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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX-509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs

    Summary
    EudraCT number
    		 2012-003439-41
    Trial protocol
    		 LT   EE   DK   NL  
    Global end of trial date
    09 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2016
    First version publication date
    07 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VX12-509-103
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01754935
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vertex Pharmaceuticals Incorporated
    Sponsor organisation address
    50 Northern Avenue, Boston, MA, United States, 02210-1862
    Public contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, 1 617-341-6777, medicalinfo@vrtx.com
    Scientific contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, 1 617-341-6777, medicalinfo@vrtx.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
    25 Apr 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    During 12 weeks of treatment in subjects with active rheumatoid arthritis (RA) on stable disease-modifying antirheumatic drug (DMARD) therapy: to evaluate the efficacy of VX-509 across a range of doses and to evaluate the early effect of VX-509 administration on joint structures as assessed by magnetic resonance imaging (MRI).
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP).
    Background therapy
    		 Stable treatment with 1 of the following DMARDs: methotrexate, sulfasalazine, leflunomide, penicillamine, or antimalarial drug.
    Evidence for comparator
    		 No active comparator.
    Actual start date of recruitment
    17 Dec 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Estonia: 2
    Country: Number of subjects enrolled
    United States: 38
    Country: Number of subjects enrolled
    Lithuania: 3
    Worldwide total number of subjects
    43
    EEA total number of subjects
    5
    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)
    40
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All 43 subjects were included in the Safety Set, and all 38 randomized subjects were included in the Full Analysis Set (FAS).

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received 6 VX-509-matched placebo tablets orally once daily for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 VX-509-matched placebo tablets orally once daily for 12 weeks.

    Arm title
    		 VX-509 100 mg
    Arm description
    		 Subjects received 2 VX-509 50 milligram (mg) tablets and 4 VX-509-matched placebo tablets orally once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VX-509
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 VX-509 50 mg tablets and 4 VX-509-matched placebo tablets orally once daily for 12 weeks.

    Arm title
    		 VX-509 200 mg
    Arm description
    		 Subjects received 4 VX-509 50 mg tablets and 2 VX-509-matched placebo tablets orally once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VX-509
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 VX-509 50 mg tablets and 2 VX-509-matched placebo tablets orally once daily for 12 weeks.

    Arm title
    		 VX-509 300 mg
    Arm description
    		 Subjects received 6 VX-509 50 mg tablets orally once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VX-509
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 VX-509 50 mg tablets orally once daily for 12 weeks.

    Number of subjects in period 1
    		Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Started
    12
    11
    10
    10
    Completed
    11
    10
    10
    10
    Not completed
    1
    1
    0
    0
         Consent withdrawn by subject
    1
    -
    -
    -
         Lost to follow-up
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received 6 VX-509-matched placebo tablets orally once daily for 12 weeks.

    Reporting group title
    VX-509 100 mg
    Reporting group description
    		 Subjects received 2 VX-509 50 milligram (mg) tablets and 4 VX-509-matched placebo tablets orally once daily for 12 weeks.

    Reporting group title
    VX-509 200 mg
    Reporting group description
    		 Subjects received 4 VX-509 50 mg tablets and 2 VX-509-matched placebo tablets orally once daily for 12 weeks.

    Reporting group title
    VX-509 300 mg
    Reporting group description
    		 Subjects received 6 VX-509 50 mg tablets orally once daily for 12 weeks.

    Reporting group values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg Total
    Number of subjects
    		 12 11 10 10 43
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.8 ( 12.25 ) 56.7 ( 6.47 ) 50.5 ( 11.9 ) 54.9 ( 5.04 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 8 5 8 31
        Male
    		 2 3 5 2 12

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received 6 VX-509-matched placebo tablets orally once daily for 12 weeks.

    Reporting group title
    VX-509 100 mg
    Reporting group description
    		 Subjects received 2 VX-509 50 milligram (mg) tablets and 4 VX-509-matched placebo tablets orally once daily for 12 weeks.

    Reporting group title
    VX-509 200 mg
    Reporting group description
    		 Subjects received 4 VX-509 50 mg tablets and 2 VX-509-matched placebo tablets orally once daily for 12 weeks.

