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    Clinical Trial Results:
    Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone

    Summary
    EudraCT number
    		 2012-003635-31
    Trial protocol
    		 BE   HU   DE   CZ   ES   AT   LV   BG  
    Global end of trial date
    14 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2016
    First version publication date
    29 May 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GLPG0634-CL-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01888874
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galapagos N.V.
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, 2800, Mechelen, Belgium,
    Public contact
    Clinical Trial Information Desk, Galapagos N.V., +32 (0)15 342 900, rd@glpg.com
    Scientific contact
    Clinical Trial Information Desk, Galapagos N.V., +32 (0)15 342 900, rd@glpg.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
    14 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy in terms of the percentage of subjects achieving an American College of Rheumatology (ACR)20 response, of different doses and dose regimens of GLPG0634 compared to placebo at Week 12.
    Protection of trial subjects
    Before initiation of the study at each study center, the protocol, the informed consent form (ICF), other written material given to the subjects, and any other relevant study documentation was to be submitted to the appropriate IEC/IRB. Written approval of the study and all relevant study information was to be obtained before the study center could be initiated or the study medication was released to the investigator. Any necessary extensions or renewals of IEC/IRB approval were to be obtained for changes to the study such as modification of the protocol, the ICF or other study documentation. The written approval of the IEC/IRB together with the approved ICF was to be filed in the study files. The investigator was to promptly report to the IEC/IRB any new information that could have adversely affected the safety of the subjects or the conduct of the study. The investigator was to submit written summaries of the study status to the IEC/IRB as required. On completion of the study, the IEC/IRB was to be notified that the study had ended.
    Background therapy
    		 Methotrexate (MTX) was the standard background therapy for this study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jul 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 59
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Bulgaria: 33
    Country: Number of subjects enrolled
    Czech Republic: 18
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Hungary: 36
    Country: Number of subjects enrolled
    Latvia: 26
    Country: Number of subjects enrolled
    Argentina: 59
    Country: Number of subjects enrolled
    Mexico: 57
    Country: Number of subjects enrolled
    Chile: 36
    Country: Number of subjects enrolled
    Colombia: 36
    Country: Number of subjects enrolled
    Guatemala: 34
    Country: Number of subjects enrolled
    Russian Federation: 45
    Country: Number of subjects enrolled
    Ukraine: 36
    Country: Number of subjects enrolled
    Moldova, Republic of: 16
    Country: Number of subjects enrolled
    United States: 72
    Country: Number of subjects enrolled
    New Zealand: 7
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    Israel: 5
    Worldwide total number of subjects
    599
    EEA total number of subjects
    191
    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)
    499
    From 65 to 84 years
    100
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Europe, South America, North America, Australia, and New Zealand. The first participant was screened on17 July 2013. The last study visit occurred on 14 May 2015.

    Pre-assignment
    Screening details
    		 1255 subjects were screened.

    Period 1
    Period 1 title
    Period 1: Weeks 1 - 12
    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
    		 Placebo
    Arm description
    		 Placebo during Weeks 1 - 12; responders (having at least 20% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to 100 mg QD or 50 mg BID during Weeks 13-24
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 placebo capsules both in the morning and in the evening

    Arm title
    		 GLPG0634 50 mg QD
    Arm description
    		 GLPG0634 50 mg once daily + placebo during Weeks 1-12; responders remained on the same treatment while non-responders switched to 100 mg QD during Weeks 13-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 50 mg capsule once daily in the morning

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule in the morning and 2 placebo capsules in the evening

    Arm title
    		 GLPG0634 100 mg QD
    Arm description
    		 GLPG0634 100 mg once daily + placebo during Weeks 1-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 100 mg capsule once daily in the morning

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule in the morning and 2 placebo capsules in the evening

    Arm title
    		 GLPG0634 200 mg QD
    Arm description
    		 GLPG0634 200 mg once daily + placebo during Weeks 1-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 GLPG0634 100 mg capsules once daily in the morning

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 placebo capsules in the evening

    Arm title
    		 GLPG0634 25 mg BID
    Arm description
    		 GLPG0634 25 mg twice daily + placebo during Weeks 1-12; responders remained on the same treatment while non-responders switched to 50 mg BID during Weeks 13-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 25 mg capsule twice daily in the morning and in the evening

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule twice daily in the morning and in the evening

    Arm title
    		 GLPG0634 50 mg BID
    Arm description
    		 GLPG0634 50 mg twice daily + placebo during Weeks 1-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 50 mg capsule twice daily in the morning and in the evening

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule twice daily in the morning and in the evening

    Arm title
    		 GLPG0634 100 mg BID
    Arm description
    		 GLPG0634 100 mg twice daily + placebo during Weeks 1-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 100 mg capsule twice daily in the morning and in the evening

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule twice daily in the morning and in the evening

    Number of subjects in period 1 [1]
    		Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Started
    86
    82
    85
    86
    86
    85
    84
    Completed
    83
    76
    78
    80
    77
    80
    83
    Not completed
    3
    6
    7
    6
    9
    5
    1
         Non-compliance with the study procedures
    -
    1
    -
    -
    -
    -
    -
         Withdrawal of the subject's consent
    2
    -
    -
    -
    -
    -
    -
         Withdrawal of the subject’s consent
    -
    2
    3
    4
    3
    -
    -
         Adverse event, non-fatal
    -
    2
    3
    1
    2
    1
    -
         Other
    1
    -
    1
    1
    3
    3
    -
         AE and treatment failure
    -
    -
    -
    -
    1
    -
    -
         Investigator’s decision
    -
    -
    -
    -
    -
    -
    1
         Lost to follow-up
    -
    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: 5 subjects who were randomized but not treated are not included in the subject disposition table.
    Period 2
    Period 2 title
    Period 2: Weeks 13 - 24
    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
    		 Placebo Responders
    Arm description
    		 Placebo during Weeks 1 - 12; responders remained on placebo during Weeks 13-24
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 placebo capsules twice daily in the morning and in the evening

    Arm title
    		 GLPG0634 50 mg QD Responders
    Arm description
    		 GLPG0634 50 mg once daily + placebo during Weeks 1-12; responders remained on the same treatment during Weeks 13-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 50 mg capsule once daily in the morning

