS) consisted of all study participants in the Safety Set (SS) with nonmissing Baseline values for the primary efficacy variable (AU flare incidence data from the prestudy period).
    End point type
    Secondary
    End point timeframe
    During the pre-study period and during the Treatment Period up to 48 weeks
    End point values
    Certolizumab Pegol (FAS)
    Number of subjects analysed
    89
    Units: flares
    number (confidence interval 95%)
        Pre-study Historical
    132.72 (109.76 to 159.06)
        On-study CZP
    18.56 (10.39 to 30.61)
    No statistical analyses for this end point

    Secondary: Number of Anterior Uveitis (AU) flares per 100 patient-years in participants with active axial SpondyloArthritis (axSpA) and at least 1 AU episode within 12 months prior Baseline at Week 96

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    End point title
    Number of Anterior Uveitis (AU) flares per 100 patient-years in participants with active axial SpondyloArthritis (axSpA) and at least 1 AU episode within 12 months prior Baseline at Week 96
    End point description
    A flare was defined as being a new episode of Anterior Uveitis (AU) that, based on the judgment of an ophthalmologist, required specific treatment. A flare was considered a new episode if a gap of at least 3 months occurred between 2 flares. The Full Analysis Set (FAS) consisted of all study participants in the Safety Set (SS) with nonmissing Baseline values for the primary efficacy variable (AU flare incidence data from the prestudy period).
    End point type
    Secondary
    End point timeframe
    During the pre-study period and during the Treatment Period up to 96 weeks
    End point values
    Certolizumab Pegol (FAS)
    Number of subjects analysed
    89
    Units: flares
    number (confidence interval 95%)
        Pre-study Historical
    97.51 (83.24 to 113.53)
        On-study CZP
    17.67 (11.74 to 25.53)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48

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    End point title
    Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48
    End point description
    The ASDAS was calculated as the sum of the following: 0.121 × Back pain (BASDAI Question 2 result) 0.058 × Duration of morning stiffness (BASDAI Question 6 result) 0.110 × PtGADA 0.073 × Peripheral pain/swelling (BASDAI Question 3 result) 0.579 × (natural logarithm (CRP [mg/L] + 1)) Back pain, PtGADA, duration of morning stiffness, and peripheral pain/swelling are all assessed on a numerical scale (0 to 10 units). The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as BLQ and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636. The SS consisted of all participants in the ES who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing ASDAS
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    86
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -1.55 ± 1.03
    No statistical analyses for this end point

    Secondary: Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96

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    End point title
    Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96
    End point description
    The ASDAS was calculated as the sum of the following: 0.121 × Back pain (BASDAI Question 2 result) 0.058 × Duration of morning stiffness (BASDAI Question 6 result) 0.110 × PtGADA 0.073 × Peripheral pain/swelling (BASDAI Question 3 result) 0.579 × (natural logarithm (CRP [mg/L] + 1)) Back pain, PtGADA, duration of morning stiffness, and peripheral pain/swelling are all assessed on a numerical scale (0 to 10 units). The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as BLQ and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636. The SS consisted of all participants in the ES who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing ASDAS at Week 96
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    82
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -1.61 ± 1.08
    No statistical analyses for this end point

    Secondary: Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 48

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    End point title
    Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 48
    End point description
    The BASDAI is a validated self-reported instrument which consists of 6 horizontal Numeric Rating Scales (NRSs), each with 10 units to measure the severity of the 5 major symptoms: fatigue, spinal pain, peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness is taken. The resulting 0 to 50 sum score is divided by 5 to give a final BASDAI score between 0 and 10, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing BASDAI at Week 48.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    86
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -3.2 ± 2.3
    No statistical analyses for this end point

    Secondary: Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96

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    End point title
    Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96
    End point description
    The BASDAI is a validated self-reported instrument which consists of 6 horizontal Numeric Rating Scales (NRSs), each with 10 units to measure the severity of the 5 major symptoms: fatigue, spinal pain, peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness is taken. The resulting 0 to 50 sum score is divided by 5 to give a final BASDAI score between 0 and 10, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing BASDAI at Week 96.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    82
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -3.4 ± 2.2
    No statistical analyses for this end point

