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    Clinical Trial Results:
    A Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX-509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2012-004342-14
    Trial protocol
    LT   EE   DK  
    Global end of trial date
    29 Jul 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    13 Jul 2016
    First version publication date
    07 Aug 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    QC data set & address issues related to earlier EudraCT system bug

    Trial information

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    Trial identification
    Sponsor protocol code
    VX12-509-104
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01830985
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Vertex Pharmaceuticals Incorporated
    Sponsor organisation address
    50 Northern Avenue, Boston, Massachusetts, 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 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of VX-509 treatment in subjects with rheumatoid arthritis (RA) on disease-modifying antirheumatic drug (DMARD) therapy.
    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 Apr 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
    United States: 36
    Country: Number of subjects enrolled
    Lithuania: 2
    Worldwide total number of subjects
    38
    EEA total number of subjects
    2
    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)
    35
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Subjects who completed the assigned study drug treatment phase of a previously designated VX-509 study (VX12-509-103) were eligible for enrollment. A total of 38 subjects were enrolled and treated. Additionally, 1 subject was enrolled but did not receive study treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    VX-509
    Arm description
    Subjects received (2 VX-509 [100 milligram (mg)] or 3 VX-509 [150 mg] or 4 VX-509 [200 mg]) tablets orally once daily up to a maximum of 12.9 months.
    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
    Study design allowed subjects to change their treatments. Subjects received 100, 150 and 200 mg VX-509 once daily. The planned duration of treatment was 104 weeks; however, the maximum actual duration of exposure was 12.9 months.

    Number of subjects in period 1
    VX-509
    Started
    38
    Completed
    33
    Not completed
    5
         Death
    1
         Unspecified
    1
         Consent withdrawn by subject
    1
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VX-509
    Reporting group description
    Subjects received (2 VX-509 [100 milligram (mg)] or 3 VX-509 [150 mg] or 4 VX-509 [200 mg]) tablets orally once daily up to a maximum of 12.9 months.

    Reporting group values
    VX-509 Total
    Number of subjects
    38 38
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    54.1 ± 9.42 -
    Gender categorical
    Units: Subjects
        Female
    27 27
        Male
    11 11

    End points

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    End points reporting groups
    Reporting group title
    VX-509
    Reporting group description
    Subjects received (2 VX-509 [100 milligram (mg)] or 3 VX-509 [150 mg] or 4 VX-509 [200 mg]) tablets orally once daily up to a maximum of 12.9 months.

    Subject analysis set title
    VX-509 100 mg
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received 2 VX-509 (100 mg) tablets orally once daily up to a maximum of 12.9 months.

    Subject analysis set title
    VX-509 150 mg
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received 2 VX-509 (150 mg) tablets orally once daily up to a maximum of 12.9 months.

    Subject analysis set title
    VX-509 200 mg
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received 2 VX-509 (200 mg) tablets orally once daily up to a maximum of 12.9 months.

    Primary: Long Term Safety and Tolerability as Assessed by Adverse Events (AEs)

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    End point title
    Long Term Safety and Tolerability as Assessed by Adverse Events (AEs) [1]
    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. serious adverse-events (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. Percentage of subjects with AEs and SAEs are reported. Analysis was performed on Open Label Extension (OLE) set included all subjects who consented to participate in VX12-509-104 (2012-004342-14) and received at least 1 dose of study drug in VX12-509-104 (2012-004342-14).
    End point type
    Primary
    End point timeframe
    From start of study up to safety follow-up (28 days after last dose [last dose = Week 56])
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned.
    End point values
    VX-509 100 mg VX-509 150 mg VX-509 200 mg
    Number of subjects analysed
    38
    32
    18
    Units: percentage of subjects
    number (not applicable)
        Percentage of subjects with AEs
    47.4
    56.3
    55.6
        Percentage of subjects with SAEs
    2.6
    9.4
    5.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) (<=10) or CDAI Remission (<=2.8)

