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    Clinical Trial Results:
    A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy

    Summary
    EudraCT number
    		 2019-001996-35
    Trial protocol
    		 EE   BE   GB   SK   HU   PL   BG   ES   CZ   NL   IT  
    Global end of trial date
    11 May 2021

    Results information
    Results version number
    		 v2
    This version publication date
    23 Mar 2022
    First version publication date
    03 Feb 2022
    Other versions
    		 v1 , v3
    Version creation reason
    • Correction of full data set
    Update to the outcome measure descriptions of outcomes 10, 11, 25 and 35. Time frame will be updated for outcome measures 26 and 27.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-431-4566
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04115748
    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
    11 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    11 May 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who are naive to biologic disease-modifying anti-rheumatic drug (DMARD) therapy. The study consists of two parts, the Main Study and the Long Term Extension (LTE).
    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
    03 Dec 2019
    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
    Australia: 4
    Country: Number of subjects enrolled
    Bulgaria: 7
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Japan: 2
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Poland: 34
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    67
    EEA total number of subjects
    48
    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)
    57
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Poland, the United States, Bulgaria, Spain, Australia, Japan, New Zealand, and Canada. The first participant was screened on 03 December 2019. The last study visit occurred on 11 May 2021.

    Pre-assignment
    Screening details
    		 161 participants were screened.

    Period 1
    Period 1 title
    Main Study (Up to 16 Weeks)
    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 (Main Study)
    Arm description
    		 Filgotinib 200 milligrams (mg) tablet orally once daily + placebo to match (PTM) filgotinib 100 mg tablet orally once daily + PTM adalimumab subcutaneous (SC) injection every two weeks for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg administered once daily with or without food

    Investigational medicinal product name
    Placebo to match (PTM) filgotinib
    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 with or without food

    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 administered once every 2 weeks

    Arm title
    		 Filgotinib 100 mg (Main Study)
    Arm description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg administered orally once daily with or without food

    Investigational medicinal product name
    PTM filgotinib
    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 orally once daily with or without food

    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 administered once every 2 weeks

    Arm title
    		 Adalimumab 40 mg (Main Study)
    Arm description
    		 PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PTM Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily with or without food

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

    Arm title
    		 Placebo (Main Study)
    Arm description
    		 PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    PTM filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally once daily with or without food

    Investigational medicinal product name
    PTM adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Injection administered subcutaneously once every 2 weeks

    Number of subjects in period 1
    		Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Started
    19
    19
    9
    20
    Completed
    4
    3
    2
    4
    Not completed
    15
    16
    7
    16
         Study terminated by sponsor
    15
    16
    7
    15
         Withdrew consent
    -
    -
    -
    1
    Period 2
    Period 2 title
    LTE (After 16 Weeks to Week 50)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Filgotinib 200 mg From Filgotinib 200 mg (LTE)
    Arm description
    		 Long term extension (LTE): Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 200 mg in the Main Study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg administered once daily with or without food

    Investigational medicinal product name
    PTM filgotinib
    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 orally once daily with or without food

    Arm title
    		 Filgotinib 100 mg From Filgotinib 100 mg (LTE)
    Arm description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 100 mg in the Main Study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg administered once daily with or without food

    Investigational medicinal product name
    PTM filgotinib
    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 orally once daily with or without food

    Arm title
    		 Filgotinib 200 mg From Adalimumab 40 mg (LTE)
    Arm description
    		 Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg administered once daily with or without food

    Investigational medicinal product name
    PTM filgotinib
    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 orally once daily with or without food

    Arm title
    		 Filgotinib 100 mg From Adalimumab 40 mg (LTE)
    Arm description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg administered once daily with or without food

    Investigational medicinal product name
    PTM filgotinib
    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 orally once daily with or without food

    Arm title
    		 Filgotinib 200 mg From Placebo (LTE)
    Arm description
    		 Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg administered once daily with or without food

    Investigational medicinal product name
    PTM filgotinib
    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 orally once daily with or without food

    Arm title
    		 Filgotinib 100 mg From Placebo (LTE)
    Arm description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg administered once daily with or without food

    Investigational medicinal product name
    PTM filgotinib
    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 orally once daily with or without food

    Number of subjects in period 2
    		Filgotinib 200 mg From Filgotinib 200 mg (LTE) Filgotinib 100 mg From Filgotinib 100 mg (LTE) Filgotinib 200 mg From Adalimumab 40 mg (LTE) Filgotinib 100 mg From Adalimumab 40 mg (LTE) Filgotinib 200 mg From Placebo (LTE) Filgotinib 100 mg From Placebo (LTE)
    Started
    4
    3
    1
    1
    2
    2
    Completed
    0
    0
    0
    0
    0
    0
    Not completed
    4
    3
    1
    1
    2
    2
         Adverse event, non-fatal
    -
    -
    -
    -
    1
    -
         Study terminated by sponsor
    4
    3
    1
    1
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Filgotinib 200 mg (Main Study)
    Reporting group description
    		 Filgotinib 200 milligrams (mg) tablet orally once daily + placebo to match (PTM) filgotinib 100 mg tablet orally once daily + PTM adalimumab subcutaneous (SC) injection every two weeks for 16 weeks.

    Reporting group title
    Filgotinib 100 mg (Main Study)
    Reporting group description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.

    Reporting group title
    Adalimumab 40 mg (Main Study)
    Reporting group description
    		 PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.

    Reporting group title
    Placebo (Main Study)
    Reporting group description
    		 PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.

    Reporting group values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study) Total
    Number of subjects
    		 19 19 9 20 67
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49 ( 13.4 ) 46 ( 10.4 ) 50 ( 10.4 ) 47 ( 15.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 7 4 10 30
        Male
    		 10 12 5 10 37
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 1 1 1 0 3
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0
        White
    		 18 18 8 20 64
        More than one race
    		 0 0 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 0 1 2
        Not Hispanic or Latino
    		 18 19 9 19 65
        Unknown or Not Reported
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Filgotinib 200 mg (Main Study)
    Reporting group description
    		 Filgotinib 200 milligrams (mg) tablet orally once daily + placebo to match (PTM) filgotinib 100 mg tablet orally once daily + PTM adalimumab subcutaneous (SC) injection every two weeks for 16 weeks.

    Reporting group title
    Filgotinib 100 mg (Main Study)
    Reporting group description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.

    Reporting group title
    Adalimumab 40 mg (Main Study)
    Reporting group description
    		 PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.

    Reporting group title
    Placebo (Main Study)
    Reporting group description
    		 PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
    Reporting group title
    Filgotinib 200 mg From Filgotinib 200 mg (LTE)
    Reporting group description
    		 Long term extension (LTE): Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 200 mg in the Main Study.

    Reporting group title
    Filgotinib 100 mg From Filgotinib 100 mg (LTE)
    Reporting group description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 100 mg in the Main Study.

    Reporting group title
    Filgotinib 200 mg From Adalimumab 40 mg (LTE)
    Reporting group description
    		 Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.

    Reporting group title
    Filgotinib 100 mg From Adalimumab 40 mg (LTE)
    Reporting group description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.

    Reporting group title
    Filgotinib 200 mg From Placebo (LTE)
    Reporting group description
    		 Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.

    Reporting group title
    Filgotinib 100 mg From Placebo (LTE)
    Reporting group description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.

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

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    End point title
    		 Percentage of Participants who Achieved an American College of Rheumatology (ACR) 20% Improvement 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: patient's global assessment of disease activity (PGADA) using a visual analogue scale (VAS) on a scale of 0 (very well) to 100 (very poor); physician's global assessment of disease activity (PHGADA) using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); health assessment questionnaire-disability index (HAQ-DI) inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain), and high-sensitivity C-reactive protein (hsCRP). Full Analysis Set (FAS) included all randomized participants who took at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
        number (confidence interval 95%)
    76.8 (57.2 to 96.5)
    63.2 (38.8 to 87.5)
    67.2 (38.8 to 98.3)
    44.8 (22.8 to 66.7)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.048 [1]
    Method
    		 Multiple imputation method
    Parameter type
    		 Difference in response rates
    Point estimate
    32.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.6
         upper limit
    		 61.6
    Notes
    [1] - The stratification factors (Geographic Region, Concurrent Use of conventional synthetic (cs) DMARD(s) and/or Apremilast at Randomization, Prior Use of biologic (bio) DMARD(s)) and treatment groups were included in the imputation model as covariates.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.23 [2]
    Method
    		 Multiple imputation method
    Parameter type
    		 Difference in response rates
    Point estimate
    18.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.4
         upper limit
    		 49.2
    Notes
    [2] - The stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) and treatment groups were included in the imputation model as covariates.