    Secondary: Percentage of participants meeting Assessment of SpondyloArthritis international Society 20 % response criteria (ASAS20) at Week 48

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    End point title
    Percentage of participants meeting Assessment of SpondyloArthritis international Society 20 % response criteria (ASAS20) at Week 48
    End point description
    The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]: - Patient’s Global Assessment of Disease Activity (PtGADA) - Pain assessment (the total spinal pain Numeric Rating Scale score) - Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) - Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Percentages were based on the number of participants with an assessment at Week 48.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    75.6
    No statistical analyses for this end point

    Secondary: Percentage of participants meeting Assessment of SpondyloArthritis international Society 20 % response criteria (ASAS20) at Week 96

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    End point title
    Percentage of participants meeting Assessment of SpondyloArthritis international Society 20 % response criteria (ASAS20) at Week 96
    End point description
    The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]: - Patient’s Global Assessment of Disease Activity (PtGADA) - Pain assessment (the total spinal pain Numeric Rating Scale score) - Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) - Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Percentages were based on the number of participants with an assessment at Week 96.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    82
    Units: percentage of participants
        number (not applicable)
    75.6
    No statistical analyses for this end point

    Secondary: Percentage of participants meeting Assessment of SpondyloArthritis international Society 40 % response criteria (ASAS40) at Week 48

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    End point title
    Percentage of participants meeting Assessment of SpondyloArthritis international Society 40 % response criteria (ASAS40) at Week 48
    End point description
    The ASAS criteria for 40 % improvement were defined as relative improvements of at least 40 %, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains below and no worsening at all in the remaining domain: - Patient’s Global Assessment of Disease Activity (PtGADA) - Pain assessment (the total spinal pain Numeric Rating Scale score) - Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) - Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Percentages were based on the number of participants with an assessment at Week 48.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    53.5
    No statistical analyses for this end point

    Secondary: Percentage of participants meeting Assessment of SpondyloArthritis international Society 40 % response criteria (ASAS40) at Week 96

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    End point title
    Percentage of participants meeting Assessment of SpondyloArthritis international Society 40 % response criteria (ASAS40) at Week 96
    End point description
    The ASAS criteria for 40 % improvement were defined as relative improvements of at least 40 %, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains below and no worsening at all in the remaining domain: - Patient’s Global Assessment of Disease Activity (PtGADA) - Pain assessment (the total spinal pain Numeric Rating Scale score) - Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) - Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Percentages were based on the number of participants with an assessment at Week 96.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    82
    Units: percentage of participants
        number (not applicable)
    58.5
    No statistical analyses for this end point

    Secondary: Percentage of participants meeting Assessment of SpondyloArthritis international Society (ASAS) 5/6 response at Week 48

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    End point title
    Percentage of participants meeting Assessment of SpondyloArthritis international Society (ASAS) 5/6 response at Week 48
    End point description
    The ASAS 5/6 response is defined as at least 20 % improvement in 5 of 6 domains, including spinal mobility (lateral spinal flexion) and C-Reactive Protein (CRP) as more objective measures. As the BASMI was not collected, and there was no alternative measure of spinal mobility available in the study data, the complete component for spinal mobility was missing. Therefore the ASAS 5/6 response criterion cannot be calculated, and the analysis of the secondary efficacy variable ASAS 5/6 had to be dropped.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    0 [1]
    Units: percentage of participants
        number (not applicable)
    Notes
    [1] - Data not collected from participants in all Arms/Groups.
    No statistical analyses for this end point

    Secondary: Percentage of participants meeting Assessment of SpondyloArthritis international Society (ASAS) 5/6 response at Week 96

