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    Clinical Trial Results:
    A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

    Summary
    EudraCT number
    2013-003752-21
    Trial protocol
    GB   DE   IT   PL   HU   ES  
    Global end of trial date

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Sep 2020
    First version publication date
    27 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BN40898
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02028884
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001625-PIP01-14
    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
    Interim
    Date of interim/final analysis
    06 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jun 2018
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the efficacy of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in participants with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD).
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    All participants received corticosteroids as background therapy.
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Feb 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Taiwan: 12
    Country: Number of subjects enrolled
    Ukraine: 3
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 2
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Japan: 22
    Country: Number of subjects enrolled
    Poland: 23
    Worldwide total number of subjects
    83
    EEA total number of subjects
    41
    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)
    7
    Adults (18-64 years)
    72
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants took part in the double-blind period up to the clinical cut-off date (CCOD: 06 June 2018). The CCOD was defined by the onset date of the 26th clinical endpoint committee-confirmed protocol-defined relapse (PDR). The study is ongoing in the open label extension period.

    Pre-assignment
    Screening details
    Participants with neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD) were randomized 1:1 to receive either satralizumab 120 mg or matching placebo, in addition to baseline immunosuppressive treatments.

    Period 1
    Period 1 title
    Double-blind Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo + Baseline Treatment, then Satralizumab
    Arm description
    Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).

    Investigational medicinal product name
    Baseline treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One of the following drugs at a stable dose was required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA); mycophenolate mofetil (MMF); or oral corticosteroids (CS). For participants aged 12 to 17 years at the time of informed consent, baseline treatment with AZA or MMF in combination with oral CS was also permitted. Change or termination of baseline treatment was only permitted during the open-label extension period.

    Arm title
    Satralizumab + Baseline Treatment, then Satralizumab
    Arm description
    Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
    Arm type
    Experimental

    Investigational medicinal product name
    Baseline treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One of the following drugs at a stable dose was required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA); mycophenolate mofetil (MMF); or oral corticosteroids (CS). For participants aged 12 to 17 years at the time of informed consent, baseline treatment with AZA or MMF in combination with oral CS was also permitted. Change or termination of baseline treatment was only permitted during the open-label extension period.

    Investigational medicinal product name
    Satralizumab
    Investigational medicinal product code
    Other name
    SA237, RG6168, RO5333787
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Satralizumab was administered SC at Weeks 0, 2, and 4, and thereafter once every 4 weeks Q4W.

    Number of subjects in period 1
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Started
    42
    41
    Completed
    24
    18
    Not completed
    18
    23
         On-going in Study
    8
    20
         Non-Compliance With Study Drug
    2
    -
         Adverse event, non-fatal
    5
    3
         Consent withdrawn by subject
    2
    -
         Eligibility Violation
    1
    -
    Period 2
    Period 2 title
    Open-label Extension Period
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo + Baseline Treatment, then Satralizumab
    Arm description
    Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period (up to approximately 216 weeks), all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
    Arm type
    Placebo

    Investigational medicinal product name
    Baseline treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One of the following drugs at a stable dose was required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA); mycophenolate mofetil (MMF); or oral corticosteroids (CS). For participants aged 12 to 17 years at the time of informed consent, baseline treatment with AZA or MMF in combination with oral CS was also permitted. Change or termination of baseline treatment was only permitted during the open-label extension period.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).

    Arm title
    Satralizumab + Baseline Treatment, then Satralizumab
    Arm description
    Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period (up to approximately 216 weeks), all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
    Arm type
    Experimental

    Investigational medicinal product name
    Baseline treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One of the following drugs at a stable dose was required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA); mycophenolate mofetil (MMF); or oral corticosteroids (CS). For participants aged 12 to 17 years at the time of informed consent, baseline treatment with AZA or MMF in combination with oral CS was also permitted. Change or termination of baseline treatment was only permitted during the open-label extension period.

    Investigational medicinal product name
    Satralizumab
    Investigational medicinal product code
    Other name
    SA237, RG6168, RO5333787
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Satralizumab was administered SC at Weeks 0, 2, and 4, and thereafter once every 4 weeks Q4W.

    Number of subjects in period 2
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Started
    24
    18
    Completed
    0
    0
    Not completed
    24
    18
         On-going in Study
    19
    14
         Lack of efficacy
    3
    -
         Non-Compliance With Study Drug
    -
    1
         Adverse event, non-fatal
    2
    1
         Consent withdrawn by subject
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo + Baseline Treatment, then Satralizumab
    Reporting group description
    Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.

    Reporting group title
    Satralizumab + Baseline Treatment, then Satralizumab
    Reporting group description
    Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.

    Reporting group values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab Total
    Number of subjects
    42 41
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    43.38 ± 12.03 40.78 ± 16.09 -
    Sex: Female, Male
    Units:
        Male
    2 4 6
        Female
    40 37 77

    End points

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    End points reporting groups
    Reporting group title
    Placebo + Baseline Treatment, then Satralizumab
    Reporting group description
    Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.

    Reporting group title
    Satralizumab + Baseline Treatment, then Satralizumab
    Reporting group description
    Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
    Reporting group title
    Placebo + Baseline Treatment, then Satralizumab
    Reporting group description
    Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period (up to approximately 216 weeks), all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.

    Reporting group title
    Satralizumab + Baseline Treatment, then Satralizumab
    Reporting group description
    Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period (up to approximately 216 weeks), all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.

    Primary: Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period

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    End point title
    Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period
    End point description
    TFR was defined as time from randomization to first occurrence of relapse in the DB period. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological NMO or NMOSD as adjudicated by an independent clinical endpoint committee (CEC). Symptoms had to persist for >24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred < 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onset days that were 30 days of one another, they were counted only as 1 relapse), and onset date used in analysis was the date of first relapse. ITT population. 99999 and 9999999=lower and upper limit of CI were not reached due to low number of participants with events. 999999=median was not reached due to low number of participants with events.
    End point type
    Primary
    End point timeframe
    Up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: weeks
        median (confidence interval 95%)
    120.6 (37.0 to 9999999)
    999999 (99999 to 9999999)
    Statistical analysis title
    Satralizumab versus Placebo
    Statistical analysis description
    Stratified by Baseline annualized relapse rate (ARR: 1, > 1) and geographic region (Asia, EU/Other).
    Comparison groups
    Placebo + Baseline Treatment, then Satralizumab v Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0184
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.16
         upper limit
    0.88

    Secondary: Change from Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain

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    End point title
    Change from Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain
    End point description
    The VAS is a subjective measure of pain consisting of a 100 mm line with two endpoints representing 0 = “no pain” and 100 = “pain as bad as it could be”. Participants rated their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the “no pain” marker was measured with a ruler giving a pain score out of 100. A higher score indicated more pain and lower scores reflected a better health state. A negative change from baseline indicates an improvement. ANCOVA was used for analysis to report the adjusted mean and standard error (SE). ITT population included all participants randomized to the treatment groups. Missing data were imputed by baseline observation carried forward (BOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard error)
        Baseline
    34.619 ± 4.026
    27.561 ± 4.399
        Change from Baseline to Week 24
    -3.505 ± 2.357
    2.871 ± 2.391
    Statistical analysis title
    Satralizumab versus Placebo
    Statistical analysis description
    ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates
    Comparison groups
    Placebo + Baseline Treatment, then Satralizumab v Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0602
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    6.376
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.28
         upper limit
    13.033
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.344

    Secondary: Change from Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score

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    End point title
    Change from Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
    End point description
    The FACIT Fatigue scale is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. As each of the 13 items of the scale ranges from 0-4, the range of possible scores was computed using FACIT scoring algorithm as 0-52, where 0 is the worst possible score and 52 the best which indicated less fatigue. A positive change from baseline indicates an improvement. ANCOVA was used for analysis to report the adjusted mean and SE. ITT population included all participants randomized to the treatment groups. Missing data were imputed by BOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard error)
        Baseline
    33.857 ± 1.746
    34.732 ± 1.646
        Change from Baseline to Week 24
    2.234 ± 0.943
    0.145 ± 0.963
    Statistical analysis title
    Satralizumab versus Placebo
    Statistical analysis description
    ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates
    Comparison groups
    Placebo + Baseline Treatment, then Satralizumab v Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1224
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.089
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.752
         upper limit
    0.574
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.338

