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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination with Conventional Synthetic Disease-Modifying Anti-Rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

    Summary
    EudraCT number
    		 2016-000569-21
    Trial protocol
    		 BE   GB   DE   FR   HU   ES   PL   NL  
    Global end of trial date
    26 Jun 2018

    Results information
    Results version number
    		 v1
    This version publication date
    04 Jul 2019
    First version publication date
    04 Jul 2019
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-417-0302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02873936
    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
    26 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Mar 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2018
    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 effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 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
    		 All participants continued to receive a stable dose of a permitted protocol-specified conventional synthetic disease-modifying antirheumatic drug (csDMARD(s)) (methotrexate, hydroxychloroquine, sulfasalazine, or leflunomide).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jul 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Hungary: 16
    Country: Number of subjects enrolled
    United States: 255
    Country: Number of subjects enrolled
    Japan: 40
    Country: Number of subjects enrolled
    Mexico: 30
    Country: Number of subjects enrolled
    Argentina: 12
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Australia: 4
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Switzerland: 2
    Worldwide total number of subjects
    449
    EEA total number of subjects
    98
    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)
    336
    From 65 to 84 years
    113
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Argentina, Australia, Europe, Israel, Japan, Mexico, South Korea, and the United States. The first participant was screened on 27 July 2016. The last study visit occurred on 26 June 2018.

    Pre-assignment
    Screening details
    		 688 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Filgotinib 200 mg
    Arm description
    		 Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet once daily + a stable dose of permitted csDMARDs for up to 24 weeks
    Arm type
    		 Experimental

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

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

    Arm title
    		 Filgotinib 100 mg
    Arm description
    		 Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet once daily + a stable dose of permitted csDMARDs for up to 24 weeks
    Arm type
    		 Experimental

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

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

    Arm title
    		 Placebo
    Arm description
    		 PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet once daily + a stable dose of permitted csDMARDs for up to 24 weeks
    Arm type
    		 Placebo

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

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

    Number of subjects in period 1 [1]
    		Filgotinib 200 mg Filgotinib 100 mg Placebo
    Started
    147
    153
    148
    Completed
    135
    130
    116
    Not completed
    12
    23
    32
         Withdrew Consent
    4
    11
    20
         Adverse Event
    3
    5
    3
         Non-Compliance with Study Drug
    1
    -
    1
         Investigator's Discretion
    3
    5
    4
         Protocol Violation
    -
    1
    3
         Lost to follow-up
    1
    1
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 participant who was randomized but not treated is not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    		 Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet once daily + a stable dose of permitted csDMARDs for up to 24 weeks

    Reporting group title
    Filgotinib 100 mg
    Reporting group description
    		 Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet once daily + a stable dose of permitted csDMARDs for up to 24 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet once daily + a stable dose of permitted csDMARDs for up to 24 weeks

    Reporting group values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo Total
    Number of subjects
    		 147 153 148 448
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56 ± 12.5 55 ± 12.0 56 ± 12.1 -
    Gender categorical
    Units: Subjects
        Female
    		 120 119 121 360
        Male
    		 27 34 27 88
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 7 9 10 26
        Asian
    		 15 20 15 50
        Black or African American
    		 14 12 21 47
        White
    		 110 109 97 316
        Other
    		 1 3 2 6
        Not Permitted
    		 0 0 3 3
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 26 40 41 107
        Not Hispanic or Latino
    		 120 112 107 339
        Not Permitted
    		 1 1 0 2

    End points

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    End points reporting groups
    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    		 Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet once daily + a stable dose of permitted csDMARDs for up to 24 weeks

    Reporting group title
    Filgotinib 100 mg
    Reporting group description
    		 Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet once daily + a stable dose of permitted csDMARDs for up to 24 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet once daily + a stable dose of permitted csDMARDs for up to 24 weeks

    Primary: Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 using the Full Analysis Set

