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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

    Summary
    EudraCT number
    2016-000568-41
    Trial protocol
    SK   GB   BE   HU   CZ   DE   ES   BG   PL   NL   IT  
    Global end of trial date
    20 Jun 2019

    Results information
    Results version number
    v2(current)
    This version publication date
    04 Jun 2021
    First version publication date
    05 Jul 2020
    Other versions
    v1
    Version creation reason
    • New data added to full data set
    Added additional secondary endpoints.

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-417-0301
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02889796
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.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
    20 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    Methotrexate (MTX) was used across all the arms as background therapy.
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Aug 2016
    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
    Slovakia: 8
    Country: Number of subjects enrolled
    South Africa: 34
    Country: Number of subjects enrolled
    Spain: 30
    Country: Number of subjects enrolled
    Taiwan: 44
    Country: Number of subjects enrolled
    Thailand: 23
    Country: Number of subjects enrolled
    Ukraine: 235
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    United States: 200
    Country: Number of subjects enrolled
    Argentina: 57
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Bulgaria: 34
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Czech Republic: 34
    Country: Number of subjects enrolled
    Germany: 20
    Country: Number of subjects enrolled
    Hong Kong: 7
    Country: Number of subjects enrolled
    Hungary: 47
    Country: Number of subjects enrolled
    India: 137
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Israel: 11
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Japan: 147
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 33
    Country: Number of subjects enrolled
    Mexico: 125
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    New Zealand: 18
    Country: Number of subjects enrolled
    Poland: 299
    Country: Number of subjects enrolled
    Romania: 31
    Country: Number of subjects enrolled
    Russian Federation: 118
    Country: Number of subjects enrolled
    Serbia: 21
    Worldwide total number of subjects
    1759
    EEA total number of subjects
    536
    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)
    1425
    From 65 to 84 years
    333
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled at study sites in Asia, South Africa, Australia, Europe, North America, South America and New Zealand. The first participant was screened on 30 August 2016. The last study visit occurred on 20 June 2019.

    Pre-assignment
    Screening details
    2582 participants were screened. Completed in the 'Placebo never received Filgotinib' arm included participants who completed 24 weeks of placebo treatment and were not rerandomized to Filgotinib 200 mg or 100 mg groups.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Filgotinib 200 mg
    Arm description
    Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match [PTM] filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034, GLPG0634
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg administered once daily

    Investigational medicinal product name
    PTM Filgotinib 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 100 mg administered once daily

    Investigational medicinal product name
    PTM Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PTM adalimumab 40 mg administered once every 2 weeks

    Arm title
    Filgotinib 100 mg
    Arm description
    Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034, GLPG0634
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg administered once daily

    Investigational medicinal product name
    PTM Filgotinib 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 200 mg administered once daily

    Investigational medicinal product name
    PTM Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PTM adalimumab 40 mg administered once every 2 weeks

    Arm title
    Adalimumab
    Arm description
    Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.
    Arm type
    Active comparator

    Investigational medicinal product name
    PTM Filgotinib 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 200 mg administered once daily

    Investigational medicinal product name
    PTM Filgotinib 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 100 mg administered once daily

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg administered once every 2 weeks

    Arm title
    Placebo to Filgotinib 200 mg
    Arm description
    Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 28.1 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    PTM Filgotinib 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 200 mg administered once daily

    Investigational medicinal product name
    PTM Filgotinib 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 100 mg administered once daily

    Investigational medicinal product name
    PTM Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PTM adalimumab 40 mg administered once every 2 weeks

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034, GLPG0634
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg administered once daily

    Arm title
    Placebo to Filgotinib 100 mg
    Arm description
    Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 28.1 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    PTM Filgotinib 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 200 mg administered once daily

    Investigational medicinal product name
    PTM Filgotinib 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 100 mg administered once daily

    Investigational medicinal product name
    PTM Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PTM adalimumab 40 mg administered once every 2 weeks

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034, GLPG0634
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg administered once daily

    Arm title
    Placebo never received Filgotinib
    Arm description
    Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    PTM Filgotinib 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 200 mg administered once daily

    Investigational medicinal product name
    PTM Filgotinib 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PTM filgotinib 100 mg administered once daily

    Investigational medicinal product name
    PTM Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PTM adalimumab 40 mg administered once every 2 weeks

    Number of subjects in period 1 [1]
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg Placebo never received Filgotinib
    Started
    475
    480
    325
    190
    191
    94
    Completed
    424
    422
    281
    181
    185
    24
    Not completed
    51
    58
    44
    9
    6
    70
         Death
    1
    1
    -
    1
    -
    1
         Non-compliance with study drug
    -
    2
    -
    -
    1
    2
         Protocol violation
    -
    1
    3
    -
    -
    4
         Adverse event
    17
    8
    8
    4
    1
    7
         Pregnancy
    -
    1
    1
    -
    -
    -
         Investigator`s discretion
    10
    9
    10
    3
    -
    15
         Withdrew consent
    18
    29
    20
    1
    2
    35
         Lost to follow-up
    5
    7
    2
    -
    2
    6
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Four participants who were randomized but did not receive the study drug are not included in analysis.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    -

    Reporting group values
    Overall Study Total
    Number of subjects
    1755 1755
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    53.0 ± 12.7 -
    Gender categorical
    Units: Subjects
        Female
    1435 1435
        Male
    320 320
    Race
    For participants in Not Permitted category: local regulators did not allow collection of race information.
    Units: Subjects
        American Indian or Alaska Native
    103 103
        Asian: Japanese
    147 147
        Asian: Chinese/Taiwanese/Hong Kong Chinese
    51 51
        Asian: Korean
    34 34
        Asian: Other
    179 179
        Black or African American
    35 35
        Native Hawaiian or Pacific Islander
    3 3
        White
    1184 1184
        Other
    17 17
        Not Permitted
    2 2
    Ethnicity
    For participants in Not Permitted category: local regulators did not allow collection of ethnicity information.
    Units: Subjects
        Hispanic or Latino
    262 262
        Not Hispanic or Latino
    1471 1471
        Not Permitted
    22 22
    Subject analysis sets

    Subject analysis set title
    Filgotinib 200 mg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of 52.1 weeks.

    Subject analysis set title
    Filgotinib 100 mg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.

    Subject analysis set title
    Adalimumab
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.

