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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 12 Weeks to Subjects With Active Ankylosing Spondylitis

    Summary
    EudraCT number
    2016-003636-21
    Trial protocol
    EE   CZ   ES   BG   BE  
    Global end of trial date
    02 Jul 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Apr 2019
    First version publication date
    24 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG0634-CL-223
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03117270
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Study Acronym: TORTUGA
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Clinical Trial Information Desk, Galapagos NV, +32 15342 900, rd@glpg.com
    Scientific contact
    Clinical Trial Information Desk, Galapagos NV, +32 15342 900, rd@glpg.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
    31 Jan 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: - Evaluate the effect of filgotinib 200 mg once daily compared with placebo once daily on the signs and symptoms of ankylosing spondylitis (AS), as assessed by the ankylosing spondylitis disease activity score (ASDAS) at Week 12 Secondary Objectives: - Evaluate the effect of filgotinib 200 mg compared with placebo on: - The signs and symptoms of AS - Physical function - Spinal mobility - Spinal and sacroiliac joint inflammation - Enthesitis - Quality of life - Evaluate the safety and tolerability of filgotinib 200 mg
    Protection of trial subjects
    This study was conducted in accordance with recognized international scientific and ethical standards including, but not limited to, the International Council for Harmonisation (ICH) guideline for Good Clinical Practice (GCP) (Sections 7.6 and 8.2), and the original principles embodied in the Declaration of Helsinki. These standards are consistent with the requirements of the European Community Directive 2001/20/EC. For Ukraine, standards were in accordance with Ukraine Guidance “Medicinal Products. Good clinical practice ССТ-Н МОЗУ 42-7.0:2008” approved by Ministry of Health Order of 16 February 2009 No. 95 and with consideration of requirements of Directive 2001/20/EC. Investigators (or designee[s]) were responsible for obtaining written informed consent from each individual who participated in this study after adequate explanation of the aims, methods, objectives, and potential hazards of the study and before undertaking any study-related procedures. Participants were informed that they were completely free to refuse to enter the study or to withdraw from it at any time for any reason.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Mar 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ukraine: 64
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Bulgaria: 24
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    Estonia: 2
    Worldwide total number of subjects
    116
    EEA total number of subjects
    52
    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)
    115
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled at study sites in Europe. The first participant was screened on 07 March 2017. The last study visit occurred on 02 July 2018.

    Pre-assignment
    Screening details
    263 subjects were screened, of whom 116 were randomized and received at least 1 dose of study drug.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Filgotinib 200 mg
    Arm description
    Participants received filgotinib 200 mg tablet orally once daily for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    GLPG0634
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received filgotinib 200 mg tablet orally once daily for 12 weeks.

    Arm title
    Placebo
    Arm description
    Participants received placebo to match filgotinib tablet orally once daily for 12 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo to match filgotinib tablet orally once daily for 12 weeks.

    Number of subjects in period 1
    Filgotinib 200 mg Placebo
    Started
    58
    58
    Completed
    55
    52
    Not completed
    3
    6
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    1
    -
         Protocol violation
    -
    1
         Lost to follow-up
    2
    2
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    Participants received filgotinib 200 mg tablet orally once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo to match filgotinib tablet orally once daily for 12 weeks.

    Reporting group values
    Filgotinib 200 mg Placebo Total
    Number of subjects
    58 58 116
    Age categorical
    Units: Subjects
        < 40 years
    26 25 51
        40 to 50 years
    19 24 43
        50 to 65 years
    12 9 21
        > 65 years
    1 0 1
    Age continuous
    Units: years
        median (full range (min-max))
    45 (21 to 73) 43 (21 to 64) -
    Gender categorical
    Units: Subjects
        Female
    13 17 30
        Male
    45 41 86
    Race
    Units: Subjects
        White
    58 58 116
    Body Mass Index
    Units: kg/m²
        median (full range (min-max))
    25.17 (18.22 to 37.90) 25.74 (16.49 to 43.82) -

    End points

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    End points reporting groups
    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    Participants received filgotinib 200 mg tablet orally once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo to match filgotinib tablet orally once daily for 12 weeks.