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    End point title
    		 Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 using the Full Analysis Set
    End point description
    ACR20 response was defined as having ≥ 20% improvement from baseline in tender joint count based on 68 joints (TJC68), ≥ 20% improvement from baseline in swollen joint count based on 66 joints (SJC66), and ≥ 20% improvement in at least 3 of the following 5 criteria: Physician’s Global Assessment of Disease Activity (PGA), Subject's Global Assessment of Disease Activity (SGA), participant’s pain assessment, Health Assessment Questionnaire - Disability Index (HAQ-DI) score, and high-sensitivity C-reactive protein (hsCRP). Full Analysis Set included all randomized participants who received at least 1 dose of study drug. Participants with missing outcomes were set as non-responders. For statistical analyses, the hierarchical testing procedure was performed to control the overall type I error rate for the primary and key secondary endpoints.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    147
    153
    148
    Units: percentage of participants
        number (confidence interval 95%)
    66.0 (58.0 to 74.0)
    57.5 (49.4 to 65.7)
    31.1 (23.3 to 38.9)
    Statistical analysis title
    		 ACR20 - Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in Response Rates
    Point estimate
    34.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23.5
         upper limit
    		 46.3
    Notes
    [1] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    		 ACR20 - Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in Response Rates
    Point estimate
    26.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15
         upper limit
    		 37.9
    Notes
    [2] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

    Secondary: Percentage of Participants who Achieve Disease Activity Score 28 C-Reactive Protein (DAS28(CRP)) ≤ 3.2 at Week 12 using the Full Analysis Set

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    End point title
    		 Percentage of Participants who Achieve Disease Activity Score 28 C-Reactive Protein (DAS28(CRP)) ≤ 3.2 at Week 12 using the Full Analysis Set
    End point description
    DAS28(CRP) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA, and hsCRP for a total possible score of 1 to 9.4. Higher values indicate more severe disease activity. Participants in the Full Analysis Set were analyzed. Participants with missing outcomes were set as non-responders. For statistical analyses, the hierarchical testing procedure was performed to control the overall type I error rate for the primary and key secondary endpoints.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    147
    153
    148
    Units: percentage of participants
        number (confidence interval 95%)
    40.8 (32.5 to 49.1)
    37.3 (29.3 to 45.2)
    15.5 (9.4 to 21.7)
    Statistical analysis title
    		 DAS28(CRP) Response - Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in Response Rates
    Point estimate
    25.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.7
         upper limit
    		 35.8
    Notes
    [3] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Statistical analysis title
    		 DAS28(CRP) Response - Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in Response Rates
    Point estimate
    21.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.4
         upper limit
    		 32
    Notes
    [4] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

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

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    End point title
    		 Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
    End point description
    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 was calculated as the average of the scores of the 8 functional areas and 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. For statistical analyses, the hierarchical testing procedure was performed to control the overall type I error rate for the primary and key secondary endpoints.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Number of subjects analysed
    137
    140
    129
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.55 ± 0.590
    -0.48 ± 0.602
    -0.23 ± 0.547
    Statistical analysis title
    		 HAQ-DI Score - Filgotinib 200 mg vs Placebo
    Comparison groups
    Filgotinib 200 mg v Placebo
    Number of subjects included in analysis
    266
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.001 [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM of Treatment Difference
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 -0.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.066
    Notes
    [5] - The mixed-effects model for repeated measures (MMRM) included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    [6] - Least square mean (LSM), 95% CI, and P-value were calculated using the MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Statistical analysis title
    		 HAQ-DI Score - Filgotinib 100 mg vs Placebo
    Comparison groups
    Filgotinib 100 mg v Placebo
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 < 0.001 [8]
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM of Treatment Difference
    Point estimate
    -0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 -0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.065
    Notes
    [7] - The MMRM included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    [8] - LSM, 95% CI, and P-value were calculated using the MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events: Enrollment up to Week 24 plus 30 days; All-Cause Mortality: Enrollment up to Posttreatment Week 4
    Adverse event reporting additional description
    Safety Analysis Set included all participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Filgotinib 200 mg
    Reporting group description
    		 Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet once daily + a stable dose of permitted csDMARDs for up to 24 weeks