    Subject analysis sets values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects
    475
    480
    325
    475
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.0 ± 12.8
    53.0 ± 12.6
    53.0 ± 12.9
    53.0 ± 12.8
    Gender categorical
    Units: Subjects
        Female
    379
    399
    266
    391
        Male
    96
    81
    59
    84
    Race
    For participants in Not Permitted category: local regulators did not allow collection of race information.
    Units: Subjects
        American Indian or Alaska Native
    27
    27
    20
    29
        Asian: Japanese
    40
    41
    28
    38
        Asian: Chinese/Taiwanese/Hong Kong Chinese
    13
    12
    8
    18
        Asian: Korean
    13
    10
    4
    7
        Asian: Other
    56
    52
    25
    46
        Black or African American
    6
    7
    10
    12
        Native Hawaiian or Pacific Islander
    1
    0
    0
    2
        White
    312
    324
    229
    319
        Other
    7
    6
    1
    3
        Not Permitted
    0
    1
    0
    1
    Ethnicity
    For participants in Not Permitted category: local regulators did not allow collection of ethnicity information.
    Units: Subjects
        Hispanic or Latino
    67
    71
    54
    70
        Not Hispanic or Latino
    404
    399
    268
    400
        Not Permitted
    4
    10
    3
    5

    End points

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    End points reporting groups
    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match [PTM] filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.

    Reporting group title
    Filgotinib 100 mg
    Reporting group description
    Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.

    Reporting group title
    Adalimumab
    Reporting group description
    Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.

    Reporting group title
    Placebo to Filgotinib 200 mg
    Reporting group description
    Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 28.1 weeks.

    Reporting group title
    Placebo to Filgotinib 100 mg
    Reporting group description
    Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 28.1 weeks.

    Reporting group title
    Placebo never received Filgotinib
    Reporting group description
    Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks.

    Subject analysis set title
    Filgotinib 200 mg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of 52.1 weeks.

    Subject analysis set title
    Filgotinib 100 mg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.

    Subject analysis set title
    Adalimumab
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.

    Primary: Percentage of Participants who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12

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    End point title
    Percentage of Participants who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
    End point description
    ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician’s global assessment of disease activity (PGA), subject’s global assessment of disease activity (SGA) using visual analog scale (VAS) on a scale of 0 (no disease activity) to 100 (maximum disease activity),participant`s pain assessment using VAS on a scale of 0 (no pain) to 100 (unbearable pain),health assessment questionnaire disability index (HAQ-DI) score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities scored on a scale of 0 (without difficulty) to 3 (unable to do);high-sensitivity C-reactive protein (hsCRP). Full Analysis Set included participants who were randomized and received at least 1 dose of study drug. Participants with missing outcomes were set as non-responders.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: percentage of participants
        number (confidence interval 95%)
    76.6 (72.7 to 80.5)
    69.8 (65.6 to 74.0)
    70.5 (65.3 to 75.6)
    49.9 (45.3 to 54.5)
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [1]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    26.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.6
         upper limit
    32.8
    Notes
    [1] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [2]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    19.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13.6
         upper limit
    26.2
    Notes
    [2] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

    Secondary: Percentage of Participants who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] ≤ 3.2 at Week 12

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    End point title
    Percentage of Participants who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] ≤ 3.2 at Week 12
    End point description
    The DAS28 score is a measure of the participant’s disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient’s Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants in the Full Analysis Set were analyzed. Participants with missing outcomes were set as non-responders.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: percentage of participants
        number (confidence interval 95%)
    49.7 (45.1 to 54.3)
    38.8 (34.3 to 43.2)
    43.4 (37.8 to 48.9)
    23.4 (19.5 to 27.3)
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [3]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    26.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.2
         upper limit
    32.4
    Notes
    [3] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [4]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    15.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.4
         upper limit
    21.4
    Notes
    [4] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Adalimumab
    Comparison groups
    Filgotinib 200 mg v Adalimumab
    Number of subjects included in analysis
    800
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [5]
    P-value
    < 0.001 [6]
    Method
    Method proposed by [Liu 2014]
    Confidence interval
    Notes
    [5] - For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.
    [6] - P-value of non-inferiority test was calculated from approach proposed by [Liu 2014].
    Statistical analysis title
    Filgotinib 100 mg vs Adalimumab
    Comparison groups
    Filgotinib 100 mg v Adalimumab
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [7]
    P-value
    = 0.054 [8]
    Method
    Method proposed by [Liu 2014]
    Confidence interval
    Notes
    [7] - For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.
    [8] - P-value of non-inferiority test was calculated from approach proposed by [Liu 2014].
    Statistical analysis title
    Filgotinib 200 mg vs Adalimumab
    Comparison groups
    Filgotinib 200 mg v Adalimumab
    Number of subjects included in analysis
    800
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.069 [9]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    6.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    13.6
    Notes
    [9] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Adalimumab
    Comparison groups
    Filgotinib 100 mg v Adalimumab
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.18 [10]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    -4.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.8
         upper limit
    2.6
    Notes
    [10] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

    Secondary: Change from Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12

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    End point title
    Change from Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
    End point description
    The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). When 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability). Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 12
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    1.59 ± 0.611
    1.55 ± 0.625
    1.59 ± 0.600
    1.63 ± 0.613
        Change at Week 12 (n=457, 459, 311, 435)
    -0.69 ± 0.613
    -0.56 ± 0.564
    -0.61 ± 0.560
    -0.42 ± 0.544
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority [11]
    P-value
    < 0.001 [12]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.36
         upper limit
    -0.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.034
    Notes
    [11] - Least squares (LS)-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measure (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    [12] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority [13]
    P-value
    < 0.001 [14]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.24
         upper limit
    -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.034
    Notes
    [13] - LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    [14] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

    Secondary: Percentage of Participants who Achieved DAS28 (CRP) < 2.6 at Week 24

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    End point title
    Percentage of Participants who Achieved DAS28 (CRP) < 2.6 at Week 24
    End point description
    The DAS28 score is a measure of the participant’s disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient’s Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants in the Full Analysis Set were analyzed. Participants with missing outcomes were set as non-responders.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: percentage of participants
        number (confidence interval 95%)
    48.4 (43.8 to 53.0)
    35.2 (30.8 to 39.6)
    35.7 (30.3 to 41.1)
    16.2 (12.8 to 19.6)
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [15]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    32.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    26.4
         upper limit
    38
    Notes
    [15] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [16]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13.4
         upper limit
    24.6
    Notes
    [16] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