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule in the morning and 2 placebo capsules in the evening

    Arm title
    		 GLPG0634 25 mg BID Responders
    Arm description
    		 GLPG0634 25 mg twice daily + placebo during Weeks 1-12; responders remained on the same treatment during Weeks 13-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 25 mg capsule twice daily in the morning and in the evening

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule twice daily in the morning and in the evening

    Arm title
    		 Placebo Switch to GLPG0634 100 mg QD
    Arm description
    		 Some nonresponders from the placebo group were re-randomized to receive GLPG0634 100 mg once daily + placebo during Weeks 13-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 100 mg capsule once daily in the morning

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule in the morning and 2 placebo capsules in the evening

    Arm title
    		 Placebo Switch to GLPG0634 50 mg BID
    Arm description
    		 Some nonresponders from the placebo group were re-randomized to receive GLPG0634 50 mg twice daily + placebo during Weeks 13-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 50 mg capsule twice daily in the morning and in the evening

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule twice daily in the morning and in the evening

    Arm title
    		 50 mg QD Switch to GLPG0634 100 mg QD
    Arm description
    		 Nonresponders from the 50 mg QD group were re-randomized to receive GLPG0634 100 mg once daily + placebo during Weeks 13-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 100 mg capsule once daily in the morning

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule in the morning and 2 placebo capsules in the evening

    Arm title
    		 25 mg BID Switch to GLPG0634 50 mg BID
    Arm description
    		 Nonresponders from the 25 mg BID group were re-randomized to receive GLPG0634 50 mg twice daily + placebo during Weeks 13-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 50 mg capsule twice daily in the morning and in the evening

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule twice daily in the morning and in the evening

    Arm title
    		 GLPG0634 100 mg QD
    Arm description
    		 GLPG0634 100 mg once daily + placebo during Weeks 1-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 100 mg capsule once daily in the morning

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule in the morning and 2 placebo capsules in the evening

    Arm title
    		 GLPG0634 200 mg QD
    Arm description
    		 GLPG0634 200 mg once daily + placebo during Weeks 1-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 GLPG0634 100 mg capsules once daily in the morning

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 placebo capsules in the evening

    Arm title
    		 GLPG0634 50 mg BID
    Arm description
    		 GLPG0634 50 mg twice daily + placebo during Weeks 1-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 50 mg capsule twice daily in the morning and in the evening

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule twice daily in the morning and in the evening

    Arm title
    		 GLPG0634 100 mg BID
    Arm description
    		 GLPG0634 100 mg twice daily + placebo during Weeks 1-24
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 100 mg capsule twice daily in the morning and in the evening

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo capsule twice daily in the morning and in the evening

    Number of subjects in period 2
    		Placebo Responders GLPG0634 50 mg QD Responders GLPG0634 25 mg BID Responders Placebo Switch to GLPG0634 100 mg QD Placebo Switch to GLPG0634 50 mg BID 50 mg QD Switch to GLPG0634 100 mg QD 25 mg BID Switch to GLPG0634 50 mg BID GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 50 mg BID GLPG0634 100 mg BID
    Started
    53
    57
    60
    15
    15
    19
    17
    78
    80
    80
    83
    Completed
    50
    55
    57
    15
    15
    19
    17
    70
    78
    77
    80
    Not completed
    3
    2
    3
    0
    0
    0
    0
    8
    2
    3
    3
         Withdrawal of the subject’s consent
    1
    1
    1
    -
    -
    -
    -
    2
    -
    -
    -
         Treatment failure
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
         Adverse event, non-fatal
    2
    -
    1
    -
    -
    -
    -
    3
    2
    1
    3
         Lost to follow-up
    -
    1
    -
    -
    -
    -
    -
    -
    -
    1
    -
         Adverse event and treatment failure
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
         Non compliance with study medication
    -
    -
    -
    -
    -
    -
    -
    2
    -
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo during Weeks 1 - 12; responders (having at least 20% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to 100 mg QD or 50 mg BID during Weeks 13-24

    Reporting group title
    GLPG0634 50 mg QD
    Reporting group description
    		 GLPG0634 50 mg once daily + placebo during Weeks 1-12; responders remained on the same treatment while non-responders switched to 100 mg QD during Weeks 13-24

    Reporting group title
    GLPG0634 100 mg QD
    Reporting group description
    		 GLPG0634 100 mg once daily + placebo during Weeks 1-24

    Reporting group title
    GLPG0634 200 mg QD
    Reporting group description
    		 GLPG0634 200 mg once daily + placebo during Weeks 1-24

    Reporting group title
    GLPG0634 25 mg BID
    Reporting group description
    		 GLPG0634 25 mg twice daily + placebo during Weeks 1-12; responders remained on the same treatment while non-responders switched to 50 mg BID during Weeks 13-24

    Reporting group title
    GLPG0634 50 mg BID
    Reporting group description
    		 GLPG0634 50 mg twice daily + placebo during Weeks 1-24

    Reporting group title
    GLPG0634 100 mg BID
    Reporting group description
    		 GLPG0634 100 mg twice daily + placebo during Weeks 1-24

