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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate

    Summary
    EudraCT number
    		 2016-001496-75
    Trial protocol
    		 CZ   PL  
    Global end of trial date
    20 Sep 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 May 2019
    First version publication date
    06 Sep 2018
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Adding text to “Limitations and Caveats” section

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-379-1582
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02885181
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active RA as measured by change from baseline in Disease Activity Score for 28 joint count using C‑reactive protein (CRP) (DAS28 (CRP)) at Week 12.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 Participants received background therapy with methotrexate administered orally or parenterally once weekly.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Sep 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Bulgaria: 7
    Country: Number of subjects enrolled
    Czech Republic: 3
    Country: Number of subjects enrolled
    United States: 33
    Country: Number of subjects enrolled
    Moldova, Republic of: 18
    Country: Number of subjects enrolled
    Georgia: 10
    Country: Number of subjects enrolled
    Ukraine: 6
    Worldwide total number of subjects
    83
    EEA total number of subjects
    16
    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)
    64
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 21 September 2016. The last study visit occurred on 20 September 2017.

    Pre-assignment
    Screening details
    		 140 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GS-9876 30 mg
    Arm description
    		 GS-9876 30 mg + filgotinib placebo for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    GS-9876 30 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GS-9876 30 mg tablet administered once daily

    Investigational medicinal product name
    Filgotinib Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Filgotinib placebo 2 tablets administered once daily

    Arm title
    		 GS-9876 10 mg
    Arm description
    		 GS-9876 10 mg + filgotinib placebo for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    GS-9876 10 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GS-9876 10 mg administered once daily

    Investigational medicinal product name
    Filgotinib Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Filgotinib placebo 2 tablets administered once daily

    Arm title
    		 Filgotinib
    Arm description
    		 Filgotinib + GS-9876 placebo for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 X 100 mg tablets administered once daily

    Investigational medicinal product name
    GS-9876 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GS-9876 placebo tablet administered once daily

    Arm title
    		 Placebo
    Arm description
    		 GS-9876 placebo + filgotinib placebo for 12 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    GS-9876 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GS-9876 placebo administered orally once daily

    Investigational medicinal product name
    Filgotinib Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Filgotinib placebo (2 tablets) administered orally once daily

    Number of subjects in period 1
    		GS-9876 30 mg GS-9876 10 mg Filgotinib Placebo
    Started
    20
    20
    21
    22
    Completed
    20
    19
    21
    19
    Not completed
    0
    1
    0
    3
         Consent withdrawn by subject
    -
    -
    -
    1
         Adverse event, non-fatal
    -
    -
    -
    1
         Investigator's discretion
    -
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GS-9876 30 mg
    Reporting group description
    		 GS-9876 30 mg + filgotinib placebo for 12 weeks

    Reporting group title
    GS-9876 10 mg
    Reporting group description
    		 GS-9876 10 mg + filgotinib placebo for 12 weeks

    Reporting group title
    Filgotinib
    Reporting group description
    		 Filgotinib + GS-9876 placebo for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 GS-9876 placebo + filgotinib placebo for 12 weeks

    Reporting group values
    		 GS-9876 30 mg GS-9876 10 mg Filgotinib Placebo Total
    Number of subjects
    		 20 20 21 22 83
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58 ± 7.0 56 ± 11.4 53 ± 15.4 54 ± 10.9 -
    Gender categorical
    Units: Subjects
        Female
    		 15 16 17 21 69
        Male
    		 5 4 4 1 14
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 0 1
        Asian
    		 0 0 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 2 0 2 4
        White
    		 20 17 21 19 77
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 1 2 0 4
        Not Hispanic or Latino
    		 19 19 19 22 79
    Disease Activity Score 28 C- Reactive Protein (DAS28 CRP)
    Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 5.78 ± 0.691 5.65 ± 0.941 6.09 ± 1.112 5.51 ± 1.003 -
    Health Assessment Questionnaire Disease Index (HAQ-DI)
    The Health Assessment Questionnaire – Disability Index (HAQ-DI) is a self-reported tool used to assess the ability to perform tasks in 8 functional categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional category were collected as 0 (without any difficulty) to 3 (unable to do a task in that area). The HAQ-DI score ranges from 0 (no disability) to 3 (completely disabled), when 6 or more categories are non-missing.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 1.38 ± 0.650 1.47 ± 0.425 1.61 ± 0.591 1.51 ± 0.577 -