    Secondary: Change from Baseline in Modified Total Sharp Score (mTSS) at Week 24

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    End point title
    Change from Baseline in Modified Total Sharp Score (mTSS) at Week 24
    End point description
    Participant`s radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0-448]) is defined as the erosion score (range [0-280]) plus the joint space narrowing (JSN) score (range [0-168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion). JSN is scored from 0 to 4, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal joint spaces). Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    467
    471
    319
    466
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    32.47 ± 47.939
    36.70 ± 53.065
    34.82 ± 55.013
    31.60 ± 53.217
        Change at Week 24 (n=405, 404, 271, 351)
    0.13 ± 0.937
    0.17 ± 0.905
    0.16 ± 0.948
    0.37 ± 1.417
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    933
    Analysis specification
    Pre-specified
    Analysis type
    superiority [17]
    P-value
    < 0.001 [18]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.43
         upper limit
    -0.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.078
    Notes
    [17] - LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    [18] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    937
    Analysis specification
    Pre-specified
    Analysis type
    superiority [19]
    P-value
    = 0.001 [20]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.4
         upper limit
    -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.078
    Notes
    [19] - LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    [20] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

    Secondary: Percentage of Participants who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24

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    End point title
    Percentage of Participants who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24
    End point description
    ACR50 response is achieved when the participant has: ≥50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0 (without difficulty) to 3 (unable to do); hsCRP. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    9.1 (6.4 to 11.7)
    5.8 (3.6 to 8.0)
    6.8 (3.9 to 9.7)
    1.1 (0.0 to 2.1)
        Week 4
    22.3 (18.5 to 26.2)
    12.9 (9.8 to 16.0)
    17.2 (13.0 to 21.5)
    5.9 (3.7 to 8.1)
        Week 12
    47.2 (42.6 to 51.8)
    36.5 (32.0 to 40.9)
    35.1 (29.7 to 40.4)
    19.8 (16.1 to 23.5)
        Week 24
    57.9 (53.3 to 62.4)
    52.7 (48.1 to 57.3)
    52.3 (46.7 to 57.9)
    33.3 (28.9 to 37.6)
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [21]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.1
         upper limit
    10.9
    Notes
    [21] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [22]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    4.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.3
         upper limit
    7.3
    Notes
    [22] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [23]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    16.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.9
         upper limit
    20.9
    Notes
    [23] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [24]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.1
         upper limit
    10.9
    Notes
    [24] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [25]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    27.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    21.4
         upper limit
    33.3
    Notes
    [25] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [26]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    16.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.9
         upper limit
    22.5
    Notes
    [26] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [27]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    24.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.3
         upper limit
    31
    Notes
    [27] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [28]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    19.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13.1
         upper limit
    25.8
    Notes
    [28] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

    Secondary: Percentage of Participants Who Achieved ACR50 at Weeks 36 and 52

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    End point title
    Percentage of Participants Who Achieved ACR50 at Weeks 36 and 52 [29]
    End point description
    ACR50 response is achieved when the participant has: ≥50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0 (without difficulty) to 3 (unable to do); hsCRP. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 36 and 52
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: percentage of participants
    number (confidence interval 95%)
        Week 36
    63.2 (58.7 to 67.6)
    57.7 (53.2 to 62.2)
    57.5 (52.0 to 63.1)
    67.9 (61.0 to 74.8)
    63.4 (56.3 to 70.4)
        Week 52
    64.2 (59.8 to 68.6)
    60.6 (56.2 to 65.1)
    62.2 (56.7 to 67.6)
    68.4 (61.5 to 75.3)
    66.0 (59.0 to 72.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24

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    End point title
    Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24
    End point description
    ACR70 response is achieved when the participant has: ≥70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0 (without difficulty) to 3 (unable to do); hsCRP. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    2.7 (1.2 to 4.3)
    1.3 (0.2 to 2.3)
    0.9 (0.0 to 2.1)
    0.4 (0.0 to 1.1)
        Week 4
    9.1 (6.4 to 11.7)
    3.3 (1.6 to 5.0)
    3.7 (1.5 to 5.9)
    1.5 (0.3 to 2.7)
        Week 12
    26.1 (22.1 to 30.2)
    18.5 (15.0 to 22.1)
    14.2 (10.2 to 18.1)
    6.7 (4.4 to 9.1)
        Week 24
    36.2 (31.8 to 40.6)
    29.6 (25.4 to 33.8)
    29.5 (24.4 to 34.7)
    14.9 (11.6 to 18.3)
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.008 [30]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    2.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.5
         upper limit
    4.1
    Notes
    [30] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.18 [31]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    2.2
    Notes
    [31] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [32]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    7.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.6
         upper limit
    10.6
    Notes
    [32] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.067 [33]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.3
         upper limit
    4
    Notes
    [33] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [34]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    19.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    14.6
         upper limit
    24.1
    Notes
    [34] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [35]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    11.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.5
         upper limit
    16.2
    Notes
    [35] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [36]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    21.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    15.7
         upper limit
    26.9
    Notes
    [36] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [37]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    14.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.2
         upper limit
    20
    Notes
    [37] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

    Secondary: Percentage of Participants Who Achieved ACR70 at Weeks 36 and 52

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    End point title
    Percentage of Participants Who Achieved ACR70 at Weeks 36 and 52 [38]
    End point description
    ACR70 response is achieved when the participant has: ≥70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0 (without difficulty) to 3 (unable to do); hsCRP. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 36 and 52
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: percentage of participants
    number (confidence interval 95%)
        Week 36
    40.2 (35.7 to 44.7)
    35.4 (31.0 to 39.8)
    32.9 (27.7 to 38.2)
    44.7 (37.4 to 52.1)
    34.6 (27.5 to 41.6)
        Week 52
    44.4 (39.8 to 49.0)
    39.0 (34.5 to 43.4)
    41.2 (35.7 to 46.7)
    48.4 (41.1 to 55.8)
    37.7 (30.6 to 44.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24

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    End point title
    Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24
    End point description
    ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0 (without difficulty) to 3 (unable to do); hsCRP. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    37.3 (32.8 to 41.7)
    27.5 (23.4 to 31.6)
    33.5 (28.3 to 38.8)
    14.9 (11.6 to 18.3)
        Week 4
    51.6 (47.0 to 56.2)
    45.6 (41.1 to 50.2)
    47.1 (41.5 to 52.7)
    31.8 (27.5 to 36.1)
        Week 24
    78.1 (74.3 to 81.9)
    77.7 (73.9 to 81.5)
    74.5 (69.6 to 79.4)
    59.2 (54.6 to 63.7)
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [39]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    22.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    16.7
         upper limit
    27.9
    Notes
    [39] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [40]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    12.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.2
         upper limit
    17.9
    Notes
    [40] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [41]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    19.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13.4
         upper limit
    26.1
    Notes
    [41] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [42]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    13.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.5
         upper limit
    20.2
    Notes
    [42] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [43]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    18.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13
         upper limit
    24.9
    Notes
    [43] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [44]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    18.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12.6
         upper limit
    24.5
    Notes
    [44] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