    Reporting group title
    VX-509 300 mg
    Reporting group description
    		 Subjects received 6 VX-509 50 mg tablets orally once daily for 12 weeks.

    Primary: Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) C-Reactive Protein (ACR20-CRP) Response at Week 12

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    End point title
    		 Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) C-Reactive Protein (ACR20-CRP) Response at Week 12
    End point description
    ACR20-CRP response: greater than equal (>=) 20% improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: subject assessment of pain (assessed on 0-100 mm VAS, higher score = more pain); subject global assessment of disease activity (assessed on 0-10 point scale, higher score = more disease activity); physician global assessment of disease activity (assessed on 0-10 point scale, higher score = more disease activity); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP levels. Analysis was performed on FAS defined as all randomized subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    12
    11
    5
    10
    Units: percentage of subjects
        number (not applicable)
    25
    63.6
    80
    60
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    VX-509 100 mg v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0678
    Method
    		 Miettinen-Nurminen method
    Parameter type
    		 Proportion difference
    Point estimate
    38.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 68.8
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    VX-509 200 mg v Placebo
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0417
    Method
    		 Miettinen-Nurminen method
    Parameter type
    		 Proportion difference
    Point estimate
    55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.2
         upper limit
    		 82.8
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    VX-509 300 mg v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1043
    Method
    		 Miettinen-Nurminen method
    Parameter type
    		 Proportion difference
    Point estimate
    35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.2
         upper limit
    		 66.6

    Primary: Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 12

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    End point title
    		 Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 12
    End point description
    DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and subject general health visual analogue scale score. A score of less than (<) 2.6 implied remission and <=3.2 implied low disease activity. Analysis was performed on FAS.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    12
    11
    5
    10
    Units: units on scale
        least squares mean (standard error)
    -0.82 ( 0.419 )
    -1.41 ( 0.456 )
    -2.07 ( 0.541 )
    -2.25 ( 0.421 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The mixed effect model for repeated measures was applied. The model includes the change from baseline of DAS28-4 (CRP) as the dependent variable, treatment group, visit, treatment by visit interaction as fixed effects, and subject as a random effect, with adjustment for the continuous baseline DAS28-4 (CRP), prior use of anti-TNF, and region.
    Comparison groups
    VX-509 100 mg v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2485
    Method
    		 Mixed effect model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.62
         upper limit
    		 0.42
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Analysis was performed as described in Statistical Analysis 1.
    Comparison groups
    VX-509 200 mg v Placebo
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0408
    Method
    		 Mixed model effect
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.46
         upper limit
    		 -0.05
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Analysis was performed as described in Statistical Analysis 1.
    Comparison groups
    VX-509 300 mg v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0055
    Method
    		 Mixed effect model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.44
         upper limit
    		 -0.43

    Primary: Change from Baseline in Outcome Measures in Rheumatology Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Synovitis Score at Week 12

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    End point title
    		 Change from Baseline in Outcome Measures in Rheumatology Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Synovitis Score at Week 12
    End point description
    Synovitis score: individual score 0-3, range 0-27 without interphalangeal (IP) joints. Wrist (4 joints) and metacarpophalangeal (MCP) joints (5 joints) were included in the calculation (IP joints were not included in the calculation). Minimum required number of evaluable joints were 3 for each segment (wrist and MCP joints). Segment scores are the sum of the joints within that segment. RAMRIS synovitis score is calculated as sum of the segment scores. Analysis was performed on FAS.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    12
    11
    5
    10
    Units: units on scale
        least squares mean (standard error)
    -0.44 ( 1.445 )
    -4.76 ( 1.467 )
    -5.76 ( 1.66 )
    -7.68 ( 1.528 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The mixed effect model for repeated measures was applied. The model includes the change from baseline of each scale score of RAMRIS as the dependent variable, treatment group, visit, treatment by visit interaction as fixed effects and subject as a random effect, with adjustment for the continuous baseline, prior use of anti-TNF and region.
    Comparison groups
    VX-509 100 mg v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0095
    Method
    		 Mixed effect model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -4.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.5
         upper limit
    		 -1.15
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Analysis was performed as described in Statistical Analysis 1.
    Comparison groups
    VX-509 200 mg v Placebo
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0088
    Method
    		 Mixed effect model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -5.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.18
         upper limit
    		 -1.46
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Analysis was performed as described in Statistical Analysis 1.
    Comparison groups
    VX-509 300 mg v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 Mixed effect model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -7.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.66
         upper limit
    		 -3.82

