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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 Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy

    Summary
    EudraCT number
    		 2016-000570-37
    Trial protocol
    		 SK   BE   GB   HU   DE   CZ   ES   PL   BG  
    Global end of trial date
    08 May 2019

    Results information
    Results version number
    		 v1
    This version publication date
    24 May 2020
    First version publication date
    24 May 2020
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-417-0303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02886728
    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
    08 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 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 in combination with methotrexate (MTX) versus MTX alone for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 24.
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 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
    Poland: 109
    Country: Number of subjects enrolled
    Slovakia: 8
    Country: Number of subjects enrolled
    Spain: 34
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Belgium: 19
    Country: Number of subjects enrolled
    Bulgaria: 54
    Country: Number of subjects enrolled
    Czech Republic: 20
    Country: Number of subjects enrolled
    Germany: 30
    Country: Number of subjects enrolled
    Hungary: 18
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    United States: 319
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    South Africa: 19
    Country: Number of subjects enrolled
    Australia: 18
    Country: Number of subjects enrolled
    New Zealand: 16
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    India: 116
    Country: Number of subjects enrolled
    Ukraine: 69
    Country: Number of subjects enrolled
    Russian Federation: 31
    Country: Number of subjects enrolled
    Serbia: 16
    Country: Number of subjects enrolled
    Romania: 10
    Country: Number of subjects enrolled
    Mexico: 116
    Country: Number of subjects enrolled
    Argentina: 40
    Country: Number of subjects enrolled
    Chile: 14
    Country: Number of subjects enrolled
    Taiwan: 23
    Country: Number of subjects enrolled
    Thailand: 13
    Country: Number of subjects enrolled
    Malaysia: 6
    Country: Number of subjects enrolled
    Hong Kong: 3
    Country: Number of subjects enrolled
    Japan: 71
    Country: Number of subjects enrolled
    Korea, Republic of: 24
    Worldwide total number of subjects
    1252
    EEA total number of subjects
    315
    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)
    997
    From 65 to 84 years
    253
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Asia, Africa, Australia, Europe, North America, South America, and New Zealand. The first participant was screened on 08 August 2016. The last study visit occurred on 08 May 2019.

    Pre-assignment
    Screening details
    		 1855 participants were screened.

    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 + MTX
    Arm description
    		 Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 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
    Placebo to match (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
    MTX
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Up to 20 mg administered once weekly

    Arm title
    		 Filgotinib 100 mg + MTX
    Arm description
    		 Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 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
    MTX
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Up to 20 mg administered once weekly

    Arm title
    		 Filgotinib 200 mg Monotherapy
    Arm description
    		 Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 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 MTX
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    PTM MTX capsules administered once weekly

    Arm title
    		 MTX Monotherapy
    Arm description
    		 Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 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
    MTX
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Up to 20 mg administered once weekly

    Number of subjects in period 1 [1]
    		Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Started
    416
    207
    210
    416
    Completed
    345
    175
    174
    331
    Not completed
    71
    32
    36
    85
         Withdrew Consent
    31
    13
    11
    47
         Adverse Event
    13
    5
    5
    11
         Non-Compliance with Study Drug
    1
    -
    1
    -
         Death
    3
    1
    -
    -
         Pregnancy
    -
    -
    1
    -
         Protocol Violation
    -
    -
    -
    4
         Lost to follow-up
    12
    6
    13
    12
         Investigator`s Discretion
    11
    7
    5
    11
    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: Three participants who were randomised but did not receive the study drug are not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Filgotinib 200 mg + MTX
    Reporting group description
    		 Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.

    Reporting group title
    Filgotinib 100 mg + MTX
    Reporting group description
    		 Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.

    Reporting group title
    Filgotinib 200 mg Monotherapy
    Reporting group description
    		 Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.

    Reporting group title
    MTX Monotherapy
    Reporting group description
    		 Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.