    Secondary: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16

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    End point title
    		 Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16
    End point description
    PASDAS is a composite measure for psoriatic arthritis with components of PGADA [using VAS scale of 0=very well to 100=very poor]; PhGADA [using VAS scale of 0=no disease activity to 100=maximum disease activity]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains with a physical component summary(PCS)with a score range of 0-100, higher scores indicates better health]; TJC68; SJC66; leeds enthesitis index(LEI) [assessed at 6 sites with a score range of 0 to 6,higher scores with higher degree of enthesitis];Tender dactylitis count(TDC)[with a score range of 0 to 60, higher score indicates higher degree of dactylitis];C-reactive protein(CRP). Total score is calculated as the sum of the individual scores(each score adjusted by weighting factors).The score of PASDAS ranges from 0 to 10, lower scores indicates better function. A negative change from baseline indicates improvement. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 4, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    8
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    5.9 ( 1.32 )
    5.3 ( 0.99 )
    5.5 ( 1.05 )
    5.5 ( 1.05 )
        Change From Baseline at Wk 4 N=19,18,8,20
    -1.5 ( 0.62 )
    -1.0 ( 0.99 )
    -1.3 ( 0.66 )
    -0.3 ( 0.80 )
        Change From Baseline at Wk 16 N=18,19,8,20
    -2.5 ( 1.26 )
    -2.0 ( 1.48 )
    -2.6 ( 1.37 )
    -1.0 ( 1.04 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16

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    End point title
    		 Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16
    End point description
    MDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: TJC68 ≤1; SJC66 ≤1; Psoriatic arthritis disease activity score (PASI) ≤1 for participants with psoriasis covering BSA <3% [PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)]; patient's global assessment of PsA pain intensity (PGAPI) ≤15 [using VAS on a scale of 0 (no pain) to 100 (serious pain)]; PGADA ≤20 [using VAS on a scale of 0 (very well) to 100 (very poor)]; HAQ-DI score ≤0.5; LEI score ≤1 for participants with enthesitis at baseline. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 4 N=19,18,9,20
    21.1 (0.1 to 42.0)
    16.7 (0.0 to 36.7)
    22.2 (0.0 to 54.9)
    5.0 (0.0 to 17.1)
        Wk 8 N=19,19,9,19
    26.3 (3.9 to 48.7)
    31.6 (8.0 to 55.1)
    22.2 (0.0 to 54.9)
    15.8 (0.0 to 34.8)
        Wk 12 N=18,19,8,19
    44.4 (18.7 to 70.2)
    47.4 (22.3 to 72.5)
    37.5 (0.0 to 77.3)
    15.8 (0.0 to 34.8)
        Wk 16 N=18,19,8,20
    27.8 (4.3 to 51.2)
    36.8 (12.5 to 61.2)
    37.5 (0.0 to 77.3)
    20.0 (0.0 to 40.0)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17 [3]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    16.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 41.9
    Notes
    [3] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.27 [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    11.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.3
         upper limit
    		 36.6
    Notes
    [4] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.42 [5]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.4
         upper limit
    		 41.5
    Notes
    [5] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.062 [6]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    28.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 62.3
    Notes
    [6] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.26 [7]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    15.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16
         upper limit
    		 47.6
    Notes
    [7] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.58 [8]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    7.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.6
         upper limit
    		 40.2
    Notes
    [8] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.047 [9]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    31.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 64.6
    Notes
    [9] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.27 [10]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    16.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.2
         upper limit
    		 49.9
    Notes
    [10] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.

    Secondary: Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16

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    End point title
    		 Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16
    End point description
    VLDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the VLDA if the participant fulfills all the seven criteria: TJC68 ≤1; SJC66 ≤1; PASI score ≤1 for participants with psoriasis covering BSA <3% [PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)]; PGAPI ≤15 [using VAS on a scale of 0 (no pain) to (serious pain)]; PGADA ≤20 [using VAS on a scale of 0 (very well) to 100 (very poor)]; HAQ-DI score ≤0.5; LEI score ≤1 with participants with enthesitis at baseline. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 4 N=19,18,9,20
    5.3 (0.0 to 17.9)
    0 (0.0 to 2.8)
    0 (0.0 to 5.6)
    0 (0.0 to 2.5)
        Wk 8 N=19,19,9,19
    5.3 (0.0 to 17.9)
    0 (0.0 to 2.6)
    0 (0.0 to 5.6)
    10.5 (0.0 to 27.0)
        Wk 12 N=18,19,8,19
    11.1 (0.0 to 28.4)
    5.3 (0.0 to 17.9)
    12.5 (0.0 to 41.7)
    5.3 (0.0 to 17.9)
        Wk 16 N=18,19,9,20
    5.6 (0.0 to 18.9)
    10.5 (0.0 to 27.0)
    11.1 (0.0 to 37.2)
    0 (0.0 to 2.5)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.9
         upper limit
    		 20.4
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 5.3
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.6
         upper limit
    		 17.1
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.6
         upper limit
    		 8.5
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    5.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.2
         upper limit
    		 28.9
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.5
         upper limit
    		 19.5
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.3
         upper limit
    		 21.4
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.4
         upper limit
    		 29.5

    Secondary: Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16
    End point description
    DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA [using VAS on a scale of 0 (very well) to 100 very poor)]; PGAPI [using a VAS on a scale of 0 (no pain) to 100 (serious pain)] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and >28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. A negative change from baseline indicates improvement. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 2, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    8
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    48.0 ( 25.55 )
    30.3 ( 10.43 )
    38.8 ( 20.82 )
    33.8 ( 17.55 )
        Change From Baseline at Wk 2 N=19,18,8,19
    -12.5 ( 11.96 )
    -5.3 ( 9.12 )
    -10.9 ( 8.39 )
    -7.5 ( 11.72 )
        Change From Baseline at Wk 4 N=19,18,8,20
    -19.3 ( 14.30 )
    -9.4 ( 12.13 )
    -14.2 ( 10.45 )
    -6.5 ( 8.41 )
        Change From Baseline at Wk 8 N=19,19,8,19
    -28.4 ( 15.67 )
    -12.4 ( 11.06 )
    -17.8 ( 12.96 )
    -10.6 ( 8.87 )
        Change From Baseline at Wk 12 N=18,19,7,19
    -27.4 ( 17.09 )
    -18.0 ( 11.00 )
    -25.2 ( 16.60 )
    -9.3 ( 9.81 )
        Change From Baseline at Wk 16 N=18,19,8,20
    -28.1 ( 13.42 )
    -17.4 ( 12.16 )
    -25.1 ( 14.55 )
    -11.3 ( 12.18 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline

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    End point title
    		 Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline
    End point description
    The PhGAP is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity is assessed by a physician according to the grades of induration, erythema, and scaling on a scale of 0 to 5. The sum of the three grades is used to obtain the total average score. PhGAP is based on the total average score on a scale of 0-5 where, 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, and 5 = severe. A negative change from baseline indicates improvement. Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 2, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    8
    5
    4
    4
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    3 ( 1.2 )
    2 ( 0.8 )
    2 ( 0.5 )
    2 ( 0.5 )
        Change From Baseline at Wk 2 N=8,5,4,3
    -1 ( 0.5 )
    0 ( 0.0 )
    0 ( 0.5 )
    0 ( 0.0 )
        Change From Baseline at Wk 4
    -1 ( 1.0 )
    0 ( 0.5 )
    -1 ( 1.0 )
    0 ( 0.5 )
        Change From Baseline at Wk 8
    -1 ( 1.0 )
    -1 ( 0.7 )
    -1 ( 0.8 )
    -1 ( 1.0 )
        Change From Baseline at Wk 12 N=7,5,3,4
    -1 ( 1.3 )
    -1 ( 1.1 )
    -2 ( 0.6 )
    0 ( 1.3 )
        Change From Baseline at Wk 16
    -1 ( 0.7 )
    -1 ( 0.8 )
    -2 ( 0.6 )
    -1 ( 1.4 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline

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    End point title
    		 Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline
    End point description
    mNAPSI is used to assess each nail abnormality for each of the participant's nails. Three features or groups of features (pitting, onycholysis together with oil-drop dyschromia, and crumbling) of each fingernail are graded on a scale from 0 (no onycholysis together with oil-drop dyschromia, no pitting, no crumbling) to 3 (>30 onycholysis together with oil-drop dyschromia, >50 pitting, >50% crumbling). Four features (leukonychia, splinter, hemorrhages, hyperkeratosis, and red spots in the lunula) are graded with the score of 1 = present or 0 = absent for each fingernail. Each finger has a score between 0 and 13. The total mNAPSI score is the sum of all abnormalities individual score across all fingers, and the total mNAPSI score ranges from 0 to 130. Lower numbers indicate fewer nail abnormalities. A negative change from baseline indicates improvement. Participants in the FAS with psoriatic nail involvement at baseline and with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    9
    11
    6
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    19 ( 15.1 )
    15 ( 12.9 )
    24 ( 32.3 )
    14 ( 12.9 )
        Change From Baseline at Wk 4 N=9,10,6,13
    -3 ( 3.5 )
    1 ( 4.5 )
    -3 ( 10.0 )
    0 ( 8.2 )
        Change From Baseline at Wk 8 N=9,11,6,12
    -3 ( 5.1 )
    -1 ( 5.9 )
    -6 ( 19.4 )
    -2 ( 5.0 )
        Change From Baseline at Wk 12 N=9,11,5,12
    -4 ( 6.0 )
    0 ( 5.4 )
    -9 ( 23.2 )
    -3 ( 10.6 )
        Change From Baseline at Wk 16 N=8,11,6,13
    0 ( 10.8 )
    -3 ( 9.6 )
    -14 ( 23.7 )
    -2 ( 9.2 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline

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    End point title
    		 Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
    End point description
    Enthesitis is assessed using LEI. The enthesitis examination by LEI evaluates the presence or absence of pain by applying local pressure on 6 anatomical sites: medial femoral condyle (left and right), lateral epicondyle (left and right), and the achilles tendon insertion (left and right). Enthesitis at each site is scored as 0 (enthesitis absent) and 1 (enthesitis present). LEI is derived as the sum of the enthesitis score over the 6 sites mentioned above. The total score ranges from 0 to 6, higher scores indicates greater degree of enthesitis. A negative change from baseline indicates improvement. Participants in the FAS with enthesitis at baseline and with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    10
    9
    6
    11
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    2 ( 1.6 )
    2 ( 1.4 )
    2 ( 1.4 )
    2 ( 1.7 )
        Change From Baseline at Wk 4
    -1 ( 0.8 )
    0 ( 0.7 )
    -1 ( 1.1 )
    0 ( 1.5 )
        Change From Baseline at Wk 8 N=10,9,6,10
    -1 ( 0.8 )
    -1 ( 1.2 )
    -2 ( 1.5 )
    0 ( 1.3 )
        Change From Baseline at Wk 12 N=10,9,5,10
    -1 ( 1.4 )
    -1 ( 1.6 )
    -2 ( 1.8 )
    0 ( 1.2 )
        Change From Baseline at Wk 16
    -1 ( 1.2 )
    -1 ( 1.5 )
    -2 ( 1.6 )
    0 ( 1.5 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16

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    End point title
    		 Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16
    End point description
    The PsAID questionnaire assesses the impact of PsA on people's lives. The PsAID is calculated based on 12 numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10. Total score is calculated as the sum of the individual scores, (some of which were multiplied by a weighting factor) divided by 20 for a total possible score of 0 to 10, where higher score indicates worse impact of disease. A negative change from baseline indicates improvement. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 4, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    8
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    4.82 ( 1.857 )
    4.46 ( 2.115 )
    5.28 ( 1.765 )
    4.44 ( 2.071 )
        Change From Baseline at Wk 4 N=19,18,8,20
    -1.71 ( 1.282 )
    -1.39 ( 1.214 )
    -1.73 ( 1.645 )
    -0.10 ( 1.520 )
        Change From Baseline at Wk 16
    -2.06 ( 1.314 )
    -2.04 ( 1.740 )
    -2.56 ( 2.062 )
    -0.52 ( 2.176 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16

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    End point title
    		 Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16
    End point description
    PASDAS is a composite measure for psoriatic arthritis with components of PGADA [using VAS scale of 0=very well to 100=very poor]; PhGADA [using VAS scale of 0=no disease activity to 100=maximum disease activity]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains with a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health]; TJC68; SJC66; leeds enthesitis index (LEI) [assessed at 6 sites with a score range of 0 to 6, higher scores with higher degree of enthesitis]; Tender dactylitis count (TDC) [with a score range of 0 to 60, higher score indicates higher degree of dactylitis];C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. PASDAS LDA is defined as PASDAS ≤ 3.2. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 4, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 4 N=19,18,8,20
    21.1 (0.1 to 42.0)
    11.1 (0.0 to 28.4)
    0 (0.0 to 6.3)
    5.0 (0.0 to 17.1)
        Wk 16 N=18,19,8,20
    38.9 (13.6 to 64.2)
    42.1 (17.3 to 66.9)
    50.0 (9.1 to 90.9)
    15.0 (0.0 to 33.1)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    16.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 41.9
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    23.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.8
         upper limit
    		 56.6
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main St
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    6.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.5
         upper limit
    		 28.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    27.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 59.4

    Secondary: Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16

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    End point title
    		 Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16
    End point description
    PASDAS is a composite measure for psoriatic arthritis with components of PGADA [using VAS scale of 0=very well to 100=very poor]; PhGADA [using VAS scale of 0=no disease activity to 100=maximum disease activity]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains with a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health]; TJC68; SJC66; leeds enthesitis index (LEI) [assessed at 6 sites with a score range of 0 to 6, higher scores with higher degree of enthesitis]; Tender dactylitis count (TDC) [with a score range of 0 to 60, higher score indicates higher degree of dactylitis];C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. PASDAS remission is defined as PASDAS ≤ 1.9. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 4, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 4 N=19,18,8,20
    0 (0.0 to 2.6)
    0 (0.0 to 2.8)
    0 (0.0 to 6.3)
    0 (0.0 to 2.5)
        Wk 16 N=18,19,8,20
    16.7 (0.0 to 36.7)
    10.5 (0.0 to 27.0)
    12.5 (0.0 to 41.7)
    5.0 (0.0 to 17.1)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 5.3
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1
         upper limit
    		 5.1
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.4
         upper limit
    		 27.4
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    11.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.3
         upper limit
    		 36.6

    Secondary: Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16
    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: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 2 N=19,18,9,19
    26.3 (3.9 to 48.7)
    5.6 (0.0 to 18.9)
    11.1 (0.0 to 37.2)
    10.5 (0.0 to 27.0)
        Wk 4 N=19,18,9,20
    52.6 (27.5 to 77.7)
    27.8 (4.3 to 51.2)
    33.3 (0.0 to 69.7)
    10.0 (0.0 to 25.6)
        Wk 8 N=19,19,9,19
    73.7 (51.3 to 96.1)
    36.8 (12.5 to 61.2)
    55.6 (17.5 to 93.6)
    31.6 (8.0 to 55.1)
        Wk 12 N=18,19,8,19
    77.8 (55.8 to 99.8)
    63.2 (38.8 to 87.5)
    75.0 (38.7 to 100.0)
    42.1 (17.3 to 66.9)
        Wk 16 N=18,19,9,20
    88.9 (71.6 to 100.0)
    52.6 (27.5 to 77.7)
    77.8 (45.1 to 100.0)
    45.0 (20.7 to 69.3)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2 [11]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    15.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.6
         upper limit
    		 45.2
    Notes
    [11] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6 [12]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    -5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.8
         upper limit
    		 17.8
    Notes
    [12] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008 [13]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    42.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.5
         upper limit
    		 73.8
    Notes
    [13] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17 [14]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    17.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12
         upper limit
    		 47.6
    Notes
    [14] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011 [15]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    42.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.1
         upper limit
    		 76.2
    Notes
    [15] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.69 [16]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.1
         upper limit
    		 40.6
    Notes
    [16] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.19 [17]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.2
         upper limit
    		 57.4
    Notes
    [17] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.033 [18]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    35.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 70.4
    Notes
    [18] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007 [19]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    43.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.4
         upper limit
    		 75.4
    Notes
    [19] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.63 [20]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    7.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.8
         upper limit
    		 44.1
    Notes
    [20] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.

    Secondary: Percentage of Participants Who Achieved an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Percentage of Participants Who Achieved an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16
    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: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 2 N=19,18,9,19
    5.3 (0.0 to 17.9)
    0 (0.0 to 2.8)
    0 (0.0 to 5.6)
    5.3 (0.0 to 17.9)
        Wk 4 N=19,18,9,20
    10.5 (0.0 to 27.0)
    5.6 (0.0 to 18.9)
    0 (0.0 to 5.6)
    5.0 (0.0 to 17.1)
        Wk 8 N=19,19,9,19
    31.6 (8.0 to 55.1)
    26.3 (3.9 to 48.7)
    11.1 (0.0 to 37.2)
    10.5 (0.0 to 27.0)
        Wk 12 N=18,19,8,19
    55.6 (29.8 to 81.3)
    42.1 (17.3 to 66.9)
    37.5 (0.0 to 77.3)
    10.5 (0.0 to 27.0)
        Wk 16 N=18,19,9,20
    27.8 (4.3 to 51.2)
    47.4 (22.3 to 72.5)
    33.3 (0.0 to 69.7)
    15.0 (0.0 to 33.1)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.98 [21]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.5
         upper limit
    		 19.5
    Notes
    [21] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5 [22]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    -5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.7
         upper limit
    		 10.2
    Notes
    [22] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.54 [23]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.4
         upper limit
    		 27.4
    Notes
    [23] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.92 [24]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19
         upper limit
    		 20.1
    Notes
    [24] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.13 [25]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.3
         upper limit
    		 51.4
    Notes
    [25] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.22 [26]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    15.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.6
         upper limit
    		 45.2
    Notes
    [26] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007 [27]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.8
         upper limit
    		 77.2
    Notes
    [27] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039 [28]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    31.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 63
    Notes
    [28] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.34 [29]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    12.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.4
         upper limit
    		 44
    Notes
    [29] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04 [30]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in response rates
    Point estimate
    32.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 64.9
    Notes
    [30] - P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.