    Reporting group values
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID Total
    Number of subjects
    		 86 82 85 86 86 85 84 594
    Age categorical
    Units: Subjects
        < 45
    		 20 20 22 13 24 11 16 126
        ≥ 45 to < 65
    		 55 47 51 58 47 59 53 370
        ≥ 65 to < 75
    		 9 14 8 13 14 11 14 83
        ≥ 75
    		 2 1 4 2 1 4 1 15
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 52 (18 to 84) 52.8 (20 to 77) 52.3 (20 to 79) 54.8 (19 to 75) 52.4 (24 to 79) 55.4 (21 to 78) 53.9 (22 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 70 69 65 74 68 65 70 481
        Male
    		 16 13 20 12 18 20 14 113
    Race
    Units: Subjects
        White
    		 59 61 62 67 63 65 66 443
        Other
    		 26 21 22 18 23 19 17 146
        Black or African American
    		 1 0 0 1 0 0 1 3
        Asian
    		 0 0 1 0 0 1 0 2
    RA duration
    Units: years
        arithmetic mean (full range (min-max))
    		 8.21 (0.5 to 36.5) 7.21 (0.6 to 21.3) 7.67 (0.6 to 32.6) 8.51 (0.5 to 34.5) 8.88 (0.5 to 30.1) 7.79 (0.5 to 28.8) 9.74 (0.5 to 43.2) -
    C-reactive protein (CRP) at Baseline
    Units: mg/L
        arithmetic mean (full range (min-max))
    		 16.25 (1 to 84.5) 27.71 (1 to 158.7) 24.54 (1 to 140.7) 27.1 (1 to 140.9) 26.01 (1.2 to 157.3) 24.6 (1 to 113.4) 26.86 (1 to 129.4) -
    Corrected tender joint count based on 68 joints (TJC68) at Baseline
    68 joints were assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68.
    Units: units on a scale
        arithmetic mean (full range (min-max))
    		 24.984 (8 to 60) 24.907 (8 to 64) 25.319 (8 to 68) 28.843 (8 to 68) 25.427 (8 to 64) 27.158 (8 to 66) 25.946 (7 to 61) -
    Corrected swollen joint count based on 66 joints (SJC66) at Baseline
    66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.
    Units: units on a scale
        arithmetic mean (full range (min-max))
    		 16.13 (6 to 48) 17.023 (6 to 66) 16.31 (6 to 54) 17.355 (6 to 58) 15.663 (6 to 40) 17.534 (6 to 62) 16.356 (6 to 48) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo during Weeks 1 - 12; responders (having at least 20% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to 100 mg QD or 50 mg BID during Weeks 13-24

    Reporting group title
    GLPG0634 50 mg QD
    Reporting group description
    		 GLPG0634 50 mg once daily + placebo during Weeks 1-12; responders remained on the same treatment while non-responders switched to 100 mg QD during Weeks 13-24

    Reporting group title
    GLPG0634 100 mg QD
    Reporting group description
    		 GLPG0634 100 mg once daily + placebo during Weeks 1-24

    Reporting group title
    GLPG0634 200 mg QD
    Reporting group description
    		 GLPG0634 200 mg once daily + placebo during Weeks 1-24

    Reporting group title
    GLPG0634 25 mg BID
    Reporting group description
    		 GLPG0634 25 mg twice daily + placebo during Weeks 1-12; responders remained on the same treatment while non-responders switched to 50 mg BID during Weeks 13-24

    Reporting group title
    GLPG0634 50 mg BID
    Reporting group description
    		 GLPG0634 50 mg twice daily + placebo during Weeks 1-24

    Reporting group title
    GLPG0634 100 mg BID
    Reporting group description
    		 GLPG0634 100 mg twice daily + placebo during Weeks 1-24
    Reporting group title
    Placebo Responders
    Reporting group description
    		 Placebo during Weeks 1 - 12; responders remained on placebo during Weeks 13-24

    Reporting group title
    GLPG0634 50 mg QD Responders
    Reporting group description
    		 GLPG0634 50 mg once daily + placebo during Weeks 1-12; responders remained on the same treatment during Weeks 13-24

    Reporting group title
    GLPG0634 25 mg BID Responders
    Reporting group description
    		 GLPG0634 25 mg twice daily + placebo during Weeks 1-12; responders remained on the same treatment during Weeks 13-24

    Reporting group title
    Placebo Switch to GLPG0634 100 mg QD
    Reporting group description
    		 Some nonresponders from the placebo group were re-randomized to receive GLPG0634 100 mg once daily + placebo during Weeks 13-24

    Reporting group title
    Placebo Switch to GLPG0634 50 mg BID
    Reporting group description
    		 Some nonresponders from the placebo group were re-randomized to receive GLPG0634 50 mg twice daily + placebo during Weeks 13-24

    Reporting group title
    50 mg QD Switch to GLPG0634 100 mg QD
    Reporting group description
    		 Nonresponders from the 50 mg QD group were re-randomized to receive GLPG0634 100 mg once daily + placebo during Weeks 13-24

    Reporting group title
    25 mg BID Switch to GLPG0634 50 mg BID
    Reporting group description
    		 Nonresponders from the 25 mg BID group were re-randomized to receive GLPG0634 50 mg twice daily + placebo during Weeks 13-24

    Reporting group title
    GLPG0634 100 mg QD
    Reporting group description
    		 GLPG0634 100 mg once daily + placebo during Weeks 1-24

    Reporting group title
    GLPG0634 200 mg QD
    Reporting group description
    		 GLPG0634 200 mg once daily + placebo during Weeks 1-24

    Reporting group title
    GLPG0634 50 mg BID
    Reporting group description
    		 GLPG0634 50 mg twice daily + placebo during Weeks 1-24

    Reporting group title
    GLPG0634 100 mg BID
    Reporting group description
    		 GLPG0634 100 mg twice daily + placebo during Weeks 1-24

