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    Clinical Trial Results:
    A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)

    Summary
    EudraCT number
    		 2009-015318-23
    Trial protocol
    		 CZ   GB   DE   HU  
    Global end of trial date
    25 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Sep 2017
    First version publication date
    10 Sep 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    205-MS-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01051349
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biogen
    Sponsor organisation address
    225 Binney Street, Cambridge, United States, 02142
    Public contact
    Biogen Study Medical Director, Biogen, +1 866-633-4636, clinicaltrials@biogen.com
    Scientific contact
    Biogen Study Medical Director, Biogen, +1 866-633-4636, clinicaltrials@biogen.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 Aug 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the safety of extended treatment with DAC HYP monotherapy in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study were to assess the long-term immunogenicity of DAC HYP and the durability of response to DAC HYP in preventing multiple sclerosis (MS) relapse, slowing disability progression, and reducing new MS lesion formation in this study population.
    Protection of trial subjects
    Written informed consent was obtained from each participant prior to evaluations performed for eligibility. Participants were given adequate time to review the information in the informed consent and were allowed to ask, and have answered, questions concerning all portions of the conduct of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 105
    Country: Number of subjects enrolled
    Poland: 100
    Country: Number of subjects enrolled
    Czech Republic: 63
    Country: Number of subjects enrolled
    Ukraine: 57
    Country: Number of subjects enrolled
    Hungary: 44
    Country: Number of subjects enrolled
    United Kingdom: 22
    Country: Number of subjects enrolled
    India: 11
    Country: Number of subjects enrolled
    Germany: 8
    Worldwide total number of subjects
    410
    EEA total number of subjects
    237
    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)
    410
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Out of 410 enrolled participants, 60 participants who received at least 6 consecutive monthly doses of DAC HYP in this study and had provided written informed consent were enrolled in to the autoinjector substudy and 91 participants who received seasonal trivalent influenza vaccine were enrolled in vaccine substudy (exploratory analyses).

    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
    		 BIIB019
    Arm description
    		 Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BIIB019
    Investigational medicinal product code
    Other name
    Daclizumab high-yield process (DAC HYP)
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    50 mg subcutaneous (SC) injection every 4 weeks.

    Number of subjects in period 1
    		BIIB019
    Started
    410
    Completed
    237
    Not completed
    173
         Adverse event, non-fatal
    88
         Subject non-compliance
    7
         Investigator Decision
    6
         Lost to follow-up
    6
         Reason not Specified
    12
         Consent Withdrawn
    54

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BIIB019
    Reporting group description
    		 Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.

    Reporting group values
    		 BIIB019 Total
    Number of subjects
    		 410 410
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 410 410
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.4 ( 8.74 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 254 254
        Male
    		 156 156

    End points

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    End points reporting groups
    Reporting group title
    BIIB019
    Reporting group description
    		 Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.

    Subject analysis set title
    BIIB019 (prefilled syringe [PFS])
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received BIIB019, 150 mg subcutaneous injection in a prefilled syringe every 4 weeks up to Week 276.

    Subject analysis set title
    BIIB019 (Autoinjector [AI])
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received BIIB019, 150 mg subcutaneous injection using an autoinjector every 4 weeks up to Week 276.

    Primary: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation due to AEs, Withdrawals due to AEs

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    End point title
    		 Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation due to AEs, Withdrawals due to AEs [1]
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
    End point type
    Primary
    End point timeframe
    Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)
    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: Statistical analysis was not performed for this endpoint.
    End point values
    		 BIIB019
    Number of subjects analysed
    410
    Units: participants
        Number of participants with an AEs
    358
        Number of participants with SAEs
    148
        Participants discontinuing treatment due to AE
    91
    No statistical analyses for this end point

    Primary: Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) after Dose 4 for Daclizumab

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    End point title
    		 Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) after Dose 4 for Daclizumab [2]
    End point description
    End point type
    Primary
    End point timeframe
    Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
    Notes
    [2] - 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: Statistical analysis was not performed for this endpoint.
    End point values
    		 BIIB019 (prefilled syringe [PFS]) BIIB019 (Autoinjector [AI])
    Number of subjects analysed
    30
    30
    Units: hr*mg/mL
        arithmetic mean (standard deviation)
    610.5 ( 253.89 )
    666.8 ( 253.19 )
    No statistical analyses for this end point