    Secondary: Relapse-Free Rate During the DB Period

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    End point title
    Relapse-Free Rate During the DB Period
    End point description
    Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD). Symptoms had to persist for >24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred < 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onset days that were 30 days of one another, they were counted only as 1 relapse), and onset date used in analysis was the date of first relapse. ITT population included all participants randomized to the treatment groups. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    34
    37
    Units: percentage
    number (not applicable)
        Week 12 (n=34, 37)
    89.86
    94.99
        Week 24 (n=30, 29)
    84.41
    88.86
        Week 36 (n=22, 25)
    69.49
    88.86
        Week 48 (n=19, 24)
    66.02
    88.86
        Week 72 (n=16, 22)
    58.68
    81.46
        Week 96 (n=16, 20)
    58.68
    77.58
        Week 120 (n=12, 19)
    54.17
    73.70
        Week 144 (n=9, 14)
    49.24
    73.70
        Week 168 (n=4, 9)
    43.77
    73.70
        Week 192 (n=0, 2)
    6666
    73.70
        Week 216 (n=0, 1)
    6666
    73.70
    No statistical analyses for this end point

    Secondary: Annualized Relapse Rate (ARR) During the DB Period

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    End point title
    Annualized Relapse Rate (ARR) During the DB Period
    End point description
    The ARR is calculated as the total number of participants with relapses experienced divided by the patient-years at risk. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological NMO or NMOSD. Symptoms had to persist for >24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred < 31 days following onset of a protocol-defined relapse were considered part of same relapse (2 relapses with onset days in 30 days of one another was counted as 1 relapse), onset date used in analysis was the date of first relapse. ITT population included all participants randomized to the treatment groups.
    End point type
    Secondary
    End point timeframe
    Up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: patients w relapse/patient-years at risk
        number (confidence interval 95%)
    0.32 (0.19 to 0.51)
    0.11 (0.05 to 0.21)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
    End point description
    The mRS is a 7-point disability scale that assesses the degree of disability in participants with neurological impairment. Possible scores range from 0 (no symptoms at all) up to 6 (death). Higher scores reflect increased disability. A negative change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=42, 41)
    1.55 ± 0.97
    1.90 ± 1.14
        Change from Baseline at Week 24 (n=29, 29)
    -0.03 ± 0.42
    -0.03 ± 0.50
        Change from Baseline at Week 48 (n=17, 24)
    -0.18 ± 0.53
    -0.13 ± 0.45
        Change from Baseline at Week 72 (n=15, 23)
    0.07 ± 0.70
    0.00 ± 0.52
        Change from Baseline at Week 96 (n=16, 21)
    0.13 ± 0.62
    -0.19 ± 0.51
        Change from Baseline at Week 120 (n=10, 20)
    -0.10 ± 0.74
    -0.05 ± 0.51
        Change from Baseline at Week 144 (n=9, 15)
    -0.11 ± 0.93
    -0.20 ± 0.41
        Change from Baseline at Week 168 (n=3, 9)
    -0.67 ± 0.58
    -0.11 ± 0.33
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    -0.50 ± 0.71
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    0.00 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period
    End point description
    The ZBI is the measurement to assess caregiver burden. The 22 items ask for the strain caregivers perceive. Responses range from 0 (never) to 4 (nearly always). The overall ZBI score ranges from 0 to 88. The higher the total score, the heavier the perceived burden. A negative change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 168
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    16
    13
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=16, 13)
    19.31 ± 9.31
    18.92 ± 12.82
        Change from Baseline at Week 24 (n=9, 7)
    -3.44 ± 5.59
    -3.57 ± 7.11
        Change from Baseline at Week 48 (n=6, 8)
    1.17 ± 8.26
    1.13 ± 13.45
        Change from Baseline at Week 72 (n=5, 7)
    2.20 ± 19.64
    -0.71 ± 11.60
        Change from Baseline at Week 96 (n=5, 6)
    3.00 ± 14.98
    4.17 ± 13.33
        Change from Baseline at Week 120 (n=3, 5)
    0.00 ± 3.61
    3.40 ± 9.29
        Change from Baseline at Week 144 (n=2, 4)
    -3.50 ± 12.02
    -3.50 ± 11.33
        Change from Baseline at Week 168 (n=2, 1)
    2.50 ± 13.44
    11.00 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
    End point description
    The EDSS is an ordinal scale with values from 0 points (normal neurological examination) to 10 points (death) increasing in half-point increments once an EDSS of 1.0 has been reached. Higher scores represent increased disability. A negative change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    41
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=41, 41)
    3.63 ± 1.32
    3.83 ± 1.57
        Change from Baseline at Week 24 (n=29, 29)
    -0.21 ± 0.68
    -0.14 ± 0.82
        Change from Baseline at Week 48 (n=18, 24)
    -0.19 ± 0.77
    -0.19 ± 0.67
        Change from Baseline at Week 72 (n=15, 21)
    -0.27 ± 0.68
    -0.29 ± 0.73
        Change from Baseline at Week 96 (n=16, 21)
    -0.19 ± 0.81
    -0.19 ± 0.75
        Change from Baseline at Week 120 (n=10, 20)
    -0.30 ± 0.79
    0.03 ± 0.57
        Change from Baseline at Week 144 (n=9, 15)
    -0.33 ± 0.83
    -0.07 ± 0.62
        Change from Baseline at Week 168 (n=3, 9)
    -0.17 ± 0.76
    -0.06 ± 0.58
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    0.00 ± 0.71
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    -0.50 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
    End point description
    Visual acuity was measured using Snellen 20-foot wall chart and then converted to logMAR visual acuity scoring. Lower values indicate better visual acuity. Data are reported for right eye (OD) and left eye (OS). A negative change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline: OD (n=42, 41)
    0.490 ± 0.928
    0.303 ± 0.593
        Baseline: OS (n=42, 41)
    0.526 ± 0.911
    0.597 ± 1.016
        Change from Baseline at Week 24: OD (n=30, 29)
    -0.064 ± 0.197
    0.042 ± 0.236
        Change from Baseline at Week 24: OS (n=30, 29)
    -0.012 ± 0.107
    0.059 ± 0.319
        Change from Baseline at Week 48: OD (n=18, 24)
    -0.019 ± 0.086
    0.008 ± 0.093
        Change from Baseline at Week 48: OS (n=18, 24)
    0.026 ± 0.096
    0.013 ± 0.061
        Change from Baseline at Week 72: OD (n=15, 21)
    -0.001 ± 0.110
    -0.034 ± 0.111
        Change from Baseline at Week 72: OS (n=15, 21)
    -0.001 ± 0.121
    -0.019 ± 0.077
        Change from Baseline at Week 96: OD (n=16, 21)
    0.018 ± 0.174
    -0.013 ± 0.095
        Change from Baseline at Week 96: OS (n=16, 21)
    -0.078 ± 0.185
    -0.010 ± 0.073
        Change from Baseline at Week 120: OD (n=10, 20)
    0.030 ± 0.150
    0.011 ± 0.103
        Change from Baseline at Week 120: OS (n=10, 20)
    -0.024 ± 0.150
    0.014 ± 0.257
        Change from Baseline at Week 144: OD (n=9, 15)
    0.058 ± 0.231
    -0.016 ± 0.120
        Change from Baseline at Week 144: OS (n=9, 15)
    -0.016 ± 0.165
    -0.028 ± 0.111
        Change from Baseline at Week 168: OD (n=3, 9)
    0.113 ± 0.306
    0.027 ± 0.199
        Change from Baseline at Week 168: OS (n=3, 9)
    0.100 ± 0.173
    -0.024 ± 0.113
        Change from Baseline at Week 192: OD (n=0, 2)
    6666 ± 6666
    0.150 ± 0.099
        Change from Baseline at Week 192: OS (n=0, 2)
    6666 ± 6666
    0.000 ± 0.000
        Change from Baseline at Week 216: OD (n=0, 1)
    6666 ± 6666
    0.120 ± 9999
        Change from Baseline at Week 216: OS (n=0, 1)
    6666 ± 6666
    0.000 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period
    End point description
    The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=42, 41)
    44.77 ± 11.08
    44.56 ± 9.75
        Change from Baseline at Week 24 (n=28, 29)
    2.53 ± 7.58
    0.57 ± 8.99
        Change from Baseline at Week 48 (n=18, 24)
    2.78 ± 7.51
    -0.61 ± 10.97
        Change from Baseline at Week 72 (n=15, 23)
    3.47 ± 7.13
    2.78 ± 8.13
        Change from Baseline at Week 96 (n=16, 21)
    5.16 ± 10.52
    1.06 ± 7.63