    Secondary: Percentage of Participants Who Achieved an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Percentage of Participants Who Achieved an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16
    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: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 2 N=19,18,9,19
    5.3 (0.0 to 17.9)
    0 (0.0 to 2.8)
    0 (0.0 to 5.6)
    0 (0.0 to 2.6)
        Wk 4 N=19,18,9,20
    5.3 (0.0 to 17.9)
    0 (0.0 to 2.8)
    0 (0.0 to 5.6)
    0 (0.0 to 2.5)
        Wk 8 N=19,19,9,19
    15.8 (0.0 to 34.8)
    10.5 (0.0 to 27.0)
    0 (0.0 to 5.6)
    5.3 (0.0 to 17.9)
        Wk 12 N=18,19,8,19
    27.8 (4.3 to 51.2)
    26.3 (3.9 to 48.7)
    12.5 (0.0 to 41.7)
    0 (0.0 to 2.6)
        Wk 16 N=18,19,9,20
    22.2 (0.2 to 44.2)
    31.6 (8.0 to 55.1)
    22.2 (0.0 to 54.9)
    10.0 (0.0 to 25.6)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 20.6
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4
         upper limit
    		 5.4
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.9
         upper limit
    		 20.4
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14
         upper limit
    		 35
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 5.3
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    27.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7
         upper limit
    		 53.9
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.1
         upper limit
    		 27.6
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    26.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 51.4
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.3
         upper limit
    		 40.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    21.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.2
         upper limit
    		 51.4

    Secondary: Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16

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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, 8, 12, and 16
    End point description
    TJC68 is an assessment of 68 joints. Each joint is evaluated as 'normal', 'tender', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all tender joints. The overall tender joint count ranged from 0 to 68, with a higher score indicating a greater degree of tenderness. A negative change from baseline indicates improvement. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 2, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: tender joint count
    arithmetic mean (standard deviation)
        Baseline
    22 ( 14.9 )
    13 ( 8.5 )
    17 ( 11.0 )
    14 ( 11.6 )
        Change From Baseline at Wk 2 N=19,18,9,19
    -6 ( 8.7 )
    -1 ( 5.2 )
    -5 ( 3.9 )
    -3 ( 6.6 )
        Change From Baseline at Wk 4 N=19,18,9,20
    -9 ( 10.3 )
    -3 ( 7.9 )
    -7 ( 5.3 )
    -3 ( 4.6 )
        Change From Baseline at Wk 8 N=19,19,9,19
    -13 ( 9.9 )
    -5 ( 6.3 )
    -7 ( 7.4 )
    -4 ( 4.8 )
        Change From Baseline at Wk 12 N=18,19,8,19
    -13 ( 7.4 )
    -7 ( 7.4 )
    -10 ( 8.5 )
    -4 ( 4.5 )
        Change From Baseline at Wk 16 N=18,19,9,20
    -14 ( 7.7 )
    -7 ( 7.9 )
    -10 ( 6.1 )
    -5 ( 8.3 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16
    End point description
    SJC66 is an assessment of 66 joints. Each joint was evaluated as 'normal', 'swollen', 'tender and swollen', or 'not able to evaluate'. It was derived as the sum of all swollen joints. The overall swollen joint count ranged from 0 to 66, with a higher score indicating a greater degree of swelling. A negative change from baseline indicates improvement. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 2, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: swollen joint count
    arithmetic mean (standard deviation)
        Baseline
    14 ( 10.3 )
    7 ( 3.3 )
    11 ( 7.3 )
    8 ( 5.9 )
        Change From Baseline at Wk 2 N=19,18,9,19
    -3 ( 3.8 )
    -1 ( 3.5 )
    -5 ( 5.2 )
    -2 ( 4.7 )
        Change From Baseline at Wk 4 N=19,18,9,20
    -5 ( 6.2 )
    -2 ( 2.9 )
    -4 ( 7.0 )
    -2 ( 3.1 )
        Change From Baseline at Wk 8 N=19,19,9,19
    -9 ( 7.0 )
    -3 ( 4.0 )
    -6 ( 6.1 )
    -3 ( 2.9 )
        Change From Baseline at Wk 12 N=18,19,8,19
    -8 ( 8.9 )
    -4 ( 3.1 )
    -8 ( 7.3 )
    -4 ( 2.9 )
        Change From Baseline at Wk 16 N=18,19,9,20
    -8 ( 7.9 )
    -4 ( 3.8 )
    -8 ( 6.7 )
    -4 ( 3.9 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Individual ACR Component: Patient’s Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Change From Baseline in Individual ACR Component: Patient’s Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16
    End point description
    PGADA is assessed by the participants using a VAS on a scale of 0 (very well) to 100 (very poor). A negative change from baseline indicates improvement. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 2, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    8
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    54 ( 26.0 )
    58 ( 22.8 )
    47 ( 24.2 )
    52 ( 24.0 )
        Change From Baseline at Wk 2 N=19,18,8,19
    -15 ( 17.8 )
    -17 ( 26.6 )
    3 ( 8.6 )
    -10 ( 12.6 )
        Change From Baseline at Wk 4 N=19,18,8,20
    -23 ( 20.3 )
    -23 ( 32.2 )
    -3 ( 11.4 )
    -4 ( 16.6 )
        Change From Baseline at Wk 8 N=19,19,8,19
    -24 ( 22.6 )
    -28 ( 33.8 )
    -4 ( 17.1 )
    -16 ( 23.4 )
        Change From Baseline at Wk 12 N=18,19,7,19
    -27 ( 25.9 )
    -38 ( 29.9 )
    -29 ( 19.7 )
    -9 ( 24.7 )
        Change From Baseline at Wk 16 N=18,19,8,20
    -31 ( 26.4 )
    -34 ( 28.5 )
    -25 ( 25.3 )
    -12 ( 23.5 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Individual ACR Component: Physician’s Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Change From Baseline in Individual ACR Component: Physician’s Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16
    End point description
    PhGADA is 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 FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 2, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    8
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    68 ( 16.4 )
    56 ( 14.3 )
    65 ( 13.1 )
    62 ( 13.4 )
        Change From Baseline at Wk 2 N=19,18,8,19
    -17 ( 12.3 )
    -4 ( 11.0 )
    -12 ( 9.2 )
    -8 ( 9.8 )
        Change From Baseline at Wk 4 N=19,18,8,20
    -23 ( 14.5 )
    -12 ( 18.6 )
    -29 ( 14.8 )
    -8 ( 11.5 )
        Change From Baseline at Wk 8 N=19,19,8,19
    -35 ( 15.1 )
    -17 ( 17.4 )
    -35 ( 13.6 )
    -21 ( 13.7 )
        Change From Baseline at Wk 12 N=18,19,7,19
    -36 ( 18.8 )
    -26 ( 22.4 )
    -42 ( 20.8 )
    -21 ( 21.8 )
        Change From Baseline at Wk 16 N=18,19,8,20
    -37 ( 16.4 )
    -27 ( 21.6 )
    -44 ( 21.0 )
    -19 ( 20.2 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)’s Pain Assessment at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)’s Pain Assessment at Weeks 2, 4, 8, 12, and 16
    End point description
    HAQ-DI`s pain assessment is done using VAS on a scale of 0 (no pain) to 100 (serious pain). A negative change from baseline indicates improvement. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 2, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    8
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    60 ( 24.7 )
    45 ( 22.3 )
    48 ( 24.3 )
    56 ( 24.2 )
        Change From Baseline at Wk 2 N=19,18,8,19
    -16 ( 15.2 )
    -4 ( 16.7 )
    -5 ( 9.5 )
    -8 ( 11.5 )
        Change From Baseline at Wk 4 N=19,18,8,20
    -24 ( 20.9 )
    -13 ( 18.6 )
    -10 ( 9.8 )
    -1 ( 14.3 )
        Change From Baseline at Wk 8 N=19,19,8,19
    -33 ( 20.9 )
    -13 ( 23.4 )
    -3 ( 17.3 )
    -11 ( 25.3 )
        Change From Baseline at Wk 12 N=18,19,7,19
    -33 ( 23.7 )
    -19 ( 21.0 )
    -28 ( 20.7 )
    -8 ( 23.3 )
        Change From Baseline at Wk 16 N=18,19,8,20
    -29 ( 24.5 )
    -17 ( 26.5 )
    -27 ( 15.2 )
    -12 ( 21.7 )
    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, 8, 12, and 16