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    End point title
    Percentage of Subjects Who Achieved Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) (<=10) or CDAI Remission (<=2.8)
    End point description
    The CDAI is the numerical sum of 4 outcome parameters: tender joints count (TJC), swollen joints count (SJC), subject global assessment (assessed on 0-10 point scale, higher score = more disease activity), and physician global assessment of disease activity (assessed on 0-10 point scale, higher score = more disease activity). CDAI total score range: 0 – 76, CDAI less than equal to (<=) 2.8 indicates remission and CDAI <=10 indicates LDA. Analysis was performed on OLE set.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 56
    End point values
    VX-509 100 mg VX-509 150 mg VX-509 200 mg
    Number of subjects analysed
    38 [2]
    32 [3]
    18 [4]
    Units: Percentage of subjects
    number (not applicable)
        Week 4: CDAI <= 10 (n= 38, 0, 0)
    26.3
    0
    0
        Week 4: CDAI <= 2.8 (n= 38, 0, 0)
    0
    0
    0
        Week 8: CDAI <= 10 (n= 38, 0, 0)
    23.7
    0
    0
        Week 8: CDAI <= 2.8 (n= 38, 0, 0)
    5.3
    0
    0
        Week 12: CDAI <= 10 (n= 13, 25, 0)
    69.2
    20
    0
        Week 12: CDAI <= 2.8 (n= 13, 25, 0)
    23.1
    0
    0
        Week 16: CDAI <= 10 (n= 13, 25, 0)
    46.2
    20
    0
        Week 16: CDAI <= 2.8 (n= 13, 25, 0)
    7.7
    0
    0
        Week 20: CDAI <= 10 (n= 9, 14, 15)
    55.6
    21.4
    20
        Week 20: CDAI <= 2.8 (n= 9, 14, 15)
    11.1
    0
    0
        Week 24: CDAI <= 10 (n= 9, 11, 15)
    55.6
    45.5
    20
        Week 24: CDAI <= 2.8 (n= 9, 11, 15)
    11.1
    0
    0
        Week 32: CDAI <= 10 (n= 6, 7, 15)
    66.7
    71.4
    6.7
        Week 32: CDAI <= 2.8 (n= 6, 7, 15)
    0
    0
    0
        Week 40: CDAI <= 10 (n= 4, 4, 8)
    50
    75
    25
        Week 40: CDAI <= 2.8 (n= 4, 4, 8)
    0
    0
    0
        Week 48: CDAI <= 10 (n= 2, 4, 6)
    0
    0
    16.7
        Week 48: CDAI <= 2.8 (n= 2, 4, 6)
    0
    0
    0
        Week 56: CDAI <= 10 (n= 1, 1, 4)
    0
    0
    0
        Week 56: CDAI <= 2.8 (n= 1, 1, 4)
    0
    0
    0
    Notes
    [2] - n = number of subjects at specified time-point
    [3] - n = number of subjects at specified time-point
    [4] - n = number of subjects at specified time-point
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving American College of Rheumatology 20%, 50%, 70% (ACR20/50/70) C-Reactive Protein (ACR20/50/70-CRP) Response