    Secondary: Percentage of Participants Who Achieved ACR20 Response at Weeks 36 and 52

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    End point title
    Percentage of Participants Who Achieved ACR20 Response at Weeks 36 and 52 [45]
    End point description
    ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0 (without difficulty) to 3 (unable to do); hsCRP. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 36 and 52
    Notes
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: percentage of participants
    number (confidence interval 95%)
        Week 36
    82.9 (79.5 to 86.4)
    79.2 (75.4 to 82.9)
    76.3 (71.5 to 81.1)
    90.5 (86.1 to 95.0)
    86.9 (81.9 to 92.0)
        Week 52
    82.9 (79.5 to 86.4)
    79.6 (75.9 to 83.3)
    77.8 (73.2 to 82.5)
    86.3 (81.2 to 91.5)
    85.9 (80.7 to 91.1)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24

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    End point title
    Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24
    End point description
    The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    1.59 ± 0.611
    1.55 ± 0.625
    1.59 ± 0.600
    1.63 ± 0.613
        Change from Baseline at Week 2 (N=463,474,317,466)
    -0.30 ± 0.443
    -0.22 ± 0.406
    -0.29 ± 0.440
    -0.15 ± 0.357
        Change from Baseline at Week 4 (N=469,471,320,461)
    -0.43 ± 0.493
    -0.33 ± 0.454
    -0.40 ± 0.460
    -0.26 ± 0.431
        Change from Baseline at Week 24(N=418,423,283,376)
    -0.82 ± 0.632
    -0.75 ± 0.597
    -0.78 ± 0.632
    -0.62 ± 0.598
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [46]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.22
         upper limit
    -0.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.025
    Notes
    [46] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [47]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.14
         upper limit
    -0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.025
    Notes
    [47] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [48]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.24
         upper limit
    -0.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.028
    Notes
    [48] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [49]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.15
         upper limit
    -0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.028
    Notes
    [49] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [50]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.34
         upper limit
    -0.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.037
    Notes
    [50] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [51]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.26
         upper limit
    -0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.037
    Notes
    [51] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

    Secondary: Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36 and 52

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    End point title
    Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36 and 52 [52]
    End point description
    The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 36 and 52
    Notes
    [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (BL)
    1.59 ± 0.611
    1.55 ± 0.625
    1.59 ± 0.600
    1.68 ± 0.578
    1.58 ± 0.603
        Change from BL at Week 36 (N=412,417,275,180,188)
    -0.88 ± 0.633
    -0.80 ± 0.611
    -0.81 ± 0.634
    -0.96 ± 0.637
    -0.69 ± 0.610
        Change from BL at Week 52 (N=400,398,265,173,177)
    -0.93 ± 0.649
    -0.85 ± 0.621
    -0.85 ± 0.647
    -0.99 ± 0.644
    -0.73 ± 0.650
    No statistical analyses for this end point

    Secondary: Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24

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    End point title
    Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24
    End point description
    TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: tender joint count
    arithmetic mean (standard deviation)
        Baseline (BL)
    25 ± 13.5
    25 ± 13.4
    24 ± 13.2
    24 ± 13.5
        Change from BL at Week 2 (N=464,473,317,464)
    -8 ± 10.1
    -7 ± 9.3
    -7 ± 8.8
    -5 ± 9.0
        Change from BL at Week 4 (N=469,471,320,461)
    -11 ± 11.1
    -10 ± 10.3
    -9 ± 9.2
    -8 ± 10.5
        Change from BL at Week 12 (N=458,458,311,435)
    -17 ± 11.1
    -15 ± 10.7
    -15 ± 9.9
    -13 ± 11.6
        Change from BL at Week 24 (N=418,423,283,375)
    -20 ± 12.1
    -19 ± 10.9
    -18 ± 11.1
    -17 ± 11.7
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [53]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4
         upper limit
    -2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6
    Notes
    [53] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.01 [54]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6
    Notes
    [54] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [55]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5
         upper limit
    -2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6
    Notes
    [55] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [56]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6
    Notes
    [56] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [57]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5
         upper limit
    -2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6
    Notes
    [57] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [58]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6
    Notes
    [58] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [59]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4
         upper limit
    -2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5
    Notes
    [59] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [60]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5
    Notes
    [60] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

    Secondary: Change From Baseline in Individual ACR Component: TJC68 at Weeks 36 and 52

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    End point title
    Change From Baseline in Individual ACR Component: TJC68 at Weeks 36 and 52 [61]
    End point description
    TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 36 and 52
    Notes
    [61] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: tender joint count
    arithmetic mean (standard deviation)
        Baseline (BL)
    25 ± 13.5
    25 ± 13.4
    24 ± 13.2
    25 ± 12.8
    24 ± 12.9
        Change from BL at Week 36 (N=411,417,275,178,188)
    -21 ± 11.9
    -20 ± 11.2
    -19 ± 11.0
    -21 ± 11.4
    -19 ± 11.5
        Change from BL at Week 52 (N=400,397,265,173,177)
    -21 ± 12.2
    -21 ± 11.4
    -20 ± 11.4
    -21 ± 11.9
    -20 ± 11.2
    No statistical analyses for this end point

    Secondary: Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24

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    End point title
    Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24
    End point description
    The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" (presence of a joint swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons) thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: swollen joint count
    arithmetic mean (standard deviation)
        Baseline (BL)
    15 ± 8.5
    15 ± 8.5
    16 ± 8.4
    16 ± 8.5
        Change from BL at Week 2 (N=464,473,317,464)
    -6 ± 6.7
    -5 ± 6.8
    -6 ± 5.8
    -5 ± 6.9
        Change from BL at Week 4 (N=469,471,320,461)
    -8 ± 7.1
    -8 ± 7.8
    -7 ± 6.6
    -6 ± 7.8
        Change from BL at Week 12 (N=458,458,311,435)
    -11 ± 7.5
    -11 ± 8.1
    -11 ± 7.1
    -10 ± 8.4
        Change from BL at Week 24 (N=418,423,283,375)
    -13 ± 7.8
    -13 ± 7.4
    -13 ± 6.9
    -12 ± 7.7
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002 [62]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2
         upper limit
    0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [62] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.047 [63]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2
         upper limit
    0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [63] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [64]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [64] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [65]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [65] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [66]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [66] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [67]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [67] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [68]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [68] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [69]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [69] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