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    End point title
    		 Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16
    End point description
    The hsCRP is the ACR core set measure of acute phase reactant. It was measured at the central laboratory to help assess the effect of filgotinib on the participant's psoriatic arthritis. A negative change from baseline indicates improvement. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 2, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline
    8.08 ( 9.335 )
    3.14 ( 2.673 )
    10.56 ( 16.354 )
    7.11 ( 9.727 )
        Change From Baseline at Wk 2 N=19,18,9,19
    -6.37 ( 8.518 )
    -0.10 ( 5.313 )
    -7.70 ( 11.874 )
    0.50 ( 4.063 )
        Change From Baseline at Wk 4 N=19,18,9,20
    -6.68 ( 8.998 )
    -0.95 ( 2.564 )
    -5.99 ( 8.981 )
    3.96 ( 13.594 )
        Change From Baseline at Wk 8 N=19,19,9,19
    -5.13 ( 11.271 )
    -0.69 ( 4.474 )
    -6.40 ( 9.740 )
    -1.15 ( 4.979 )
        Change From Baseline at Wk 12 N=18,19,8,19
    -6.04 ( 8.518 )
    -1.11 ( 3.161 )
    -3.80 ( 7.334 )
    2.25 ( 7.788 )
        Change From Baseline at Wk 16 N=18,19,9,20
    -5.88 ( 9.195 )
    -0.47 ( 5.496 )
    -6.80 ( 10.918 )
    1.05 ( 5.623 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16
    End point description
    The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA [using a VAS on a scale of 0 (very well) to 100 (very poor)] 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 FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 2, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    8
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    4.9 ( 1.27 )
    4.2 ( 0.78 )
    4.5 ( 0.97 )
    4.4 ( 0.92 )
        Change From Baseline at Wk 2 N=19,18,8,19
    -0.9 ( 0.62 )
    -0.5 ( 0.74 )
    -0.9 ( 0.70 )
    -0.6 ( 0.83 )
        Change From Baseline at Wk 4 N=19,18,8,20
    -1.2 ( 0.63 )
    -0.9 ( 1.04 )
    -1.2 ( 0.60 )
    -0.5 ( 0.65 )
        Change From Baseline at Wk 8 N=19,19,8,19
    -1.8 ( 0.87 )
    -1.2 ( 0.71 )
    -1.2 ( 0.83 )
    -1.0 ( 0.66 )
        Change From Baseline at Wk 12 N=18,19,7,19
    -1.9 ( 0.96 )
    -1.5 ( 0.89 )
    -1.9 ( 0.88 )
    -0.8 ( 0.78 )
        Change From Baseline at Wk 16 N=18,19,8,20
    -1.8 ( 0.62 )
    -1.8 ( 0.97 )
    -2.0 ( 0.71 )
    -0.8 ( 0.92 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16
    End point description
    The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28(CRP) ≤ 3.2. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 2 N=19,18,9,19
    31.6 (8.0 to 55.1)
    33.3 (8.8 to 57.9)
    33.3 (0.0 to 69.7)
    42.1 (17.3 to 66.9)
        Wk 4 N=19,18,9,20
    36.8 (12.5 to 61.2)
    44.4 (18.7 to 70.2)
    55.6 (17.5 to 93.6)
    25.0 (3.5 to 46.5)
        Wk 8 N=19,19,9,19
    63.2 (38.8 to 87.5)
    63.2 (38.8 to 87.5)
    33.3 (0.0 to 69.7)
    52.6 (27.5 to 77.7)
        Wk 12 N=18,19,8,19
    66.7 (42.1 to 91.2)
    68.4 (44.9 to 92.0)
    62.5 (22.7 to 100.0)
    36.8 (12.5 to 61.2)
        Wk 16 N=18,19,9,20
    50.0 (24.1 to 75.9)
    84.2 (65.2 to 100.0)
    66.7 (30.3 to 100.0)
    45.0 (20.7 to 69.3)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46.3
         upper limit
    		 25.2
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -8.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45.3
         upper limit
    		 27.7
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    11.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.1
         upper limit
    		 45.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    19.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.6
         upper limit
    		 54.5
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26
         upper limit
    		 47
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    31.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 67
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26
         upper limit
    		 47
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    29.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 66
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    39.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.8
         upper limit
    		 71.6
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32
         upper limit
    		 42

    Secondary: Percentage of Participants Who Achieved DAS28 (CRP) Remission at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Percentage of Participants Who Achieved DAS28 (CRP) Remission at Weeks 2, 4, 8, 12, and 16
    End point description
    The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) remission is defined as DAS28 (CRP) < 2.6. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 2 N=19,18,9,19
    10.5 (0.0 to 27.0)
    11.1 (0.0 to 28.4)
    22.2 (0.0 to 54.9)
    10.5 (0.0 to 27.0)
        Wk 4 N=19,18,9,20
    10.5 (0.0 to 27.0)
    27.8 (4.3 to 51.2)
    22.2 (0.0 to 54.9)
    15.0 (0.0 to 33.1)
        Wk 8 N=19,19,9,19
    47.4 (22.3 to 72.5)
    26.3 (3.9 to 48.7)
    22.2 (0.0 to 54.9)
    26.3 (3.9 to 48.7)
        Wk 12 N=18,19,8,19
    55.6 (29.8 to 81.3)
    42.1 (17.3 to 66.9)
    50.0 (9.1 to 90.9)
    21.1 (0.1 to 42.0)
        Wk 16 N=18,19,9,20
    44.4 (18.7 to 70.2)
    52.6 (27.5 to 77.7)
    44.4 (6.4 to 82.5)
    20.0 (0.0 to 40.0)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.8
         upper limit
    		 24.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.9
         upper limit
    		 26
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.5
         upper limit
    		 21.5
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    12.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.4
         upper limit
    		 44
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.3
         upper limit
    		 33.3
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.1
         upper limit
    		 56.3
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13
         upper limit
    		 55.1
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    34.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 69.3
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    24.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 58.6
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    32.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 66.2

    Secondary: Time to Achieve DAS28 (CRP) LDA

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    End point title
    		 Time to Achieve DAS28 (CRP) LDA
    End point description
    The DAS28 (CRP) is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28 (CRP) ≤ 3.2. Time to achieve DAS28 (CRP) LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAS28 (CRP) LDA. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Approximately 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: days
        median (full range (min-max))
    57 (13 to 116)
    58 (14 to 116)
    29 (14 to 127)
    59 (14 to 133)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16
    End point description
    DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA [using VAS on a scale of 0 (very well) to 100 very poor)]; PGAPI [using a VAS on a scale of 0 (no pain) to 100 (serious pain)] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and >28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. DAPSA LDA is defined as DAPSA ≤ 14. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 2 N=19,18,9,19
    15.8 (0.0 to 34.8)
    11.1 (0.0 to 28.4)
    22.2 (0.0 to 54.9)
    31.6 (8.0 to 55.1)
        Wk 4 N=19,18,9,20
    31.6 (8.0 to 55.1)
    38.9 (13.6 to 64.2)
    44.4 (6.4 to 82.5)
    25.0 (3.5 to 46.5)
        Wk 8 N=19,19,9,19
    52.6 (27.5 to 77.7)
    42.1 (17.3 to 66.9)
    33.3 (0.0 to 69.7)
    36.8 (12.5 to 61.2)
        Wk 12 N=18,19,8,19
    61.1 (35.8 to 86.4)
    57.9 (33.1 to 82.7)
    62.5 (22.7 to 100.0)
    36.8 (12.5 to 61.2)
        Wk 16 N=18,19,9,20
    44.4 (18.7 to 70.2)
    63.2 (38.8 to 87.5)
    55.6 (17.5 to 93.6)
    40.0 (16.0 to 64.0)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -15.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -47.6
         upper limit
    		 16
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -20.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51.3
         upper limit
    		 10.4
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    6.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.8
         upper limit
    		 39.9
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    15.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.7
         upper limit
    		 52.3
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    13.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.8
         upper limit
    		 48.6
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    24.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.4
         upper limit
    		 60.9
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31
         upper limit
    		 41.6
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.2
         upper limit
    		 57.4
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    4.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.3
         upper limit
    		 41.2
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    23.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.5
         upper limit
    		 58.8