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    End point title
    Percentage of participants meeting Assessment of SpondyloArthritis international Society (ASAS) 5/6 response at Week 96
    End point description
    The ASAS 5/6 response is defined as at least 20 % improvement in 5 of 6 domains, including spinal mobility (lateral spinal flexion) and C-Reactive Protein (CRP) as more objective measures. As the BASMI was not collected, and there was no alternative measure of spinal mobility available in the study data, the complete component for spinal mobility was missing. Therefore the ASAS 5/6 response criterion cannot be calculated, and the analysis of the secondary efficacy variable ASAS 5/6 had to be dropped.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    0 [2]
    Units: percentage of participants
        number (not applicable)
    Notes
    [2] - Data not collected from participants in all Arms/Groups.
    No statistical analyses for this end point

    Secondary: Percentage of participants with Assessment of SpondyloArthritis international Society (ASAS) partial remission (PR) response at Week 48

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    End point title
    Percentage of participants with Assessment of SpondyloArthritis international Society (ASAS) partial remission (PR) response at Week 48
    End point description
    The ASAS PR response is defined as a score of ≤2 units on a 0 to 10 unit scale in all of the 4 following domains: - Patient’s Global Assessment of Disease Activity (PtGADA) - Pain assessment (the total spinal pain Numeric Rating Scale score) - Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) - Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Percentages were based on the number of participants with an assessment at Week 48.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    31.4
    No statistical analyses for this end point

    Secondary: Percentage of participants with Assessment of SpondyloArthritis international Society (ASAS) partial remission (PR) response at Week 96

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    End point title
    Percentage of participants with Assessment of SpondyloArthritis international Society (ASAS) partial remission (PR) response at Week 96
    End point description
    The ASAS PR response is defined as a score of ≤2 units on a 0 to 10 unit scale in all of the 4 following domains: - Patient’s Global Assessment of Disease Activity (PtGADA) - Pain assessment (the total spinal pain Numeric Rating Scale score) - Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) - Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Percentages were based on the number of participants with an assessment at Week 96.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    82
    Units: percentage of participants
        number (not applicable)
    36.6
    No statistical analyses for this end point

    Secondary: Change from Baseline in tender joint count (44 joint count) at Week 48

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    End point title
    Change from Baseline in tender joint count (44 joint count) at Week 48
    End point description
    The following 44 joints were to be examined for swelling and tenderness by the Investigator, another delegated physician, or an appropriately qualified medical professional: - Upper body (4) – bilateral sternoclavicular and acromioclavicular joints - Upper extremity (26) – bilateral shoulders, elbows, wrists (includes radiocarpal, carpal, and carpometacarpal bones considered as a single unit), metacarpophalangeals (MCPs) I,II, III, IV, and V, and thumb interphalangeals (IPs), and proximal IPs (PIPs) II, III, IV, and V - Lower extremity (14) – bilateral knees, ankles, and metatarsophalangeals (I, II, III, IV, and V) The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The SS consisted of all study participants in the ES who had received at least 1 dose of IMP. Number of participants analyzed reflect those with at least one tender joint count at Baseline (N=59) and had a non-missing tender joint count at Week 48 (N=55).
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    55
    Units: tender joints
        arithmetic mean (standard deviation)
    -4.9 ± 6.7
    No statistical analyses for this end point

    Secondary: Change from Baseline in tender joint count (44 joint count) at Week 96

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    End point title
    Change from Baseline in tender joint count (44 joint count) at Week 96
    End point description
    The following 44 joints were to be examined for swelling and tenderness by the Investigator, another delegated physician, or an appropriately qualified medical professional: - Upper body (4) – bilateral sternoclavicular and acromioclavicular joints - Upper extremity (26) – bilateral shoulders, elbows, wrists (includes radiocarpal, carpal, and carpometacarpal bones considered as a single unit), metacarpophalangeals (MCPs) I,II, III, IV, and V, and thumb interphalangeals (IPs), and proximal IPs (PIPs) II, III, IV, and V - Lower extremity (14) – bilateral knees, ankles, and metatarsophalangeals (I, II, III, IV, and V) The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The SS consisted of all study participants in the ES who had received at least 1 dose of IMP. Number of participants analyzed reflect those with at least one tender joint count at Baseline (N=59) and had a non-missing tender joint count at Week 96 (N=51).
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    51
    Units: tender joints
        arithmetic mean (standard deviation)
    -4.7 ± 8.2
    No statistical analyses for this end point