    Primary: Percentage of subjects achieving an ACR20 response at Week 12

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    End point title
    		 Percentage of subjects achieving an ACR20 response at Week 12
    End point description
    The American College of Rheumatology (ACR) response is a measurement of improvement in multiple disease assessment criteria. The ACR20 response is defined as: 1) ≥ 20% improvement from baseline in swollen joint count based on 66 joints (SJC66), and 2) ≥ 20% improvement from baseline in tender joint count based on 68 joints (TJC68), and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain visual analog scale (VAS) (taken from the Health Assessment Questionnaire – Disability Index [HAQ-DI]), 2. Patient’s Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. C-reactive protein (CRP). Intent-to-Treat (ITT) Population: all participants in the Safety Population who had post-randomization data for at least one efficacy parameter. Non-responder imputation was used (ie, to impute a missing response, the subject was assumed to be a non-responder).
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Number of subjects analysed
    86
    82
    85
    86
    86
    85
    84
    Units: percentage of subjects
        number (not applicable)
    44.2
    56.1
    63.5
    68.6
    57
    60
    78.6
    Statistical analysis title
    		 ACR20 Response at Week 12 - Placebo vs 50 mg QD
    Statistical analysis description
    Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics;
    Comparison groups
    Placebo v GLPG0634 50 mg QD
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1236 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in percentage rates
    Point estimate
    11.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 26.9
    Notes
    [1] - P-value has been corrected for multiplicity according to Hommel's closed-testing method.
    Statistical analysis title
    		 ACR20 Response at Week 12 - Placebo vs 100 mg QD
    Statistical analysis description
    Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics;
    Comparison groups
    Placebo v GLPG0634 100 mg QD
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0435 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in percentage rates
    Point estimate
    19.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.7
         upper limit
    		 34
    Notes
    [2] - P-value has been corrected for multiplicity according to Hommel's closed-testing method.
    Statistical analysis title
    		 ACR20 Response at Week 12 - Placebo vs 200 mg QD
    Statistical analysis description
    Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics;
    Comparison groups
    Placebo v GLPG0634 200 mg QD
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0068 [3]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in percentage rates
    Point estimate
    24.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.1
         upper limit
    		 38.8
    Notes
    [3] - P-value has been corrected for multiplicity according to Hommel's closed-testing method.
    Statistical analysis title
    		 ACR20 Response at Week 12 - Placebo vs 25 mg BID
    Statistical analysis description
    Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics;
    Comparison groups
    Placebo v GLPG0634 25 mg BID
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1236 [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in percentage rates
    Point estimate
    12.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 27.6
    Notes
    [4] - P-value has been corrected for multiplicity according to Hommel's closed-testing method.
    Statistical analysis title
    		 ACR20 Response at Week 12 - Placebo vs 50 mg BID
    Statistical analysis description
    Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics;
    Comparison groups
    Placebo v GLPG0634 50 mg BID
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1056 [5]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in percentage rates
    Point estimate
    15.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 30.6
    Notes
    [5] - P-value has been corrected for multiplicity according to Hommel's closed-testing method.
    Statistical analysis title
    		 ACR20 Response at Week 12 - Placebo vs 100 mg BID
    Statistical analysis description
    Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics;
    Comparison groups
    Placebo v GLPG0634 100 mg BID
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [6]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in percentage rates
    Point estimate
    34.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.7
         upper limit
    		 48.1
    Notes
    [6] - P-value has been corrected for multiplicity according to Hommel's closed-testing method.

    Secondary: Percentage of subjects achieving an ACR20 response at Week 24

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    End point title
    		 Percentage of subjects achieving an ACR20 response at Week 24
    End point description
    ACR20 response was defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2. Patient’s Global Assessment of Disease Activity VAS, 3. Physician’s Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Intent-to-Treat (ITT) Population. Subjects who switched treatment at Week 12 were handled as if they discontinued at Week 12. Non-responder imputation was used.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Number of subjects analysed
    86
    82
    85
    86
    86
    85
    84
    Units: percentage of subjects
        number (not applicable)
    41.9
    54.9
    61.2
    73.3
    55.8
    60
    79.8
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving an ACR50 response at Weeks 1, 2, 4, 8, 12, and 24

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    End point title
    		 Percentage of subjects achieving an ACR50 response at Weeks 1, 2, 4, 8, 12, and 24
    End point description
    ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2. Patient’s Global Assessment of Disease Activity VAS 3. Physician’s Global Assessment of Disease Activity VAS 4. Total HAQ-DI score 5. CRP. Intent-to-Treat (ITT) Population. Subjects who switched treatment at Week 12 were handled as if they discontinued at Week 12. Non-responder imputation was used.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 8, 12, and 24
    End point values
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Number of subjects analysed
    86
    82
    85
    86
    86
    85
    84
    Units: percentage of subjects
    number (not applicable)
        Week 1
    1.2
    2.4
    4.7
    4.7
    3.5
    7.1
    7.1
        Week 2
    5.8
    7.3
    20
    10.5
    7
    11.8
    21.4
        Week 4
    7
    13.4
    32.9
    17.4
    15.1
    18.8
    34.5
        Week 8
    12.8
    26.8
    35.3
    33.7
    25.6
    34.1
    45.2
        Week 12
    15.1
    32.9
    37.6
    43
    27.9
    34.1
    54.8
        Week 24
    16.3
    35.4
    47.1
    50
    34.9
    35.3
    54.8
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving ACR70 response at Weeks 1, 2, 4, 8, 12, and 24

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    End point title
    		 Percentage of subjects achieving ACR70 response at Weeks 1, 2, 4, 8, 12, and 24
    End point description
    ACR70 response: 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2. Patient’s Global Assessment of Disease Activity VAS, 3. Physician’s Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Intent-to-Treat (ITT) Population. Subjects who switched treatment at Week 12 were handled as if they discontinued at Week 12. Non-responder imputation was used.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 8, 12, and 24
    End point values
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Number of subjects analysed
    86
    82
    85
    86
    86
    85
    84
    Units: percentage of subjects
    number (not applicable)
        Week 1
    1.2
    0
    0
    1.2
    1.2
    2.4
    4.8
        Week 2
    1.2
    2.4
    7.1
    5.8
    2.3
    5.9
    3.6
        Week 4
    3.5
    7.3
    14.1
    4.7
    5.8
    9.4
    10.7
        Week 8
    7
    11
    23.5
    18.6
    9.3
    14.1
    27.4
        Week 12
    8.1
    15.9
    21.2
    24.4
    14
    18.8
    31
        Week 24
    9.3
    22
    32.9
    29.1
    20.9
    23.5
    39.3
    No statistical analyses for this end point