    Reporting group values
    		 Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy Total
    Number of subjects
    		 416 207 210 416 1249
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53 ( 13.8 ) 54 ( 12.6 ) 52 ( 13.9 ) 53 ( 13.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 325 158 166 312 961
        Male
    		 91 49 44 104 288
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 26 12 18 33 89
        Asian: Japanese
    		 23 11 12 25 71
        Asian: Chinese/Taiwanese/Hong Kong Chinese
    		 7 4 6 10 27
        Asian: Vietnamese
    		 1 0 0 0 1
        Asian: Korean
    		 6 8 2 8 24
        Asian: Other
    		 53 28 27 42 150
        Black or African American
    		 15 8 8 14 45
        Native Hawaiian or Pacific Islander
    		 1 0 1 3 5
        White
    		 278 132 135 278 823
        Other
    		 6 4 0 3 13
        Not Permitted
    		 0 0 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 93 40 45 84 262
        Not Hispanic or Latino
    		 322 167 165 332 986
        Not Permitted
    		 1 0 0 0 1
    Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
    Full Analysis Set included participants who were randomised and received at least 1 dose of study drug. It is scored on a scale of 0-3, 0 indicating no disability and 3 indicating complete disability. For additional description, please see outcome measure 2 (N=414,207,210,416).
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 1.52 ( 0.622 ) 1.56 ( 0.654 ) 1.56 ( 0.655 ) 1.60 ( 0.625 ) -
    Modified Total Sharp Score [mTSS]
    Participants in the Full Analysis Set with available data were analyzed. It is scored on a scale of 0-448, 0 indicating no erosion, normal joint spaces and 3 indicating maximum erosion, complete loss of joint spaces. For additional description, please see outcome measure 4 (N=410,204,204,408).
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 11.35 ( 19.922 ) 13.31 ( 26.980 ) 16.53 ( 32.372 ) 13.72 ( 29.168 ) -

    End points

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    End points reporting groups
    Reporting group title
    Filgotinib 200 mg + MTX
    Reporting group description
    		 Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.

    Reporting group title
    Filgotinib 100 mg + MTX
    Reporting group description
    		 Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.

    Reporting group title
    Filgotinib 200 mg Monotherapy
    Reporting group description
    		 Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.

    Reporting group title
    MTX Monotherapy
    Reporting group description
    		 Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.

    Primary: Percentage of Participants who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24

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    End point title
    		 Percentage of Participants who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24
    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) and subject’s global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100(0 and 100 indicate no disease activity and maximum disease activity)participant`s pain assessment using VAS on a scale of 0-100(0 and 100 indicate no pain and 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 and scored on a scale of 0-3(0 and 3 indicate without difficulty and unable to do)high-sensitivity C-reactive protein (hsCRP).The Full Analysis Set included participants who were randomised and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Number of subjects analysed
    416
    207
    210
    416
    Units: percentage of responders
        number (confidence interval 95%)
    81.0 (77.1 to 84.9)
    80.2 (74.5 to 85.9)
    78.1 (72.3 to 83.9)
    71.4 (66.9 to 75.9)
    Statistical analysis title
    		 Filgotinib 200 mg + MTX vs MTX Monotherapy
    Comparison groups
    Filgotinib 200 mg + MTX v MTX Monotherapy
    Number of subjects included in analysis
    832
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in Response Rates
    Point estimate
    9.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.6
         upper limit
    		 15.6
    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 + MTX vs MTX Monotherapy
    Comparison groups
    Filgotinib 100 mg + MTX v MTX Monotherapy
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in Response Rates
    Point estimate
    8.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 16.1
    Notes
    [2] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    		 Filgotinib 200 mg Monotherapy vs MTX Monotherapy
    Comparison groups
    Filgotinib 200 mg Monotherapy v MTX Monotherapy
    Number of subjects included in analysis
    626
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.058 [3]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in Response Rates
    Point estimate
    6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 14.1
    Notes
    [3] - 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 24