    Primary: Change From Baseline in the Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12

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    End point title
    Change From Baseline in the Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
    End point description
    The ASDAS is a composite score of 5 domains: total back pain rated on a 0 to 10 numeric rating scale (NRS) (0 = not severe and 10 = very severe); patient’s global assessment of disease activity (PGADA) rated on a 0 to 10 NRS (0 = not active and 10 = very active); peripheral joint pain and/or swelling rated on a 0 to 10 NRS (0 = not severe and 10 = very severe); duration of morning stiffness rated on a 0 to 10 NRS (0 = 0 hours and 10 = 2 or more hours); high-sensitivity C-reactive protein (hsCRP) in mg/L (if hsCRP was nonmissing and < 2 mg/L, 2 mg/L was used in calculation). ASDAS = 0.121 × (total back pain) + 0.110 × (PGADA) + 0.073 × (peripheral joint pain and/or swelling) + 0.058 × (duration of morning stiffness) + 0.579 × Ln(max[hsCRP, 2] + 1). The ASDAS has a continuous scale starting from 0 with no defined upper end. A higher score indicated higher disease activity. The Full Analysis Set included all randomized participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58 [1]
    58 [2]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    4.2 ± 0.62
    4.2 ± 0.79
        Change at Week 12
    -1.5 ± 1.04
    -0.6 ± 0.82
    Notes
    [1] - Missing values were imputed using the Last Observation Carried Forward (LOCF) method.
    [2] - Missing values were imputed using the Last Observation Carried Forward (LOCF) method.
    Statistical analysis title
    Change in ASDAS at Week 12
    Statistical analysis description
    Analysis of covariance (ANCOVA) model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Least-Squares (LS) Mean Difference
    Point estimate
    -0.85
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.17
         upper limit
    -0.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16

    Secondary: Percentage of Participants Achieving Assessment of Spondylo Arthritis international Society (ASAS)20 Response at Week 12

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    End point title
    Percentage of Participants Achieving Assessment of Spondylo Arthritis international Society (ASAS)20 Response at Week 12
    End point description
    The ASAS20 response was defined as at least 20% improvement and at least 1-unit improvement in at least 3 out of 4 domains, and no worsening by at least 20% and at least 1 unit in the remaining domain. The 4 domains used were: PGADA rated on a 0 to 10 NRS (0 = not active and 10 = very active); patient’s assessment of spinal pain (PASP) rated on a 0 to 10 NRS (0 = no pain and 10 = most severe pain); bath ankylosing spondylitis functional index (BASFI) that rated physical functioning on a 0 to 10 NRS (0 = easy and 10 = impossible); and morning stiffness intensity and duration rated on a 0 to 10 NRS (0 = not severe or 0 hours and 10 = very severe or ≥ 2 hours). The 95% confidence interval (CI) for response rate was computed using the Wilson method. The participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: percentage of participants
        number (confidence interval 95%)
    75.9 (63.47 to 85.04)
    39.7 (28.09 to 52.51)
    Statistical analysis title
    ASAS20 Response Rate at Week 12
    Statistical analysis description
    Cochran-Mantel-Haenszel test for general association, controlling for randomization stratification factors was used for the calculation of between-group p-value. 95% CI for the difference in response rate was computed using the Newcombe method.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    36.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.35
         upper limit
    50.97

    Secondary: Percentage of Participants Achieving ASAS40 Response at Week 12

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    End point title
    Percentage of Participants Achieving ASAS40 Response at Week 12
    End point description
    The ASAS40 response was defined as at least 40% improvement and at least 2-unit improvement in at least 3 out of 4 domains, and no worsening at all in the remaining domain. The 4 domains used were: PGADA rated on a 0 to 10 NRS (0 = not active and 10 = very active); PASP rated on a 0 to 10 NRS (0 = no pain and 10 = most severe pain); BASFI that rated physical functioning on a 0 to 10 NRS (0 = easy and 10 = impossible); and morning stiffness intensity and duration rated on a 0 to 10 NRS (0 = not severe or 0 hours and 10 = very severe or ≥ 2 hours). The 95% CI for response rate was computed using the Wilson method. The participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: percentage of participants
        number (confidence interval 95%)
    37.9 (26.56 to 50.80)
    19.0 (10.93 to 30.85)
    Statistical analysis title
    ASAS40 Response Rate at Week 12
    Statistical analysis description
    Cochran-Mantel-Haenszel test for general association, controlling for randomization stratification factors was used for the calculation of between-group p-value. 95% CI for the difference in response rate was computed using the Newcombe method.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0189
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    18.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.52
         upper limit
    34.13