    Secondary: Number of Participants with New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline

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    End point title
    		 Number of Participants with New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
    End point description
    New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader.
    End point type
    Secondary
    End point timeframe
    From Baseline through 288 weeks
    End point values
    		 BIIB019
    Number of subjects analysed
    410
    Units: participants
        Week 48 New or newly enlarging T2 lesions=0(n=363)
    255
        Week 48 New or newly enlarging T2 lesions=1(n=363)
    39
        Week 48 New or newly enlarging T2 lesions=2(n=363)
    27
        Week 48 New or newly enlarging T2 lesions=3(n=363)
    12
        Week 48 New or newly enlarging T2 lesions=4(n=363)
    5
        Week 48 New/newly enlarging T2 lesions=5-6(n=363)
    6
        Week 48 New/newly enlarging T2 lesions=7-10(n=363)
    8
        Week 48 New/newly enlarging T2 lesions>=11(n=363)
    11
        Week 96 New/newly enlarging T2 lesions=0(n=333)
    213
        Week 96 New/newly enlarging T2 lesions=1(n=333)
    41
        Week 96 New/newly enlarging T2 lesions=2(n=333)
    17
        Week 96 New/newly enlarging T2 lesions=3(n=333)
    17
        Week 96 New/newly enlarging T2 lesions=4(n=333)
    11
        Week 96 New/newly enlarging T2 lesions=5-6(n=333)
    6
        Week 96 New/newly enlarging T2 lesions=7-10(n=333)
    10
        Week 96 New/newly enlarging T2 lesions>=11(n=333)
    18
        Week 144 New/newly enlarging T2 lesions=0(n=53)
    33
        Week 144 New/newly enlarging T2 lesions=1(n=53)
    5
        Week 144 New/newly enlarging T2 lesions=2(n=53)
    1
        Week 144 New/newly enlarging T2 lesions=3(n=53)
    2
        Week 144 New/newly enlarging T2 lesions=4(n=53)
    1
        Week 144 New/newly enlarging T2 lesions=5-6(n=53)
    4
        Week 144 New/newly enlarging T2 lesions=7-10(n=53)
    1
        Week 144 New/newly enlarging T2 lesions>=11(n=53)
    6
        Week 192 New/newly enlarging T2 lesions=0(n=262)
    144
        Week 192 New/newly enlarging T2 lesions=1(n=262)
    30
        Week 192 New/newly enlarging T2 lesions=2(n=262)
    24
        Week 192 New/newly enlarging T2 lesions=3(n=262)
    13
        Week 192 New/newly enlarging T2 lesions=4(n=262)
    9
        Week 192 Ne/newly enlarging T2 lesions=5-6(n=262)
    11
        Week 192 New/newly enlarging T2lesions=7-10(n=262)
    11
        Week 192 New/newly enlarging T2 lesions>=11(n=262)
    20
        Week 240 New/newly enlarging T2 lesions=0(n=121)
    60
        Week 240 New/newly enlarging T2 lesions=1(n=121)
    10
        Week 240 New/newly enlarging T2 lesions=2(n=121)
    14
        Week 240 New/newly enlarging T2 lesions=3(n=121)
    9
        Week 240 New/newly enlarging T2 lesions=4(n=121)
    7
        Week 240 New/newly enlarging T2 lesions=5-6(n=121)
    7
        Week 240 New/newly enlarging T2lesions=7-10(n=121)
    3
        Week 240 New/newly enlarging T2 lesions>=11(n=121)
    11
        Week 288 New/newly enlarging T2 lesions=0(n=27)
    14
        Week 288 New/newly enlarging T2 lesions=1(n=27)
    1
        Week 288 New/newly enlarging T2 lesions=2(n=27)
    4
        Week 288 New/ newly enlarging T2 lesions=3(n=27)
    1
        Week 288 New/newly enlarging T2 lesions=4(n=27)
    0
        Week 288 New/newly enlarging T2 lesions=5-6(n=27)
    1
        Week 288 New/newly enlarging T2 lesions=7-10(n=27)
    3
        Week 288 New/newly enlarging T2 lesions>=11(n=27)
    3
    No statistical analyses for this end point