    Secondary: Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16
    End point description
    DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA [using VAS on a scale of 0 (very well) to 100 very poor)]; PGAPI [using a VAS on a scale of 0 (no pain) to 100 (serious pain)] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and >28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. DAPSA remission is defined as DAPSA ≤ 4. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 2 N=19,18,9,19
    5.3 (0.0 to 17.9)
    0 (0.0 to 2.8)
    0 (0.0 to 5.6)
    5.3 (0.0 to 17.9)
        Wk 4 N=19,18,9,20
    5.3 (0.0 to 17.9)
    5.6 (0.0 to 18.9)
    0 (0.0 to 5.6)
    5.0 (0.0 to 17.1)
        Wk 8 N=19,19,9,19
    10.5 (0.0 to 27.0)
    5.3 (0.0 to 17.9)
    0 (0.0 to 5.6)
    10.5 (0.0 to 27.0)
        Wk 12 N=18,19,8,19
    22.2 (0.2 to 44.2)
    31.6 (8.0 to 55.1)
    12.5 (0.0 to 41.7)
    5.3 (0.0 to 17.9)
        Wk 16 N=18,19,9,20
    16.7 (0.0 to 36.7)
    21.1 (0.1 to 42.0)
    22.2 (0.0 to 54.9)
    10.0 (0.0 to 25.6)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.5
         upper limit
    		 19.5
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.7
         upper limit
    		 10.2
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.7
         upper limit
    		 19.3
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19
         upper limit
    		 20.1
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.8
         upper limit
    		 24.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.6
         upper limit
    		 17.1
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    26.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 54.8
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.1
         upper limit
    		 44
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.3
         upper limit
    		 33.6
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    11.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.6
         upper limit
    		 38.7

    Secondary: Time to Achieve DAPSA LDA

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    End point title
    		 Time to Achieve DAPSA LDA
    End point description
    DAPSA is sum of components:TJC68;SJC66;PGADA [using VAS on a scale of 0 (very well) to 100 very poor)]; PGAPI [using a VAS on a scale of 0 (no pain) to 100 (serious pain)] and CRP. DAPSA scores 0-4=remission, 5-14=low disease activity, 15-28=moderate disease activity, and >28=high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. Time to achieve DAPSA LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAPSA LDA. If DAPSA LDA is not achieved during main study phase, the time will be censored at the last non-missing DAPSA LDA assessment date during main study phase. If the component scores are at different dates for a visit, the latest date will be used to derive time to achieve DAPSA LDA. Participants in the FAS with available data were analyzed. 99.999= Median was not calculated as there was than 50% of participants.
    End point type
    Secondary
    End point timeframe
    Approximately 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    18
    18
    7
    18
    Units: days
        median (full range (min-max))
    73 (15 to 116)
    82 (15 to 128)
    83 (15 to 127)
    99.999 (14 to 133)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16
    End point description
    The PsARC response is defined as improvement in at least 2 of the following 4 criteria; ≥ 30% decrease in SJC66, ≥ 30% decrease in TJC68, ≥ 20% decrease in PGADA (VAS; 0 = very well to 100 = very poor), ≥ 20% decrease in PhGADA (VAS; 0 = no disease activity to 100 = maximum disease activity), and with at least one of the 2 joint criteria, with no deterioration in any other criteria. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    9
    20
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 2 N=19,18,9,19
    31.6 (8.0 to 55.1)
    16.7 (0.0 to 36.7)
    11.1 (0.0 to 37.2)
    31.6 (8.0 to 55.1)
        Wk 4 N=19,18,9,20
    57.9 (33.1 to 82.7)
    38.9 (13.6 to 64.2)
    44.4 (6.4 to 82.5)
    30.0 (7.4 to 52.6)
        Wk 8 N=19,19,9,19
    78.9 (58.0 to 99.9)
    47.4 (22.3 to 72.5)
    44.4 (6.4 to 82.5)
    57.9 (33.1 to 82.7)
        Wk 12 N=18,19,8,19
    72.2 (48.8 to 95.7)
    68.4 (44.9 to 92.0)
    75.0 (38.7 to 100.0)
    47.4 (22.3 to 72.5)
        Wk 16 N=18,19,9,20
    88.9 (71.6 to 100.0)
    57.9 (33.1 to 82.7)
    77.8 (45.1 to 100.0)
    45.0 (20.7 to 69.3)
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -14.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -47.4
         upper limit
    		 17.6
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.8
         upper limit
    		 34.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    8.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.6
         upper limit
    		 44.3
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    27.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.2
         upper limit
    		 63
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13
         upper limit
    		 55.1
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -47.4
         upper limit
    		 26.3
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    24.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.1
         upper limit
    		 60.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.9
         upper limit
    		 57
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    43.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.4
         upper limit
    		 75.4
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    12.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.4
         upper limit
    		 49.1

    Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline

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    End point title
    		 Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
    End point description
    PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, where 0 = none, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A higher score indicates more severe disease. A negative change from baseline indicates improvement. Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    8
    5
    4
    4
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    9.5 ( 6.70 )
    13.8 ( 14.12 )
    6.5 ( 5.90 )
    9.6 ( 10.60 )
        Change From Baseline at Wk 4
    -2.2 ( 5.19 )
    -5.0 ( 5.14 )
    -1.8 ( 1.54 )
    -1.1 ( 5.41 )
        Change From Baseline at Wk 8
    -3.4 ( 4.91 )
    -5.5 ( 4.93 )
    -3.0 ( 1.98 )
    -5.6 ( 7.03 )
        Change From Baseline at Wk 12 N=7,5,3,4
    -3.7 ( 5.65 )
    -5.6 ( 6.13 )
    -3.0 ( 2.10 )
    -4.9 ( 7.12 )
        Change From Baseline at Wk 16
    -5.5 ( 7.80 )
    -7.0 ( 7.69 )
    -5.2 ( 4.56 )
    -6.4 ( 9.85 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline

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    End point title
    		 Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
    End point description
    PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI50, the improvement threshold from baseline in PASI score is 50%. A higher score indicates more severe disease. Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    8
    5
    4
    4
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 4
    37.5 (0.0 to 77.3)
    40.0 (0.0 to 92.9)
    50.0 (0.0 to 100.0)
    0 (0.0 to 12.5)
        Wk 8
    25.0 (0.0 to 61.3)
    40.0 (0.0 to 92.9)
    50.0 (0.0 to 100.0)
    50.0 (0.0 to 100.0)
        Wk 12 N=7,5,3,4
    57.1 (13.3 to 100.0)
    40.0 (0.0 to 92.9)
    100.0 (83.3 to 100.0)
    50.0 (0.0 to 100.0)
        Wk 16
    62.5 (22.7 to 100.0)
    40.0 (0.0 to 92.9)
    100.0 (87.5 to 100.0)
    25.0 (0.0 to 79.9)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    37.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.8
         upper limit
    		 89.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    40
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.4
         upper limit
    		 100
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -100
         upper limit
    		 51.2
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -97.7
         upper limit
    		 77.7
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -73.7
         upper limit
    		 88
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    37.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.3
         upper limit
    		 100
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -97.7
         upper limit
    		 77.7
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -67.9
         upper limit
    		 97.9

    Secondary: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline

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    End point title
    		 Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
    End point description
    PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI75, the improvement threshold from baseline in PASI score is 75%. A higher score indicates more severe disease. Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    8
    5
    4
    4
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 4
    12.5 (0.0 to 41.7)
    20.0 (0.0 to 65.1)
    0 (0.0 to 12.5)
    0 (0.0 to 12.5)
        Wk 8
    25.0 (0.0 to 61.3)
    40.0 (0.0 to 92.9)
    25.0 (0.0 to 79.9)
    0 (0.0 to 12.5)
        Wk 12 N=7,5,3,4
    42.9 (0.0 to 86.7)
    40.0 (0.0 to 92.9)
    66.7 (0.0 to 100.0)
    0 (0.0 to 12.5)
        Wk 16
    62.5 (22.7 to 100.0)
    20.0 (0.0 to 65.1)
    75.0 (20.1 to 100.0)
    25.0 (0.0 to 79.9)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    12.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.2
         upper limit
    		 54.2
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.6
         upper limit
    		 77.6
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.8
         upper limit
    		 73.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    40
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.4
         upper limit
    		 100
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    40
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.4
         upper limit
    		 100
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    42.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.4
         upper limit
    		 99.2
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    -5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -82.5
         upper limit
    		 72.5
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Placebo (Main Study) v Filgotinib 200 mg (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    37.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.3
         upper limit
    		 100