    Secondary: Percentage of Participants Achieving ASAS5/6 Response at Week 12

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    End point title
    Percentage of Participants Achieving ASAS5/6 Response at Week 12
    End point description
    The ASAS5/6 response was defined as at least 20% improvement in at least 5 out of 6 domains. The 6 domains used were: PGADA rated on a 0 to 10 NRS (0 = not active and 10 = very active); PASP rated on a 0 to 10 NRS (0 = no pain and 10 = most severe pain); BASFI that rated physical functioning on a 0 to 10 NRS (0 = easy and 10 = impossible); morning stiffness intensity and duration rated on a 0 to 10 NRS (0 = not severe or 0 hours and 10 = very severe or ≥ 2 hours); lateral spinal flexion (measured in cm with higher value = improvement); and hsCRP (higher value = worsening). The 95% CI for response rate was computed using the Wilson method. The participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: percentage of participants
        number (confidence interval 95%)
    58.6 (45.80 to 70.37)
    20.7 (12.25 to 32.77)
    Statistical analysis title
    ASAS5/6 Response Rate at Week 12
    Statistical analysis description
    Cochran-Mantel-Haenszel test for general association, controlling for randomization stratification factors was used for the calculation of between-group p-value. 95% CI for the difference in response rate was computed using the Newcombe method.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    37.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.31
         upper limit
    52.4

    Secondary: Percentage of Participants Achieving ASAS Partial Remission (ASASPR) Response at Week 12

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    End point title
    Percentage of Participants Achieving ASAS Partial Remission (ASASPR) Response at Week 12
    End point description
    The ASASPR response was defined as achieving a value of not above 2 in each of 4 domains. The 4 domains used were: PGADA rated on a 0 to 10 NRS (0 = not active and 10 = very active); PASP rated on a 0 to 10 NRS (0 = no pain and 10 = most severe pain); BASFI that rated physical functioning on a 0 to 10 NRS (0 = easy and 10 = impossible); and morning stiffness intensity and duration rated on a 0 to 10 NRS (0 = not severe or 0 hours and 10 = very severe or ≥ 2 hours). The 95% CI for response rate was computed using the Wilson method. The participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: percentage of participants
        number (confidence interval 95%)
    12.1 (5.97 to 22.88)
    3.4 (0.95 to 11.73)
    Statistical analysis title
    ASASPR Response Rate at Week 12
    Statistical analysis description
    Cochran-Mantel-Haenszel test for general association, controlling for randomization stratification factors was used for the calculation of between-group p-value. 95% CI for the difference in response rate was computed using the Newcombe method.
    Comparison groups
    Placebo v Filgotinib 200 mg
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1028
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    8.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.66
         upper limit
    19.72

    Secondary: Change From Baseline in the Tender Joint Count of 44 Joints (TJC44) at Week 12

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    End point title
    Change From Baseline in the Tender Joint Count of 44 Joints (TJC44) at Week 12
    End point description
    Each of the following 44 joints were evaluated for tenderness: 2 sternoclavicular joints (left and right); 2 acromioclavicular joints (left and right); 2 shoulder joints (left and right); 2 elbows (left and right); 2 wrists (left and right); 10 metacarpophalangeal joints (left and right); 10 proximal interphalangeal joints (hands) (left and right); 2 knees (left and right); 2 ankles (left and right); 10 metatarsophalangeal joints (left and right). The tender joint count was done by scoring the presence or absence of tenderness as assessed by pressure and joint manipulation on physical examination. Baseline value was the last non-missing value on or prior to first dose date of study drug. Missing values were imputed using the LOCF method. The participants in Full Analysis Set with ≥ 1 tender joint at baseline were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    41
    47
    Units: tender joints
    arithmetic mean (standard deviation)
        Baseline
    5.2 ± 4.93
    4.0 ± 2.46
        Change at Week 12
    -2.9 ± 3.00
    -1.5 ± 2.49
    Statistical analysis title
    Change in TJC44 at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0849
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.68
         upper limit
    0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.45