    Secondary: ACR N% improvement (ACR-N) response at Weeks 1, 2, 4, 8, 12, and 24

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    End point title
    		 ACR N% improvement (ACR-N) response at Weeks 1, 2, 4, 8, 12, and 24
    End point description
    The ACR-N is the smallest percentage improvement in swollen and tender joints and the median of the remaining 5 core parameters, and is expected to be more sensitive to change than the ACR20, ACR50 or ACR70. It is a number varying between 0 and 100, with higher numbers indicating less severity of symptoms. Intent-to-Treat (ITT) Population. Subjects who switched treatment at Week 12 were handled as if they discontinued at Week 12. Last observation carried forward (LOCF) algorithm was used (ie, to impute a missing value, the last preceding nonmissing value was used).
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 8, 12, and 24
    End point values
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Number of subjects analysed
    84
    82
    80
    86
    83
    85
    82
    Units: units on a scale
    arithmetic mean (standard error)
        Week 1
    9.27 ( 1.519 )
    10.31 ( 1.578 )
    14.69 ( 2.04 )
    14.25 ( 1.822 )
    9.01 ( 1.603 )
    11.36 ( 1.939 )
    17.63 ( 2.206 )
        Week 2
    13.85 ( 1.949 )
    16.36 ( 2.125 )
    25.2 ( 2.986 )
    22.61 ( 2.517 )
    15.2 ( 2.063 )
    20.01 ( 2.47 )
    27.77 ( 2.606 )
        Week 4
    16.93 ( 2.332 )
    21.08 ( 2.598 )
    31.32 ( 3.354 )
    27.45 ( 2.573 )
    23.17 ( 2.668 )
    26.37 ( 2.961 )
    35.69 ( 2.861 )
        Week 8
    21.6 ( 2.644 )
    30.16 ( 3.015 )
    38.24 ( 3.484 )
    37.88 ( 3.097 )
    31.2 ( 2.845 )
    33.4 ( 3.15 )
    45.36 ( 3.246 )
        Week 12
    23.09 ( 2.911 )
    34.03 ( 3.335 )
    39.87 ( 3.449 )
    42.1 ( 3.277 )
    34.12 ( 3.144 )
    35.86 ( 3.29 )
    51.17 ( 3.379 )
        Week 24
    22.06 ( 2.846 )
    37.13 ( 3.582 )
    50.86 ( 3.645 )
    50.4 ( 3.291 )
    38.56 ( 3.384 )
    40.5 ( 3.299 )
    58.69 ( 3.204 )
    No statistical analyses for this end point

    Secondary: Percentage of subjects with Disease Activity Score 28 Joints Corrected for CRP (DAS28 (CRP)) European League Against Rheumatism (EULAR) response at Weeks 1, 2, 4, 8, 12, and 24

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    End point title
    		 Percentage of subjects with Disease Activity Score 28 Joints Corrected for CRP (DAS28 (CRP)) European League Against Rheumatism (EULAR) response at Weeks 1, 2, 4, 8, 12, and 24
    End point description
    DAS28 (CRP) was categorized into EULAR response categories (none, moderate, good) as follows: None = Actual DAS28 (CRP) ≤ 3.2, > 3.2 to ≤ 5.1, or > 5.1 AND Improvement in DAS28 (CRP) from baseline ≤ 6.0 or > 0.6 to ≤ 1.2; Moderate = Actual DAS28 (CRP) ≤ 3.2 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2, Actual DAS28 (CRP) > 3.2 to ≤ 5.1 or > 5.1 AND Improvement in DAS28 (CRP) from baseline > 1.2, or Actual DAS28 (CRP) > 3.2 to ≤ 5.1 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2; Good = Actual DAS28 (CRP) ≤ 3.2 AND Improvement in DAS28 (CRP) from baseline > 1.2. Intent-to-Treat (ITT) Population. Subjects who switched treatment at Week 12 were handled as if they discontinued at Week 12. LOCF algorithm was used.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 8, 12, and 24
    End point values
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Number of subjects analysed
    86
    82
    85
    86
    86
    85
    84
    Units: percentage of subjects
    number (not applicable)
        Week 1: None
    73
    61
    58
    42
    63
    64
    40
        Week 1: Moderate
    21
    38
    35
    55
    34
    32
    49
        Week 1: Good
    6
    1
    7
    3
    3
    5
    11
        Week 2: None
    58
    49
    39
    31
    51
    44
    20
        Week 2: Moderate
    33
    45
    42
    53
    43
    46
    62
        Week 2: Good
    9
    6
    19
    15
    6
    11
    18
        Week 4: None
    56
    44
    29
    16
    37
    35
    15
        Week 4: Moderate
    34
    46
    40
    65
    44
    42
    61
        Week 4: Good
    10
    10
    31
    19
    19
    22
    24
        Week 8: None
    44
    34
    20
    15
    24
    24
    8
        Week 8: Moderate
    43
    45
    52
    49
    51
    49
    46
        Week 8: Good
    13
    21
    28
    36
    24
    27
    45
        Week 12: None
    41
    33
    18
    8
    28
    15
    7
        Week 12: Moderate
    45
    44
    48
    55
    44
    56
    43
        Week 12: Good
    14
    23
    34
    37
    28
    28
    50
        Week 24: None
    48
    33
    12
    10
    23
    14
    5
        Week 24: Moderate
    34
    35
    38
    38
    37
    49
    31
        Week 24: Good
    19
    32
    51
    51
    40
    36
    64
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving ACR/EULAR remission at Weeks 2, 4, 8, 12, and 24

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    End point title
    		 Percentage of subjects achieving ACR/EULAR remission at Weeks 2, 4, 8, 12, and 24
    End point description
    A subject’s disease activity status can be defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and Patient Global Assessment of Disease Activity (cm) are all ≤ 1. Intent-to-Treat (ITT) Population. Subjects who switched treatment at Week 12 were handled as if they discontinued at Week 12. Non-responder imputation was used.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, and 24
    End point values
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Number of subjects analysed
    86
    82
    85
    86
    86
    85
    84
    Units: percentage of subjects
    number (not applicable)
        Week 2
    0
    0
    3.5
    0
    0
    0
    1.2
        Week 4
    1.2
    1.2
    1.2
    2.3
    0
    0
    2.4
        Week 8
    1.2
    3.7
    3.5
    3.5
    1.2
    1.2
    3.6
        Week 12
    3.5
    3.7
    3.5
    5.8
    4.7
    4.7
    9.5
        Week 24
    1.2
    11
    8.2
    11.6
    5.8
    3.5
    19
    No statistical analyses for this end point

    Secondary: Simplified Disease Activity Index (SDAI) at baseline and change from baseline at Weeks 1, 2, 4, 8, 12, and 24