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    End point title
    		 Change from Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 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 administered 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). Mixed-effects model for repeated measures (MMRM) was used for analyses. 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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Number of subjects analysed
    372
    190
    185
    370
    Units: score on a scale
        arithmetic mean (standard deviation)
    -0.94 ( 0.722 )
    -0.90 ( 0.675 )
    -0.89 ( 0.631 )
    -0.79 ( 0.634 )
    Statistical analysis title
    		 Filgotinib 200 mg + MTX vs MTX Monotherapy
    Comparison groups
    Filgotinib 200 mg + MTX v MTX Monotherapy
    Number of subjects included in analysis
    742
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0.001 [5]
    Method
    		 MMRM
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 -0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.041
    Notes
    [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.
    [5] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Statistical analysis title
    		 Filgotinib 100 mg + MTX vs MTX Monotherapy
    Comparison groups
    Filgotinib 100 mg + MTX v MTX Monotherapy
    Number of subjects included in analysis
    560
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.009 [7]
    Method
    		 MMRM
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 -0.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.049
    Notes
    [6] - 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.
    [7] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Statistical analysis title
    		 Filgotinib 200 mg Monotherapy vs MTX Monotherapy
    Comparison groups
    Filgotinib 200 mg Monotherapy v MTX Monotherapy
    Number of subjects included in analysis
    555
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.032 [9]
    Method
    		 MMRM
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 -0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05
    Notes
    [8] - 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.
    [9] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.

    Secondary: Percentage of Participants who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)]< 2.6 at Week 24

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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)]< 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 CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Number of subjects analysed
    416
    207
    210
    416
    Units: percentage of responders
        number (confidence interval 95%)
    54.1 (49.2 to 59.0)
    42.5 (35.5 to 49.5)
    42.4 (35.5 to 49.3)
    29.1 (24.6 to 33.6)
    Statistical analysis title
    		 Filgotinib 200 mg + MTX vs MTX Monotherapy
    Comparison groups
    Filgotinib 200 mg + MTX v MTX Monotherapy
    Number of subjects included in analysis
    832
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [10]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in Response Rates
    Point estimate
    25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.3
         upper limit
    		 31.7
    Notes
    [10] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    		 Filgotinib 100 mg + MTX vs MTX Monotherapy
    Comparison groups
    Filgotinib 100 mg + MTX v MTX Monotherapy
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [11]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in Response Rates
    Point estimate
    13.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 21.8
    Notes
    [11] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    		 Filgotinib 200 mg Monotherapy vs MTX Monotherapy
    Comparison groups
    Filgotinib 200 mg Monotherapy v MTX Monotherapy
    Number of subjects included in analysis
    626
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [12]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in Response Rates
    Point estimate
    13.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 21.6
    Notes
    [12] - 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 no/normal JSN and 4 indicating complete loss of joint space. The maximal TSS is 448. Positive change in value indicates improvement (less erosion of bone, normal joint spaces). MMRM was used for analyses. 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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Number of subjects analysed
    355
    184
    173
    356
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.21 ( 1.684 )
    0.22 ( 1.526 )
    -0.04 ( 1.710 )
    0.51 ( 2.887 )
    Statistical analysis title
    		 Filgotinib 200 mg + MTX vs MTX Monotherapy
    Comparison groups
    Filgotinib 200 mg + MTX v MTX Monotherapy
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 = 0.068 [14]
    Method
    		 MMRM
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.61
         upper limit
    		 0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.161
    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 subjects being the random effect.
    Statistical analysis title
    		 Filgotinib 100 mg + MTX vs MTX Monotherapy
    Comparison groups
    Filgotinib 100 mg + MTX v MTX Monotherapy
    Number of subjects included in analysis
    540
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 = 0.14 [16]
    Method
    		 MMRM
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.67
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.195
    Notes
    [15] - 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.
    [16] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Statistical analysis title
    		 Filgotinib 200 mg Monotherapy vs MTX Monotherapy
    Comparison groups
    Filgotinib 200 mg Monotherapy v MTX Monotherapy
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.006 [18]
    Method
    		 MMRM
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.94
         upper limit
    		 -0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.199
    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 subjects being the random effect.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose date up to last dose date (Maximum: 56 weeks) plus 30 days
    Adverse event reporting additional description
    The Safety Analysis Set included all participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Filgotinib 200 mg + MTX
    Reporting group description
    		 Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + methotrexate (MTX) up to 20 mg orally, once weekly for up to 54 weeks.

    Reporting group title
    Filgotinib 100 mg + MTX
    Reporting group description
    		 Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.

    Reporting group title
    Filgotinib 200 mg Monotherapy
    Reporting group description
    		 Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.

    Reporting group title
    MTX Monotherapy
    Reporting group description
    		 Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.