        Change from Baseline at Week 120 (n=10, 20)
    3.63 ± 8.62
    0.71 ± 7.23
        Change from Baseline at Week 144 (n=9, 15)
    2.83 ± 8.79
    3.82 ± 7.15
        Change from Baseline at Week 168 (n=3, 9)
    2.79 ± 6.85
    3.60 ± 9.50
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    11.60 ± 7.32
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    14.05 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
    End point description
    The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=42, 41)
    41.54 ± 9.11
    43.60 ± 10.47
        Change from Baseline at Week 24 (n=28, 29)
    2.79 ± 5.61
    1.30 ± 6.01
        Change from Baseline at Week 48 (n=18, 24)
    0.18 ± 5.33
    1.22 ± 5.77
        Change from Baseline at Week 72 (n=15, 23)
    1.97 ± 6.23
    1.16 ± 4.79
        Change from Baseline at Week 96 (n=16, 21)
    -1.15 ± 7.52
    1.88 ± 5.72
        Change from Baseline at Week 120 (n=10, 20)
    -0.13 ± 7.10
    2.34 ± 6.60
        Change from Baseline at Week 144 (n=9, 15)
    1.78 ± 5.50
    3.05 ± 4.23
        Change from Baseline at Week 168 (n=3, 9)
    0.22 ± 9.23
    0.76 ± 5.98
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    0.23 ± 0.55
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    -1.63 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
    End point description
    The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=42, 41)
    43.91 ± 10.22
    45.94 ± 11.56
        Change from Baseline at Week 24 (n=29, 29)
    2.71 ± 7.06
    0.03 ± 11.06
        Change from Baseline at Week 48 (n=18, 24)
    0.81 ± 5.60
    0.12 ± 6.99
        Change from Baseline at Week 72 (n=15, 23)
    3.55 ± 8.20
    2.30 ± 6.99
        Change from Baseline at Week 96 (n=16, 21)
    1.31 ± 7.13
    1.15 ± 8.86
        Change from Baseline at Week 120 (n=10, 20)
    2.22 ± 9.96
    -1.45 ± 9.13
        Change from Baseline at Week 144 (n=9, 15)
    3.58 ± 8.53
    3.14 ± 8.18
        Change from Baseline at Week 168 (n=3, 9)
    1.61 ± 10.58
    3.05 ± 9.00
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    8.07 ± 0.57
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    3.63 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
    End point description
    The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=42, 41)
    39.65 ± 7.90
    41.23 ± 9.29
        Change from Baseline at Week 24 (n=29, 29)
    1.84 ± 5.68
    -0.60 ± 7.26
        Change from Baseline at Week 48 (n=18, 24)
    -0.66 ± 5.53
    -0.27 ± 6.00
        Change from Baseline at Week 72 (n=15, 23)
    -0.16 ± 6.25
    0.94 ± 5.57
        Change from Baseline at Week 96 (n=16, 21)
    -1.90 ± 6.17
    1.86 ± 6.12
        Change from Baseline at Week 120 (n=10, 20)
    -0.33 ± 4.03
    3.76 ± 6.72
        Change from Baseline at Week 144 (n=9, 15)
    -0.95 ± 5.66
    5.20 ± 7.11
        Change from Baseline at Week 168 (n=3, 9)
    -5.23 ± 7.41
    3.06 ± 6.99
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    1.19 ± 5.04
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    -2.38 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
    End point description
    The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=42, 41)
    43.71 ± 10.92
    43.59 ± 10.55
        Change from Baseline at Week 24 (n=29, 29)
    5.23 ± 7.69
    0.99 ± 10.21
        Change from Baseline at Week 48 (n=18, 24)
    2.76 ± 8.54
    0.11 ± 10.73
        Change from Baseline at Week 72 (n=15, 23)
    5.23 ± 7.66
    3.18 ± 9.72
        Change from Baseline at Week 96 (n=16, 21)
    4.09 ± 8.49
    2.12 ± 8.13
        Change from Baseline at Week 120 (n=10, 20)
    3.14 ± 7.06
    1.57 ± 6.76
        Change from Baseline at Week 144 (n=9, 15)
    3.49 ± 7.04
    4.88 ± 8.38
        Change from Baseline at Week 168 (n=3, 9)
    4.36 ± 3.02
    4.07 ± 10.72
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    13.09 ± 14.80
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    23.55 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
    End point description
    The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=42, 41)
    42.50 ± 10.53
    43.46 ± 10.34
        Change from Baseline at Week 24 (n=29, 29)
    3.56 ± 7.04
    1.49 ± 7.05
        Change from Baseline at Week 48 (n=18, 24)
    1.92 ± 4.30
    1.86 ± 7.73
        Change from Baseline at Week 72 (n=15, 23)
    3.19 ± 6.54
    0.88 ± 6.52
        Change from Baseline at Week 96 (n=16, 21)
    0.84 ± 6.77
    2.37 ± 7.75
        Change from Baseline at Week 120 (n=10, 20)
    -0.19 ± 8.39
    2.58 ± 6.03
        Change from Baseline at Week 144 (n=9, 15)
    2.55 ± 4.06
    3.32 ± 5.72
        Change from Baseline at Week 168 (n=3, 9)
    1.92 ± 5.06
    0.00 ± 5.50
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    1.91 ± 2.70
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    1.91 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
    End point description
    The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=42, 41)
    43.98 ± 11.46
    43.01 ± 10.55
        Change from Baseline at Week 24 (n=28, 29)
    2.24 ± 10.35
    0.36 ± 10.12
        Change from Baseline at Week 48 (n=18, 24)
    3.29 ± 8.05
    0.00 ± 12.49
        Change from Baseline at Week 72 (n=15, 23)
    1.39 ± 9.38
    2.57 ± 7.66
        Change from Baseline at Week 96 (n=16, 21)
    4.13 ± 14.40
    0.83 ± 10.20
        Change from Baseline at Week 120 (n=10, 20)
    3.13 ± 12.44
    0.35 ± 6.95
        Change from Baseline at Week 144 (n=9, 15)
    3.09 ± 9.61
    3.25 ± 7.38
        Change from Baseline at Week 168 (n=3, 9)
    1.16 ± 5.32
    4.64 ± 9.05
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    12.19 ± 2.46
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    6.97 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
    End point description
    The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=42, 41)
    40.74 ± 10.12
    41.88 ± 11.38
        Change from Baseline at Week 24 (n=28, 29)
    3.93 ± 9.56
    3.02 ± 6.95
        Change from Baseline at Week 48 (n=18, 24)
    1.37 ± 7.23
    1.40 ± 8.66
        Change from Baseline at Week 72 (n=15, 23)
    2.40 ± 7.94
    2.83 ± 7.81
        Change from Baseline at Week 96 (n=16, 21)
    0.42 ± 9.03
    1.71 ± 4.60
        Change from Baseline at Week 120 (n=10, 20)
    1.57 ± 9.47
    3.14 ± 7.44
        Change from Baseline at Week 144 (n=9, 15)
    2.99 ± 6.05
    2.69 ± 6.80
        Change from Baseline at Week 168 (n=3, 9)
    3.74 ± 10.61
    2.25 ± 6.45
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    4.49 ± 6.35
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    8.98 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
    End point description
    The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=42, 41)
    41.70 ± 11.62
    44.26 ± 10.92
        Change from Baseline at Week 24 (n=29, 29)
    1.73 ± 7.96
    0.86 ± 8.69
        Change from Baseline at Week 48 (n=18, 24)
    1.12 ± 7.80
    0.00 ± 10.24
        Change from Baseline at Week 72 (n=15, 23)
    2.34 ± 7.78
    2.18 ± 7.22
        Change from Baseline at Week 96 (n=16, 21)
    2.82 ± 11.72
    0.00 ± 9.38
        Change from Baseline at Week 120 (n=10, 20)
    1.51 ± 13.59
    0.25 ± 9.13
        Change from Baseline at Week 144 (n=9, 15)
    0.56 ± 9.85
    2.01 ± 7.29
        Change from Baseline at Week 168 (n=3, 9)
    1.67 ± 22.61
    0.00 ± 5.61
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    0.00 ± 0.00
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    -5.01 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
    End point description
    The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=42, 41)
    45.95 ± 9.14
    46.66 ± 9.65
        Change from Baseline at Week 24 (n=29, 29)
    2.66 ± 7.38
    1.74 ± 8.61
        Change from Baseline at Week 48 (n=18, 24)
    1.65 ± 5.60
    -0.25 ± 8.71
        Change from Baseline at Week 72 (n=15, 23)
    4.55 ± 6.91
    1.38 ± 9.12
        Change from Baseline at Week 96 (n=16, 21)
    4.08 ± 8.53
    2.41 ± 8.28
        Change from Baseline at Week 120 (n=10, 20)
    2.97 ± 5.24
    2.67 ± 8.45
        Change from Baseline at Week 144 (n=9, 15)
    3.96 ± 6.12
    4.16 ± 10.03
        Change from Baseline at Week 168 (n=3, 9)
    2.97 ± 2.97
    0.99 ± 10.82
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    7.43 ± 10.51
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    11.89 ± 9999
    No statistical analyses for this end point