    Secondary: Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline

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    End point title
    		 Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
    End point description
    New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader.
    End point type
    Secondary
    End point timeframe
    From Baseline through 288 weeks
    End point values
    		 BIIB019
    Number of subjects analysed
    410
    Units: mm^3
    arithmetic mean (standard deviation)
        Change from Baseline at Week 48 (n=362)
    -340.8 ( 1237.64 )
        Change from Baseline at Week 96 (n=330)
    -237.7 ( 1382.86 )
        Change from Baseline at Week 144 (n=51)
    38.2 ( 1825.06 )
        Change from Baseline at Week 192 (n=262)
    -251.2 ( 2326.41 )
        Change from Baseline at Week 240 (n=122)
    -269.7 ( 1188.82 )
        Change from Baseline at Week 288 (n=27)
    31.9 ( 1008.87 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Total Number of New Gadolinium-enhancing Lesions

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    End point title
    		 Number of Participants with Total Number of New Gadolinium-enhancing Lesions
    End point description
    New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader.
    End point type
    Secondary
    End point timeframe
    From Baseline through 288 weeks
    End point values
    		 BIIB019
    Number of subjects analysed
    410
    Units: participants
        Week 48 new Gd-enhancing lesions=1 (n=372)
    22
        Week 48 new Gd-enhancing lesions=2 (n=372)
    3
        Week 48 new Gd-enhancing lesions=3 (n=372)
    6
        Week 48 new Gd-enhancing lesions=>4 (n=372)
    11
        Week 96 new Gd-enhancing lesions=1 (n=338)
    14
        Week 96 new Gd-enhancing lesions=2 (n=338)
    7
        Week 96 new Gd-enhancing lesions=3 (n=338)
    4
        Week 96 new Gd-enhancing lesions=>4 (n=338)
    5
        Week 144 new Gd-enhancing lesions=1 (n=55)
    1
        Week 144 new Gd-enhancing lesions=2 (n=55)
    0
        Week 144 new Gd-enhancing lesions=3 (n=55)
    1
        Week 144 new Gd-enhancing lesions=>4 (n=55)
    2
        Week 192 new Gd-enhancing lesions=1 (n=266)
    13
        Week 192 new Gd-enhancing lesions=2 (n=266)
    5
        Week 192 new Gd-enhancing lesions=3 (n=266)
    1
        Week 192 new Gd-enhancing lesions=>4 (n=266)
    0
        Week 240 new Gd-enhancing lesions=1 (n=124)
    5
        Week 240 new Gd-enhancing lesions=2 (n=124)
    0
        Week 240 new Gd-enhancing lesions=3 (n=124)
    0
        Week 240 new Gd-enhancing lesions=>4 (n=124)
    0
        Week 288 new Gd-enhancing lesions=1 (n=27)
    2
        Week 288 new Gd-enhancing lesions=2 (n=27)
    0
        Week 288 new Gd-enhancing lesions=3 (n=27)
    0
        Week 288 new Gd-enhancing lesions=>4 (n=27)
    0
    No statistical analyses for this end point

    Secondary: Annual Change in Number of T1 Hypointense Lesions

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    End point title
    		 Annual Change in Number of T1 Hypointense Lesions
    End point description
    T1 hypointense lesions changes reflect tissue destruction. Volume of T1 hypointense lesions is deemed a more valuable assessment. Hence number of T1 hypointense lesions were not assessed and reported.
    End point type
    Secondary
    End point timeframe
    From Baseline through 288 weeks
    End point values
    		 BIIB019
    Number of subjects analysed
    0 [3]
    Units: Lesions
    Notes
    [3] - This endpoint was not assessed and reported.
    No statistical analyses for this end point

    Secondary: Annual Change in Volume of New Gadolinium-Enhancing Lesions

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    End point title
    		 Annual Change in Volume of New Gadolinium-Enhancing Lesions
    End point description
    Gd enhancing lesion volume reflects acute inflammatory activity. The number of Gd lesions is a more valuable outcome measure. Hence the volume of Gd enhancing lesions was not assessed and reported.
    End point type
    Secondary
    End point timeframe
    From Baseline through 288 weeks
    End point values
    		 BIIB019
    Number of subjects analysed
    0 [4]
    Units: mm^3
        arithmetic mean (standard deviation)
    ( )
    Notes
    [4] - This endpoint was not assessed and reported.
    No statistical analyses for this end point