    Secondary: Change From Baseline in Individual ACR Component: SJC66 at Weeks 36 and 52

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    End point title
    Change From Baseline in Individual ACR Component: SJC66 at Weeks 36 and 52 [70]
    End point description
    The total SJC66 was based on 66 joints. It was derived as the sum of all "1s" (presence of a joint swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons) thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 36 and 52
    Notes
    [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: swollen joint count
    arithmetic mean (standard deviation)
        Baseline (BL)
    15 ± 8.5
    15 ± 8.5
    16 ± 8.4
    16 ± 8.2
    15 ± 7.9
        Change from BL at Week 36 (N=411,417,275,178,188)
    -14 ± 7.8
    -13 ± 7.6
    -14 ± 7.1
    -14 ± 7.3
    -13 ± 7.2
        Change from BL at Week 52 (N=400,397,265,173,177)
    -14 ± 8.1
    -13 ± 7.6
    -14 ± 7.5
    -14 ± 7.8
    -13 ± 7.4
    No statistical analyses for this end point

    Secondary: Change From Baseline in Individual ACR Component: Subject’s Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24

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    End point title
    Change From Baseline in Individual ACR Component: Subject’s Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24
    End point description
    SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (BL)
    67 ± 19.2
    65 ± 19.7
    67 ± 19.1
    68 ± 18.7
        Change from BL at Week 2 (N=464,474,318,466)
    -16 ± 20.1
    -11 ± 18.4
    -13 ± 18.1
    -8 ± 17.2
        Change from BL at Week 4 (N=469,472,319,461)
    -22 ± 21.5
    -16 ± 20.8
    -19 ± 20.8
    -13 ± 20.2
        Change from BL at Week 12 (N=457,458,311,435)
    -33 ± 24.8
    -28 ± 24.7
    -28 ± 23.2
    -21 ± 24.8
        Change from BL at Week 24 (N=418,423,283,376)
    -39 ± 25.8
    -36 ± 24.9
    -36 ± 24.9
    -31 ± 26.9
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [71]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11
         upper limit
    -7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Notes
    [71] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [72]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7
         upper limit
    -2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Notes
    [72] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [73]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12
         upper limit
    -7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.3
    Notes
    [73] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [74]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7
         upper limit
    -2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.3
    Notes
    [74] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [75]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -16
         upper limit
    -10
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.5
    Notes
    [75] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [76]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -10
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12
         upper limit
    -7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.5
    Notes
    [76] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [77]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14
         upper limit
    -7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.6
    Notes
    [77] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [78]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11
         upper limit
    -5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.6
    Notes
    [78] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

    Secondary: Change From Baseline in Individual ACR Component: SGA at Weeks 36 and 52

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    End point title
    Change From Baseline in Individual ACR Component: SGA at Weeks 36 and 52 [79]
    End point description
    SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 36 and 52
    Notes
    [79] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (BL)
    67 ± 19.2
    65 ± 19.7
    67 ± 19.1
    70 ± 17.8
    66 ± 18.7
        Change from BL at Week 36 (N=412,417,274,180,188)
    -42 ± 24.2
    -39 ± 25.3
    -39 ± 25.2
    -45 ± 24.7
    -38 ± 25.5
        Change from BL at Week 52 (N=400,398,265,173,177)
    -44 ± 24.4
    -41 ± 25.4
    -42 ± 25.7
    -45 ± 27.6
    -41 ± 25.3
    No statistical analyses for this end point

    Secondary: Change From Baseline in Individual ACR Component: Physician’s Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24

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    End point title
    Change From Baseline in Individual ACR Component: Physician’s Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24
    End point description
    PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (BL)
    66 ± 16.0
    65 ± 16.5
    67 ± 15.5
    66 ± 16.2
        Change from BL at Week 2 (N=463,469,315,463)
    -20 ± 19.3
    -18 ± 18.5
    -19 ± 17.9
    -13 ± 17.8
        Change from BL at Week 4 (N=468,466,318,457)
    -28 ± 21.2
    -26 ± 19.7
    -26 ± 19.6
    -20 ± 19.6
        Change from BL at Week 12 (N=457,450,308,433)
    -41 ± 20.2
    -39 ± 20.3
    -39 ± 20.4
    -34 ± 22.4
        Change from BL at Week 24 (N=413,419,283,373)
    -48 ± 19.2
    -46 ± 19.6
    -47 ± 19.4
    -42 ± 20.4
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [80]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10
         upper limit
    -6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Notes
    [80] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [81]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8
         upper limit
    -4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Notes
    [81] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [82]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11
         upper limit
    -6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Notes
    [82] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [83]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9
         upper limit
    -5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Notes
    [83] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [84]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10
         upper limit
    -6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Notes
    [84] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [85]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10
         upper limit
    -5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Notes
    [85] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [86]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11
         upper limit
    -6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Notes
    [86] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [87]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10
         upper limit
    -5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Notes
    [87] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

    Secondary: Change From Baseline in Individual ACR Component: PGA at Weeks 36 and 52

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    End point title
    Change From Baseline in Individual ACR Component: PGA at Weeks 36 and 52 [88]
    End point description
    PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 36 and 52
    Notes
    [88] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (BL)
    66 ± 16.0
    65 ± 16.5
    67 ± 15.5
    68 ± 15.6
    64 ± 16.3
        Change from BL at Week 36 (N=409,416,273,176,187)
    -51 ± 19.0
    -49 ± 19.8
    -50 ± 18.6
    -53 ± 19.5
    -47 ± 20.0
        Change from BL at Week 52 (N=400,398,265,173,177)
    -53 ± 18.2
    -50 ± 19.2
    -52 ± 18.9
    -54 ± 19.7
    -50 ± 19.3
    No statistical analyses for this end point

    Secondary: Change From Baseline in Individual ACR Component: Subject`s Pain Assessment at Weeks 2, 4, 12, and 24