    Secondary: Change from Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period

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    End point title
    Change from Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
    End point description
    The EQ-5D is a participant-answered questionnaire measuring 5 dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 possible response categories: 1) no problems; 2) some problems; 3) severe problems. The scores from 5 dimensions are used as input to generate EQ-5D index score using scoring algorithm. The EQ-5D index score is scored on a scale of -0.2 to 1. A higher score reflects a better health state. A positive change from baseline indicates an improvement. ITT population included all participants randomized to the treatment groups. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 216
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    40
    Units: score on scale
    arithmetic mean (standard deviation)
        Baseline (n=42, 40)
    0.7297 ± 0.1863
    0.7634 ± 0.1811
        Change from Baseline at Week 24 (n=29, 28)
    0.0649 ± 0.1596
    -0.0082 ± 0.1882
        Change from Baseline at Week 48 (n=18, 23)
    0.0352 ± 0.1830
    0.0011 ± 0.1256
        Change from Baseline at Week 72 (n=15, 22)
    0.0724 ± 0.2088
    0.0241 ± 0.1084
        Change from Baseline at Week 96 (n=16, 20)
    0.0349 ± 0.1758
    0.0167 ± 0.1056
        Change from Baseline at Week 120 (n=10, 19)
    0.0336 ± 0.2111
    0.0257 ± 0.1178
        Change from Baseline at Week 144 (n=9, 15)
    0.0846 ± 0.1650
    0.0488 ± 0.1424
        Change from Baseline at Week 168 (n=3, 9)
    0.0648 ± 0.1031
    0.0307 ± 0.1335
        Change from Baseline at Week 192 (n=0, 2)
    6666 ± 6666
    0.1873 ± 0.2890
        Change from Baseline at Week 216 (n=0, 1)
    6666 ± 6666
    0.3322 ± 9999
    No statistical analyses for this end point

    Secondary: Serum Satralizumab Concentration During the DB Period

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    End point title
    Serum Satralizumab Concentration During the DB Period [1]
    End point description
    The safety analysis population (SAF) included all randomized participants who had received at least 1 dose of satralizumab or placebo. 9999=SD was not calculable for 1 participant.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 5, 6, 8, and every 4 weeks thereafter up to Week 224
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint reports data only for the arm treated with satralizumab.
    End point values
    Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    41
    Units: ng/mL
    arithmetic mean (standard deviation)
        Baseline (n=40)
    100.00 ± 0.00
        Week 2 (n=41)
    11343.66 ± 5125.84
        Week 4 (n=38)
    22222.63 ± 8003.48
        Week 5 (n=20)
    28461.00 ± 12542.52
        Week 6 (n=20)
    28174.50 ± 11199.00
        Week 8 (n=39)
    21246.92 ± 9045.31
        Week 12 (n=38)
    20927.63 ± 9536.07
        Week 16 (n=35)
    20274.86 ± 10694.38
        Week 20 (n=33)
    20146.06 ± 10740.65
        Week 24 (n=30)
    20189.00 ± 10140.88
        Week 28 (n=28)
    20826.07 ± 10995.92
        Week 32 (n=28)
    20631.79 ± 11110.94
        Week 36 (n=26)
    21114.62 ± 11190.52
        Week 40 (n=25)
    22224.76 ± 13389.71
        Week 44 (n=23)
    22582.17 ± 12031.13
        Week 48 (n=25)
    23324.80 ± 13979.87
        Week 52 (n=24)
    24570.83 ± 15798.38
        Week 56 (n=24)
    24252.50 ± 15433.80
        Week 60 (n=24)
    23061.67 ± 15777.82
        Week 64 (n=22)
    23369.55 ± 13447.96
        Week 68 (n=23)
    26194.43 ± 16836.77
        Week 72 (n=23)
    26618.87 ± 14999.38
        Week 76 (n=22)
    26539.09 ± 13736.30
        Week 80 (n=21)
    26868.00 ± 14005.87
        Week 84 (n=21)
    27037.62 ± 15460.97
        Week 88 (n=20)
    26203.00 ± 14309.81
        Week 92 (n=21)
    28308.10 ± 15111.34
        Week 96 (n=21)
    26754.43 ± 15146.20
        Week 100 (n=21)
    27707.14 ± 14225.93
        Week 104 (n=21)
    26203.81 ± 13616.28
        Week 108 (n=21)
    26112.38 ± 12521.65
        Week 112 (n=21)
    24925.10 ± 12181.81
        Week 116 (n=20)
    26360.50 ± 13885.76
        Week 120 (n=20)
    24910.00 ± 13217.57
        Week 124 (n=20)
    24689.50 ± 14352.30
        Week 128 (n=19)
    22395.53 ± 12954.00
        Week 132 (n=19)
    23804.74 ± 14878.32
        Week 136 (n=19)
    25856.32 ± 15506.85
        Week 140 (n=18)
    26118.56 ± 15264.89
        Week 144 (n=15)
    27975.33 ± 11536.28
        Week 148 (n=12)
    27935.83 ± 11940.90
        Week 152 (n=10)
    28967.00 ± 10354.22
        Week 156 (n=9)
    27990.00 ± 10444.75
        Week 160 (n=9)
    28983.33 ± 11429.02
        Week 164 (n=9)
    28903.33 ± 10780.69
        Week 168 (n=9)
    23683.33 ± 11615.40
        Week 172 (n=9)
    24498.89 ± 11106.23
        Week 176 (n=9)
    26300.00 ± 11498.48
        Week 180 (n=6)
    28300.00 ± 9431.86
        Week 184 (n=5)
    32380.00 ± 9427.19
        Week 188 (n=3)
    36600.00 ± 8214.62
        Week 192 (n=2)
    32650.00 ± 7848.89
        Week 196 (n=2)
    30800.00 ± 4808.33
        Week 200 (n=2)
    28400.00 ± 3818.38
        Week 204 (n=2)
    25300.00 ± 3252.69
        Week 208 (n=1)
    25900.00 ± 9999
        Week 212 (n=1)
    17000.00 ± 9999
        Week 216 (n=1)
    28600.00 ± 9999
        Week 220 (n=1)
    31600.00 ± 9999
        Week 224 (n=1)
    28700.00 ± 9999
    No statistical analyses for this end point