    Secondary: Annual Change in Volume of T1 Hypointense Lesions

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    End point title
    		 Annual Change in Volume of T1 Hypointense Lesions
    End point description
    Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader.
    End point type
    Secondary
    End point timeframe
    From Baseline through 288 weeks
    End point values
    		 BIIB019
    Number of subjects analysed
    410
    Units: mm^3
    arithmetic mean (standard deviation)
        Change from Baseline at Week 48 (n=360)
    -183.5 ( 370.66 )
        Change from Baseline at Week 96 (n=325)
    -160.6 ( 443.78 )
        Change from Baseline at Week 144 (n=51)
    -142.4 ( 432.57 )
        Change from Baseline at Week 192 (n=259)
    -115.2 ( 826.84 )
        Change from Baseline at Week 240 (n=121)
    -140.8 ( 514.38 )
        Change from Baseline at Week 288 (n=27)
    -148.4 ( 500.07 )
    No statistical analyses for this end point

    Secondary: Percent Change in Total Brain Volume

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    End point title
    		 Percent Change in Total Brain Volume
    End point description
    To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader.
    End point type
    Secondary
    End point timeframe
    From Baseline through 288 weeks
    End point values
    		 BIIB019
    Number of subjects analysed
    410
    Units: mL
    arithmetic mean (standard deviation)
        Change from Week 0 to Week 48 (n=347)
    -0.4 ( 1 )
        Change from Week 48 to Week 96 (n=303)
    -0.4 ( 0.78 )
        Change from Week 96 to Week 144 (n=37)
    -0.2 ( 1 )
        Change from Week 144 to Week 192 (n=30)
    -0.5 ( 0.59 )
        Change from Week 192 to Week 240 (n=86)
    -0.2 ( 0.83 )
        Change from Week 240 to Week 288 (n=27)
    0.1 ( 0.73 )
    No statistical analyses for this end point

    Secondary: Annualized Relapse Rate (ARR)

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    End point title
    		 Annualized Relapse Rate (ARR)
    End point description
    Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365. Adjusted ARR was reported.
    End point type
    Secondary
    End point timeframe
    Week 288
    End point values
    		 BIIB019
    Number of subjects analysed
    410
    Units: relapses per person-year
        number (confidence interval 95%)
    0.124 (0.099 to 0.156)
    No statistical analyses for this end point

    Secondary: Number of Participants with Antibodies to DAC HYP

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    End point title
    		 Number of Participants with Antibodies to DAC HYP
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Week 288
    End point values
    		 BIIB019
    Number of subjects analysed
    407
    Units: participants
    43
    No statistical analyses for this end point

    Secondary: Number of Participants with Sustained Disability Progression for 12 Weeks

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    End point title
    		 Number of Participants with Sustained Disability Progression for 12 Weeks
    End point description
    Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.
    End point type
    Secondary
    End point timeframe
    Week 48 up to Week 288
    End point values
    		 BIIB019
    Number of subjects analysed
    410
    Units: participants
        Weeks 0 - 48
    22
        Weeks 49 - 96
    17
        Weeks 97 - 144
    13
        Weeks 145 -192
    7
        Week 193 - 288
    2
    No statistical analyses for this end point

    Secondary: Number of Participants with Sustained Disability Progression for 24 Weeks

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    End point title
    		 Number of Participants with Sustained Disability Progression for 24 Weeks
    End point description
    Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.
    End point type
    Secondary
    End point timeframe
    Week 48 up to Week 288
    End point values
    		 BIIB019
    Number of subjects analysed
    410
    Units: participants
        Weeks 0 - 48
    19
        Weeks 49 - 96
    18
        Weeks 97 - 144
    11
        Weeks 145 -192
    7
        Week 193 - 288
    3
    No statistical analyses for this end point

    Secondary: Observed Maximum Concentration (Cmax) after Dose 4 for Daclizumab

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    End point title
    		 Observed Maximum Concentration (Cmax) after Dose 4 for Daclizumab
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
    End point values
    		 BIIB019 (prefilled syringe [PFS]) BIIB019 (Autoinjector [AI])
    Number of subjects analysed
    30
    30
    Units: mg/mL
        arithmetic mean (standard deviation)
    31.8 ( 13.11 )
    33.6 ( 14.79 )
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Concentration (Tmax) for Daclizumab after Dose 4