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    End point title
    Percentage of Subjects Achieving American College of Rheumatology 20%, 50%, 70% (ACR20/50/70) C-Reactive Protein (ACR20/50/70-CRP) Response
    End point description
    ACR20/50/70-CRP response: greater than equal to (>=) 20/50/70% improvement in TJC; >= 20/50/70% improvement in SJC; and >= 20/50/70% improvement in at least 3 of 5 remaining ACR core measures: subject assessment of pain (assessed on 0-100 millimeter (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 OLE Set.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 56
    End point values
    VX-509 100 mg VX-509 150 mg VX-509 200 mg
    Number of subjects analysed
    38 [5]
    32 [6]
    18 [7]
    Units: percentage of subjects
    number (not applicable)
        Week 4: ACR20-CRP Response (n= 38, 0, 0)
    63.2
    0
    0
        Week 4: ACR50-CRP Response (n= 38, 0, 0)
    36.8
    0
    0
        Week 4: ACR70-CRP Response (n= 38, 0, 0)
    21.1
    0
    0
        Week 8: ACR20-CRP Response (n= 38, 0, 0)
    68.4
    0
    0
        Week 8: ACR50-CRP Response (n= 38, 0, 0)
    34.2
    0
    0
        Week 8: ACR70-CRP Response (n= 38, 0, 0)
    15.8
    0
    0
        Week 12: ACR20-CRP Response (n= 13, 25, 0)
    76.9
    72
    0
        Week 12: ACR50-CRP Response (n= 13, 25, 0)
    69.2
    44
    0
        Week 12: ACR70-CRP Response (n= 13, 25, 0)
    46.2
    16
    0
        Week 16: ACR20-CRP Response (n= 13, 25, 0)
    69.2
    72
    0
        Week 16: ACR50-CRP Response (n= 13, 25, 0)
    53.8
    32
    0
        Week 16: ACR70-CRP Response (n= 13, 25, 0)
    30.8
    8
    0
        Week 20: ACR20-CRP Response (n= 9, 14, 15)
    88.9
    57.1
    66.7
        Week 20: ACR50-CRP Response (n= 9, 14, 15)
    55.6
    57.1
    33.3
        Week 20: ACR70-CRP Response (n= 9, 14, 15)
    44.4
    28.6
    26.7
        Week 24: ACR20-CRP Response (n= 9, 11, 15)
    88.9
    54.5
    60
        Week 24: ACR50-CRP Response (n= 9, 11, 15)
    66.7
    36.4
    40
        Week 24: ACR70-CRP Response (n= 9, 11, 15)
    33.3
    9.1
    26.7
        Week 32: ACR20-CRP Response (n= 6, 7, 15)
    83.3
    85.7
    46.7
        Week 32: ACR50-CRP Response (n= 6, 7, 15)
    83.3
    42.9
    40
        Week 32: ACR70-CRP Response (n= 6, 7, 15)
    83.3
    28.6
    6.7
        Week 40: ACR20-CRP Response (n= 4, 4, 8)
    50
    75
    37.5
        Week 40: ACR50-CRP Response (n= 4, 4, 8)
    50
    75
    37.5
        Week 40: ACR70-CRP Response (n= 4, 4, 8)
    50
    50
    25
        Week 48: ACR20-CRP Response (n= 2, 4, 6)
    50
    50
    50
        Week 48: ACR50-CRP Response (n= 2, 4, 6)
    50
    25
    33.3
        Week 48: ACR70-CRP Response (n= 2, 4, 6)
    0
    0
    16.7
        Week 56: ACR20-CRP Response (n= 1, 1, 4)
    0
    0
    50
        Week 56: ACR50-CRP Response (n= 1, 1, 4)
    0
    0
    25
        Week 56: ACR70-CRP Response (n= 1, 1, 4)
    0
    0
    0
    Notes
    [5] - n = number of subjects at specified time-point
    [6] - n = number of subjects at specified time-point
    [7] - n = number of subjects at specified time-point
    No statistical analyses for this end point

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

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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])
    End point description
    DAS28-4(CRP) was calculated from SJC and TJC using the 28 joints count, CRP milligram per liter [mg/L] and subject general health on visual analogue scale. A score of less than (<) 2.6 implied remission and <=3.2 implied low disease activity. Analysis was performed on OLE set. The number 99999 in data field signifies the data not available/applicable.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 56
    End point values
    VX-509 100 mg VX-509 150 mg VX-509 200 mg
    Number of subjects analysed
    38 [8]
    32 [9]
    18 [10]
    Units: units on scale
    arithmetic mean (standard deviation)
        Week 4: (n= 38, 0, 0)
    -1.888 ± 1.284
    0 ± 0
    0 ± 0
        Week 8: (n= 37, 0, 0)
    -2.183 ± 1.1887
    0 ± 0
    0 ± 0
        Week 12: (n= 11, 23, 0)
    -2.939 ± 1.2092
    -2.412 ± 1.1784
    0 ± 0
        Week 16: (n= 12, 21, 0)
    -2.047 ± 1.4031
    -2.372 ± 1.1644
    0 ± 0
        Week 20: (n= 8, 10, 14)
    -2.786 ± 0.9364
    -3.159 ± 1.3263
    -2.227 ± 1.3663
        Week 24: (n= 8, 8, 13)
    -2.581 ± 1.1552
    -2.858 ± 0.9788
    -2.282 ± 1.4409
        Week 32: (n= 5, 6, 7)
    -2.889 ± 0.5588
    -2.673 ± 0.6799
    -3.12 ± 0.9276
        Week 40: (n= 3, 4, 3)
    -2.368 ± 0.9968
    -3.152 ± 1.0118
    -3.734 ± 0.9939
        Week 48: (n= 1, 3, 3)
    -1.791 ± 99999
    -1.656 ± 0.9
    -2.961 ± 0.3821
        Week 56: (n= 0, 1, 2)
    0 ± 0
    -2.455 ± 99999
    -2.533 ± 1.1736
    Notes
    [8] - n = number of subjects at specified time-point
    [9] - n = number of subjects at specified time-point
    [10] - n = number of subjects at specified time-point
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With DAS28-4(CRP) <2.6 (DAS remission)