    Secondary: Change From Baseline in the Swollen Joint Count of 44 Joints (SJC44) at Week 12

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    End point title
    Change From Baseline in the Swollen Joint Count of 44 Joints (SJC44) at Week 12
    End point description
    Each of the following 44 joints were evaluated for swelling: 2 sternoclavicular joints (left and right); 2 acromioclavicular joints (left and right); 2 shoulder joints (left and right); 2 elbows (left and right); 2 wrists (left and right); 10 metacarpophalangeal joints (left and right); 10 proximal interphalangeal joints (hands) (left and right); 2 knees (left and right); 2 ankles (left and right); 10 metatarsophalangeal joints (left and right). Synovial fluid and/or soft tissue swelling, but not bony overgrowth, represented a positive result for swollen joint count. Baseline value was the last non-missing value on or prior to first dose date of study drug. Missing values were imputed using the LOCF method. The participants in Full Analysis Set with ≥ 1 swollen joint at baseline were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    15
    20
    Units: swollen joints
    arithmetic mean (standard deviation)
        Baseline
    1.8 ± 1.82
    2.2 ± 1.54
        Change at Week 12
    -1.7 ± 1.88
    -1.8 ± 1.65
    Statistical analysis title
    Change in SJC44 at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1779
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.76
         upper limit
    0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22

    Secondary: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) (Decrease of ASDAS From Baseline ≥ 1.1) at Week 12

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    End point title
    Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) (Decrease of ASDAS From Baseline ≥ 1.1) at Week 12
    End point description
    The CMI was defined as a decrease in ASDAS from baseline of ≥ 1.1 points. The ASDAS is a composite score of 5 domains: total back pain (0 to 10 NRS, 0 = not severe and 10 = very severe); PGADA (0 to 10 NRS, 0 = not active and 10 = very active); peripheral joint pain and/or swelling (0 to 10 NRS, 0 = not severe and 10 = very severe); duration of morning stiffness (0 to 10 NRS, 0 = 0 hours and 10 = 2 or more hours); hsCRP in mg/L. ASDAS = 0.121 × (total back pain) + 0.110 × (PGADA) + 0.073 × (peripheral joint pain and/or swelling) + 0.058 × (duration of morning stiffness) + 0.579 × Ln(max[hsCRP, 2] + 1). The ASDAS has a continuous scale starting from 0 with no defined upper end. A higher score indicated higher disease activity. The 95% CI for response rate was computed using the Wilson method. The participants in Full Analysis Set with baseline ASDAS value ≥ 1.1 were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: percentage of participants
        number (confidence interval 95%)
    65.5 (52.67 to 76.44)
    25.9 (16.35 to 38.38)
    Statistical analysis title
    CMI at Week 12
    Statistical analysis description
    Cochran-Mantel-Haenszel test for general association, controlling for randomization stratification factors was used for the calculation of between-group p-value. 95% CI for the difference in response rate was computed using the Newcombe method.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    39.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    21.72
         upper limit
    54.14

    Secondary: Percentage of Participants Achieving Major Improvement (MI) (Decrease of ASDAS From Baseline ≥ 2.0) at Week 12

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    End point title
    Percentage of Participants Achieving Major Improvement (MI) (Decrease of ASDAS From Baseline ≥ 2.0) at Week 12
    End point description
    The MI was defined as a decrease in ASDAS from baseline of ≥ 2.0 points. The ASDAS is a composite score of 5 domains: total back pain (0 to 10 NRS, 0 = not severe and 10 = very severe); PGADA (0 to 10 NRS, 0 = not active and 10 = very active); peripheral joint pain and/or swelling (0 to 10 NRS, 0 = not severe and 10 = very severe); duration of morning stiffness (0 to 10 NRS, 0 = 0 hours and 10 = 2 or more hours); hsCRP in mg/L. ASDAS = 0.121 × (total back pain) + 0.110 × (PGADA) + 0.073 × (peripheral joint pain and/or swelling) + 0.058 × (duration of morning stiffness) + 0.579 × Ln(max[hsCRP, 2] + 1). The ASDAS has a continuous scale starting from 0 with no defined upper end. A higher score indicated higher disease activity. The 95% CI for response rate was computed using the Wilson method. The participants in Full Analysis Set with baseline ASDAS value ≥ 2.0 were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: percentage of participants
        number (confidence interval 95%)
    32.8 (22.08 to 45.58)
    1.7 (0.31 to 9.14)
    Statistical analysis title
    MI at Week 12
    Statistical analysis description
    Cochran-Mantel-Haenszel test for general association, controlling for randomization stratification factors was used for the calculation of between-group p-value. 95% CI for the difference in response rate was computed using the Newcombe method.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    31.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.04
         upper limit
    43.93