    End points

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    End points reporting groups
    Reporting group title
    GS-9876 30 mg
    Reporting group description
    		 GS-9876 30 mg + filgotinib placebo for 12 weeks

    Reporting group title
    GS-9876 10 mg
    Reporting group description
    		 GS-9876 10 mg + filgotinib placebo for 12 weeks

    Reporting group title
    Filgotinib
    Reporting group description
    		 Filgotinib + GS-9876 placebo for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 GS-9876 placebo + filgotinib placebo for 12 weeks

    Primary: Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12

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    End point title
    		 Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12
    End point description
    Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. Participants in the Full Analysis Set (participants who received at least 1 dose of study drug) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline; Week 12
    End point values
    		 GS-9876 30 mg GS-9876 10 mg Filgotinib Placebo
    Number of subjects analysed
    20
    17
    21
    19
    Units: units on a scale
        arithmetic mean (standard deviation)
    -1.26 ± 1.276
    -0.78 ± 1.119
    -2.46 ± 1.242
    -1.36 ± 1.044
    Statistical analysis title
    		 GS-9876 30 mg vs. Placebo
    Comparison groups
    GS-9876 30 mg v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.978
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Least Squares (LS) Means of Differences
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.74
         upper limit
    		 0.76
    Statistical analysis title
    		 GS-9876 10 mg vs. Placebo
    Comparison groups
    GS-9876 10 mg v Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 LS Means of Differences
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.36
         upper limit
    		 1.16
    Statistical analysis title
    		 Filgotinib vs. Placebo
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 LS Means of Differences]
    Point estimate
    -1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.92
         upper limit
    		 -0.43

    Secondary: Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12

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    End point title
    		 Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12
    End point description
    American College of Rheumatology (ACR)20 response was defined as having ≥ 20% improvement from baseline in the number of tender and the number of swollen joints, and a 20% improvement in at least 3 of the following 5 criteria: Physician’s Global Assessment of Disease Activity (PhGA), Participant’s Global Assessment of Disease Activity (PtGA), Participant’s pain assessment, Participant’s assessment of physical function (HAQ-DI) score, and C-reactive protein (CRP). Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GS-9876 30 mg GS-9876 10 mg Filgotinib Placebo
    Number of subjects analysed
    20
    20
    21
    22
    Units: percentage of participants
        number (not applicable)
    35.0
    25.0
    81.0
    40.9
    Statistical analysis title
    		 GS-9876 30 mg vs. Placebo
    Comparison groups
    GS-9876 30 mg v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.66
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Response Rates
    Point estimate
    -5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36
         upper limit
    		 24
    Statistical analysis title
    		 GS-9876 10 mg vs. Placebo
    Comparison groups
    GS-9876 10 mg v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.277
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Response Rates
    Point estimate
    -15.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.7
         upper limit
    		 13.8
    Statistical analysis title
    		 Filgotinib vs. Placebo
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Response Rates
    Point estimate
    40
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.7
         upper limit
    		 65.6

    Secondary: Percentage of Participants Who Achieved ACR50 Improvement at Week 12

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    End point title
    		 Percentage of Participants Who Achieved ACR50 Improvement at Week 12
    End point description
    ACR50 response was defined as having ≥ 50% improvement from baseline in the number of tender and the number of swollen joints, and a 50% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant’s pain assessment, HAQ-DI score, and CRP. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GS-9876 30 mg GS-9876 10 mg Filgotinib Placebo
    Number of subjects analysed
    20
    20
    21
    22
    Units: percentage of participants
        number (not applicable)
    20.0
    20.0
    47.6
    22.7
    Statistical analysis title
    		 Gs-9876 30 mg vs. Placebo
    Comparison groups
    GS-9876 30 mg v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.853
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Response Rates
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32
         upper limit
    		 27.5
    Statistical analysis title
    		 GS-9876 10 mg vs. Placebo
    Comparison groups
    Placebo v GS-9876 10 mg
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.852
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Response Rates
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32
         upper limit
    		 27.5
    Statistical analysis title
    		 Filgotinib vs. Placebo
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.092
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Response Rates
    Point estimate
    24.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 51.5