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    End point title
    Percentage of Subjects With DAS28-4(CRP) <2.6 (DAS remission)
    End point description
    DAS28-4(CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and subject general health on visual analogue scale. A score of less than (<) 2.6 implied remission and <=3.2 implied low disease activity. Analysis was performed on OLE set.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 56
    End point values
    VX-509 100 mg VX-509 150 mg VX-509 200 mg
    Number of subjects analysed
    38 [11]
    32 [12]
    18 [13]
    Units: percentage of subjects
    number (not applicable)
        Week 4: (n= 38, 0, 0)
    18.4
    0
    0
        Week 8: (n= 38, 0, 0)
    23.7
    0
    0
        Week 12: (n= 13, 25, 0)
    53.8
    16
    0
        Week 16: (n= 13, 25, 0)
    23.1
    16
    0
        Week 20: (n= 9, 14, 15)
    66.7
    21.4
    0
        Week 24: (n= 9, 11, 15)
    33.3
    27.3
    13.3
        Week 32: (n= 6, 7, 15)
    50
    42.9
    6.7
        Week 40: (n= 4, 4, 8)
    50
    75
    25
        Week 48: (n= 2, 4, 6)
    0
    25
    0
        Week 56: (n= 1, 1, 4)
    0
    100
    0
    Notes
    [11] - n = number of subjects at specified time-point
    [12] - n = number of subjects at specified time-point
    [13] - n = number of subjects at specified time-point
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With European League Against Rheumatism (EULAR) Good or Moderate Response

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    End point title
    Percentage of Subjects With European League Against Rheumatism (EULAR) Good or Moderate Response
    End point description
    DAS28-4 (CRP) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (BL) 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 greater than (>) 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 CPR >5.1. Analysis was performed on OLE set.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 56
    End point values
    VX-509 100 mg VX-509 150 mg VX-509 200 mg
    Number of subjects analysed
    38 [14]
    32 [15]
    18 [16]
    Units: percentage of subjects
    number (not applicable)
        Week 4: (n= 38, 0, 0)
    71.1
    0
    0
        Week 8: (n= 38, 0, 0)
    81.6
    0
    0
        Week 12: (n= 13, 25, 0)
    84.6
    84
    0
        Week 16: (n= 13, 25, 0)
    76.9
    72
    0
        Week 20: (n= 9, 14, 15)
    88.9
    71.4
    73.3
        Week 24: (n= 9, 11, 15)
    88.9
    72.7
    66.7
        Week 32: (n= 6, 7, 15)
    83.3
    85.7
    46.7
        Week 40: (n= 4, 4, 8)
    75
    100
    37.5
        Week 48: (n= 2, 4, 6)
    50
    75
    50
        Week 56: (n= 1, 1, 4)
    0
    100
    50
    Notes
    [14] - n = number of subjects at specified time-point
    [15] - n = number of subjects at specified time-point
    [16] - n = number of subjects at specified time-point
    No statistical analyses for this end point