    Secondary: Percentage of Participants Achieving Inactive Disease (ID) (ASDAS <1.3) at Week 12

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    End point title
    Percentage of Participants Achieving Inactive Disease (ID) (ASDAS <1.3) at Week 12
    End point description
    The ID was defined as an ASDAS value < 1.3. The ASDAS is a composite score of 5 domains: total back pain (0 to 10 NRS, 0 = not severe and 10 = very severe); PGADA (0 to 10 NRS, 0 = not active and 10 = very active); peripheral joint pain and/or swelling (0 to 10 NRS, 0 = not severe and 10 = very severe); duration of morning stiffness (0 to 10 NRS, 0 = 0 hours and 10 = 2 or more hours); hsCRP in mg/L. ASDAS = 0.121 × (total back pain) + 0.110 × (PGADA) + 0.073 × (peripheral joint pain and/or swelling) + 0.058 × (duration of morning stiffness) + 0.579 × Ln(max[hsCRP, 2] + 1). The ASDAS has a continuous scale starting from 0 with no defined upper end. A higher score indicated higher disease activity. The 95% CI for response rate was computed using the Wilson method. The participants in Full Analysis Set with baseline ASDAS value ≥ 1.3 were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: percentage of participants
        number (confidence interval 95%)
    5.2 (1.77 to 14.14)
    0.0 (0.00 to 6.21)
    Statistical analysis title
    ID at Week 12
    Statistical analysis description
    Cochran-Mantel-Haenszel test for general association, controlling for randomization stratification factors was used for the calculation of between-group p-value. 95% CI for the difference in response rate was computed using the Newcombe method.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0921
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    5.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.91
         upper limit
    14.14

    Secondary: Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50% Response (BASDAI50) at Week 12

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    End point title
    Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50% Response (BASDAI50) at Week 12
    End point description
    The BASDAI is a 6-item index (fatigue, spinal pain, peripheral arthritis, enthesitis, intensity and duration of morning stiffness) in which the items were rated on a 0 to 10 NRS (0 = none or 0 hour and 10 = very severe or ≥ 2 hours). The BASDAI total score = (Q1 + Q2 + Q3 + Q4 + [(Q5 + Q6)/2])/5. The BASDAI total score ranged from 0 to 10, with a higher score indicating more severe disease activity. The BASDAI50 response was defined as a decrease in BASDAI total score from baseline of ≥ 50%. The 95% CI for response rate was computed using the Wilson method. The participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: percentage of participants
        number (confidence interval 95%)
    24.1 (14.96 to 36.53)
    13.8 (7.16 to 24.93)
    Statistical analysis title
    BASDAI50 Response Rate at Week 12
    Statistical analysis description
    Cochran-Mantel-Haenszel test for general association, controlling for randomization stratification factors was used for the calculation of between-group p-value. 95% CI for the difference in response rate was computed using the Newcombe method.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1134
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    10.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.08
         upper limit
    24.4

    Secondary: Percentage of Participants Achieving ≥ 2 Units Improvement in BASDAI Total Score From Baseline at Week 12