    Secondary: Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period

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    End point title
    Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
    End point description
    The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 224
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: ng/mL
    arithmetic mean (standard deviation)
        Baseline (n=42, 40)
    32.52 ± 7.78
    35.13 ± 21.52
        Week 2 (n=41, 41)
    33.82 ± 8.30
    437.41 ± 72.31
        Week 4 (n=40, 41)
    33.13 ± 8.52
    572.29 ± 94.84
        Week 8 (n=37, 39)
    34.02 ± 9.43
    642.92 ± 115.51
        Week 12 (n=33, 39)
    32.58 ± 8.52
    651.41 ± 99.20
        Week 16 (n=32, 35)
    32.67 ± 9.32
    640.57 ± 97.41
        Week 20 (n=31, 33)
    34.22 ± 8.15
    636.64 ± 109.75
        Week 24 (n=30, 30)
    34.44 ± 9.31
    639.20 ± 108.94
        Week 28 (n=26, 28)
    33.70 ± 8.28
    649.11 ± 131.85
        Week 32 (n=24, 28)
    33.48 ± 8.74
    651.82 ± 162.04
        Week 36 (n=23, 26)
    34.39 ± 11.01
    652.12 ± 124.70
        Week 40 (n=19, 24)
    33.31 ± 7.86
    664.21 ± 158.61
        Week 44 (n=18, 23)
    33.94 ± 7.77
    677.13 ± 173.99
        Week 48 (n=18, 25)
    34.50 ± 9.14
    627.23 ± 217.06
        Week 52 (n=18, 24)
    44.01 ± 44.26
    656.29 ± 173.67
        Week 56 (n=18, 24)
    37.00 ± 7.42
    626.83 ± 155.56
        Week 60 (n=18, 24)
    36.39 ± 7.81
    617.00 ± 142.13
        Week 64 (n=17, 22)
    35.14 ± 8.78
    621.27 ± 152.45
        Week 68 (n=17, 23)
    35.35 ± 8.68
    664.91 ± 130.58
        Week 72 (n=15, 23)
    36.02 ± 10.73
    648.83 ± 134.32
        Week 76 (n=16, 22)
    36.94 ± 9.46
    643.91 ± 118.60
        Week 80 (n=16, 21)
    36.45 ± 9.50
    667.24 ± 133.49
        Week 84 (n=16, 21)
    34.60 ± 8.88
    649.38 ± 137.64
        Week 88 (n=13, 20)
    31.95 ± 8.29
    651.35 ± 150.58
        Week 92 (n=16, 21)
    34.30 ± 9.71
    633.43 ± 134.36
        Week 96 (n=16, 21)
    32.88 ± 9.39
    630.62 ± 162.28
        Week 100 (n=15, 21)
    33.78 ± 9.04
    651.90 ± 162.09
        Week 104 (n=14, 21)
    31.61 ± 9.13
    649.57 ± 185.99
        Week 108 (n=13, 21)
    31.49 ± 9.23
    658.67 ± 152.61
        Week 112 (n=12, 21)
    32.75 ± 7.77
    683.90 ± 135.07
        Week 116 (n=13, 20)
    33.68 ± 8.31
    653.98 ± 194.92
        Week 120 (n=12, 20)
    33.73 ± 6.20
    667.10 ± 152.24
        Week 124 (n=10, 20)
    33.06 ± 9.31
    696.45 ± 138.17
        Week 128 (n=10, 19)
    34.07 ± 8.83
    670.05 ± 138.28
        Week 132 (n=10, 19)
    34.28 ± 4.95
    671.84 ± 138.75
        Week 136 (n=10, 19)
    32.43 ± 8.12
    674.95 ± 170.04
        Week 140 (n=10, 18)
    32.97 ± 6.52
    645.72 ± 132.32
        Week 144 (n=9, 15)
    35.37 ± 8.91
    699.80 ± 101.84
        Week 148 (n=7, 12)
    37.97 ± 12.40
    672.42 ± 107.40
        Week 152 (n=5, 10)
    35.08 ± 9.08
    701.60 ± 110.27
        Week 156 (n=5, 9)
    36.92 ± 7.77
    720.33 ± 103.58
        Week 160 (n=4, 9)
    40.38 ± 7.31
    704.89 ± 109.86
        Week 164 (n=4, 9)
    43.08 ± 10.54
    723.67 ± 136.20
        Week 168 (n=3, 9)
    42.30 ± 5.92
    744.22 ± 123.47
        Week 172 (n=3, 9)
    42.03 ± 5.87
    706.33 ± 127.63
        Week 176 (n=2, 9)
    39.85 ± 6.15
    730.56 ± 121.75
        Week 180 (n=2, 6)
    38.85 ± 12.09
    769.83 ± 119.50
        Week 184 (n=0, 5)
    6666 ± 6666
    736.80 ± 152.09
        Week 188 (n=0, 3)
    6666 ± 6666
    853.67 ± 38.02
        Week 192 (n=0, 2)
    6666 ± 6666
    930.00 ± 49.50
        Week 196 (n=0, 2)
    6666 ± 6666
    887.00 ± 91.92
        Week 200 (n=0, 2)
    6666 ± 6666
    902.50 ± 79.90
        Week 204 (n=0, 2)
    6666 ± 6666
    935.00 ± 7.07
        Week 208 (n=0, 1)
    6666 ± 6666
    941.00 ± 9999
        Week 212 (n=0, 1)
    6666 ± 6666
    971.00 ± 9999
        Week 216 (n=0, 1)
    6666 ± 6666
    896.00 ± 9999
        Week 220 (n=0, 1)
    6666 ± 6666
    901.00 ± 9999
        Week 224 (n=0, 1)
    6666 ± 6666
    831.00 ± 9999
    No statistical analyses for this end point

    Secondary: Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period

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    End point title
    Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
    End point description
    The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 224
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline (n=42, 41)
    1.48 ± 2.08
    1.68 ± 2.49
        Week 2 (n=41, 40)
    1.65 ± 2.86
    0.78 ± 2.93
        Week 4 (n=40, 41)
    1.59 ± 2.27
    0.44 ± 0.72
        Week 8 (n=37, 39)
    1.76 ± 2.25
    0.59 ± 1.26
        Week 12 (n=33, 38)
    1.48 ± 2.07
    0.47 ± 0.60
        Week 16 (n=32, 35)
    1.91 ± 3.34
    0.49 ± 0.51
        Week 20 (n=31, 33)
    1.91 ± 3.44
    0.48 ± 0.50
        Week 24 (n=30, 30)
    2.45 ± 6.87
    0.58 ± 0.91
        Week 28 (n=26, 28)
    1.96 ± 3.24
    0.73 ± 1.34
        Week 32 (n=24, 28)
    2.36 ± 4.96
    0.73 ± 1.21
        Week 36 (n=23, 26)
    2.48 ± 3.59
    0.56 ± 0.66
        Week 40 (n=19, 25)
    2.49 ± 4.53
    1.13 ± 2.26
        Week 44 (n=18, 23)
    1.41 ± 1.47
    0.72 ± 1.20
        Week 48 (n=18, 25)
    1.59 ± 2.07
    0.86 ± 1.44
        Week 52 (n=18, 24)
    2.60 ± 3.87
    0.67 ± 0.88
        Week 56 (n=18, 23)
    1.43 ± 1.58
    0.72 ± 1.02
        Week 60 (n=18, 24)
    2.63 ± 4.34
    1.05 ± 2.15
        Week 64 (n=17, 22)
    11.10 ± 40.09
    0.64 ± 0.89
        Week 68 (n=17, 23)
    1.86 ± 2.66
    0.57 ± 0.47
        Week 72 (n=15, 23)
    3.80 ± 8.83
    0.59 ± 0.71
        Week 76 (n=15, 22)
    5.24 ± 10.68
    0.51 ± 0.37
        Week 80 (n=16, 21)
    2.11 ± 2.63
    0.58 ± 0.51
        Week 84 (n=16, 21)
    2.08 ± 2.26
    0.59 ± 0.61
        Week 88 (n=14, 20)
    5.19 ± 12.83
    0.60 ± 0.53
        Week 92 (n=16, 21)
    2.07 ± 2.21
    0.60 ± 0.70
        Week 96 (n=16, 20)
    2.92 ± 4.60
    0.74 ± 1.01
        Week 100 (n=15, 21)
    2.58 ± 4.53
    0.87 ± 1.49
        Week 104 (n=14, 21)
    1.41 ± 2.05
    0.84 ± 1.40
        Week 108 (n=13, 21)
    1.93 ± 2.25
    0.66 ± 0.58
        Week 112 (n=12, 21)
    1.54 ± 1.56
    0.82 ± 0.87
        Week 116 (n=13, 20)
    2.39 ± 3.91
    0.84 ± 1.26
        Week 120 (n=12, 20)
    1.53 ± 1.33
    0.98 ± 1.58
        Week 124 (n=10, 20)
    1.43 ± 1.43
    0.72 ± 0.67
        Week 128 (n=10, 19)
    6.00 ± 16.28
    0.96 ± 1.29
        Week 132 (n=10, 19)
    1.08 ± 0.94
    0.70 ± 0.84
        Week 136 (n=10, 19)
    1.43 ± 1.54
    0.99 ± 1.68
        Week 140 (n=10, 18)
    1.15 ± 1.28
    1.06 ± 2.25
        Week 144 (n=9, 15)
    0.82 ± 0.73
    0.44 ± 0.37
        Week 148 (n=7, 12)
    1.29 ± 1.43
    0.35 ± 0.18
        Week 152 (n=5, 10)
    1.08 ± 0.97
    0.38 ± 0.23
        Week 156 (n=5, 9)
    1.52 ± 1.42
    0.35 ± 0.18
        Week 160 (n=4, 9)
    0.83 ± 0.53
    0.37 ± 0.22
        Week 164 (n=4, 9)
    3.18 ± 4.89
    0.38 ± 0.20
        Week 168 (n=3, 9)
    0.80 ± 0.26
    0.40 ± 0.19
        Week 172 (n=3, 8)
    1.37 ± 1.00
    0.26 ± 0.17
        Week 176 (n=2, 8)
    0.95 ± 0.64
    0.31 ± 0.19
        Week 180 (n=2, 6)
    30.15 ± 41.65
    0.28 ± 0.15
        Week 184 (n=0, 5)
    6666 ± 6666
    0.20 ± 0.11
        Week 188 (n=0, 3)
    6666 ± 6666
    0.37 ± 0.06
        Week 192 (n=0, 2)
    6666 ± 6666
    0.15 ± 0.00
        Week 196 (n=0, 2)
    6666 ± 6666
    0.23 ± 0.11
        Week 200 (n=0, 2)
    6666 ± 6666
    0.23 ± 0.11
        Week 204 (n=0, 2)
    6666 ± 6666
    0.23 ± 0.11
        Week 208 (n=0, 1)
    6666 ± 6666
    0.30 ± 9999
        Week 212 (n=0, 1)
    6666 ± 6666
    0.40 ± 9999
        Week 216 (n=0, 1)
    6666 ± 6666
    0.30 ± 9999
        Week 220 (n=0, 1)
    6666 ± 6666
    0.40 ± 9999
        Week 224 (n=0, 1)
    6666 ± 6666
    0.15 ± 9999
    No statistical analyses for this end point