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    End point title
    Change From Baseline in Individual ACR Component: Subject`s Pain Assessment at Weeks 2, 4, 12, and 24
    End point description
    The participant assessed their pain severity using a VAS on a scale of 0 (no pain) to 100 (severe pain). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (BL)
    65 ± 20.4
    64 ± 20.1
    64 ± 19.5
    66 ± 19.0
        Change from BL at Week 2 (N=463,474,317,466)
    -16 ± 21.0
    -12 ± 18.7
    -13 ± 20.4
    -7 ± 18.2
        Change from BL at Week 4 (N=469,471,319,461)
    -21 ± 23.7
    -18 ± 20.9
    -18 ± 21.9
    -12 ± 20.8
        Change from BL at Week 12 (N=457,458,311,435)
    -31 ± 26.9
    -29 ± 25.3
    -27 ± 23.6
    -21 ± 26.0
        Change from BL at Week 24 (N=418,423,283,376)
    -38 ± 27.0
    -37 ± 25.6
    -35 ± 24.2
    -30 ± 27.0
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [89]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12
         upper limit
    -7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Notes
    [89] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [90]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8
         upper limit
    -3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Notes
    [90] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [91]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12
         upper limit
    -7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.3
    Notes
    [91] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [92]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9
         upper limit
    -4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.3
    Notes
    [92] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [93]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15
         upper limit
    -9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.5
    Notes
    [93] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [94]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -10
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13
         upper limit
    -7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.5
    Notes
    [94] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [95]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14
         upper limit
    -7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.6
    Notes
    [95] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [96]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12
         upper limit
    -6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.6
    Notes
    [96] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

    Secondary: Change From Baseline in Individual ACR Component: Subject`s Pain Assessment at Weeks 36 and 52

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    End point title
    Change From Baseline in Individual ACR Component: Subject`s Pain Assessment at Weeks 36 and 52 [97]
    End point description
    The participant assessed their pain severity using a VAS on a scale of 0 (no pain) to 100 (severe pain). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 36 and 52
    Notes
    [97] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (BL)
    65 ± 20.4
    64 ± 20.1
    64 ± 19.5
    68 ± 18.0
    65 ± 19.2
        Change from BL at Week 36 (N=412,417,274,180,188)
    -40 ± 26.3
    -38 ± 26.2
    -37 ± 25.5
    -44 ± 24.9
    -39 ± 25.9
        Change from BL at Week 52 (N=400,398,265,173,177)
    -43 ± 26.2
    -41 ± 25.9
    -41 ± 25.6
    -45 ± 26.6
    -41 ± 25.6
    No statistical analyses for this end point

    Secondary: Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24

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    End point title
    Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline (BL)
    16.13 ± 21.005
    16.74 ± 22.982
    14.56 ± 18.003
    16.25 ± 24.051
        Change from BL at Week 2 (N=455,467,315,463)
    -10.85 ± 20.154
    -7.67 ± 17.888
    -8.03 ± 15.594
    -0.07 ± 17.244
        Change from BL at Week 4 (N=465,468,319,456)
    -9.99 ± 21.146
    -8.44 ± 20.201
    -7.17 ± 16.896
    -1.12 ± 19.940
        Change from BL at Week 12 (N=456,454,308,431)
    -11.00 ± 18.659
    -9.55 ± 21.330
    -7.85 ± 20.632
    -3.26 ± 22.711
        Change from BL at Week 24 (N=416,419,281,370)
    -11.84 ± 20.693
    -10.54 ± 22.215
    -6.17 ± 24.224
    -4.00 ± 19.614
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [98]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -10.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.7
         upper limit
    -8.96
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.952
    Notes
    [98] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [99]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -7.73
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.58
         upper limit
    -5.87
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.947
    Notes
    [99] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [100]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -9.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.33
         upper limit
    -7.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.989
    Notes
    [100] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [101]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -7.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.29
         upper limit
    -5.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.987
    Notes
    [101] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [102]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -8.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.9
         upper limit
    -6.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.961
    Notes
    [102] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [103]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -6.46
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.35
         upper limit
    -4.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.96
    Notes
    [103] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [104]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -7.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.88
         upper limit
    -5.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.007
    Notes
    [104] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [105]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -6.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.56
         upper limit
    -4.62
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.005
    Notes
    [105] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

    Secondary: Change From Baseline in Individual ACR Component: hsCRP at Weeks 36 and 52

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    End point title
    Change From Baseline in Individual ACR Component: hsCRP at Weeks 36 and 52 [106]
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 36 and 52
    Notes
    [106] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline (BL)
    16.13 ± 21.005
    16.74 ± 22.982
    14.56 ± 18.003
    16.54 ± 24.782
    15.76 ± 21.871
        Change from BL at Week 36 (N=408,413,273,179,184)
    -11.51 ± 21.990
    -10.72 ± 22.569
    -8.73 ± 18.214
    -12.12 ± 23.151
    -8.50 ± 19.749
        Change from BL at Week 52 (N=396,386,259,169,171)
    -12.19 ± 20.773
    -11.27 ± 23.129
    -9.60 ± 16.511
    -11.43 ± 20.873
    -8.74 ± 19.921
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24

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    End point title
    Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24
    End point description
    The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled) when 6 or more categories are non-missing, so total possible score is 3. Improvement is defined as reduction in HAQ-DI, (baseline value - postbaseline value) ≥ 0.22. If more than 2 categories are missing, the HAQ-DI score is set to missing. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2 (N=459,467,316,463)
    52.5 (47.8 to 57.2)
    46.7 (42.0 to 51.3)
    51.9 (46.2 to 57.6)
    40.2 (35.6 to 44.7)
        Week 4 (N=459,467,316,463)
    66.2 (61.8 to 70.7)
    58.0 (53.4 to 62.6)
    63.9 (58.5 to 69.4)
    49.9 (45.2 to 54.6)
        Week 12 (N=459,467,316,463)
    78.9 (75.0 to 82.7)
    71.5 (67.3 to 75.7)
    72.8 (67.6 to 77.9)
    57.9 (53.3 to 62.5)
        Week 24 (N=459,467,316,463)
    76.0 (72.0 to 80.0)
    73.4 (69.3 to 77.6)
    71.2 (66.1 to 76.4)
    59.4 (54.8 to 64.0)
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [107]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    12.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.7
         upper limit
    18.9
    Notes
    [107] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.043 [108]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    6.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.1
         upper limit
    13.1
    Notes
    [108] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [109]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    16.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.8
         upper limit
    22.8
    Notes
    [109] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.011 [110]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    8.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.5
         upper limit
    14.7
    Notes
    [110] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [111]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    14.9
         upper limit
    27
    Notes
    [111] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [112]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    13.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.3
         upper limit
    19.9
    Notes
    [112] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [113]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    16.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.5
         upper limit
    22.8
    Notes
    [113] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [114]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    14.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.8
         upper limit
    20.3
    Notes
    [114] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

