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    Clinical Trial Results:
    A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus

    Summary
    EudraCT number
    		 2010-024069-30
    Trial protocol
    		 NL   GB   HU   ES   DE   IT   BG  
    Global end of trial date
    17 Apr 2014

    Results information
    Results version number
    		 v1
    This version publication date
    02 May 2016
    First version publication date
    12 Aug 2015
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CD-IA-MEDI-545-1067
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01283139
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    SE-151 85, Södertälje, Sweden,
    Public contact
    Gabor Illei, MD, Senior Director,Clinical development, AstraZeneca AB, IlleiG@Medimmune.com
    Scientific contact
    Gabor Illei, MD, Senior Director,Clinical development, AstraZeneca AB, IlleiG@Medimmune.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Apr 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of sifalimumab compared to placebo in participants with chronic, moderately-to-severely active Systemic Lupus Erythematosus (SLE) with an inadequate response to standard of care (SOC) for SLE on Day 365 (Week 52).
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Participating participant signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 20
    Country: Number of subjects enrolled
    Brazil: 45
    Country: Number of subjects enrolled
    Bulgaria: 16
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Chile: 16
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 24
    Country: Number of subjects enrolled
    Hungary: 20
    Country: Number of subjects enrolled
    India: 6
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Mexico: 34
    Country: Number of subjects enrolled
    Peru: 34
    Country: Number of subjects enrolled
    Philippines: 45
    Country: Number of subjects enrolled
    Poland: 29
    Country: Number of subjects enrolled
    Romania: 19
    Country: Number of subjects enrolled
    South Africa: 20
    Country: Number of subjects enrolled
    Spain: 28
    Country: Number of subjects enrolled
    Thailand: 12
    Country: Number of subjects enrolled
    United Kingdom: 13
    Country: Number of subjects enrolled
    United States: 38
    Worldwide total number of subjects
    432
    EEA total number of subjects
    161
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    423
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 834 participants were screened out of which 402 participants did not meet eligibility criteria and were considered screen failures, and 432 participants were randomized into the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.

    Arm title
    		 Sifalimumab 200 milligram (mg)
    Arm description
    		 Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sifalimumab 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.

    Arm title
    		 Sifalimumab 600 mg
    Arm description
    		 Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sifalimumab 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.

    Arm title
    		 Sifalimumab 1,200 mg
    Arm description
    		 Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sifalimumab 1,200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.

    Number of subjects in period 1
    		Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
    Started
    108
    108
    109
    107
    Completed
    91
    90
    91
    92
    Not completed
    17
    18
    18
    15
         Adverse event, serious fatal
    2
    -
    2
    2
         Consent withdrawn by subject
    8
    8
    6
    8
         Pregnancy
    -
    1
    1
    -
         Missed follow-up visit
    -
    1
    2
    2
         Participant randomized in error
    -
    -
    1
    -
         Early termination due to AE/SAE
    1
    1
    -
    -
         Lost to follow-up
    5
    2
    3
    1
         Lack of efficacy
    1
    2
    2
    1
         Participant's refusal to continue
    -
    3
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.

    Reporting group title
    Sifalimumab 200 milligram (mg)
    Reporting group description
    		 Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.

    Reporting group title
    Sifalimumab 600 mg
    Reporting group description
    		 Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.

    Reporting group title
    Sifalimumab 1,200 mg
    Reporting group description
    		 Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.

    Reporting group values
    		 Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg Total
    Number of subjects
    		 108 108 109 107 432
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 38.4 ( 12.3 ) 39.9 ( 11.4 ) 40.1 ( 11.3 ) 39.4 ( 12.1 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 101 103 98 97 399
        Male
    		 7 5 11 10 33

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.

    Reporting group title
    Sifalimumab 200 milligram (mg)
    Reporting group description
    		 Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.

    Reporting group title
    Sifalimumab 600 mg
    Reporting group description
    		 Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.

    Reporting group title
    Sifalimumab 1,200 mg
    Reporting group description
    		 Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.

    Subject analysis set title
    Modified Intent-to-treat (mITT) Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all participants who received any investigational product.

    Primary: Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4])

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    End point title
    		 Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4])
    End point description
    SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points (with increased deoxyribonucleic acid [DNA] binding item of SLEDAI-2K score based on the ANA Multi−Lyte® ANA−II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new ‘A’ score or 2 new ‘B’ scores on the BILAG-2004 compared with baseline). The modified intent-to-treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement.
    End point type
    Primary
    End point timeframe
    Day 365
    End point values
    		 Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
    Number of subjects analysed
    108
    108
    108
    107
    Units: percentage of participants
        number (not applicable)
    45.4
    58.3
    56.5
    59.8
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v Sifalimumab 200 milligram (mg)
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.057
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.71
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 2.71
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v Sifalimumab 1,200 mg
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.031
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.84
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.16
         upper limit
    		 2.94
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v Sifalimumab 600 mg
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.094
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 2.54

    Primary: Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants

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    End point title
    		 Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants
    End point description
    SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of >=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi−Lyte® ANA−II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new ‘A’ score or 2 new ‘B’ scores on the BILAG-2004 compared with baseline). The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement.
    End point type
    Primary
    End point timeframe
    Day 365
    End point values
    		 Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
    Number of subjects analysed
    88
    87
    88
    87
    Units: percentage of participants
        number (not applicable)
    42
    57.5
    50
    57.5
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v Sifalimumab 200 milligram (mg)
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.042
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.88
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 3.14
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v Sifalimumab 600 mg
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.264
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.41
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 2.35
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v Sifalimumab 1,200 mg
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.038
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.91
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.14
         upper limit
    		 3.19