    Secondary: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline

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    End point title
    		 Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
    End point description
    PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI90, the improvement threshold from baseline in PASI score is 90%. A higher score indicates more severe disease. Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    8
    5
    4
    4
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 4
    0 (0.0 to 6.3)
    0 (0.0 to 10.0)
    0 (0.0 to 12.5)
    0 (0.0 to 12.5)
        Wk 8
    12.5 (0.0 to 41.7)
    0 (0.0 to 10.0)
    25.0 (0.0 to 79.9)
    0 (0.0 to 12.5)
        Wk 12 N=7,5,3,4
    14.3 (0.0 to 47.4)
    20.0 (0.0 to 65.1)
    66.7 (0.0 to 100.0)
    0 (0.0 to 12.5)
        Wk 16
    25.0 (0.0 to 61.3)
    20.0 (0.0 to 65.1)
    50.0 (0.0 to 100.0)
    0 (0.0 to 12.5)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.8
         upper limit
    		 18.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.5
         upper limit
    		 22.5
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    12.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.2
         upper limit
    		 54.2
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.5
         upper limit
    		 22.5
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    14.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.3
         upper limit
    		 59.9
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.6
         upper limit
    		 77.6
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.8
         upper limit
    		 73.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.6
         upper limit
    		 77.6

    Secondary: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline

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    End point title
    		 Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
    End point description
    PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI100, the improvement threshold from baseline in PASI score is 100%. A higher score indicates more severe disease. Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, and 16
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    8
    5
    4
    4
    Units: percentage of participants
    number (confidence interval 95%)
        Wk 4
    0 (0.0 to 6.3)
    0 (0.0 to 10.0)
    0 (0.0 to 12.5)
    0 (0.0 to 12.5)
        Wk 8
    0 (0.0 to 6.3)
    0 (0.0 to 10.0)
    25.0 (0.0 to 79.9)
    0 (0.0 to 12.5)
        Wk 12 N=7,5,3,4
    14.3 (0.0 to 47.4)
    0 (0.0 to 10.0)
    66.7 (0.0 to 100.0)
    0 (0.0 to 12.5)
        Wk 16
    12.5 (0.0 to 41.7)
    20.0 (0.0 to 65.1)
    25.0 (0.0 to 79.9)
    0 (0.0 to 12.5)
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.8
         upper limit
    		 18.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.5
         upper limit
    		 22.5
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.8
         upper limit
    		 18.8
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.5
         upper limit
    		 22.5
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    14.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.3
         upper limit
    		 59.9
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.5
         upper limit
    		 22.5
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    12.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.2
         upper limit
    		 54.2
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.6
         upper limit
    		 77.6

    Secondary: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline

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    End point title
    		 Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
    End point description
    The enthesitis examination is based on the 16 anatomical sites: the medial epicondyle (left and right), the lateral epicondyle (left and right), the supraspinatus insertion (left and right), the bilateral greater trochanter (left and right), the quadriceps tendon insertion into superior border of patella (left and right), the patellar ligament insertion into inferior pole of patella or tibial tuberosity (left and right), the achilles tendon insertion (left and right), and the plantar fascia insertion (left and right). Enthesitis at each site is scored as either 0 (enthesitis absent) and 1 (enthesitis present). SPARCC enthesitis index has an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. Negative change from baseline indicates improvement. Participants in the FAS with enthesitis at baseline and with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    10
    9
    6
    11
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    4 ( 3.4 )
    4 ( 2.4 )
    4 ( 1.7 )
    5 ( 4.5 )
        Change From Baseline at Wk 4
    -2 ( 2.6 )
    0 ( 2.0 )
    -2 ( 1.2 )
    0 ( 3.1 )
        Change From Baseline at Wk 8 N=10,9,6,10
    -2 ( 2.4 )
    -1 ( 1.6 )
    -3 ( 1.9 )
    -2 ( 3.3 )
        Change From Baseline at Wk 12 N=10,9,5,10
    -3 ( 3.5 )
    -2 ( 1.8 )
    -2 ( 1.5 )
    -1 ( 1.7 )
        Change From Baseline at Wk 16
    -3 ( 3.3 )
    -2 ( 2.6 )
    -3 ( 1.5 )
    -1 ( 3.2 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline

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    End point title
    		 Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
    End point description
    LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are those with an at least 10% difference in the ratio of circumference of the affected digit to the contralateral digit (digit on opposite hand or foot), or if contralateral digit is also affected, values from a standard reference table. Total score= {{[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1}x 100} x Tenderness score. Tenderness score (0 = no tenderness, and 1 = tender). The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. No theoretical range exists for the Leeds Dactylitis Index. Lower Leeds Dactylitis Index score represent better outcome. A negative change from baseline indicates improvement. Participants in the FAS with dactylitis were analyzed. 9999=SD cannot be calculated for 1 participant.
    End point type
    Secondary
    End point timeframe
    Baseline, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    6
    3
    1
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    69.5 ( 56.62 )
    28.9 ( 17.35 )
    159.1 ( 9999 )
    15.2 ( 19.45 )
        Change From Baseline at Wk 4
    -13.4 ( 16.81 )
    13.0 ( 19.44 )
    -159.1 ( 9999 )
    13.3 ( 30.64 )
        Change From Baseline at Wk 8
    -40.8 ( 45.15 )
    -2.5 ( 18.34 )
    -159.1 ( 9999 )
    3.6 ( 40.81 )
        Change From Baseline at Wk 12
    -49.3 ( 40.86 )
    -14.0 ( 9.80 )
    -159.1 ( 9999 )
    2.1 ( 44.13 )
        Change From Baseline at Wk 16
    -40.2 ( 51.12 )
    8.4 ( 41.91 )
    -159.1 ( 9999 )
    2.0 ( 31.30 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline

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    End point title
    		 Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
    End point description
    Tender score (0 = no tenderness, 1 = tender, 2 = tender and wince, 3 = tender and withdraw) is collected for Dactylitis Assessments on the Dactylitis Score Sheet that is used for calculation of LDI total score. Tender dactylitis count (TDC) equals the number of tender fingers and toes (tendor score >0). For participants with dactylitis status absent for all the fingers and toes, the TDC is set as 0. The total score range of TDC is from 0 to 60, higher scores indicate greater presence of dactylitis. A negative change from baseline indicates improvement. Participants in the FAS with dactylitis at baseline were analyzed. 9999=SD cannot be calculated for one participant.
    End point type
    Secondary
    End point timeframe
    Baseline, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    6
    3
    1
    5
    Units: tender dactylitis count
    arithmetic mean (standard deviation)
        Baseline
    4 ( 4.1 )
    2 ( 1.0 )
    6 ( 9999 )
    1 ( 1.3 )
        Change From Baseline at Wk 4
    -1 ( 0.9 )
    1 ( 1.0 )
    -6 ( 9999 )
    0 ( 1.5 )
        Change From Baseline at Wk 8
    -3 ( 3.3 )
    0 ( 1.5 )
    -6 ( 9999 )
    0 ( 2.1 )
        Change From Baseline at Wk 12
    -3 ( 3.0 )
    -1 ( 1.5 )
    -6 ( 9999 )
    0 ( 2.2 )
        Change From Baseline at Wk 16
    -3 ( 3.3 )
    0 ( 2.1 )
    -6 ( 9999 )
    0 ( 1.5 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16

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    End point title
    		 Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16
    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. A negative change from baseline indicates improvement (less disability). Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 2, 4, 8, 12, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    8
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    1.05 ( 0.601 )
    0.80 ( 0.547 )
    0.95 ( 0.630 )
    0.92 ( 0.602 )
        Change From Baseline at Wk 2 N=19,18,8,19
    -0.13 ( 0.293 )
    -0.09 ( 0.345 )
    0.03 ( 0.332 )
    -0.08 ( 0.321 )
        Change From Baseline at Wk 4 N=19,18,8,20
    -0.20 ( 0.264 )
    -0.24 ( 0.474 )
    -0.16 ( 0.297 )
    -0.01 ( 0.337 )
        Change From Baseline at Wk 8 N=19,19,8,19
    -0.37 ( 0.387 )
    -0.24 ( 0.516 )
    -0.16 ( 0.281 )
    -0.12 ( 0.407 )
        Change From Baseline at Wk 12 N=18,19,7,19
    -0.33 ( 0.374 )
    -0.20 ( 0.477 )
    -0.39 ( 0.274 )
    -0.07 ( 0.438 )
        Change From Baseline at Wk 16 N=18,19,8,20
    -0.33 ( 0.407 )
    -0.33 ( 0.575 )
    -0.34 ( 0.297 )
    -0.19 ( 0.487 )
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.94 [31]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.2
    Notes
    [31] - P-value was calculated from mixed-effects model for repeated measures (MMRM) including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 2
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.81 [32]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.24
    Notes
    [32] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.13 [33]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.39
         upper limit
    		 0.05
    Notes
    [33] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.073 [34]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.02
    Notes
    [34] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.083 [35]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 0.03
    Notes
    [35] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 8
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.28 [36]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    -0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.38
         upper limit
    		 0.11
    Notes
    [36] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.038 [37]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 -0.02
    Notes
    [37] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 12
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.25 [38]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    -0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 0.11
    Notes
    [38] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41 [39]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.39
         upper limit
    		 0.16
    Notes
    [39] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.26 [40]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    -0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.12
    Notes
    [40] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.