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    End point title
    		 Time to Reach Maximum Concentration (Tmax) for Daclizumab after Dose 4
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
    End point values
    		 BIIB019 (prefilled syringe [PFS]) BIIB019 (Autoinjector [AI])
    Number of subjects analysed
    30
    30
    Units: hour
        median (full range (min-max))
    5 (1 to 14)
    6 (1 to 14)
    No statistical analyses for this end point

    Secondary: Observed Minimum Concentration (Cmin) for Daclizumab after Dose 4

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    End point title
    		 Observed Minimum Concentration (Cmin) for Daclizumab after Dose 4
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
    End point values
    		 BIIB019 (prefilled syringe [PFS]) BIIB019 (Autoinjector [AI])
    Number of subjects analysed
    30
    30
    Units: mg/mL
        arithmetic mean (standard deviation)
    13.8 ( 7.13 )
    15.7 ( 7.31 )
    No statistical analyses for this end point

    Secondary: Participant-Reported Pain Visual Analog Scale (VAS) Score

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    End point title
    		 Participant-Reported Pain Visual Analog Scale (VAS) Score
    End point description
    The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end (“0 [no pain]” on the left and “100 [very painful]” on the right). The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain.
    End point type
    Secondary
    End point timeframe
    First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose
    End point values
    		 BIIB019 (prefilled syringe [PFS]) BIIB019 (Autoinjector [AI])
    Number of subjects analysed
    30
    30
    Units: score on a scale
    arithmetic mean (standard deviation)
        First injection, 0 hour post-dose (n=30, 30)
    12.7 ( 17.45 )
    14.5 ( 19.47 )
        First injection, 30 minutes post-dose (n=30,30)
    0.1 ( 0.31 )
    0.4 ( 1.01 )
        First injection, 60 minutes post-dose (n=30, 30)
    0.1 ( 0.25 )
    0.3 ( 0.6 )
        First injection, 8 hours post-dose (n=30, 30)
    0.1 ( 0.25 )
    0.2 ( 0.5 )
        Fourth injection, 0 hour post-dose (n=30, 28)
    14.5 ( 21.7 )
    15.6 ( 24.7 )
        Fourth injection, 30 minutes post-dose (n=30, 28)
    0.9 ( 3.51 )
    1.3 ( 3.42 )
        Fourth injection, 60 minutes post-dose (n=30, 28)
    0 ( 0.18 )
    0.1 ( 0.31 )
        Fourth injection, 8 hours post-dose (n=30, 28)
    0.1 ( 0.4 )
    0.1 ( 0.31 )
    No statistical analyses for this end point