    Primary: Change from Baseline in OMERACT RAMRIS Osteitis Score at Week 12

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    End point title
    		 Change from Baseline in OMERACT RAMRIS Osteitis Score at Week 12
    End point description
    Osteitis (bone marrow edema) score: individual score 0-3, range 0-75 without IP joints. Wrist (15 joints) and MCP bones (10 joints) were included in the calculation (IP joints were not included in the calculation). Minimum required number of evaluable joints were 8 and 6 for wrist and MCP segment, respectively. Segment scores are the sum of the joints within that segment. RAMRIS synovitis score is calculated as sum of the segment scores. Analysis was performed on FAS.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    12
    11
    5
    10
    Units: units on scale
        least squares mean (standard error)
    -2.91 ( 1.478 )
    -4.71 ( 1.613 )
    -5.14 ( 1.765 )
    -7.41 ( 1.482 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The mixed effect model for repeated measures was applied. The model includes the change from baseline of each scale score of RAMRIS as the dependent variable, treatment group, visit, treatment by visit interaction as fixed effects and subject as a random effect, with adjustment for the continuous baseline, prior use of anti-TNF and region.
    Comparison groups
    VX-509 100 mg v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2193
    Method
    		 Mixed effect model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.77
         upper limit
    		 1.16
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Analysis was performed as described in Statistical Analysis 1.
    Comparison groups
    VX-509 200 mg v Placebo
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.213
    Method
    		 Mixed effect model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -2.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.84
         upper limit
    		 1.38
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Analysis was performed as described in Statistical Analysis 1.
    Comparison groups
    VX-509 300 mg v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0076
    Method
    		 Mixed effect model
    Parameter type
    		 LS Mean Difference
    Point estimate
    -4.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.68
         upper limit
    		 -1.33

    Primary: Change from Baseline in OMERACT RAMRIS Erosion Score at Week 12

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    End point title
    		 Change from Baseline in OMERACT RAMRIS Erosion Score at Week 12
    End point description
    Erosion score: individual score 0-10, range 0-250 without IP joints. Wrist (15 joints) and MCP bones (10 joints) were included in the calculation (IP joints were not included in the calculation). Minimum required number of evaluable joints were 8 and 6 for wrist and MCP segment, respectively. Segment scores are the sum of the joints within that segment. RAMRIS synovitis score is calculated as sum of the segment scores. Analysis was performed on FAS.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    12
    11
    5
    10
    Units: units on scale
        least squares mean (standard error)
    0.15 ( 0.177 )
    0.45 ( 0.188 )
    0.37 ( 0.212 )
    0.35 ( 0.191 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The mixed effect model for repeated measures was applied. The model includes the change from baseline of each scale score of RAMRIS as the dependent variable, treatment group, visit, treatment by visit interaction as fixed effects and subject as a random effect, with adjustment for the continuous baseline, prior use of anti-TNF and region.
    Comparison groups
    Placebo v VX-509 100 mg
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1274
    Method
    		 Mixed effect model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.7
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Analysis was performed as described in Statistical Analysis 1.
    Comparison groups
    VX-509 200 mg v Placebo
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3587
    Method
    		 Mixed effect model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 0.71
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Analysis was performed as described in Statistical Analysis 1.
    Comparison groups
    VX-509 300 mg v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3268
    Method
    		 Mixed effect model
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.63

    Secondary: Percentage of Subjects Achieving ACR50-CRP and ACR70-CRP Response at Week 12