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    End point title
    		 Simplified Disease Activity Index (SDAI) at baseline and change from baseline at Weeks 1, 2, 4, 8, 12, and 24
    End point description
    The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, Patient Global Assessment of Disease Activity (in cm), Physician’s Global Assessment of Disease Activity (in cm), and CRP (mg/dL). The SDAI was categorized as follows: • High disease activity: SDAI > 26 • Moderate disease activity: 11 to 26 • Low disease activity: 3.3 to 11 • Remission: ≤ 3.3. Intent-to-Treat (ITT) Population. Subjects who switched treatment at Week 12 were handled as if they discontinued at Week 12. LOCF algorithm was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1, 2, 4, 8, 12, and 24
    End point values
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Number of subjects analysed
    86
    82
    85
    86
    86 [7]
    85
    84
    Units: units on a scale
    arithmetic mean (standard error)
        Baseline
    43.756 ( 1.2717 )
    43.77 ( 1.3499 )
    45.42 ( 1.3909 )
    45.611 ( 1.3362 )
    43.951 ( 1.3224 )
    44.794 ( 1.4043 )
    44.542 ( 1.3097 )
        Change at Week 1
    -8.3 ( 1.25 )
    -8 ( 1.14 )
    -12.2 ( 1.45 )
    -12.8 ( 1.29 )
    -8.2 ( 1.17 )
    -10 ( 1.22 )
    -14.5 ( 1.31 )
        Change at Week 2
    -11.4 ( 1.45 )
    -12.5 ( 1.46 )
    -18.6 ( 1.64 )
    -16.4 ( 1.35 )
    -13.4 ( 1.29 )
    -15.1 ( 1.43 )
    -20.3 ( 1.35 )
        Change at Week 4
    -13.1 ( 1.47 )
    -16.3 ( 1.64 )
    -22.7 ( 1.78 )
    -22.2 ( 1.28 )
    -17.8 ( 1.44 )
    -19.3 ( 1.74 )
    -24.9 ( 1.54 )
        Change at Week 8
    -16.3 ( 1.64 )
    -20.1 ( 1.86 )
    -24.6 ( 1.57 )
    -25.9 ( 1.57 )
    -22.2 ( 1.68 )
    -23.2 ( 1.8 )
    -29.2 ( 1.58 )
        Change at Week 12
    -16.3 ( 1.84 )
    -21 ( 1.84 )
    -25.2 ( 1.69 )
    -27.2 ( 1.55 )
    -22.3 ( 1.71 )
    -24.5 ( 1.87 )
    -30.6 ( 1.57 )
        Change at Week 24
    -15.8 ( 2 )
    -22.8 ( 2.07 )
    -30.1 ( 1.66 )
    -31 ( 1.62 )
    -24.9 ( 1.85 )
    -27.9 ( 2 )
    -34.4 ( 1.47 )
    Notes
    [7] - Except for at Baseline (N = 85)
    No statistical analyses for this end point

    Secondary: Clinical Disease Activity Index (CDAI) at baseline and change from baseline at Weeks 1, 2, 4, 8, 12, and 24

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    End point title
    		 Clinical Disease Activity Index (CDAI) at baseline and change from baseline at Weeks 1, 2, 4, 8, 12, and 24
    End point description
    The CDAI is the SDAI modified to exclude CRP and is the sum of the 4 outcome parameters: TJC28, SJC28, Patient Global Assessment of Disease Activity (in cm), and Physician’s Global Assessment of Disease Activity (in cm). The CDAI was be categorized as follows: • High disease activity: > 22 • Moderate disease activity: 10 to 22 • Mild disease activity: 2.8 to 10 • Remission: ≤ 2.8. Intent-to-Treat (ITT) Population. Subjects who switched treatment at Week 12 were handled as if they discontinued at Week 12. LOCF algorithm was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1, 2, 4, 8, 12, and 24
    End point values
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Number of subjects analysed
    86
    82
    85
    86
    86 [8]
    85
    84
    Units: units on a scale
    arithmetic mean (standard error)
        Baseline
    42.131 ( 1.236 )
    40.999 ( 1.2104 )
    42.966 ( 1.3014 )
    42.901 ( 1.2844 )
    41.347 ( 1.2442 )
    42.333 ( 1.3186 )
    41.856 ( 1.2462 )
        Change at Week 1
    -8.5 ( 1.23 )
    -7.2 ( 1.09 )
    -11.1 ( 1.38 )
    -11.1 ( 1.22 )
    -7.3 ( 1.14 )
    -9 ( 1.15 )
    -12.8 ( 1.27 )
        Change at Week 2
    -11.6 ( 1.43 )
    -11.7 ( 1.39 )
    -17.3 ( 1.58 )
    -14.6 ( 1.29 )
    -12.4 ( 1.26 )
    -14 ( 1.38 )
    -18.4 ( 1.31 )
        Change at Week 4
    -13.3 ( 1.42 )
    -15.2 ( 1.54 )
    -21.4 ( 1.71 )
    -20.4 ( 1.24 )
    -17.1 ( 1.35 )
    -18 ( 1.71 )
    -22.8 ( 1.51 )
        Change at Week 8
    -16.4 ( 1.58 )
    -18.9 ( 1.78 )
    -23.4 ( 1.52 )
    -24.2 ( 1.5 )
    -21.1 ( 1.67 )
    -21.9 ( 1.75 )
    -27.1 ( 1.53 )
        Change at Week 12
    -16.6 ( 1.84 )
    -19.7 ( 1.77 )
    -23.8 ( 1.66 )
    -25.5 ( 1.5 )
    -21.3 ( 1.65 )
    -23.2 ( 1.81 )
    -28.5 ( 1.49 )
        Change at Week 24
    -16 ( 1.95 )
    -21.3 ( 1.97 )
    -28.6 ( 1.63 )
    -29.4 ( 1.5 )
    -23.8 ( 1.75 )
    -26.7 ( 1.9 )
    -32.4 ( 1.39 )
    Notes
    [8] - Except for Baseline (N = 85)
    No statistical analyses for this end point

    Secondary: Quality of Life using the functional assessment of chronic illness therapy [FACIT] Fatigue Score at baseline and change from baseline at Weeks 4, 12, and 24