    Secondary: Change from Baseline in swollen joint count (44 joint count) at Week 48

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    End point title
    Change from Baseline in swollen joint count (44 joint count) at Week 48
    End point description
    The following 44 joints were to be examined for swelling and tenderness by the Investigator, another delegated physician, or an appropriately qualified medical professional: - Upper body (4) – bilateral sternoclavicular and acromioclavicular joints - Upper extremity (26) – bilateral shoulders, elbows, wrists (includes radiocarpal, carpal, and carpometacarpal bones considered as a single unit), metacarpophalangeals (MCPs) I,II, III, IV, and V, and thumb interphalangeals (IPs), and proximal IPs (PIPs) II, III, IV, and V - Lower extremity (14) – bilateral knees, ankles, and metatarsophalangeals (I, II, III, IV, and V) The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The SS consisted of all study participants in the ES who had received at least 1 dose of IMP. Number of participants analyzed reflect those with at least one swollen joint count at Baseline (N=33) and had a non-missing swollen joint count at Week 48 (N=32).
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    32
    Units: swollen joints
        arithmetic mean (standard deviation)
    -4.2 ± 4.8
    No statistical analyses for this end point

    Secondary: Change from Baseline in swollen joint count (44 joint count) at Week 96

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    End point title
    Change from Baseline in swollen joint count (44 joint count) at Week 96
    End point description
    The following 44 joints were to be examined for swelling and tenderness by the Investigator, another delegated physician, or an appropriately qualified medical professional: - Upper body (4) – bilateral sternoclavicular and acromioclavicular joints - Upper extremity (26) – bilateral shoulders, elbows, wrists (includes radiocarpal, carpal, and carpometacarpal bones considered as a single unit), metacarpophalangeals (MCPs) I,II, III, IV, and V, and thumb interphalangeals (IPs), and proximal IPs (PIPs) II, III, IV, and V - Lower extremity (14) – bilateral knees, ankles, and metatarsophalangeals (I, II, III, IV, and V) The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The SS consisted of all study participants in the ES who had received at least 1 dose of IMP. Number of participants analyzed reflect those with at least one swollen joint count at Baseline (N=33) and had a non-missing swollen joint count at Week 96 (N=30).
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    30
    Units: swollen joints
        arithmetic mean (standard deviation)
    -3.9 ± 5.2
    No statistical analyses for this end point

    Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 48

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    End point title
    Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 48
    End point description
    The Investigator assessed the overall status of the participant with respect to the axSpA signs and symptoms and the functional capacity of the participant using a Visual Analog Scale (VAS) where 0 is “very good, asymptomatic and no limitation of normal activities” and 100 is “very poor, very severe symptoms that are intolerable, and the inability to carry out all normal activities.” This assessment by the Investigator should be made without any knowledge of the Patient's Global Assessment of Disease Activity (PtGADA). Total score ranges from 0 to 100, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing PhGADA at Week 48.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    86
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -43.8 ± 21.6
    No statistical analyses for this end point

    Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 96

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    End point title
    Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 96
    End point description
    The Investigator assessed the overall status of the participant with respect to the axSpA signs and symptoms and the functional capacity of the participant using a Visual Analog Scale (VAS) where 0 is “very good, asymptomatic and no limitation of normal activities” and 100 is “very poor, very severe symptoms that are intolerable, and the inability to carry out all normal activities.” This assessment by the Investigator should be made without any knowledge of the Patient's Global Assessment of Disease Activity (PtGADA). Total score ranges from 0 to 100, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing PhGADA at Week 96.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    82
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -42.5 ± 27.1
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 48