    Secondary: Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36 and 52

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    End point title
    Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36 and 52 [115]
    End point description
    The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled) when 6 or more categories are non-missing, so total possible score is 3. Improvement is defined as reduction in HAQ-DI, (baseline value - postbaseline value) ≥ 0.22. If more than 2 categories are missing, the HAQ-DI score is set to missing. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 36 and 52
    Notes
    [115] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: percentage of participants
    number (confidence interval 95%)
        Week 36 (N=459,467,316,185,188)
    77.1 (73.2 to 81.1)
    74.9 (70.9 to 79.0)
    71.5 (66.4 to 76.7)
    83.2 (77.6 to 88.9)
    77.7 (71.4 to 83.9)
        Week 52 (N=459,467,316,185,188)
    75.8 (71.8 to 79.8)
    73.0 (68.9 to 77.2)
    70.3 (65.1 to 75.5)
    81.6 (75.8 to 87.5)
    71.8 (65.1 to 78.5)
    No statistical analyses for this end point

    Secondary: Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24

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    End point title
    Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24
    End point description
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    5.8 ± 0.88
    5.7 ± 0.95
    5.7 ± 0.88
    5.7 ± 0.91
        Change from Baseline at Week 2 (N=452,464,314,461)
    -1.3 ± 1.05
    -1.0 ± 0.90
    -1.1 ± 0.90
    -0.6 ± 0.79
        Change from Baseline at Week 4 (N=463,467,318,454)
    -1.7 ± 1.19
    -1.4 ± 1.07
    -1.4 ± 1.04
    -0.9 ± 0.98
        Change from Baseline at Week 12(N=455,452,308,431)
    -2.5 ± 1.24
    -2.2 ± 1.17
    -2.2 ± 1.12
    -1.6 ± 1.19
        Change from Baseline at Week 24(N=415,419,281,368)
    -3.1 ± 1.17
    -2.8 ± 1.08
    -2.7 ± 1.20
    -2.2 ± 1.20
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [116]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.9
         upper limit
    -0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.06
    Notes
    [116] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [117]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.06
    Notes
    [117] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [118]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.9
         upper limit
    -0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.07
    Notes
    [118] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [119]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.7
         upper limit
    -0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.07
    Notes
    [119] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [120]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    -0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.07
    Notes
    [120] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [121]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.8
         upper limit
    -0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.07
    Notes
    [121] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [122]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    -0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08
    Notes
    [122] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [123]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.8
         upper limit
    -0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08
    Notes
    [123] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

    Secondary: Change From Baseline in DAS28 (CRP) at Weeks 36 and 52

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    End point title
    Change From Baseline in DAS28 (CRP) at Weeks 36 and 52 [124]
    End point description
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 36 and 52
    Notes
    [124] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (BL)
    5.8 ± 0.88
    5.7 ± 0.95
    5.7 ± 0.88
    5.9 ± 0.89
    5.6 ± 0.89
        Change from BL at Week 36 (N=407,413,272,177,184)
    -3.2 ± 1.09
    -2.9 ± 1.17
    -2.9 ± 1.16
    -3.3 ± 1.10
    -2.8 ± 1.08
        Change from BL at Week 52 (N=393,385,259,169,171)
    -3.4 ± 1.11
    -3.1 ± 1.09
    -3.1 ± 1.13
    -3.3 ± 1.16
    -3.0 ± 1.04
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24

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    End point title
    Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24
    End point description
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    13.1 (9.9 to 16.2)
    8.1 (5.6 to 10.7)
    9.8 (6.5 to 13.2)
    3.6 (1.8 to 5.4)
        Week 4
    25.5 (21.5 to 29.5)
    20.4 (16.7 to 24.1)
    20.9 (16.3 to 25.5)
    9.3 (6.6 to 12.0)
        Week 24
    60.6 (56.1 to 65.1)
    53.1 (48.6 to 57.7)
    50.5 (44.9 to 56.1)
    33.7 (29.3 to 38.0)
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [125]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    9.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.8
         upper limit
    13.1
    Notes
    [125] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.004 [126]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    4.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.4
         upper limit
    7.7
    Notes
    [126] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [127]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    16.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.3
         upper limit
    21.1
    Notes
    [127] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [128]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    11.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.5
         upper limit
    15.8
    Notes
    [128] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 24
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [129]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    26.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.6
         upper limit
    33.3
    Notes
    [129] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 24
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [130]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    19.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13.1
         upper limit
    25.8
    Notes
    [130] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

    Secondary: Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36 and 52

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    End point title
    Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36 and 52 [131]
    End point description
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 36 and 52
    Notes
    [131] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: percentage of participants
    number (confidence interval 95%)
        Week 36
    67.4 (63.0 to 71.7)
    60.2 (55.7 to 64.7)
    58.2 (52.6 to 63.7)
    74.7 (68.3 to 81.2)
    66.5 (59.5 to 73.4)
        Week 52
    68.2 (63.9 to 72.5)
    62.1 (57.6 to 66.5)
    61.8 (56.4 to 67.3)
    69.5 (62.7 to 76.3)
    67.5 (60.6 to 74.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 12

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    End point title
    Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 12
    End point description
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, and 12
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    5.1 (3.0 to 7.1)
    1.7 (0.4 to 2.9)
    3.4 (1.3 to 5.5)
    0.6 (0.0 to 1.4)
        Week 4
    13.7 (10.5 to 16.9)
    8.8 (6.1 to 11.4)
    8.0 (4.9 to 11.1)
    2.9 (1.3 to 4.6)
        Week 12
    34.1 (29.7 to 38.5)
    23.8 (19.8 to 27.7)
    23.7 (18.9 to 28.5)
    9.3 (6.6 to 12.0)
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [132]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    4.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.1
         upper limit
    6.7
    Notes
    [132] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.17 [133]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    2.6
    Notes
    [133] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [134]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    10.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.1
         upper limit
    14.4
    Notes
    [134] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [135]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    5.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.6
         upper limit
    9
    Notes
    [135] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [136]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    24.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    19.6
         upper limit
    30
    Notes
    [136] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [137]
    Method
    Regression, Logistic
    Parameter type
    Difference in Response Rates
    Point estimate
    14.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.7
         upper limit
    19.3
    Notes
    [137] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

    Secondary: Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36 and 52

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    End point title
    Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36 and 52 [138]
    End point description
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 36 and 52
    Notes
    [138] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: percentage of participants
    number (confidence interval 95%)
        Week 36
    50.3 (45.7 to 54.9)
    42.9 (38.4 to 47.4)
    42.5 (36.9 to 48.0)
    52.1 (44.7 to 59.5)
    46.1 (38.7 to 53.4)
        Week 52
    54.5 (49.9 to 59.1)
    44.8 (40.2 to 49.3)
    48.6 (43.0 to 54.2)
    50.5 (43.2 to 57.9)
    50.8 (43.4 to 58.1)
    No statistical analyses for this end point