    Secondary: Number of Subjects With Shift from Baseline in Dose of Disease-Modifying Anti-rheumatic Drug (DMARD) And Corticosteroid

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    End point title
    Number of Subjects With Shift from Baseline in Dose of Disease-Modifying Anti-rheumatic Drug (DMARD) And Corticosteroid
    End point description
    DMARDs dose was classified as Standard-dose (SD) DMARD, Low-dose (LD) DMARD, and No DMARD. Corticosteroid (Cort) dose was classified as Full-dose (FD) Corticosteroids, Low-dose (LD) Corticosteroids, and No Corticosteroids. Shift from baseline (BL) is reported. Analysis was performed on OLE set.
    End point type
    Secondary
    End point timeframe
    Week (Wk) 8, 16, 24, 32, 40, 48, and 56
    End point values
    VX-509 100 mg VX-509 150 mg VX-509 200 mg
    Number of subjects analysed
    38 [17]
    32 [18]
    18 [19]
    Units: subjects
    number (not applicable)
        BL SD DMARDs, Wk 8 SD DMARDs (n=38,0,0)
    35
    0
    0
        BL LD DMARDs, Wk 8 LD DMARDs (n=38,0,0)
    3
    0
    0
        BL SD DMARDs, Wk 16 SD DMARDs (n=12,23,0)
    10
    20
    0
        BL SD DMARDs, Wk 16 LD DMARDs (n=12,23,0)
    0
    2
    0
        BL LD DMARDs, Wk 16 LD DMARDs (n=12,23,0)
    2
    1
    0
        BL SD DMARDs, Wk 24 SD DMARDs (n=8,8,14)
    4
    7
    12
        BL SD DMARDs, Wk 24 LD DMARDs (n=8,8,14)
    2
    1
    1
        BL LD DMARDs, Wk 24 LD DMARDs (n=8,8,14)
    2
    0
    1
        BL SD DMARDs, Wk 32 SD DMARDs (n=5,6,11)
    2
    5
    9
        BL SD DMARDs, Wk 32 LD DMARDs (n=5,6,11)
    2
    1
    1
        BL LD DMARDs, Wk 32 LD DMARDs (n=5,6,11)
    1
    0
    1
        BL SD DMARDs, Wk 40 SD DMARDs (n=3,4,3)
    2
    3
    2
        BL SD DMARDs, Wk 40 LD DMARDs (n=3,4,3)
    1
    1
    1
        BL SD DMARDs, Wk 48 SD DMARDs (n=1,4,3)
    0
    3
    2
        BL SD DMARDs, Wk 48 LD DMARDs (n=1,4,3)
    1
    1
    1
        BL SD DMARDs, Wk 56 SD DMARDs (n=0,1,2)
    0
    1
    2
        BL FD Cort, WK 8 FD Cort (n=38,0,0)
    6
    0
    0
        BL LD Cort, WK 8 LD Cort (n=38,0,0)
    9
    0
    0
        BL no Cort, WK 8 no Cort (n=38,0,0)
    23
    0
    0
        BL FD Cort, WK 16 FD Cort (n=12,23,0)
    0
    4
    0
        BL LD Cort, WK 16 LD Cort (n=12,23,0)
    4
    4
    0
        BL no Cort, WK 16 no Cort (n=12,23,0)
    8
    15
    0
        BL FD Cort, WK 24 FD Cort (n=8,8,14)
    0
    0
    3
        BL FD Cort, WK 24 LD Cort (n=8,8,14)
    0
    1
    0
        BL LD Cort, WK 24 LD Cort (n=8,8,14)
    1
    2
    2
        BL no Cort, WK 24 no Cort (n=8,8,14)
    7
    5
    9
        BL FD Cort, WK 32 FD Cort (n=5,6,11)
    0
    0
    2
        BL FD Cort, WK 32 LD Cort (n=5,6,11)
    0
    0
    1
        BL LD Cort, WK 32 LD Cort (n=5,6,11)
    1
    1
    0
        BL no Cort, WK 32 no Cort (n=5,6,11)
    4
    5
    8
        BL FD Cort, WK 40 FD Cort (n=3,4,3)
    0
    0
    1
        BL FD Cort, WK 40 LD Cort (n=3,4,3)
    0
    0
    1
        BL LD Cort, WK 40 LD Cort (n=3,4,3)
    0
    1
    0
        BL no Cort, WK 40 no Cort (n=3,4,3)
    3
    3
    1
        BL FD Cort, WK 48 FD Cort (n=1,4,3)
    0
    0
    1
        BL FD Cort, WK 48 LD Cort (n=1,4,3)
    0
    0
    1
        BL LD Cort, WK 48 LD Cort (n=1,4,3)
    0
    1
    0
        BL no Cort, WK 48 no Cort (n=1,4,3)
    1
    3
    1
        BL FD Cort, WK 56 FD Cort (n=0,1,2)
    0
    0
    1
        BL LD Cort, WK 56 LD Cort (n=0,1,2)
    0
    1
    0
        BL no Cort, WK 56 no Cort (n=0,1,2)
    0
    0
    1
    Notes
    [17] - n = number of subjects at specified time-point
    [18] - n = number of subjects at specified time-point
    [19] - n = number of subjects at specified time-point
    No statistical analyses for this end point