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    End point title
    		 Quality of Life using the functional assessment of chronic illness therapy [FACIT] Fatigue Score at baseline and change from baseline at Weeks 4, 12, and 24
    End point description
    FACIT-Fatigue scale is a 13-item questionnaire, each scored on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the subject's response to the questions (with the exception of 2 negatively stated that are scored reversely), the greater the fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score), with a higher score indicating a better quality of life. Intent-to-Treat (ITT) Population. Subjects who switched treatment at Week 12 were handled as if they discontinued at Week 12. LOCF algorithm was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12, and 24
    End point values
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Number of subjects analysed
    86
    82
    85 [9]
    86
    86
    85
    84 [10]
    Units: units on a scale
    arithmetic mean (standard error)
        Baseline
    26.2 ( 1.09 )
    26.2 ( 1.1 )
    26.6 ( 1.06 )
    25.2 ( 1.25 )
    28.1 ( 1.18 )
    26.2 ( 1.04 )
    25.6 ( 1.25 )
        Change at Week 4
    4.9 ( 1.06 )
    4.4 ( 1.11 )
    9.1 ( 1.14 )
    8.5 ( 1.23 )
    4.5 ( 1.06 )
    6.6 ( 0.88 )
    9.9 ( 0.97 )
        Change at Week 12
    5.6 ( 1.06 )
    7.6 ( 1.26 )
    9.5 ( 1.21 )
    11.4 ( 1.37 )
    6.9 ( 1.12 )
    8.4 ( 1.08 )
    11.3 ( 1.25 )
        Change at Week 24
    6 ( 1.04 )
    7.9 ( 1.21 )
    11.1 ( 1.2 )
    11.6 ( 1.33 )
    7.7 ( 1.17 )
    9 ( 1.04 )
    12.8 ( 1.36 )
    Notes
    [9] - Except at Baseline (N = 84)
    [10] - Except at Baseline (N = 83)
    No statistical analyses for this end point

    Secondary: Quality of Life using the Short Form-36 (SF-36) scores at baseline and change from baseline at Weeks 4, 12, and 24

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    End point title
    		 Quality of Life using the Short Form-36 (SF-36) scores at baseline and change from baseline at Weeks 4, 12, and 24
    End point description
    The SF-36 is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Intent-to-Treat (ITT) Population. Subjects who switched treatment at Week 12 were handled as if they discontinued at Week 12. LOCF algorithm was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 12, and 24
    End point values
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Number of subjects analysed
    86
    82
    85 [11]
    86
    86
    85
    84 [12]
    Units: units on a scale
    arithmetic mean (standard error)
        PCS at Baseline
    32.999 ( 0.7121 )
    32.691 ( 0.7474 )
    31.636 ( 0.7926 )
    31.625 ( 0.6355 )
    31.634 ( 0.6858 )
    31.332 ( 0.726 )
    32.249 ( 0.7844 )
        PSC Change at Week 4
    3 ( 0.65 )
    4.1 ( 0.88 )
    6.1 ( 0.98 )
    6.4 ( 0.87 )
    5 ( 0.69 )
    4.2 ( 0.8 )
    7.2 ( 0.77 )
        PSC Change at Week 12
    3.2 ( 0.74 )
    6.7 ( 1 )
    8.4 ( 0.93 )
    8.9 ( 0.9 )
    7.5 ( 0.92 )
    7.1 ( 0.96 )
    10.5 ( 0.98 )
        PSC Change at Week 24
    2.8 ( 0.75 )
    7.3 ( 1.02 )
    9.9 ( 1.09 )
    9.7 ( 0.99 )
    7.8 ( 0.85 )
    7.9 ( 0.91 )
    11.6 ( 1.1 )
        MCS at Baseline
    42.849 ( 1.0861 )
    42.199 ( 1.2581 )
    43.953 ( 1.1118 )
    41.362 ( 1.1427 )
    45.527 ( 1.288 )
    44.748 ( 1.228 )
    42.059 ( 1.2898 )
        MCS Change at Week 4
    3 ( 0.92 )
    3.4 ( 0.91 )
    4.9 ( 0.85 )
    5.4 ( 0.98 )
    2.4 ( 0.78 )
    2.7 ( 0.84 )
    5.6 ( 0.92 )
        MCS Change at Week 12
    4.3 ( 1.05 )
    4.4 ( 1.11 )
    5.1 ( 0.96 )
    8.1 ( 1.17 )
    3.5 ( 0.97 )
    3.1 ( 1.02 )
    6.2 ( 0.98 )
        MCS Change at Week 24
    4.7 ( 0.96 )
    4.3 ( 1.04 )
    6.7 ( 0.91 )
    7.2 ( 1.12 )
    3.8 ( 0.96 )
    3.5 ( 1.01 )
    7.1 ( 1.21 )
    Notes
    [11] - Except at Baseline (N = 84)
    [12] - Except at Baseline (N = 83)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through end of study drug treatment (average exposure: 160.7 days) plus 10 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Adverse events reported in this group includes all subjects randomized to the Placebo group during Weeks 1-12. Subjects who switched treatment at Week 12 were included in the other groups of the same dose for adverse events reported during Weeks 13-24.

    Reporting group title
    GLPG0634 50 mg QD
    Reporting group description
    		 Adverse events reported in this group include all subjects randomized to the GLPG0634 50 mg QD group during Weeks 1-12 and responders in this group during Weeks 13-24. Subjects who switched treatment at Week 12 were included in the other groups of the same dose for adverse events reported during Weeks 13-24.

    Reporting group title
    GLPG0634 100 mg QD
    Reporting group description
    		 Adverse events reported in this group includes all subjects randomized to the GLPG0634 100 mg QD group during Weeks 1-24, some nonresponders originally randomized to the Placebo group during Weeks 13-24, and all nonresponders originally randomized to the GLPG0634 50 mg QD group during Weeks 13-24. Subjects who switched treatment at Week 12 were included in the other groups of the same dose for adverse events reported during Weeks 13-24.

    Reporting group title
    GLPG0634 200 mg QD
    Reporting group description
    		 Adverse events reported in this group includes all subjects randomized to the GLPG0634 200 mg QD group during Weeks 1-24.

    Reporting group title
    GLPG0634 25 mg BID
    Reporting group description
    		 Adverse events reported in this group includes all subjects randomized to the GLPG0634 25 mg BID group during Weeks 1-12 and responders in this group during Weeks 13-24. Subjects who switched treatment at Week 12 were included in the other groups of the same dose for adverse events reported during Weeks 13-24.

    Reporting group title
    GLPG0634 50 mg BID
    Reporting group description
    		 Adverse events reported in this group includes all subjects randomized to the GLPG0634 50 mg BID group during Weeks 1-24, some nonresponders originally randomized to the Placebo group during Weeks 13-24, and all nonresponders originally randomized to the GLPG0634 25 mg BID group during Weeks 13-24. Subjects who switched treatment at Week 12 were included in the other groups of the same dose for adverse events reported during Weeks 13-24.