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    End point title
    		 Percentage of Subjects Achieving ACR50-CRP and ACR70-CRP Response at Week 12
    End point description
    ACR50-CRP/ACR70-CRP response: >= 50%/70% improvement in TJC; >= 50%/70% improvement in SJC; and >= 50%/70% improvement in at least 3 of 5 remaining ACR core measures: subject assessment of pain (assessed on 0-100 mm VAS, higher score = more pain); subject global assessment of disease activity (assessed on 0-10 point scale, higher score = more disease activity); physician global assessment of disease activity (assessed on 0-10 point scale, higher score = more disease activity); self-assessed disability (disability index of the HAQ); and CRP levels. Analysis was performed on safety set defined as all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    12
    11
    10
    10
    Units: percentage of subjects
    number (not applicable)
        ACR50-CRP Response
    8.3
    27.3
    30
    60
        ACR70-CRP Response
    8.3
    18.2
    10
    20
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with DAS28-4 (CRP) Remission, DAS28-4 (ESR) Remission, and European League Against Rheumatism (EULAR) Moderate or Good Response at Week 12

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    End point title
    		 Percentage of Subjects with DAS28-4 (CRP) Remission, DAS28-4 (ESR) Remission, and European League Against Rheumatism (EULAR) Moderate or Good Response at Week 12
    End point description
    DAS28-4 (CRP) is defined in second primary endpoint. DAS28-4 (CRP) and DAS28-4 (ESR) remission was defined as having a score <2.6. EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28-4 (CRP) =< 3.2; moderate responders: change from baseline >1.2 with DAS28-4 (CRP) >3.2 or change from baseline >0.6 to =<1.2 with DAS28-4 (CRP) =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28-4 (CRP) >5.1. DAS28-4 (CRP) remission was defined as having a score <2.6.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    12
    11
    10
    10
    Units: percentage of subjects
    number (not applicable)
        DAS28-4 (CRP) Remission
    0
    27.3
    10
    10
        DAS28-4 (ESR) Remission
    0
    9.1
    20
    30
        EULAR Moderate/Good Response
    41.7
    54.5
    60
    60
    No statistical analyses for this end point

    Secondary: ACR Hybrid Score at Week 12

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    End point title
    		 ACR Hybrid Score at Week 12
    End point description
    Evaluates the improvement in active RA by combining elements of the ACR20/50/70 with a continuous score of the mean change in core set measures. Analysis was performed on safety set.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    12
    11
    10
    10
    Units: units on a scale
        least squares mean (standard error)
    10.83 ( 9.227 )
    38.87 ( 10.007 )
    38.81 ( 9.672 )
    50.5 ( 9.236 )
    No statistical analyses for this end point

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

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    End point title
    		 Change from baseline in Health Assessment Questionnaire -Disability Index (HAQ-DI) at Week 12
    End point description
    HAQ-DI is a self-completed subject questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component: 0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=unable to do. Domain score = total score of individual questions divided by total number of questions. HAQ-DI total score = total of domain scores divided by number of domains, range: 0 (best) to 3 (worst). Analysis was performed on safety set.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    12
    11
    10
    10
    Units: units on scale
        least squares mean (standard error)
    -0.12 ( 0.155 )
    -0.32 ( 0.168 )
    -0.47 ( 0.163 )
    -0.67 ( 0.156 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Physical Function Subscale and Physical and Mental Health Components of the SF-36 at Week 12

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    End point title
    		 Change from Baseline in the Physical Function Subscale and Physical and Mental Health Components of the SF-36 at Week 12
    End point description
    The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well-being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline for physical function subscale is reported. Analysis was performed on safety set.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    11
    10
    8
    9
    Units: units on scale
    arithmetic mean (standard deviation)
        Change at Week 12 in Physical Functioning Score
    1.216 ( 5.3627 )
    3.636 ( 6.0822 )
    7.655 ( 8.9187 )
    7.754 ( 6.6217 )
        Change at Week 12 in Mental Component Score
    5.111 ( 7.082 )
    0.737 ( 7.03 )
    1.645 ( 15.3951 )
    1.772 ( 10.5995 )
        Change at Week 12 in Physical Component Score
    0.243 ( 6.3369 )
    7.867 ( 8.2593 )
    8.694 ( 8.9138 )
    9.674 ( 7.8496 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in OMERACT RAMRIS Synovitis, Osteitis and Erosion Scores at Week 6