    Secondary: ACR Hybrid Score

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    End point title
    ACR Hybrid Score
    End point description
    ACR hybrid score 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 OLE set. The number 99999 in data field signifies data not available/applicable.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 56
    End point values
    VX-509 100 mg VX-509 150 mg VX-509 200 mg
    Number of subjects analysed
    38 [20]
    32 [21]
    18 [22]
    Units: units on scale
    arithmetic mean (standard deviation)
        Week 4: (n= 37, 0, 0)
    43.688 ± 25.8279
    0 ± 0
    0 ± 0
        Week 8: (n= 38, 0, 0)
    45.033 ± 25.1458
    0 ± 0
    0 ± 0
        Week 12: (n= 12, 24, 0)
    64.419 ± 26.1777
    49.437 ± 23.2752
    0 ± 0
        Week 16: (n= 12, 23, 0)
    46.936 ± 38.995
    49.012 ± 20.2113
    0 ± 0
        Week 20: (n= 8, 10, 14)
    62.974 ± 20.9817
    61.483 ± 25.6113
    49.939 ± 23.2619
        Week 24: (n= 8, 8, 14)
    67.045 ± 15.9479
    52.163 ± 22.4091
    47.198 ± 27.8454
        Week 32: (n= 5, 6, 7)
    78.725 ± 8.6201
    64.12 ± 16.2678
    66.442 ± 8.6957
        Week 40: (n= 3, 4, 3)
    59.129 ± 34.994
    64.301 ± 30.5619
    76.041 ± 11.9408
        Week 48: (n= 1, 3, 3)
    61.861 ± 99999
    38.481 ± 20.9365
    58.64 ± 10.2764
        Week 56: (n= 0, 1, 2)
    0 ± 0
    19.99 ± 99999
    52.159 ± 19.5505
    Notes
    [20] - n = number of subjects at specified time-point
    [21] - n = number of subjects at specified time-point
    [22] - n = number of subjects at specified time-point
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With DAS28 4(ESR) Remission and Low Disease Activity