    Secondary: Percentage of Participants Who Achieved ACR70 Improvement at Week 12

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    End point title
    		 Percentage of Participants Who Achieved ACR70 Improvement at Week 12
    End point description
    ACR70 response was defined as having ≥ 70% improvement from baseline in the number of tender and the number of swollen joints, and a 70% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant’s pain assessment, HAQ-DI score, and CRP. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GS-9876 30 mg GS-9876 10 mg Filgotinib Placebo
    Number of subjects analysed
    20
    20
    21
    22
    Units: percentage of participants
        number (not applicable)
    5.0
    15.0
    38.1
    13.6
    Statistical analysis title
    		 GS-9876 30 mg vs. Placebo
    Comparison groups
    GS-9876 30 mg v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.36
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Response Rates
    Point estimate
    -8.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.9
         upper limit
    		 22.5
    Statistical analysis title
    		 GS-9876 10 mg va. Placebo
    Comparison groups
    GS-9876 10 mg v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.896
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Response Rates
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28
         upper limit
    		 31.7
    Statistical analysis title
    		 Filgotinib vs. Placebo
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.072
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Response Rates
    Point estimate
    24.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 50.1

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

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    End point title
    		 Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
    End point description
    The Health Assessment Questionnaire – Disability Index (HAQ-DI) is a self-reported tool used to assess the ability to perform tasks in 8 functional categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Responses in each functional category were collected as 0 (without any difficulty) to 3 (unable to do a task in that area). The HAQ-DI score ranges from 0 (no disability) to 3 (completely disabled), when 6 or more categories are non-missing. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 12
    End point values
    		 GS-9876 30 mg GS-9876 10 mg Filgotinib Placebo
    Number of subjects analysed
    20
    19
    21
    19
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.46 ± 0.480
    -0.18 ± 0.800
    -0.70 ± 0.649
    -0.39 ± 0.389
    Statistical analysis title
    		 GS-9876 30 mg vs. Placebo
    Comparison groups
    GS-9876 30 mg v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.528
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 LS Means of Differences
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 0.25
    Statistical analysis title
    		 GS9876 10 mg vs. Placebo
    Comparison groups
    GS-9876 10 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.293
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 LS Means of Differences
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.57
    Statistical analysis title
    		 Filfotinib vs. Placebo
    Comparison groups
    Filgotinib v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.072
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 LS Means of Differences
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.03

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 weeks + 30 days
    Adverse event reporting additional description
    Safety Analysis Set: participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    GS-9876 30 mg
    Reporting group description
    		 GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly

    Reporting group title
    GS-9876 10 mg
    Reporting group description
    		 GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeksand background therapy with methotrexate orally or parenterally once weekly

    Reporting group title
    Filgotinib
    Reporting group description
    		 Filgotinib 2 x 100 mg tablets orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly

    Reporting group title
    Placebo
    Reporting group description
    		 GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly

    Serious adverse events
    		 GS-9876 30 mg GS-9876 10 mg Filgotinib Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GS-9876 30 mg GS-9876 10 mg Filgotinib Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 20 (35.00%)
    8 / 20 (40.00%)
    4 / 21 (19.05%)
    1 / 22 (4.55%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Condition aggravated
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Liver function test increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Meniere's disease
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye disorders
    Hypermetropia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Epigastric discomfort
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jun 2016
    • Addition of filgotinib treatment arm for exploratory objectives • Other changes to correct discrepancies between different sections of the protocol and/or to provide further clarification

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    An unplanned review of unblinded clinical trial data was performed in this study that was not prospectively specified in the protocol. There was no impact on the overall integrity or conclusions of the study.
    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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