    Secondary: Summary of Injection Site Assessment Performed by Clinician

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    End point title
    		 Summary of Injection Site Assessment Performed by Clinician
    End point description
    Injection site assessment was performed by clinician and are defined as erythema (redness) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; pigmentation changes (skin discoloration other than redness) rated on a 3 point scale from 0-2, where 0=none, 1=hypopigmentation and 2=hyperpigmentation; induration (swelling) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; tenderness to pressure rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; and local temperature changes of injection sites rated on a 3 point scale where 0=normal, 1=warm and 1=hot. Only those score categories for which there was at least 1 participant are reported. Here, Injection=Inj, post-dose=PD
    End point type
    Secondary
    End point timeframe
    First injection (Day 1) and fourth injection (Day 90) 30 minutes; 8, 24, 72, and 120 hours; and 7, 10, and 14 days post-dose
    End point values
    		 BIIB019 (prefilled syringe [PFS]) BIIB019 (Autoinjector [AI])
    Number of subjects analysed
    30
    30
    Units: participants
        Erythema: Ist Inj 30 min PD: None (n=30,30)
    29
    29
        Erythema:Ist Inj 30 min PD: Mild (n=30, 30)
    1
    1
        Erythema: Ist Inj 8 h PD: None (n=30, 30)
    30
    29
        Erythema:Ist Inj 8 h PD: MIld (n=30, 30)
    0
    1
        Erythema: Ist Inj 24 h PD: None (n=28,27)
    28
    27
        Erythema: Ist Inj 72 h PD: None (n=26,26)
    26
    26
        Erythema: Ist Inj 120 h PD: None (n=26,26)
    26
    26
        Erythema: Ist Inj 7 days PD: None (n=26,26)
    26
    26
        Erythema: Ist Inj 10 days PD: None (n=26,26)
    26
    26
        Erythema: Ist Inj 14 days PD: None (n=26,26)
    26
    26
        Erythema: 4th Inj 30 min PD: None (n=30,28)
    30
    27
        Erythema: 4th Inj 30 min PD: Mild (n=30,28)
    0
    1
        Erythema: 4th Inj 8 h PD: None (n=30,28)
    30
    28
        Erythema: 4th Inj 24 h PD: None (n=30,27)
    30
    27
        Erythema: 4th Inj 72 h PD: None (n=29,26)
    29
    26
        Erythema: 4th Inj 120 h PD: None (n=30,27)
    30
    27
        Erythema: 4th Inj 7 days PD: None (n=30,28)
    30
    28
        Erythema: 4th Inj 10 days PD: None (n=30,28)
    30
    28
        Erythema: 4th Inj 14 days PD: None (n=30,28)
    30
    28
        Pigmentation: 1st Inj, 30 min PD: None (n=30,30)
    30
    30
        Pigmentation: 1st Inj, 8 h PD: None (n=30,30)
    30
    30
        Pigmentation: 1st Inj, 24 h PD: None (n=28, 27)
    28
    27
        Pigmentation: 1st Inj, 72 h PD: None (n=26, 26)
    26
    26
        Pigmentation: 1st Inj, 120 h PD: None (n=26, 26)
    26
    26
        Pigmentation: 1st Inj, 7 days PD: None (n=26, 26)
    26
    26
        Pigmentation: 1st Inj, 10 days PD: None (n=26, 26)
    26
    26
        Pigmentation: 1st Inj, 14 days PD: None (n=26, 26)
    26
    26
        Pigmentation: 4th Inj, 30 min PD: None (n=30,28)
    30
    28
        Pigmentation: 4th Inj, 8 h PD: None (n=30,28)
    30
    28
        Pigmentation: 4th Inj, 24 h PD: None (n=30,27)
    30
    27
        Pigmentation: 4th Inj, 72 h PD: None (n=29,26)
    28
    26
        Pigmentation: 4th Inj, 72 h PD: Hyper- (n=29,26)
    1
    0
        Pigmentation: 4th Inj, 120 h PD: None (n=30, 27)
    29
    27
        Pigmentation: 4th Inj, 120 h PD: Hyper- (n=30, 27)
    1
    0
        Pigmentation: 4th Inj, 7 days PD: None (n=30, 28)
    30
    28
        Pigmentation: 4th Inj, 10 days PD: None (n=30, 28)
    30
    28
        Pigmentation: 4th Inj, 14 days PD: None (n=30, 28)
    30
    28
        Induration: 1st Inj, 30 min PD: None (n=30, 30)
    30
    30
        Induration: 1st Inj, 8 h PD: None (n=30, 30)
    30
    30
        Induration: 1st Inj, 24 h PD: None (n=28, 27)
    28
    27
        Induration: 1st Inj, 72 h PD: None (n=26, 26)
    26
    26
        Induration: 1st Inj, 120 h PD: None (n=26, 26)
    26
    26
        Induration: 1st Inj, 7 days PD: None (n=26, 26)
    26
    26
        Induration: 1st Inj, 10 days PD: None (n=26, 26)
    26
    26
        Induration: 1st Inj, 14 days PD: None (n=26, 26)
    26
    26
        Induration: 4th Inj, 30 min PD: None (n=30, 28)
    30
    28
        Induration: 4th Inj, 8 h PD: None (n=30, 28)
    30
    28
        Induration: 4th Inj, 24 h PD: None (n=30, 27)
    30
    27
        Induration: 4th Inj, 72 h PD: None (n=29, 26)
    29
    26
        Induration: 4th Inj, 120 h PD: None (n=30, 27)
    30
    27
        Induration: 4th Inj, 7 days PD: None (n=30, 28)
    30
    28
        Induration: 4th Inj, 10 days PD: None (n=30, 28)
    30
    28
        Induration: 4th Inj, 14 days PD: None (n=30, 28)
    30
    28
        Tenderness: 1st Inj, 30 min PD: None (n=30, 30)
    30
    29
        Tenderness: 1st Inj, 30 min PD: Mild (n=30, 30)
    0
    1
        Tenderness: 1st Inj, 8 h PD: None (n=30, 30)
    30
    30
        Tenderness: 1st Inj, 24 h PD: None (n=28, 27)
    28
    27
        Tenderness: 1st Inj, 72 h PD: None (n=26, 26)
    26
    26
        Tenderness: 1st Inj, 120 h PD: None (n=26, 26)
    26
    26
        Tenderness: 1st Inj, 7 days PD: None (n=26, 26)
    26
    26
        Tenderness: 1st Inj, 10 days PD: None (n=26, 26)
    26
    26
        Tenderness: 1st Inj, 14 days PD: None (n=26, 26)
    26
    26
        Tenderness: 4th Inj, 30 min PD: None (n=30, 28)
    30
    27
        Tenderness: 4th Inj, 30 min PD: Mild (n=30, 28)
    0
    1
        Tenderness: 4th Inj, 8 h PD: None (n=30, 28)
    30
    27
        Tenderness: 4th Inj, 8 h PD: Mild (n=30, 28)
    0
    1
        Tenderness: 4th Inj, 24 h PD: None (n=30, 27)
    30
    27
        Tenderness: 4th Inj, 72 h PD: None (n=29, 26)
    29
    26
        Tenderness: 4th Inj, 120 h PD: None (n=30, 27)
    30
    27
        Tenderness: 4th Inj, 7 days PD: None (n=30, 28)
    30
    28
        Tenderness: 4th Inj, 10 days PD: None (n=30, 28)
    30
    28
        Tenderness: 4th Inj, 14 days PD: None (n=30, 28)
    30
    28
        Temperature: 1st Inj, 30 min PD: Normal (n=30, 30)
    30
    30
        Temperature: 1st Inj, 8 h PD: Normal (n=30, 30)
    30
    30
        Temperature: 1st Inj, 24 h PD: Normal (n=28, 27)
    28
    27
        Temperature: 1st Inj, 72 h PD: Normal (n=26, 26)
    26
    26
        Temperature: 1st Inj, 120 h PD: Normal (n=26, 26)
    26
    26
        Temperature: 1st Inj, 7 days PD: Normal (n=26, 26)
    26
    26
        Temperature: 1st Inj,10 days PD: Normal (n=26, 26)
    26
    26
        Temperature: 1st Inj,14 days PD: Normal (n=26, 26)
    26
    26
        Temperature: 4th Inj, 30 min PD: Normal (n=30, 28)
    30
    28
        Temperature: 4th Inj, 8 h PD: Normal (n=30, 28)
    30
    28
        Temperature: 4th Inj, 24 h PD: Normal (n=30, 27)
    30
    27
        Temperature: 4th Inj, 72 h PD: Normal (n=29, 26)
    29
    26
        Temperature: 4th Inj, 120 h PD: Normal (n=30, 27)
    30
    27
        Temperature: 4th Inj, 7 days PD: Normal (n=30, 28)
    30
    28
        Temperature: 4th Inj,10 days PD: Normal (n=30, 28)
    30
    28
        Temperature: 4th Inj,14 days PD: Normal (n=30, 28)
    30
    28
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)
    Adverse event reporting additional description
    Treatment emergent AEs are presented regardless of seriousness or relationship to investigational product
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    BIIB019
    Reporting group description
    		 Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276.