    Secondary: Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16

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    End point title
    		 Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16
    End point description
    FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Higher scores indicate less fatigue. Positive change in value indicates improvement (no or less severity of fatigue). Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 4, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    8
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    32.5 ( 9.83 )
    33.9 ( 13.06 )
    33.4 ( 10.66 )
    31.4 ( 10.37 )
        Change From Baseline at Wk 4 N=19,18,8,20
    4.6 ( 9.75 )
    4.1 ( 8.53 )
    0.5 ( 7.23 )
    1.6 ( 6.53 )
        Change From Baseline at Wk 16
    5.6 ( 9.45 )
    6.4 ( 10.42 )
    4.6 ( 9.18 )
    2.4 ( 9.27 )
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.14 [41]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 7.9
    Notes
    [41] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Stu
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.18 [42]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 7.7
    Notes
    [42] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.15 [43]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 8.7
    Notes
    [43] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.062 [44]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 9.9
    Notes
    [44] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.

    Secondary: Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16

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    End point title
    		 Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16
    End point description
    The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicated improvement (better health status). Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 4, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    8
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    49.9 ( 12.48 )
    50.5 ( 11.43 )
    44.8 ( 7.67 )
    48.9 ( 9.27 )
        Change From Baseline at Wk 4 N=19,18,8,20
    3.3 ( 9.66 )
    0.4 ( 9.40 )
    0.6 ( 6.80 )
    -0.4 ( 5.58 )
        Change From Baseline at Wk 16
    2.8 ( 10.34 )
    0.2 ( 9.42 )
    -0.4 ( 5.58 )
    0.3 ( 5.95 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16

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    End point title
    		 Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16
    End point description
    The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicates improvement (better health status). Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, 4, and 16 weeks
    End point values
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study)
    Number of subjects analysed
    19
    19
    8
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    37.1 ( 8.11 )
    39.2 ( 9.60 )
    39.2 ( 7.58 )
    37.2 ( 7.83 )
        Change From Baseline at Wk 4 N=19,18,8,20
    6.4 ( 5.87 )
    5.6 ( 7.00 )
    2.9 ( 7.12 )
    1.1 ( 5.24 )
        Change From Baseline at Wk 16
    8.4 ( 6.86 )
    7.4 ( 9.80 )
    8.1 ( 7.73 )
    4.6 ( 7.85 )
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo (Main Study) v Filgotinib 100 mg (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [45]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 8.3
    Notes
    [45] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 4
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003 [46]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.9
         upper limit
    		 8.6
    Notes
    [46] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 200 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 200 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.076 [47]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 8
    Notes
    [47] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.
    Statistical analysis title
    		 Fil 100 mg (Main Study) vs Placebo (Main Study)
    Statistical analysis description
    Week 16
    Comparison groups
    Filgotinib 100 mg (Main Study) v Placebo (Main Study)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1 [48]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 7.7
    Notes
    [48] - P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
    Adverse event reporting additional description
    Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Filgotinib 200 mg (Main Study)
    Reporting group description
    		 Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.

    Reporting group title
    Filgotinib 100 mg (Main Study)
    Reporting group description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.

    Reporting group title
    Adalimumab 40 mg (Main Study)
    Reporting group description
    		 PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.

    Reporting group title
    Placebo (Main Study)
    Reporting group description
    		 PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.

    Reporting group title
    Filgotinib 200 mg From Filgotinib 200 mg (LTE)
    Reporting group description
    		 Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 200 mg in the Main Study.

    Reporting group title
    Filgotinib 100 mg From Filgotinib 100 mg (LTE)
    Reporting group description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 100 mg in the Main Study.

    Reporting group title
    Filgotinib 200 mg From Adalimumab 40 mg (LTE)
    Reporting group description
    		 Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.

    Reporting group title
    Filgotinib 100 mg From Adalimumab 40 mg (LTE)
    Reporting group description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.

    Reporting group title
    Filgotinib 200 mg From Placebo (LTE)
    Reporting group description
    		 Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.

    Reporting group title
    Filgotinib 100 mg From Placebo (LTE)
    Reporting group description
    		 Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.

    Serious adverse events
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study) Filgotinib 200 mg From Filgotinib 200 mg (LTE) Filgotinib 100 mg From Filgotinib 100 mg (LTE) Filgotinib 200 mg From Adalimumab 40 mg (LTE) Filgotinib 100 mg From Adalimumab 40 mg (LTE) Filgotinib 200 mg From Placebo (LTE) Filgotinib 100 mg From Placebo (LTE)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Helicobacter infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Filgotinib 200 mg (Main Study) Filgotinib 100 mg (Main Study) Adalimumab 40 mg (Main Study) Placebo (Main Study) Filgotinib 200 mg From Filgotinib 200 mg (LTE) Filgotinib 100 mg From Filgotinib 100 mg (LTE) Filgotinib 200 mg From Adalimumab 40 mg (LTE) Filgotinib 100 mg From Adalimumab 40 mg (LTE) Filgotinib 200 mg From Placebo (LTE) Filgotinib 100 mg From Placebo (LTE)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 19 (21.05%)
    7 / 19 (36.84%)
    2 / 9 (22.22%)
    9 / 20 (45.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    1 / 2 (50.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Initial insomnia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Rib fracture
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Nervous system disorders
    Tension headache
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    3 / 20 (15.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Tendon pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    2 / 20 (10.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    Covid-19
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Laryngitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Suspected COVID-19
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Aug 2019
    • Clarified initial DMC data review. • Clarified laboratory retesting criteria. • Clarified inadequate responder definition. • Clarified vaccination recommendations. • Optional skin biopsy time points were revised. • Inconsistencies to the MRI investigation were corrected. • Clarified the primary estimand. • Viral monitoring frequency was increased. • Urine drug screen panel was revised. • Aligned C-reactive protein (CRP) blinding to be consistent throughout protocol. • Secondary and exploratory endpoints were recategorized. • Clarified stratification at randomization • Added optional HLA-B27 sample collection. • CTCAE Version 4.03 was updated to Version 5.0. • Added follicle-stimulating hormone testing after screening. • Updated sample questionnaires for Clinical and Patient Reported Outcomes and corrected inconsistencies with nomenclature. • Eligibility criteria was clarified as needed. • Inconsistencies regarding timing of the first MRI (at screening) were corrected. • Inconsistencies regarding the window for imaging assessments were corrected.
    17 Apr 2020
    • Increased planned number of sites to support enrollment. • Removed secondary objective for modified Total Sharp Score (mTSS). • Removed restriction on use of Week 16 data. • Updated Study Design to end (Main Study) at Week 16, revised last in-clinic visit at • Week 120, reduced study duration to 2.25 years, and reduced sample size. • Corrected and clarified inclusion and exclusion criteria with respect to cyclosporine removal, • region-specific age requirements, and total bilirubin at screening; removed inclusion criteria for x-rays • Updated key secondary, other secondary, and exploratory endpoints including the removal of mTSS endpoint. • Added description for graphical approach test procedures and safety estimands; updated sample size assumptions and calculations. • Updated Preclinical Pharmacology and Toxicology section to align with current IB. • Added patient discontinuation requirement for thromboembolic events and for patients with active disease at Week 24. • Included biomarker collection visits in Study Procedures Table footnotes and peripheral blood mononuclear cell collection clarification for North America only. • Clarified patient could withdraw MRI consent, and updated objectives to match revised collection time point. • Removed CRP collection at screening and updated CRP at Day 1 to be unblinded to the sponsor. • Updated concomitant medications as a result of shortened Main Study and to include a note for medications that could cause dermatitis and exacerbate psoriasis. • Revised timing of rescue therapy with uncontrolled PsA disease activity. • Updated AE terminology, Special Situations reporting, SAE and death reporting. • Added toxicity management for thromboembolic events. • Added more detailed process language for DMC. • Updated MACE and thromboembolic events language to include/add more detailed description of adjudication process. • Clarified when early termination and safety follow-up visits were to occur.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    19 Mar 2020
    There was a temporary halt to recruitment following the declaration of the COVID-19 pandemic by WHO.
    18 Jun 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to early termination of the study and insufficient number of participants enrolled, all the hypothesis testing performed and the p values reported were nominal. Therefore, the results need to be interpreted with caution.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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