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    End point title
    Percentage of Subjects With DAS28 4(ESR) Remission and Low Disease Activity
    End point description
    DAS28-4 erythrocyte sedimentation rate (ESR) was calculated from SJC and TJC using the 28 joints count, ESR millimeter per hour (mm/hour) and subject general health on visual analogue scale. A score of <2.6 implied remission and <=3.2 implied low disease activity. Analysis was performed on OLE Set.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 56
    End point values
    VX-509 100 mg VX-509 150 mg VX-509 200 mg
    Number of subjects analysed
    38 [23]
    32 [24]
    18 [25]
    Units: percentage of subjects
    number (not applicable)
        Week 4: DAS28-4(ESR) (<2.6) (n= 38, 0, 0)
    10.5
    0
    0
        Week 4: DAS28-4(ESR) (<=3.2) (n= 38, 0, 0)
    21.1
    0
    0
        Week 8: DAS28-4(ESR) (<2.6) (n= 38, 0, 0)
    18.4
    0
    0
        Week 8: DAS28-4(ESR) (<=3.2) (n= 38, 0, 0)
    21.1
    0
    0
        Week 12: DAS28-4(ESR) (<2.6) (n= 13, 25, 0)
    30.8
    12
    0
        Week 12: DAS28-4(ESR) (<=3.2) (n= 13, 25, 0)
    61.5
    16
    0
        Week 16: DAS28-4(ESR) (<2.6) (n= 13, 25, 0)
    15.4
    0
    0
        Week 16: DAS28-4(ESR) (<=3.2) (n= 13, 25, 0)
    30.8
    8
    0
        Week 20: DAS28-4(ESR) (<2.6) (n= 9, 14, 15)
    22.2
    14.3
    0
        Week 20: DAS28-4(ESR) (<=3.2) (n= 9, 14, 15)
    44.4
    35.7
    6.7
        Week 24: DAS28-4(ESR) (<2.6) (n= 9, 11, 15)
    22.2
    27.3
    0
        Week 24: DAS28-4(ESR) (<=3.2) (n= 9, 11, 15)
    33.3
    36.4
    13.3
        Week 32: DAS28-4(ESR) (<2.6) (n= 6, 7, 15)
    0
    28.6
    13.3
        Week 32: DAS28-4(ESR) (<=3.2) (n= 6, 7, 15)
    50
    42.9
    13.3
        Week 40: DAS28-4(ESR) (<2.6) (n= 4, 4, 8)
    0
    50
    25
        Week 40: DAS28-4(ESR) (<=3.2) (n= 4, 4, 8)
    25
    100
    25
        Week 48: DAS28-4(ESR) (<2.6) (n= 2, 4, 6)
    0
    0
    16.7
        Week 48: DAS28-4(ESR) (<=3.2) (n= 2, 4, 6)
    0
    25
    16.7
        Week 56: DAS28-4(ESR) (<2.6) (n= 1, 1, 4)
    0
    0
    0
        Week 56: DAS28-4(ESR) (<=3.2) (n= 1, 1, 4)
    0
    100
    25
    Notes
    [23] - n = number of subjects at specified time-point
    [24] - n = number of subjects at specified time-point
    [25] - n = number of subjects at specified time-point
    No statistical analyses for this end point

    Secondary: Change from Baseline in Health Assessment Questionnaire -Disability Index (HAQ-DI)

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    End point title
    Change from Baseline in Health Assessment Questionnaire -Disability Index (HAQ-DI)
    End point description
    The 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; 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 OLE set.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 56
    End point values
    VX-509 100 mg VX-509 150 mg VX-509 200 mg
    Number of subjects analysed
    38 [26]
    32 [27]
    18 [28]
    Units: units on scale
    arithmetic mean (standard deviation)
        Week 4: (n= 38, 0, 0)
    -0.4704 ± 0.54944
    0 ± 0
    0 ± 0
        Week 8: (n= 38, 0, 0)
    -0.4309 ± 0.52769
    0 ± 0
    0 ± 0
        Week 12: (n= 12, 24, 0)
    -0.7396 ± 0.45992
    -0.4479 ± 0.42336
    0 ± 0
        Week 16: (n= 12, 23, 0)
    -0.7604 ± 0.47511
    -0.4022 ± 0.33277
    0 ± 0
        Week 20: (n= 8, 10, 14)
    -0.75 ± 0.47716
    -0.475 ± 0.40311
    -0.5 ± 0.3766
        Week 24: (n= 8, 8, 14)
    -0.7188 ± 0.46651
    -0.4688 ± 0.32562
    -0.5089 ± 0.39365
        Week 32: (n= 5, 6, 7)
    -1.25 ± 0.08839
    -0.4167 ± 0.3594
    -0.6786 ± 0.40734
        Week 40: (n= 3, 4, 3)
    -0.9167 ± 0.68845
    -0.5938 ± 0.27717
    -0.625 ± 0.5
        Week 48: (n= 1, 3, 3)
    -0.625 ± 99999
    -0.7083 ± 0.52042
    -0.5833 ± 0.43899
        Week 56: (n= 0, 1, 2)
    0 ± 0
    -0.875 ± 99999
    -0.5625 ± 0.08839
    Notes
    [26] - n = number of subjects at specified time-point
    [27] - n = number of subjects at specified time-point
    [28] - n = number of subjects at specified time-point
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With DAS28-4(CRP) <3.2 (DAS LDA)