    Secondary: American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24

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    End point title
    American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24
    End point description
    ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject`s pain assessment, HAQ-DI and hsCRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0 (without difficulty) to 3 (unable to do). If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: percent improvement
    arithmetic mean (standard deviation)
        Week 2 (N=441,451,306,450)
    18.3 ± 19.98
    14.0 ± 17.14
    16.3 ± 18.41
    8.0 ± 12.82
        Week 4 (N=453,453,311,443)
    27.4 ± 25.24
    23.0 ± 22.26
    23.8 ± 22.94
    15.1 ± 18.92
        Week 12 (N=445,436,300,422)
    46.8 ± 28.46
    40.6 ± 27.32
    40.4 ± 26.18
    28.1 ± 25.22
        Week 24 (N=402,408,276,360)
    58.8 ± 27.76
    55.4 ± 26.47
    54.3 ± 28.13
    42.6 ± 27.73
    No statistical analyses for this end point

    Secondary: ACR N Percent Improvement (ACR-N) at Weeks 36 and 52

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    End point title
    ACR N Percent Improvement (ACR-N) at Weeks 36 and 52 [139]
    End point description
    ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject`s pain assessment, HAQ-DI and hsCRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0 (without difficulty) to 3 (unable to do). If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 36 and 52
    Notes
    [139] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: percent improvement
    arithmetic mean (standard deviation)
        Week 36 (N=397,406,267,171,181)
    62.5 ± 26.01
    59.1 ± 27.47
    58.6 ± 27.17
    63.2 ± 24.59
    56.1 ± 27.30
        Week 52 (N=385,379,255,165,170)
    66.0 ± 25.89
    63.1 ± 26.34
    63.5 ± 27.03
    63.8 ± 28.00
    59.7 ± 26.81
    No statistical analyses for this end point

    Secondary: Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24

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    End point title
    Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24
    End point description
    Good Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline >1.2. Moderate Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline >0.6 and ≤1.2; DAS28(CRP) at visit >3.2 and ≤5.1 and improvement from baseline >0.6; DAS 28(CRP) at visit >5.1 and improvement from baseline >1.2. No Response: DAS28(CRP) at visit ≤5.1 and improvement from baseline ≤0.6; DAS 28(CRP) >5.1 at visit and improvement from baseline ≤1.2. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: participants
        Week 2: Good Response (N=452,464,314,461)
    58
    32
    27
    15
        Week 2: Moderate Response (N=452,464,314,461)
    237
    213
    158
    133
        Week 2: No Response (N=452,464,314,461)
    157
    219
    129
    313
        Week 4: Good Response (N=463,467,318,454)
    117
    86
    61
    37
        Week 4: Moderate Response (N=463,467,318,454)
    231
    242
    156
    189
        Week 4: No Response (N=463,467,318,454)
    115
    139
    101
    228
        Week 12: Good Response (N=455,452,308,431)
    234
    177
    138
    106
        Week 12: Moderate Response (N=455,452,308,431)
    188
    225
    138
    224
        Week 12: No Response (N=455,452,308,431)
    33
    50
    32
    101
        Week 24: Good Response (N=415,419,281,368)
    284
    250
    163
    154
        Week 24: Moderate Response (N=415,419,281,368)
    124
    156
    97
    170
        Week 24: No Response (N=415,419,281,368)
    7
    13
    21
    44
    No statistical analyses for this end point

    Secondary: Number of Participants With EULAR Response at Weeks 36 and 52

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    End point title
    Number of Participants With EULAR Response at Weeks 36 and 52 [140]
    End point description
    Good Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline >1.2. Moderate Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline >0.6 and ≤1.2; DAS28(CRP) at visit >3.2 and ≤5.1 and improvement from baseline >0.6; DAS 28(CRP) at visit >5.1 and improvement from baseline >1.2. No Response: DAS28(CRP) at visit ≤5.1 and improvement from baseline ≤0.6; DAS 28(CRP) >5.1 at visit and improvement from baseline ≤1.2. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 36 and 52
    Notes
    [140] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points.
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo to Filgotinib 200 mg Placebo to Filgotinib 100 mg
    Number of subjects analysed
    475
    480
    325
    190
    191
    Units: participants
        Week 36: Good Response (N=407,413,272,177,184)
    306
    276
    180
    139
    124
        Week 36: Moderate Response (N=407,413,272,177,184)
    99
    126
    84
    38
    54
        Week 36: No Response (N=407,413,272,177,184)
    2
    11
    8
    0
    6
        Week 52: Good Response (N=393,385,259,169,171)
    308
    282
    189
    129
    126
        Week 52: Moderate Response (N=393,385,259,169,171)
    82
    98
    66
    38
    42
        Week 52: No Response (N=393,385,259,169,171)
    3
    5
    4
    2
    3
    No statistical analyses for this end point

    Secondary: Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24

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    End point title
    Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24
    End point description
    CDAI is calculated using formula: CDAI = TJC based on 28 joints (TJC28) + SJC based on 28 joints (SJC28) + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 12, and 24
    End point values
    Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
    Number of subjects analysed
    475
    480
    325
    475
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (BL)
    39.5 ± 11.85
    38.6 ± 12.23
    39.2 ± 11.51
    39.6 ± 11.66
        Change from BL at Week 2 (N=463,469,315,461)
    -12.7 ± 11.86
    -10.7 ± 11.17
    -11.7 ± 10.06
    -8.2 ± 10.10
        Change from BL at Week 4 (N=468,466,317,457)
    -17.6 ± 12.66
    -15.6 ± 12.07
    -15.4 ± 11.13
    -12.4 ± 11.79
        Change from BL at Week 12 (N=456,449,308,433)
    -26.0 ± 12.41
    -23.3 ± 12.32
    -23.5 ± 11.43
    -20.3 ± 13.30
        Change from BL at Week 24 (N=413,419,283,373)
    -30.6 ± 11.88
    -28.6 ± 11.57
    -28.4 ± 11.45
    -26.3 ± 12.38
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [141]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -4.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.9
         upper limit
    -3.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.68
    Notes
    [141] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [142]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.3
         upper limit
    -1.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.68
    Notes
    [142] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 200 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    950
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [143]
    Method
    MMRM
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -5.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.6
         upper limit
    -3.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.73
    Notes
    [143] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    Filgotinib 100 mg vs Placebo
    Statistical analysis description
    Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    955