    Serious adverse events
    		 BIIB019
    Total subjects affected by serious adverse events
         subjects affected / exposed
    148 / 410 (36.10%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anal cancer
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Breast cancer
         subjects affected / exposed
    3 / 410 (0.73%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Carcinoid tumour pulmonary
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Intraductal papilloma of breast
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prolactinoma
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    T-cell lymphoma
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Drug detoxification
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eyelid operation
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Mammoplasty
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Impaired healing
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Uterine inflammation
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Concussion
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Foot fracture
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pubis fracture
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Road traffic accident
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Spinal column injury
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Wound
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Grand mal convulsion
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple sclerosis relapse
         subjects affected / exposed
    62 / 410 (15.12%)
         occurrences causally related to treatment / all
    1 / 112
         deaths causally related to treatment / all
    0 / 0
    Neurological decompensation
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Histiocytosis haematophagic
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    6 / 410 (1.46%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    Lymphoid tissue hyperplasia
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenic purpura
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Choroiditis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    3 / 410 (0.73%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterocolitis haemorrhagic
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastritis
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lip oedema
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Autoimmune hepatitis
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Jaundice hepatocellular
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Liver disorder
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dermatitis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Drug eruption
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Erythema nodosum
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Erythrodermic psoriasis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psoriasis
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Photodermatosis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stevens-johnson syndrome
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    3 / 410 (0.73%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Urticaria
         subjects affected / exposed
    3 / 410 (0.73%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Glomerulonephritis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nephroptosis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Arthritis reactive
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Furuncle
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatitis c
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    HIV infection
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 410 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    5 / 410 (1.22%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 410 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BIIB019
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    296 / 410 (72.20%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    61 / 410 (14.88%)
         occurrences all number
    72
    Aspartate aminotransferase increased
         subjects affected / exposed
    49 / 410 (11.95%)
         occurrences all number
    54
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    21 / 410 (5.12%)
         occurrences all number
    27
    Nervous system disorders
    Headache
         subjects affected / exposed
    44 / 410 (10.73%)
         occurrences all number
    340
    Multiple sclerosis relapse
         subjects affected / exposed
    110 / 410 (26.83%)
         occurrences all number
    189
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    23 / 410 (5.61%)
         occurrences all number
    26
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    25 / 410 (6.10%)
         occurrences all number
    47
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    32 / 410 (7.80%)
         occurrences all number
    38
    Rash
         subjects affected / exposed
    31 / 410 (7.56%)
         occurrences all number
    43
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    21 / 410 (5.12%)
         occurrences all number
    40
    Back pain
         subjects affected / exposed
    39 / 410 (9.51%)
         occurrences all number
    160
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    28 / 410 (6.83%)
         occurrences all number
    37
    Nasopharyngitis
         subjects affected / exposed
    68 / 410 (16.59%)
         occurrences all number
    147
    Pharyngitis
         subjects affected / exposed
    42 / 410 (10.24%)
         occurrences all number
    66
    Respiratory tract infection viral
         subjects affected / exposed
    35 / 410 (8.54%)
         occurrences all number
    55
    Upper respiratory tract infection
         subjects affected / exposed
    60 / 410 (14.63%)
         occurrences all number
    142
    Urinary tract infection
         subjects affected / exposed
    42 / 410 (10.24%)
         occurrences all number
    90
    Viral infection
         subjects affected / exposed
    23 / 410 (5.61%)
         occurrences all number
    30