    Reporting group title
    Filgotinib 100 mg
    Reporting group description
    		 Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet once daily + a stable dose of permitted csDMARDs for up to 24 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet once daily + a stable dose of permitted csDMARDs for up to 24 weeks

    Serious adverse events
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 147 (4.08%)
    8 / 153 (5.23%)
    5 / 148 (3.38%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 147 (0.68%)
    0 / 153 (0.00%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 147 (0.68%)
    0 / 153 (0.00%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 147 (0.00%)
    0 / 153 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 147 (0.68%)
    0 / 153 (0.00%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 147 (0.00%)
    0 / 153 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial ischaemia
         subjects affected / exposed
    0 / 147 (0.00%)
    1 / 153 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 147 (0.00%)
    1 / 153 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 147 (0.00%)
    0 / 153 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 147 (0.00%)
    0 / 153 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 147 (0.68%)
    0 / 153 (0.00%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 147 (0.68%)
    0 / 153 (0.00%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 147 (0.00%)
    0 / 153 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 147 (0.00%)
    0 / 153 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine haemorrhage
         subjects affected / exposed
    1 / 147 (0.68%)
    0 / 153 (0.00%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 147 (0.00%)
    0 / 153 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 147 (0.68%)
    0 / 153 (0.00%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 147 (0.00%)
    1 / 153 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    1 / 147 (0.68%)
    0 / 153 (0.00%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 147 (0.00%)
    1 / 153 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 147 (0.00%)
    1 / 153 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 147 (0.00%)
    0 / 153 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 147 (0.00%)
    0 / 153 (0.00%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess oral
         subjects affected / exposed
    0 / 147 (0.00%)
    1 / 153 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 147 (0.00%)
    1 / 153 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 147 (0.68%)
    0 / 153 (0.00%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder empyema
         subjects affected / exposed
    0 / 147 (0.00%)
    1 / 153 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulval abscess
         subjects affected / exposed
    0 / 147 (0.00%)
    1 / 153 (0.65%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 147 (0.68%)
    0 / 153 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 147 (0.00%)
    0 / 153 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    1 / 147 (0.68%)
    0 / 153 (0.00%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Filgotinib 200 mg Filgotinib 100 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 147 (26.53%)
    35 / 153 (22.88%)
    31 / 148 (20.95%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 147 (5.44%)
    9 / 153 (5.88%)
    2 / 148 (1.35%)
         occurrences all number
    8
    11
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 147 (4.76%)
    8 / 153 (5.23%)
    5 / 148 (3.38%)
         occurrences all number
    9
    8
    5
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 147 (1.36%)
    2 / 153 (1.31%)
    8 / 148 (5.41%)
         occurrences all number
    2
    2
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    15 / 147 (10.20%)
    9 / 153 (5.88%)
    7 / 148 (4.73%)
         occurrences all number
    15
    11
    7
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 147 (5.44%)
    9 / 153 (5.88%)
    6 / 148 (4.05%)
         occurrences all number
    9
    9
    6
    Bronchitis
         subjects affected / exposed
    8 / 147 (5.44%)
    3 / 153 (1.96%)
    8 / 148 (5.41%)
         occurrences all number
    9
    5
    8

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jul 2016
    ● Updated to reflect the removal of radiologic assessments (including removal of modified Total Sharp Score [mTSS] objectives as a measure of joint structural damage derived from x-rays) ● Added urine biomarker samples as an exploratory endpoint ● Updated study procedures to collect body weight at all study visits ● Updated study procedures to include Treatment Satisfaction Questionnaire for Medication (TSQM) collection at several study visits ● Added a carotid artery ultrasound substudy ● Added an assessment of quantitative immunoglobulin (Ig) at Day 1 and Week 24 (Early Termination) ● Added assessments of hemoglobin A1c (HbA1c), leptin, low-density lipoprotein (LDL) particle, homocysteine, and Apo A1/B for subjects participating in the carotid artery ultrasound substudy ● Removed peripheral blood mononuclear cell biomarker sampling ● Clarified criteria for interruption of study drugs ● Updated the definition of postmenopausal females

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

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