    Secondary: Serum Interleukin-6 (IL-6) Concentration During the DB Period

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    End point title
    Serum Interleukin-6 (IL-6) Concentration During the DB Period
    End point description
    The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. 9999=SD was not calculable for 1 participant. 6666=0 participants.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 224
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: pg/mL
    arithmetic mean (standard deviation)
        Baseline (n=42, 40)
    1.63 ± 0.39
    1.92 ± 1.36
        Week 2 (n=41, 41)
    1.84 ± 0.95
    40.12 ± 118.83
        Week 4 (n=40, 41)
    2.33 ± 2.99
    28.30 ± 31.31
        Week 8 (n=37, 38)
    1.69 ± 0.55
    32.37 ± 77.99
        Week 12 (n=33, 39)
    1.71 ± 0.60
    22.95 ± 20.55
        Week 16 (n=32, 35)
    1.84 ± 0.90
    25.76 ± 30.85
        Week 20 (n=31, 33)
    2.99 ± 5.45
    23.07 ± 15.37
        Week 24 (n=30, 29)
    2.02 ± 1.52
    21.53 ± 17.91
        Week 28 (n=26, 28)
    1.95 ± 1.38
    25.14 ± 24.27
        Week 32 (n=24, 28)
    1.74 ± 0.84
    23.77 ± 18.53
        Week 36 (n=23, 26)
    2.13 ± 1.41
    23.08 ± 15.56
        Week 40 (n=19, 24)
    1.66 ± 0.40
    27.31 ± 47.45
        Week 44 (n=17, 21)
    1.57 ± 0.00
    17.01 ± 15.38
        Week 48 (n=18, 25)
    1.69 ± 0.53
    19.45 ± 19.36
        Week 52 (n=18, 24)
    2.12 ± 1.36
    21.11 ± 17.42
        Week 56 (n=18, 22)
    1.57 ± 0.00
    21.74 ± 20.96
        Week 60 (n=18, 23)
    2.27 ± 1.46
    23.25 ± 23.36
        Week 64 (n=17, 22)
    2.46 ± 3.22
    24.31 ± 20.74
        Week 68 (n=17, 23)
    1.94 ± 1.14
    31.30 ± 53.79
        Week 72 (n=15, 23)
    1.93 ± 0.97
    24.69 ± 24.45
        Week 76 (n=16, 21)
    2.21 ± 1.87
    20.45 ± 13.79
        Week 80 (n=16, 21)
    2.19 ± 2.51
    23.29 ± 19.64
        Week 84 (n=16, 21)
    2.66 ± 2.36
    22.71 ± 21.49
        Week 88 (n=12, 20)
    2.59 ± 2.77
    29.17 ± 25.58
        Week 92 (n=16, 20)
    1.84 ± 0.77
    24.51 ± 32.02
        Week 96 (n=16, 21)
    3.06 ± 3.19
    21.52 ± 20.20
        Week 100 (n=15, 21)
    2.04 ± 1.02
    21.77 ± 24.98
        Week 104 (n=13, 21)
    1.95 ± 0.96
    22.61 ± 26.55
        Week 108 (n=13, 21)
    1.76 ± 0.70
    24.18 ± 20.55
        Week 112 (n=12, 21)
    1.57 ± 0.00
    32.18 ± 36.15
        Week 116 (n=13, 20)
    1.57 ± 0.00
    22.33 ± 22.20
        Week 120 (n=12, 20)
    1.71 ± 0.52
    21.86 ± 24.54
        Week 124 (n=9, 19)
    1.57 ± 0.00
    26.23 ± 27.67
        Week 128 (n=10, 19)
    1.57 ± 0.00
    25.40 ± 31.20
        Week 132 (n=10, 19)
    1.57 ± 0.00
    25.48 ± 27.38
        Week 136 (n=10, 19)
    1.57 ± 0.00
    27.23 ± 37.56
        Week 140 (n=10, 18)
    1.57 ± 0.00
    20.66 ± 18.10
        Week 144 (n=9, 15)
    1.57 ± 0.00
    16.82 ± 16.16
        Week 148 (n=7, 12)
    2.04 ± 1.25
    17.10 ± 11.33
        Week 152 (n=5, 10)
    1.57 ± 0.00
    16.62 ± 13.75
        Week 156 (n=5, 8)
    2.34 ± 1.72
    12.67 ± 5.73
        Week 160 (n=4, 9)
    1.96 ± 0.80
    11.15 ± 5.12
        Week 164 (n=4, 9)
    1.57 ± 0.00
    12.84 ± 6.93
        Week 168 (n=3, 9)
    1.57 ± 0.00
    13.30 ± 8.89
        Week 172 (n=3, 9)
    1.57 ± 0.00
    13.89 ± 6.94
        Week 176 (n=2, 9)
    1.57 ± 0.00
    15.11 ± 7.16
        Week 180 (n=2, 6)
    1.57 ± 0.00
    13.34 ± 6.68
        Week 184 (n=0, 5)
    6666 ± 6666
    15.24 ± 9.91
        Week 188 (n=0, 3)
    6666 ± 6666
    13.96 ± 9.74
        Week 192 (n=0, 2)
    6666 ± 6666
    16.71 ± 13.15
        Week 196 (n=0, 2)
    6666 ± 6666
    14.34 ± 12.81
        Week 200 (n=0, 2)
    6666 ± 6666
    18.55 ± 8.84
        Week 204 (n=0, 2)
    6666 ± 6666
    18.24 ± 12.53
        Week 208 (n=0, 1)
    6666 ± 6666
    9.95 ± 9999
        Week 212 (n=0, 1)
    6666 ± 6666
    8.02 ± 9999
        Week 216 (n=0, 1)
    6666 ± 6666
    6.45 ± 9999
        Week 220 (n=0, 1)
    6666 ± 6666
    45.80 ± 9999
        Week 224 (n=0, 1)
    6666 ± 6666
    34.30 ± 9999
    No statistical analyses for this end point

    Secondary: Number of Participants with at Least One Adverse Event in the DB Period

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    End point title
    Number of Participants with at Least One Adverse Event in the DB Period
    End point description
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
    End point type
    Secondary
    End point timeframe
    Up to Week 224
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: participants
    40
    37
    No statistical analyses for this end point

    Secondary: Number of Participants with at Least One Serious Adverse Event in the DB Period

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    End point title
    Number of Participants with at Least One Serious Adverse Event in the DB Period
    End point description
    A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above. The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
    End point type
    Secondary
    End point timeframe
    Up to Week 224
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: participants
    9
    7
    No statistical analyses for this end point

    Secondary: Number of Participants with Non-Serious Adverse Events of Special Interest in the DB Period

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    End point title
    Number of Participants with Non-Serious Adverse Events of Special Interest in the DB Period
    End point description
    Non-serious adverse events of special interest for this study included: 1) cases of an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, 2) suspected transmission of an infectious agent by the study treatment. The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
    End point type
    Secondary
    End point timeframe
    Up to Week 224
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: participants
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Selected Adverse Events in the DB Period