    Reporting group title
    GLPG0634 100 mg BID
    Reporting group description
    		 Adverse events reported in this group includes all subjects randomized to the GLPG0634 100 mg BID group during Weeks 1-24.

    Serious adverse events
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 86 (4.65%)
    0 / 82 (0.00%)
    4 / 119 (3.36%)
    2 / 86 (2.33%)
    2 / 86 (2.33%)
    0 / 117 (0.00%)
    3 / 84 (3.57%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Angina unstable
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 119 (0.84%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    Acute myocardial infarction
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 119 (0.84%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Abortion spontaneous complete
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic cerebral infarction
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Inflammation
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 119 (0.84%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    Pancytopenia
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hyperventilation
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Musculoskeletal and connective tissue disorders
    Muscle twitching
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Pneumonia
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 119 (0.84%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Diabetic gangrene
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 119 (0.84%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    Subcutaneous abscess
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    1 / 119 (0.84%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    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
    Erysipelas
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    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
    Intervertebral discitis
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 117 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 86 (51.16%)
    39 / 82 (47.56%)
    48 / 119 (40.34%)
    50 / 86 (58.14%)
    44 / 86 (51.16%)
    57 / 117 (48.72%)
    45 / 84 (53.57%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 86 (2.33%)
    3 / 82 (3.66%)
    6 / 119 (5.04%)
    4 / 86 (4.65%)
    3 / 86 (3.49%)
    4 / 117 (3.42%)
    1 / 84 (1.19%)
         occurrences all number
    2
    3
    6
    4
    3
    4
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 86 (4.65%)
    1 / 82 (1.22%)
    1 / 119 (0.84%)
    6 / 86 (6.98%)
    6 / 86 (6.98%)
    3 / 117 (2.56%)
    2 / 84 (2.38%)
         occurrences all number
    4
    5
    1
    8
    6
    6
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 86 (3.49%)
    7 / 82 (8.54%)
    0 / 119 (0.00%)
    3 / 86 (3.49%)
    3 / 86 (3.49%)
    3 / 117 (2.56%)
    1 / 84 (1.19%)
         occurrences all number
    3
    8
    0
    3
    4
    4
    1
    Vomiting
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
    0 / 119 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    6 / 117 (5.13%)
    2 / 84 (2.38%)
         occurrences all number
    1
    0
    0
    0
    0
    7
    3
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
    1 / 119 (0.84%)
    2 / 86 (2.33%)
    5 / 86 (5.81%)
    2 / 117 (1.71%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    1
    4
    5
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 86 (4.65%)
    8 / 82 (9.76%)
    3 / 119 (2.52%)
    3 / 86 (3.49%)
    4 / 86 (4.65%)
    2 / 117 (1.71%)
    4 / 84 (4.76%)
         occurrences all number
    4
    8
    3
    3
    4
    2
    6
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 86 (1.16%)
    2 / 82 (2.44%)
    2 / 119 (1.68%)
    4 / 86 (4.65%)
    4 / 86 (4.65%)
    6 / 117 (5.13%)
    2 / 84 (2.38%)
         occurrences all number
    1
    2
    2
    5
    4
    7
    2
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 82 (2.44%)
    0 / 119 (0.00%)
    5 / 86 (5.81%)
    2 / 86 (2.33%)
    1 / 117 (0.85%)
    4 / 84 (4.76%)
         occurrences all number
    0
    2
    0
    5
    2
    1
    4

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Apr 2013
    • Due to the implementation of a new method for CRP measurements carried out by the central laboratory (Quest Diagnostics), the ULN and its fold change that were used to calculate the numeric value for the inclusion criteria were likely to change. Therefore, instead of a numeric value, CRP as inclusion criterion was expressed as a 1.5-fold change ULN. • As adjustments for the body surface area were not going to be carried out (Cockroft-Gault formula), the estimated creatinine clearance was expressed as mL/min. • In order to reduce the recording burden for subjects included in the study, the date and time of the taken capsules was recorded on selected visits only and not at every visit. • To confirm the absence of interaction of GLPG0634 on MTX disposition in a broader population of subjects with RA, the measurement of MTX and its metabolite (7-hydroxy-methotrexate) in plasma samples collected in the study could be performed. • Size of the SST tubes that were planned to be used for the additional PD assessment, was changed (instead of two 4-mL SST tubes, only one 8.5-mL SST tube was collected). • Due to the administration of MTX in this study, the expectedness of AEs arising due to the use of MTX was determined in the definitions for unexpected adverse events/safety information.
    17 Apr 2013
    Introduced stratification according to the previous use of a biological DMARD in a single clinical study setting, in addition to the stratification according to region. This aimed to obtain equal distribution of subjects, who had been previously exposed to a biological DMARD during a single clinical study setting between the study groups, to reduce heterogeneity and therefore be beneficial for results interpretation. Consequently the statistical methods section was adapted accordingly: Cochran-Mantel-Haenszel and logrank tests, both controlling for region, were changed to logistic and proportional hazards regression models in order to include more factors.
    02 Aug 2013
    This amendment was applicable for all countries apart from France and the US and addressed specific comments received from Competent Authorities and Ethics Committees. • The overall benefit/risk assessment was updated in view of recent advances in the product development and the current status of the scientific field for JAK development. • The inclusion/exclusion criteria were refined with further specified and strengthened laboratory test limits, and additional criteria to manage the overall health status at Screening were introduced. • Criteria for individual subject withdrawal were further specified. • An independent DSMB was introduced. • The section on prior and concomitant therapy was updated.
    20 May 2014
    This amendment was applicable for all countries apart from France and the US. • The inclusion/exclusion criteria were adjusted to better represent the current RA population without compromising the study objective, including a decrease in entry level for CRP to > 0.70 x ULN. • The individual subject withdrawal criteria were adjusted. • The general study procedures (calendar days, re-Screening and retesting guidelines) were refined to provide further guidance to investigators. • In addition, the protocol amendment included an update of the background information on GLPG0634 and the benefit/risk section in accordance with the current version of the IB (Edition 7.0, February 2014).

    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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