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jun 2011
    • The primary reason for this amendment was to increase subject monitoring for laboratory signals related to hepatic function (Liver function test (LFT) monitoring was increased from every 6 months to monthly throughout the treatment period) and to add criteria for temporary suspension and discontinuation of study treatment for subjects who developed elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin. Subjects who permanently discontinued study treatment due to elevated LFTs were to be evaluated for possible toxicological, infectious, immunological, and metabolic causes of liver injury. • Additional guidance was provided to Investigators on the evaluation and management of cutaneous events. • The use of the DAC HYP PFS was allowed.
    05 Apr 2012
    • The primary reason for this amendment was to prohibit concomitant treatment with medications that have an established association with hepatotoxicity or cutaneous hypersensitivity reactions. • Monthly LFT results were provided to the Neurologist prior to administration of study treatment to assess whether treatment suspension criteria were met. • Subjects were provided an additional 3 years of open-label treatment with DAC HYP.
    12 Dec 2012
    • The primary reason for this amendment was the addition of the 2013-2014 influenza vaccine substudy
    24 May 2013
    • The primary reason for this amendment was to reintroduce physical examination, vital signs, hematology, and blood chemistry assessments at Week 96.
    13 Jun 2013
    • The primary reason for this amendment was to reintroduce urinalysis assessment at Week 96.

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

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