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    End point title
    Percentage of Participants Achieving ≥ 2 Units Improvement in BASDAI Total Score From Baseline at Week 12
    End point description
    The BASDAI is a 6-item index (fatigue, spinal pain, peripheral arthritis, enthesitis, intensity and duration of morning stiffness) in which the items were rated on a 0 to 10 NRS (0 = none or 0 hour and 10 = very severe or ≥ 2 hours). The BASDAI total score = (Q1 + Q2 + Q3 + Q4 + [(Q5 + Q6)/2])/5. The BASDAI total score ranged from 0 to 10, with a higher score indicating more severe disease activity. Percentage of participants achieving ≥ 2 units improvement in BASDAI from baseline at different time points was reported. The 95% CI for response rate was computed using the Wilson method. The participants in Full Analysis Set with baseline BASDAI value ≥ 2 were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: percentage of participants
        number (confidence interval 95%)
    58.6 (45.80 to 70.37)
    31.0 (20.62 to 43.80)
    Statistical analysis title
    BASDAI ≥ 2 units improvement at Week 12
    Statistical analysis description
    Cochran-Mantel-Haenszel test for general association, controlling for randomization stratification factors was used for the calculation of between-group p-value. 95% CI for the difference in response rate was computed using the Newcombe method.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0025
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Response Rate Difference
    Point estimate
    27.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.49
         upper limit
    43.29

    Secondary: Change From Baseline in BASDAI Total Score at Week 12

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    End point title
    Change From Baseline in BASDAI Total Score at Week 12
    End point description
    The BASDAI is a 6-item index (fatigue, spinal pain, peripheral arthritis, enthesitis, intensity and duration of morning stiffness) in which the items were rated on a 0 to 10 NRS (0 = none or 0 hour and 10 = very severe or ≥ 2 hours). The BASDAI total score = (Q1 + Q2 + Q3 + Q4 + [(Q5 + Q6)/2])/5. The BASDAI total score ranged from 0 to 10, with a higher score indicating more severe disease activity. Baseline value was the last non-missing value on or prior to first dose date of study drug. Missing values were imputed using the LOCF method. The participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    6.9 ± 1.16
    7.0 ± 1.33
        Change at Week 12
    -2.4 ± 2.01
    -1.4 ± 2.02
    Statistical analysis title
    Change in BASDAI Total Score at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0052
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.69
         upper limit
    -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.35

    Secondary: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 12

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    End point title
    Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 12
    End point description
    The BASFI total score was calculated as the average of 10 items (putting on socks, bending, reaching up, 2 items on getting up, standing, climbing steps, looking over shoulder, physical demanding activities, and full day’s activities) that were rated on a 0 to 10 NRS (0 = easy and 10 = impossible). The BASFI total score ranged from 0 to 10, with a higher BASFI indicating a higher level of functional impairment. Baseline value was the last non-missing value on or prior to first dose date of study drug. Missing values were imputed using the LOCF method. The participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    7.0 ± 1.48
    6.9 ± 1.55
        Change at Week 12
    -2.4 ± 1.90
    -1.2 ± 1.88
    Statistical analysis title
    Change in BASFI Total Score at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0015
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -1.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.78
         upper limit
    -0.43
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34

    Secondary: Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Week 12

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    End point title
    Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Week 12
    End point description
    The BASMI total score was calculated as the average of 5 items (lateral spinal flexion, tragus-to-wall distance, lumber flexion [modified Schober], maximal intermalleolar distance, and cervical rotation). The unit for the first 4 items was ‘cm’, the unit for cervical rotation was ‘degree’. Each item outcome was converted to score ranging from 0 to 10. The BASMI total score ranged from 0 to 10, with a higher score indicating a more severe limitation of movement due to ankylosing spondylitis. Baseline value was the last non-missing value on or prior to first dose date of study drug. Missing values were imputed using the LOCF method. The participants in Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    56
    58
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    5.1 ± 1.65
    5.3 ± 1.55
        Change at Week 12
    -0.8 ± 1.02
    -0.4 ± 0.70
    Statistical analysis title
    Change in BASMI Total Score at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0093
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.68
         upper limit
    -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15

    Secondary: Change From Baseline in Chest Expansion at Week 12

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    End point title
    Change From Baseline in Chest Expansion at Week 12
    End point description
    Chest expansion was measured as the difference between maximal inspiration and maximal forced expiration at the fourth intercostal space (in cm). The better of 2 assessments was reported. Baseline value was the last non-missing value on or prior to first dose date of study drug. Missing values were imputed using the LOCF method. The participants in Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    56
    58
    Units: cm
    arithmetic mean (standard deviation)
        Baseline
    3.2 ± 2.12
    2.5 ± 1.55
        Change at Week 12
    0.2 ± 1.53
    0.0 ± 1.31
    Statistical analysis title
    Change in Chest Expansion at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0254
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0.53
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.07
         upper limit
    0.99
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23