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    End point title
    Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 48
    End point description
    For the PtGADA questionnaire, participants scored their global assessment of their disease activity in response to the question “How active was your spondylitis on average during the last week?” using a Numeric Rating Scale (NRS) where 0 was “not active” and 10 was “very active”. Total score ranges from 0 to 10, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing PtGADA at Week 48.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    86
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -3.6 ± 2.5
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 96

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    End point title
    Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 96
    End point description
    For the PtGADA questionnaire, participants scored their global assessment of their disease activity in response to the question “How active was your spondylitis on average during the last week?” using a Numeric Rating Scale (NRS) where 0 was “not active” and 10 was “very active”. Total score ranges from 0 to 10, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing PtGADA at Week 96.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    82
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -3.9 ± 2.7
    No statistical analyses for this end point

    Secondary: Change from Baseline in total spinal pain at Week 48 assessed by Numerical Rating Scale (NRS)

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    End point title
    Change from Baseline in total spinal pain at Week 48 assessed by Numerical Rating Scale (NRS)
    End point description
    The total spinal pain was assessed with the question 'How much pain of your spine due to spondylitis do you have?' using a Numeric Rating Scale (NRS) where 0 was 'No pain' and 10 was 'Most severe pain'. Usually, a 10 % difference (ie, a 1 point difference on a Numeric Rating Scale (NRS) ranging from 0 to 10) is considered the minimal clinically important difference used to interpret scores (Dworkin et al, 2008). Total score ranges from 0 to 10, with lower scores indicating a worse outcome. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing total spinal pain assessment at Week 48.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    86
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -3.8 ± 2.5
    No statistical analyses for this end point

    Secondary: Change from Baseline in total spinal pain at Week 96 assessed by Numerical Rating Scale (NRS)

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    End point title
    Change from Baseline in total spinal pain at Week 96 assessed by Numerical Rating Scale (NRS)
    End point description
    The total spinal pain was assessed with the question 'How much pain of your spine due to spondylitis do you have?' using a Numeric Rating Scale (NRS) where 0 was 'No pain' and 10 was 'Most severe pain'. Usually, a 10 % difference (ie, a 1 point difference on a Numeric Rating Scale (NRS) ranging from 0 to 10) is considered the minimal clinically important difference used to interpret scores (Dworkin et al, 2008). Total score ranges from 0 to 10, with lower scores indicating a worse outcome. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing total spinal pain assessment at Week 96.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    82
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -4.1 ± 2.6
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 48 in the Bath Ankylosing Spondylitis Functional Index (BASFI)

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    End point title
    Change from Baseline to Week 48 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
    End point description
    The BASFI is a validated disease-specific instrument for assessing physical function (van Tubergen et al, 2015; Calin et al, 1994; van der Heijde et al, 2005). The BASFI comprises 10 items relating to the past week. The Numeric Rating Scale (NRS) version was used for the answering options of each item on a scale of 0 (“Easy”) to 10 (“Impossible”) (van Tubergen et al, 2002). The BASFI score is the mean of the 10 items such that the total score ranges from 0 to 10, with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing BASFI at Week 48.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    86
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -2.23 ± 2.33
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 96 in the Bath Ankylosing Spondylitis Functional Index (BASFI)

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    End point title
    Change from Baseline to Week 96 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
    End point description
    The BASFI is a validated disease-specific instrument for assessing physical function (van Tubergen et al, 2015; Calin et al, 1994; van der Heijde et al, 2005). The BASFI comprises 10 items relating to the past week. The Numeric Rating Scale (NRS) version was used for the answering options of each item on a scale of 0 (“Easy”) to 10 (“Impossible”) (van Tubergen et al, 2002). The BASFI score is the mean of the 10 items such that the total score ranges from 0 to 10, with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing BASFI at Week 96.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    82
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -2.28 ± 2.53
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 48 in Inflammation assessed by the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness and duration