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    End point title
    		 Change from Baseline in OMERACT RAMRIS Synovitis, Osteitis and Erosion Scores at Week 6
    End point description
    Different OMERACT RAMRIS scores are defined in Primary Endpoints. Analysis was performed on safety set.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    12
    11
    10
    10
    Units: units on scale
    least squares mean (standard error)
        Change at Week 6 in Synovitis Score
    -0.81 ( 1.301 )
    -3.23 ( 1.382 )
    -3.26 ( 1.3 )
    -5.56 ( 1.332 )
        Change at Week 6 in Osteitis Score
    -3.8 ( 1.509 )
    -4.29 ( 1.655 )
    -5.17 ( 1.611 )
    -5.62 ( 1.441 )
        Change at Week 6 in Erosion Score
    0.21 ( 0.163 )
    0.27 ( 0.177 )
    0.43 ( 0.165 )
    0.4 ( 0.17 )
    No statistical analyses for this end point

    Secondary: PK parameters of VX -509 and its Metabolite in Plasma: Maximum Observed Concentration [Cmax] at Week 12

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    End point title
    		 PK parameters of VX -509 and its Metabolite in Plasma: Maximum Observed Concentration [Cmax] at Week 12
    End point description
    As per Sponsor’s decision to modify the drug development plan for VX-509, the PK and PK/PD analyses were not performed, hence no data could be reported.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    0 [1]
    0 [2]
    0 [3]
    0 [4]
    Units: ng/ml
        number (not applicable)
    Notes
    [1] - Reason for no analysis is provided in endpoint description.
    [2] - Reason for no analysis is provided in endpoint description.
    [3] - Reason for no analysis is provided in endpoint description.
    [4] - Reason for no analysis is provided in endpoint description.
    No statistical analyses for this end point

    Secondary: PK parameters of VX-509 and its Metabolite in Area Under The Concentration Versus Time Curve [AUC] at Week 12

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    End point title
    		 PK parameters of VX-509 and its Metabolite in Area Under The Concentration Versus Time Curve [AUC] at Week 12
    End point description
    As per Sponsor’s decision to modify the drug development plan for VX-509, the PK and PK/PD analyses were not performed, hence no data could be reported.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    0 [8]
    Units: ng/mL
        number (not applicable)
    Notes
    [5] - Reason for no analysis is provided in endpoint description.
    [6] - Reason for no analysis is provided in endpoint description.
    [7] - Reason for no analysis is provided in endpoint description.
    [8] - Reason for no analysis is provided in endpoint description.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    AE: any untoward medical occurrence in a subject during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE included serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Analysis was performed on safety set included all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to Week 16
    End point values
    		 Placebo VX-509 100 mg VX-509 200 mg VX-509 300 mg
    Number of subjects analysed
    12
    11
    10
    10
    Units: percentage of subjects
    number (not applicable)
        Subjects with AEs
    41.7
    72.7
    80
    90
        Subjects with SAEs
    0
    9.1
    10
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 16
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    VX-509 100 mg
    Reporting group description
    		 VX-509 100 mg tablet orally once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matched to VX-509 tablet orally once daily for 12 weeks.

    Reporting group title
    VX-509 300 mg
    Reporting group description
    		 VX-509 300 mg tablet orally once daily for 12 weeks.

    Reporting group title
    VX-509 200 mg
    Reporting group description
    		 VX-509 200 mg tablet orally once daily for 12 weeks.

    Serious adverse events
    		 VX-509 100 mg Placebo VX-509 300 mg VX-509 200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Partial seizures
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 VX-509 100 mg Placebo VX-509 300 mg VX-509 200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 11 (63.64%)
    5 / 12 (41.67%)
    9 / 10 (90.00%)
    8 / 10 (80.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    Genital rash
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Pelvic pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Prostatomegaly
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Sinus congestion
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    1
    Cough
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    1
    Depression
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Blood erythropoietin increased
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood triglycerides increased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Tremor
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 12 (16.67%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    2 / 10 (20.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    1
    0
    0
    2
    Abdominal pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Dry mouth
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lip ulceration
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Rash papular
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Swelling face
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Joint effusion
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Arthralgia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    1
    Blister infected
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Body tinea
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Sep 2012
    Updated inclusion exclusion criteria.
    09 Oct 2012
    Added secondary endpoint: Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12. Updated inclusion criteria.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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