    Secondary: Change From Baseline in Occiput-To-Wall Distance at Week 12

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    End point title
    Change From Baseline in Occiput-To-Wall Distance at Week 12
    End point description
    Occiput-to-wall distance was measured as the distance (in cm) between the occiput and the wall with the participant’s heels and back rested against the wall. The better of 2 assessments was reported. Baseline value was the last non-missing value on or prior to first dose date of study drug. Missing values were imputed using the LOCF method. The participants in Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    56
    58
    Units: cm
    arithmetic mean (standard deviation)
        Baseline
    10.5 ± 8.31
    10.6 ± 7.99
        Change at Week 12
    -1.5 ± 3.80
    -1.0 ± 4.70
    Statistical analysis title
    Change in Occiput-To-Wall Distance at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6141
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.85
         upper limit
    1.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.74

    Secondary: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score at Week 12

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    End point title
    Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score at Week 12
    End point description
    The MRI images of the spine and sacroiliac joints were scored by a central reader using the SPARCC scoring system. Spine lesions were scored in all 23 spinal discovertebral units and total scores were provided. The maximal score for each discovertebral unit was 18, so the maximum SPARCC spine total score was 18 × 23 = 414. Sacroiliac joints were scored using 6 consecutive coronal slices from posterior to anterior. The maximal score for a single coronal slice was 12, so the maximum SPARCC sacroiliac joint total score was 12 × 6 = 72. The participants in Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    56
    53
    Units: units on a scale
    arithmetic mean (standard deviation)
        Spine Lesion: Baseline (n = 54, 52)
    19.0 ± 19.71
    13.8 ± 19.93
        Spine Lesion: Change at Week 12 (n = 47, 42)
    -5.8 ± 11.13
    0.5 ± 7.47
        Sacroiliac Joints: Baseline (n = 56, 53)
    6.8 ± 10.89
    5.3 ± 6.93
        Sacroiliac Joints: Change at Week 12 (n = 48, 42)
    -3.5 ± 7.31
    0.1 ± 3.51
    Statistical analysis title
    Change in Spine Lesions SPARCC MRI at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value. Actual number of subjects included in this analysis = 89.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0066
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -5.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.75
         upper limit
    -1.62
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.04
    Statistical analysis title
    Change in Sacroiliac Joints SPARCC MRI at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value. Actual number of subjects included in this analysis = 90.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.015
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -2.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.2
         upper limit
    -0.46
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.94

    Secondary: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12

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    End point title
    Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12
    End point description
    The MASES assessed the enthesitis disease status in 13 sites: costochondral 1 right/left, costochondral 7 right/left, spina iliaca anterior superior right/left, crista iliaca right/left, spina iliaca posterior right/left, processus spinosus L5, Achilles tendon, proximal insertion right/left. Each site was categorized as: permanently not assessable, temporarily not assessable, asymptomatic, and tender only. Both “permanently not assessable” and “temporarily not assessable” were considered as missing assessments. For each non-missing site, a score of 1 was assigned for “tender only” and a score of 0 otherwise. The MASES was calculated as the sum of the scores of the 13 sites and ranged from 0 to 13. A higher score indicated a higher level of enthesitis. Baseline value was the last non-missing value on or prior to first dose date of study drug. Missing values were imputed using the LOCF method. The participants in Full Analysis Set with enthesitis at baseline were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    47
    48
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    4.9 ± 2.79
    4.1 ± 2.86
        Change at Week 12
    -2.5 ± 2.79
    -2.2 ± 3.30
    Statistical analysis title
    Change in MASES at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6012
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.7
         upper limit
    1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.48