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    End point title
    Number of Participants with Selected Adverse Events in the DB Period
    End point description
    Selected adverse events for this study included: 1) non-serious infections that required treatments with intravenous (IV) antibiotic, antifungal, antiviral, 2) opportunistic infections that required treatments with oral antibiotics, antifungals, or antivirals, 3) injection-related reactions (IRRs; an AE which occured within 24 hours after study treatment injection except where the event was not considered an allergic reaction), and 4) anaphylaxis (an acute allergic/hypersensitivity reaction). The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
    End point type
    Secondary
    End point timeframe
    Up to Week 224
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    42
    41
    Units: participants
        Non serious Infections requiring IV treatment
    4
    1
        Potential Opportunistic Infections
    5
    4
        Injection Related Reactions
    2
    5
        Anaphylaxis
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period

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    End point title
    Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period
    End point description
    The Columbia-Suicide Severity Rating Scale (C-SSRS) is an assessment tool to evaluate suicidal ideation and behavior. Categories have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a "yes" answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present. A score of 1 or higher indicates suicidal ideation or behavior. The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
    End point type
    Secondary
    End point timeframe
    Baseline and Post-Baseline (up to Week 224)
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    41
    41
    Units: participants
        Baseline (n=41, 40)
    5
    12
        Post-Baseline (n=41, 41)
    2
    3
    No statistical analyses for this end point

    Secondary: Blood Anti-Aquaporin-4 (AQP4) Antibody Concentration Over Time

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    End point title
    Blood Anti-Aquaporin-4 (AQP4) Antibody Concentration Over Time
    End point description
    Drift in the anti-AQP4 antibody titer cell-based assay over time confounded longitudinal assessment of anti-AQP4 antibody titers and therefore these results cannot be reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 24, 48, and every 24 weeks thereafter of double-blind period; every 24 weeks for first 48 weeks of open-label extension period (up to approximately 7 years)
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Units/mL
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [2] - Longitudinal assessments of anti-AQP4 Ab titers were confounded and data are therefore not reported.
    [3] - Longitudinal assessments of anti-AQP4 Ab titers were confounded and data are therefore not reported.
    No statistical analyses for this end point

    Secondary: Percentage of Blood Plasmablast Over Time

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    End point title
    Percentage of Blood Plasmablast Over Time
    End point description
    The plasmablast assay lacked the sensitivity required to measure plasmablast levels at baseline in the majority of participants. Since most participants had plasmablast values below lower limit of quantitation (LLOQ) at baseline, longitudinal assessments could not be performed and therefore plasmablast results are not reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 24, 48 and every 24 weeks thereafter of double-blind period (up to approximately 30 months)
    End point values
    Placebo + Baseline Treatment, then Satralizumab Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: percentage of plasmablasts
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [4] - Due to lack of sensitivity of the plasmablast assay results are not reported.
    [5] - Due to lack of sensitivity of the plasmablast assay results are not reported.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti-Drug Antibodies to Satralizumab in the DB Period

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    End point title
    Percentage of Participants with Anti-Drug Antibodies to Satralizumab in the DB Period [6]
    End point description
    Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during the DB period. The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
    End point type
    Secondary
    End point timeframe
    Up to approximately Week 224
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint reports data only for the arm treated with satralizumab.
    End point values
    Satralizumab + Baseline Treatment, then Satralizumab
    Number of subjects analysed
    41
    Units: percentage
        number (not applicable)
    41.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to clinical cut-off date, 06 June 2018 (up to approximately 224 weeks).
    Adverse event reporting additional description
    The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo + Baseline Treatment, DB Period
    Reporting group description
    Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment.

    Reporting group title
    Placebo, then Satralizumab, OLE Period
    Reporting group description
    Following placebo treatment in the DB period participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD).

    Reporting group title
    Satralizumab, then Satralizumab, OLE Period
    Reporting group description
    Following satralizumab treatment in the DB period participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD.

    Reporting group title
    Satralizumab + Baseline Treatment, DB Period
    Reporting group description
    Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment.