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    End point title
    Percentage of Subjects With DAS28-4(CRP) <3.2 (DAS LDA)
    End point description
    DAS28-4 (ESR) was calculated from SJC and TJC using the 28 joints count, ESR (mm/hour) and subject general health on visual analogue scale. A score of <2.6 implied remission and <=3.2 implied low disease activity. Analysis was performed on OLE Set.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 56
    End point values
    VX-509 100 mg VX-509 150 mg VX-509 200 mg
    Number of subjects analysed
    38 [29]
    32 [30]
    18 [31]
    Units: percentage of subjects
    number (not applicable)
        Week 4: DAS28-4( CRP) (<=3.2) (n= 38, 0, 0)
    42.1
    0
    0
        Week 8: DAS28-4( CRP) (<=3.2) (n= 38, 0, 0)
    39.5
    0
    0
        Week 12: DAS28-4( CRP) (<=3.2) (n= 13, 25, 0)
    69.2
    28
    0
        Week 16: DAS28-4( CRP) (<=3.2) (n= 13, 25, 0)
    61.5
    24
    0
        Week 20: DAS28-4( CRP) (<=3.2) (n= 9, 14, 15)
    66.7
    57.1
    33.3
        Week 24: DAS28-4( CRP) (<=3.2) (n= 9, 11, 15)
    66.7
    54.5
    26.7
        Week 32: DAS28-4( CRP) (<=3.2) (n= 6, 7, 15)
    83.3
    71.4
    26.7
        Week 40: DAS28-4( CRP) (<=3.2) (n= 4, 4, 8)
    50
    100
    25
        Week 48: DAS28-4( CRP) (<=3.2) (n= 2, 4, 6)
    0
    25
    33.3
        Week 56: DAS28-4( CRP) (<=3.2) (n= 1, 1, 4)
    0
    100
    25
    Notes
    [29] - n = number of subjects at specified time-point
    [30] - n = number of subjects at specified time-point
    [31] - n = number of subjects at specified time-point
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study up to safety follow-up (28 days after last dose [last dose = Week 56])
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    VX-509
    Reporting group description
    Subjects received (2 VX-509 [100 mg] or 3 VX-509 [150 mg] or 4 VX-509 [200 mg]) tablets orally once daily up to a maximum of 12.9 months.

    Serious adverse events
    VX-509
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 38 (10.53%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder neoplasm
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrioventricular block complete
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    VX-509
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 38 (76.32%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Anxiety
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Blood magnesium decreased
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Blood cholesterol increased
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Blood triglycerides increased
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Cardiac disorders
    Bundle branch block right
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Sinus congestion
         subjects affected / exposed
    3 / 38 (7.89%)
         occurrences all number
    3
    Pleurisy
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Pneumonitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Anaemia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Eye disorders
    Cataract nuclear
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Gingival ulceration
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Oral pain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    3
    Dermatitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Ecchymosis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Livedo reticularis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Rosacea
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Petechiae
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Skin ulcer
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Rheumatoid nodule
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Tendon pain
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Hyperlipidaemia
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Dehydration
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Diabetes mellitus
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Bronchitis
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Sinusitis
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 38 (5.26%)
         occurrences all number
    2
    Oral herpes
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Otitis media
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Subcutaneous abscess
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Tooth abscess
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences all number
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    The study was terminated early on 01-May-2014 by the sponsor due to a decision to modify the drug development plan. The planned treatment duration was 104 weeks; however subjects received treatment up to Week 56.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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