    Secondary: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Week 12

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    End point title
    Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Week 12
    End point description
    The FACIT-Fatigue scale consisted of 13 items, each scored on a 5-point scale (0 = not at all to 4 = very much). The larger the participant's response to the questions (with the exception of 2 negatively stated that are scored reversely), the greater the fatigue. The sum of all responses resulted in the FACIT-Fatigue total score that ranged from 0 (worse score) to 52 (better score), with a higher score indicating a better quality of life. Baseline value was the last non-missing value on or prior to first dose date of study drug. Missing values were imputed using the LOCF method. The participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    24.1 ± 9.56
    24.2 ± 9.39
        Change at Week 12
    8.9 ± 8.86
    5.3 ± 10.94
    Statistical analysis title
    Change in FACIT-Fatigue Total Score at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0422
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    3.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.12
         upper limit
    6.75
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.67

    Secondary: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Summary Scores at Week 12

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    End point title
    Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Summary Scores at Week 12
    End point description
    The SF-36 questionnaire consisted of 36 questions divided over 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health), with each domain score ranging from 0 (worst) to 100 (best), and higher scores reflecting better health-related functional status. Two summary scores (Mental Component Summary [MCS] and Physical Component Summary [PCS]) were computed based on weighted combinations of the 8 domain scores. The summary scores were standardized to score ranging from 0 to 100 using the SF-36’s recalibration software, with higher scores indicated a better quality of life. Baseline value was the last non-missing value on or prior to first dose date of study drug. Missing values were imputed using the LOCF method. The participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: units on a scale
    arithmetic mean (standard deviation)
        MCS: Baseline
    43.7 ± 11.11
    44.2 ± 10.62
        MCS: Change at Week 12
    4.0 ± 7.05
    1.0 ± 9.83
        PCS: Baseline
    33.1 ± 5.63
    33.3 ± 5.79
        PCS: Change at Week 12
    8.4 ± 8.18
    3.8 ± 7.10
    Statistical analysis title
    Change in SF36-MCS at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0703
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    2.54
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.21
         upper limit
    5.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.39
    Statistical analysis title
    Change in SF36-PCS at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0008
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    4.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.88
         upper limit
    6.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.27

    Secondary: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Week 12

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    End point title
    Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Week 12
    End point description
    The ASQoL consisted of 18 yes/no questions, with 1 point assigned for each ‘yes’ response. The ASQoL total score was the sum of the 18 items and ranged from 0 to 18. A lower score indicated a better quality of life. Baseline value was the last non-missing value on or prior to first dose date of study drug. Missing values were imputed using the LOCF method. The participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Filgotinib 200 mg Placebo
    Number of subjects analysed
    58
    58
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    12.8 ± 3.52
    11.8 ± 4.52
        Change at Week 12
    -4.8 ± 4.50
    -2.2 ± 3.97
    Statistical analysis title
    Change in ASQoL Total Score at Week 12
    Statistical analysis description
    ANCOVA model with factors for treatment, baseline value, and randomization stratification was used for the calculation of between-group p-value.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0038
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -2.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.92
         upper limit
    -0.77
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.79

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 12 plus 30 days
    Adverse event reporting additional description
    The Safety Analysis Set included all participants who received at least 1 dose of study drug. The threshold of 3.4% applied for reporting non-serious adverse events corresponds to 2 subjects in a group.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    Participants received filgotinib 200 mg tablet orally once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo to match filgotinib tablet orally once daily for 12 weeks.

    Serious adverse events
    Filgotinib 200 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Pneumonia bacterial
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3.4%
    Non-serious adverse events
    Filgotinib 200 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 58 (31.03%)
    18 / 58 (31.03%)
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 58 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    0
    3
    Neutrophil count decreased
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 58 (1.72%)
         occurrences all number
    3
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 58 (5.17%)
    0 / 58 (0.00%)
         occurrences all number
    4
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    2 / 58 (3.45%)
    3 / 58 (5.17%)
         occurrences all number
    2
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 58 (3.45%)
    4 / 58 (6.90%)
         occurrences all number
    2
    4
    Urinary tract infection
         subjects affected / exposed
    1 / 58 (1.72%)
    2 / 58 (3.45%)
         occurrences all number
    1
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2017
    The benefit-risk assessment was updated based on clinical information regarding serious infections, lymphoma, and other malignancies, in accordance with the current version of the Investigator’s Brochure (Edition 12, dated 22 May 2017). Also, an optional substudy was added, requiring a separate consent, in which urine and stool samples were to be collected for biomarker analysis. In addition, minor corrections, clarifications, and wording changes were made.

    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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