    Serious adverse events
    		 Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 416 (6.25%)
    13 / 207 (6.28%)
    17 / 210 (8.10%)
    28 / 416 (6.73%)
         number of deaths (all causes)
    3
    1
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Giant cell tumour of tendon sheath
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid vasculitis
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    2 / 416 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Lung consolidation
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia, obstructive
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lupus myocarditis
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral amyloid angiopathy
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral artery occlusion
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebral artery aneurysm
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Bone marrow failure
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytosis
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 416 (0.48%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendiceal mucocoele
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal fistula
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Megacolon
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Prurigo
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 416 (0.00%)
    2 / 207 (0.97%)
    1 / 210 (0.48%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 416 (0.00%)
    2 / 207 (0.97%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    4 / 416 (0.96%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia infection
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia cryptococcal
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyonephrosis
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 416 (0.00%)
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    1 / 210 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 416 (0.00%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 416 (0.24%)
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    179 / 416 (43.03%)
    88 / 207 (42.51%)
    78 / 210 (37.14%)
    164 / 416 (39.42%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    23 / 416 (5.53%)
    6 / 207 (2.90%)
    3 / 210 (1.43%)
    11 / 416 (2.64%)
         occurrences all number
    26
    8
    3
    12
    Vascular disorders
    Hypertension
         subjects affected / exposed
    21 / 416 (5.05%)
    10 / 207 (4.83%)
    15 / 210 (7.14%)
    14 / 416 (3.37%)
         occurrences all number
    25
    10
    15
    14
    Nervous system disorders
    Headache
         subjects affected / exposed
    23 / 416 (5.53%)
    8 / 207 (3.86%)
    8 / 210 (3.81%)
    25 / 416 (6.01%)
         occurrences all number
    24
    10
    8
    30
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    51 / 416 (12.26%)
    35 / 207 (16.91%)
    15 / 210 (7.14%)
    50 / 416 (12.02%)
         occurrences all number
    58
    43
    15
    62
    Diarrhoea
         subjects affected / exposed
    17 / 416 (4.09%)
    12 / 207 (5.80%)
    6 / 210 (2.86%)
    21 / 416 (5.05%)
         occurrences all number
    18
    15
    8
    23
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    17 / 416 (4.09%)
    15 / 207 (7.25%)
    4 / 210 (1.90%)
    20 / 416 (4.81%)
         occurrences all number
    17
    16
    4
    20
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    42 / 416 (10.10%)
    9 / 207 (4.35%)
    14 / 210 (6.67%)
    34 / 416 (8.17%)
         occurrences all number
    48
    11
    15
    40
    Nasopharyngitis
         subjects affected / exposed
    21 / 416 (5.05%)
    17 / 207 (8.21%)
    17 / 210 (8.10%)
    25 / 416 (6.01%)
         occurrences all number
    27
    20
    22
    31
    Urinary tract infection
         subjects affected / exposed
    19 / 416 (4.57%)
    13 / 207 (6.28%)
    11 / 210 (5.24%)
    11 / 416 (2.64%)
         occurrences all number
    23
    14
    11
    12
    Bronchitis
         subjects affected / exposed
    12 / 416 (2.88%)
    11 / 207 (5.31%)
    4 / 210 (1.90%)
    15 / 416 (3.61%)
         occurrences all number
    15
    11
    4
    16

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jul 2016
    • Added urine biomarker samples as an exploratory endpoint • Updated study procedures to collect body weight at all study visits • Updated study procedures to include Treatment Satisfaction Questionnaire for Medication (TSQM) collection every 3 months • Updated the Prior and Concomitant Medications section to clarify documentation of prior medications and restriction window on injectable corticosteroids • Added an assessment of quantitative immunoglobulin (Ig) at Day 1, Week 24, and Week 52/ET • Updated to remove peripheral blood mononuclear cell substudy • Clarified eligibility criteria as needed • Updated the definition of postmenopausal females • Clarified that the magnetic resonance imaging (MRI) substudy would be performed post randomization within 7 days of first dose, at Week 12, and at Week 24 • Clarified that radiographs performed after Day 1 could be done ± 7 days of the scheduled visit • Terminology for the open label extension study was changed to long-term extension (LTE)study • Updated the disease specific questionnaires and activity scales to accurately reflect the relevant literature

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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