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    End point title
    Change from Baseline to Week 48 in Inflammation assessed by the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness and duration
    End point description
    The BASDAI is a validated self-reported instrument which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration for each disease activity, respectively) over the last week. The mean of the 2 BASDAI questions related to morning stiffness (questions 5 and 6) ranged from 0 to 10, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing BASDAI at Week 48.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 48
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    86
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -3.7 ± 2.8
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 96 in Inflammation assessed by the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness and duration

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    End point title
    Change from Baseline to Week 96 in Inflammation assessed by the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness and duration
    End point description
    The BASDAI is a validated self-reported instrument which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration for each disease activity, respectively) over the last week. The mean of the 2 BASDAI questions related to morning stiffness (questions 5 and 6) ranged from 0 to 10, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP. Number of participants analyzed reflect those with a non-missing BASDAI at Week 96.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 96
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    82
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -3.8 ± 2.7
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting at least one Treatment-Emergent Adverse Events (TEAEs) during the study

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    End point title
    Percentage of participants reporting at least one Treatment-Emergent Adverse Events (TEAEs) during the study
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The Safety Set consisted of all study participants in the Enrolled Set who had received at least 1 dose of IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline up to the Safety Follow-up Visit (up to Week 104)
    End point values
    Certolizumab Pegol (SS)
    Number of subjects analysed
    89
    Units: percentage of participants
        number (not applicable)
    80.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events were collected from Baseline to the Safety Follow-up Visit (up to Week 104)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Certolizumab Pegol (SS)
    Reporting group description
    Participants received a loading dose of Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc Q2W (starting at Week 6 until Week 94).

    Serious adverse events
    Certolizumab Pegol (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 89 (12.36%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemangioma
         subjects affected / exposed
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 89 (2.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Sarcoidosis
         subjects affected / exposed
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Uveitis
         subjects affected / exposed
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Incarcerated hernia
         subjects affected / exposed
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vestibular disorder
         subjects affected / exposed
    2 / 89 (2.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Anal polyp
         subjects affected / exposed
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Tenosynovitis
         subjects affected / exposed
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia haemophilus
         subjects affected / exposed
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Certolizumab Pegol (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    51 / 89 (57.30%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 89 (5.62%)
         occurrences all number
    5
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    5 / 89 (5.62%)
         occurrences all number
    5
    Eye disorders
    Uveitis
         subjects affected / exposed
    14 / 89 (15.73%)
         occurrences all number
    23
    Iridocyclitis
         subjects affected / exposed
    8 / 89 (8.99%)
         occurrences all number
    12
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 89 (6.74%)
         occurrences all number
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    15 / 89 (16.85%)
         occurrences all number
    22
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 89 (13.48%)
         occurrences all number
    15
    Influenza
         subjects affected / exposed
    6 / 89 (6.74%)
         occurrences all number
    9
    Rhinitis
         subjects affected / exposed
    6 / 89 (6.74%)
         occurrences all number
    9

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jan 2017
    Global Protocol Amendment 2 (dated 17 Jan 2017) was a substantial protocol amendment implemented to provide clarification on Magnetic Resonance Imaging (MRI) and x-ray assessments. In addition, information concerning the collection of data for the assessment of Anterior Uveitis (AU) flares and information concerning Hy’s Law cases was added. Other minor updates/clarifications were also made. Details of global changes are provided below: • Clarification was added that if no chest x-ray was available within the 3 months prior to Screening, the x-ray could be done during the Screening Period. If the modified New York (mNY) classification criteria were met in the x-ray performed prior to Screening, the x-ray was not to be repeated. • Clarification was added that an MRI assessment was not needed for study participants with Ankylosing Spondylitis (AS) and that AS study participants were to have evidence of sacroiliitis on x-ray taken prior to Baseline, meeting the mNY classification criteria according to the Investigator. • Minor updates were made to ophthalmic exclusion criteria and prior concomitant medications exclusion table. • Minor edits were made to text concerning storage conditions at the site. • Details about the information collected for the assessment of AU flares were added. • Information concerning Hy’s Law cases was added to the Adverse Events (AEs) of Interest section. • Minor corrections were made globally.

    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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