    Serious adverse events
    Placebo + Baseline Treatment, DB Period Placebo, then Satralizumab, OLE Period Satralizumab, then Satralizumab, OLE Period Satralizumab + Baseline Treatment, DB Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 42 (21.43%)
    6 / 24 (25.00%)
    5 / 18 (27.78%)
    7 / 41 (17.07%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia macrocytic
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune thrombocytopenia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphopenia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal vein thrombosis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Gait disturbance
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis infectious
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo + Baseline Treatment, DB Period Placebo, then Satralizumab, OLE Period Satralizumab, then Satralizumab, OLE Period Satralizumab + Baseline Treatment, DB Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 42 (85.71%)
    23 / 24 (95.83%)
    16 / 18 (88.89%)
    33 / 41 (80.49%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    2 / 18 (11.11%)
    1 / 41 (2.44%)
         occurrences all number
    0
    2
    2
    1
    Hypertension
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    2 / 18 (11.11%)
    3 / 41 (7.32%)
         occurrences all number
    0
    2
    4
    4
    Hypotension
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    2
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 24 (12.50%)
    1 / 18 (5.56%)
    2 / 41 (4.88%)
         occurrences all number
    1
    3
    1
    2
    Pyrexia
         subjects affected / exposed
    5 / 42 (11.90%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    7
    1
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    2 / 18 (11.11%)
    2 / 41 (4.88%)
         occurrences all number
    0
    0
    2
    2
    Chills
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Feeling hot
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Feeling abnormal
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Malaise
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    2 / 18 (11.11%)
    2 / 41 (4.88%)
         occurrences all number
    1
    1
    3
    2
    Depression
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    1
    0
    1
    1
    Panic disorder
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    2 / 18 (11.11%)
    1 / 41 (2.44%)
         occurrences all number
    0
    2
    2
    1
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Ligament sprain
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 24 (12.50%)
    0 / 18 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    1
    3
    0
    1
    Thermal burn
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 24 (4.17%)
    2 / 18 (11.11%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    2
    1
    Compression fracture
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    2 / 41 (4.88%)
         occurrences all number
    0
    0
    1
    2
    Arthropod sting
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Contusion
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Excoriation
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Joint injury
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Lower limb fracture
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Pelvic fracture
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Wound
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 24 (8.33%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    1
    2
    2
    2
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 24 (8.33%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    4
    3
    1
    1
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 24 (8.33%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    2
    2
    1
    1
    Serum ferritin decreased
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    1
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 24 (8.33%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    2
    2
    1
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 24 (4.17%)
    2 / 18 (11.11%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    2
    1
    Blood fibrinogen decreased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    2 / 18 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Blood fibrinogen increased
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood urine
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Complement factor decreased
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    2 / 18 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Low density lipoprotein increased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    2 / 41 (4.88%)
         occurrences all number
    0
    0
    1
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2
    0
    2
    Platelet count decreased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Protein urine present
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urobilinogen urine increased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Weight decreased
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    1
    1
    Weight increased
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    1
    1
    White blood cell count decreased
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    2
    0
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Bradycardia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    1
    1
    Palpitations
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Congenital, familial and genetic disorders
    Left ventricle outflow tract obstruction
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 24 (8.33%)
    1 / 18 (5.56%)
    3 / 41 (7.32%)
         occurrences all number
    1
    2
    1
    4
    Epistaxis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    2 / 41 (4.88%)
         occurrences all number
    0
    0
    1
    2
    Rhinorrhoea
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    1
    0
    2
    1
    Pharyngeal erythema
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 42 (11.90%)
    3 / 24 (12.50%)
    5 / 18 (27.78%)
    3 / 41 (7.32%)
         occurrences all number
    8
    3
    6
    3
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    2 / 41 (4.88%)
         occurrences all number
    1
    1
    1
    3
    Leukopenia
         subjects affected / exposed
    4 / 42 (9.52%)
    5 / 24 (20.83%)
    3 / 18 (16.67%)
    6 / 41 (14.63%)
         occurrences all number
    12
    5
    8
    10
    Lymphopenia
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 24 (4.17%)
    3 / 18 (16.67%)
    3 / 41 (7.32%)
         occurrences all number
    9
    1
    9
    7
    Neutropenia
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    2 / 41 (4.88%)
         occurrences all number
    3
    1
    2
    3
    Hypofibrinogenaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Polycythaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 24 (12.50%)
    0 / 18 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    1
    3
    0
    3
    Headache
         subjects affected / exposed
    4 / 42 (9.52%)
    4 / 24 (16.67%)
    7 / 18 (38.89%)
    10 / 41 (24.39%)
         occurrences all number
    6
    5
    11
    28
    Hypoaesthesia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Epilepsy
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Intercostal neuralgia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    1
    0
    1
    1
    Muscle spasticity
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    2 / 18 (11.11%)
    1 / 41 (2.44%)
         occurrences all number
    0
    4
    2
    1
    Blepharitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blepharospasm
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cataract
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    1
    1
    Conjunctival deposit
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    2 / 18 (11.11%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Dry eye
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    1
    1
    Eye pruritus
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Glaucoma
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    2 / 18 (11.11%)
    2 / 41 (4.88%)
         occurrences all number
    1
    1
    5
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 24 (12.50%)
    0 / 18 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    1
    3
    0
    1
    Constipation
         subjects affected / exposed
    7 / 42 (16.67%)
    4 / 24 (16.67%)
    1 / 18 (5.56%)
    2 / 41 (4.88%)
         occurrences all number
    8
    7
    2
    2
    Dental caries
         subjects affected / exposed
    2 / 42 (4.76%)
    4 / 24 (16.67%)
    1 / 18 (5.56%)
    2 / 41 (4.88%)
         occurrences all number
    2
    5
    1
    2
    Diarrhoea
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 24 (8.33%)
    3 / 18 (16.67%)
    1 / 41 (2.44%)
         occurrences all number
    3
    2
    4
    3
    Gastritis
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    2 / 18 (11.11%)
    4 / 41 (9.76%)
         occurrences all number
    0
    2
    2
    4
    Nausea
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 24 (4.17%)
    2 / 18 (11.11%)
    3 / 41 (7.32%)
         occurrences all number
    3
    1
    2
    3
    Toothache
         subjects affected / exposed
    1 / 42 (2.38%)
    4 / 24 (16.67%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    5
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2
    0
    2
    Dyspepsia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Large intestine polyp
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Pancreatitis acute
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Plicated tongue
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    2
    0
    2
    2
    Hepatic function abnormal
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    3
    3
    0
    2
    Haematuria
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Nephrolithiasis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 24 (12.50%)
    0 / 18 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    1
    3
    0
    2
    Urticaria
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    2
    0
    3
    Acne
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    1
    1
    Alopecia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    2 / 18 (11.11%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    2
    1
    Rash
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    2
    1
    3
    0
    Erythema
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    1
    1
    Rash pruritic
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    4 / 41 (9.76%)
         occurrences all number
    0
    1
    1
    4
    Back pain
         subjects affected / exposed
    5 / 42 (11.90%)
    2 / 24 (8.33%)
    3 / 18 (16.67%)
    4 / 41 (9.76%)
         occurrences all number
    9
    2
    3
    4
    Myalgia
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 24 (12.50%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    2
    4
    6
    5
    Pain in extremity
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    3
    0
    0
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Myopathy toxic
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    1
    0
    1
    1
    Neck pain
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Spinal pain
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    2 / 41 (4.88%)
         occurrences all number
    1
    0
    1
    2
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    1
    2
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    5 / 42 (11.90%)
    3 / 24 (12.50%)
    1 / 18 (5.56%)
    4 / 41 (9.76%)
         occurrences all number
    5
    4
    7
    10
    Hyperlipidaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    2 / 18 (11.11%)
    2 / 41 (4.88%)
         occurrences all number
    0
    0
    2
    2
    Dehydration
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Iron deficiency
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    2 / 41 (4.88%)
         occurrences all number
    0
    0
    1
    3
    Infections and infestations
    Cystitis
         subjects affected / exposed
    4 / 42 (9.52%)
    2 / 24 (8.33%)
    4 / 18 (22.22%)
    3 / 41 (7.32%)
         occurrences all number
    6
    2
    5
    4
    Herpes zoster
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    1
    2
    0
    2
    Influenza
         subjects affected / exposed
    4 / 42 (9.52%)
    2 / 24 (8.33%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    5
    3
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    7 / 42 (16.67%)
    10 / 24 (41.67%)
    2 / 18 (11.11%)
    10 / 41 (24.39%)
         occurrences all number
    13
    35
    5
    22
    Oral herpes
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 24 (8.33%)
    1 / 18 (5.56%)
    2 / 41 (4.88%)
         occurrences all number
    19
    3
    3
    6
    Pharyngitis
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    4 / 41 (9.76%)
         occurrences all number
    10
    0
    1
    6
    Rhinitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    0
    0
    4
    Sinusitis
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    1 / 18 (5.56%)
    3 / 41 (7.32%)
         occurrences all number
    0
    2
    1
    4
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 42 (14.29%)
    6 / 24 (25.00%)
    5 / 18 (27.78%)
    10 / 41 (24.39%)
         occurrences all number
    11
    7
    18
    26
    Urinary tract infection
         subjects affected / exposed
    7 / 42 (16.67%)
    7 / 24 (29.17%)
    2 / 18 (11.11%)
    6 / 41 (14.63%)
         occurrences all number
    7
    11
    11
    8
    Bacteriuria
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hordeolum
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Onychomycosis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Otitis externa
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Periodontitis
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 24 (8.33%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    0
    5
    1
    1
    Pneumonia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyelonephritis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
    0 / 41 (0.00%)
         occurrences all number
    2
    3
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
    1 / 41 (2.44%)
         occurrences all number
    2
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Nov 2013
    Definition of NMOSD was changed. The population was limited to optic neuritis or transverse myelitis with seropositivity in anti-AQP4 antibody. Adolescent subjects aged 1217 years were allowed to enter the study. Considering the impact of previous treatment on safety and efficacy, the treatment prohibited duration was modified. Methods and duration of contraception were added to exclusion criteria. Because patients with NMO/NMOSD tend to show lower white blood cell value due to baseline treatment with immunosuppressant drugs, the white blood cell exclusion criterion was modified. The protocol v2 was released prior to any patients being enrolled in the study.
    27 Feb 2014
    Suicidality assessment (C-SSRS) was added as a safety objective per Food and Drug Administration (FDA) request. Based on epidemiologic data, the percentage of patients with negative anti-AQP4 serostatus at screening was capped at 30% in order to reflect the real world population. Further clarifications on the process of screening for potential clinical relapses were added. The roles and responsibilities of the treating and assessing investigator were introduced and the blinding of study and site personnel to certain laboratory parameters were clarified.
    18 Dec 2014
    The criteria for protocol-defined relapse (PDR) were aligned with another pivotal Phase III study in patients with NMO/NMOSD (study BN40900 / SA309JG/ EudraCT ID 2015-005431-41), which was modified based on FDA's comment. According to the Paediatric Committee’s (PDCO’s) request at least 8 adolescents were to be enrolled. Combination baseline treatment for adolescents was allowed given the low prevalence of pediatric patients and their treatment situation. Additional follow up assessments for adolescents were added. A blood sample collected before screening was accepted for anti-AQP4 antibody screening assessment in case the blood sample at screening was negative for anti-AQP4 antibody, considering the possibility that anti-AQP4 antibody status may change from positive to negative due to treatment for relapse. Permitted relapse treatments and prohibited treatments were modified considering clinical practice. Time limit of relapse evaluation to be recognized as PDR was aligned to another pivotal Phase III study in participants with NMO/NMOSD (study BN40900/SA-309JG// EudraCT ID 2015-005431-41) to avoid incomplete or biased reporting, and relapse assessment procedures were clarified. To avoid missing potential relapses, additional phone calls between visits and instructions to remind participants of possible relapse symptoms were added. The conditions when a participant could move from the double blind (DB) period to the open-label extension (OLE) period were clarified.
    03 Jun 2015
    Considering the clinical situation where no drugs have been approved for treatment of NMO and NMOSD, the open-label extension period was extended from an ethical point of view. This change was also in alignment with the agreed pediatric investigation plan (PIP). Inclusion of adolescents with negative anti-AQP4 serostatus at screening was allowed.
    19 Oct 2015
    Clarification that the population which was capped by anti-AQP4 antibody status at screening was limited only to adults.
    14 Dec 2016
    Addition that adolescents may be enrolled into the OLE period after the total number of PDRs confirmed by the clinical endpoint committee (CEC) reached 26. The minimum number of adolescents (12 to 17 years old) with positive anti- AQP4 serostatus at screening was changed from 6 to 4. The use of satralizumab prefilled syringe (PFS) with needle safety device (NSD) were implemented to be used in the OLE period after the total number of CEC confirmed PDRs reached 26.
    17 Apr 2017
    The description on the timing of satralizumab PFS with NSD implementation was modified so that satralizumab PFS with NSD could be administered for participants who had already entered into open-label extension period after availability at each study site. The reporting procedure when the medical device (satralizumab PFS with NSD) resulted in an adverse event (AE) to an individual other than the study participant was clarified.

    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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