    Secondary: Percentage of Participants on Greater Than or Equal to 10 mg/day Oral Prednisone (or Equivalent) at Baseline who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/day

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    End point title
    		 Percentage of Participants on Greater Than or Equal to 10 mg/day Oral Prednisone (or Equivalent) at Baseline who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/day
    End point description
    Percentage of participants on >=10 mg/day oral corticosteroids (OCS) at baseline who were able to taper it to <=7.5 mg/day by Day 365 were recorded. The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies number of participants analyzed on >=10 mg/day oral prednisone (or equivalent) at baseline.
    End point type
    Secondary
    End point timeframe
    Day 365
    End point values
    		 Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
    Number of subjects analysed
    62
    61
    53
    65
    Units: percentage of participants
    number (not applicable)
        Reduce OCS to <=7.5 mg/day: Yes
    6.5
    8.2
    9.4
    6.2
        Reduce OCS to <=7.5 mg/day: No
    93.5
    91.8
    90.6
    93.8
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v Sifalimumab 200 milligram (mg)
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.808
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.19
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 3.81
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v Sifalimumab 600 mg
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.598
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.45
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 4.66
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v Sifalimumab 1,200 mg
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.884
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 3.02

    Secondary: Percentage of Participants with a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction

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    End point title
    		 Percentage of Participants with a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction
    End point description
    The CLASI consists of two scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. The percentage of participants with a CLASI activity score >=10 at baseline who achieved a clinically significant (>=4-point) reduction at Day 365 were reported. The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies number of participants analyzed with a CLASI activity score >=10 at baseline.
    End point type
    Secondary
    End point timeframe
    Day 365
    End point values
    		 Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
    Number of subjects analysed
    35
    33
    33
    26
    Units: percentage of participants
    number (not applicable)
        Achieved >=4-point reduction: Yes
    48.6
    72.7
    57.6
    73.1
        Achieved >=4-point reduction: No
    51.4
    27.3
    42.4
    26.9
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v Sifalimumab 200 milligram (mg)
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.044
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.92
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.22
         upper limit
    		 7.01
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v Sifalimumab 600 mg
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.498
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 3.19
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v Sifalimumab 1,200 mg
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.049
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 7.68

    Secondary: Percentage of Participants who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale

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    End point title
    		 Percentage of Participants who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
    End point description
    FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies number of participants analyzed with a FACIT-fatigue score <49 at baseline.
    End point type
    Secondary
    End point timeframe
    Day 365
    End point values
    		 Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
    Number of subjects analysed
    105
    105
    102
    101
    Units: percentage of participants
    number (not applicable)
        Achieved > 3-point improvement: Yes
    30.5
    38.1
    42.2
    35.6
        Achieved > 3-point improvement: No
    69.5
    61.9
    57.8
    64.4
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v Sifalimumab 200 milligram (mg)
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.27
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.39
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 2.25
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v Sifalimumab 600 mg
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.077
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.69
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 2.74
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v Sifalimumab 1,200 mg
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.453
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 2.05

    Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study. The safety population included all participants who received any investigational product.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 74
    End point values
    		 Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
    Number of subjects analysed
    108
    108
    108
    107
    Units: participants
        TEAE
    94
    97
    97
    93
        TESAE
    19
    16
    22
    21
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants with Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
    End point description
    Laboratory investigations included hematology, serum chemistries and urinalysis parameters. Participants with clinically significant abnormalities in these laboratory investigations recorded as TEAEs were reported. The safety population included all participants who received any investigational product.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 61
    End point values
    		 Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
    Number of subjects analysed
    108
    108
    108
    107
    Units: participants
        Anaemia
    1
    4
    4
    2
        White blood cell count increased
    3
    1
    2
    3
        Neutrophil count increased
    3
    1
    2
    2
        Iron deficiency anaemia
    1
    2
    0
    2
        Haemoglobin decreased
    0
    1
    0
    1
        Lymphocyte count decreased
    2
    1
    1
    0
        White blood cell count decreased
    1
    0
    1
    1
        Autoimmune haemolytic anaemia
    1
    1
    0
    0
        Eosinophilia
    0
    0
    0
    1
        Haematocrit increased
    0
    0
    1
    0
        Haemoglobin increased
    0
    0
    1
    0
        Leukopenia
    0
    1
    0
    0
        Lymphopenia
    1
    1
    0
    0
        Neutropenia
    3
    0
    0
    1
        Neutrophil count decreased
    1
    0
    0
    1
        Platelet count increased
    0
    0
    1
    0
        Red blood cell count decreased
    0
    0
    0
    1
        Thrombocytopenia
    0
    1
    0
    0
        Platelet count decreased
    2
    0
    0
    0
        Monocyte count increased
    1
    0
    0
    0
        Hypokalaemia
    4
    1
    4
    5
        Alanine aminotransferase increased
    5
    1
    1
    3
        Gamma-glutamyltransferase increased
    5
    0
    1
    4
        Hypertriglyceridaemia
    2
    1
    1
    3
        Dyslipidaemia
    2
    0
    2
    2
        Hepatic enzyme increased
    2
    2
    2
    0
        Aspartate aminotransferase increased
    2
    1
    0
    2
        Blood creatine phosphokinase increased
    2
    0
    2
    0
        Blood creatinine increased
    0
    1
    0
    1
        Blood glucose increased
    1
    0
    0
    2
        Hyperglycaemia
    1
    0
    0
    2
        Transaminases increased
    1
    0
    1
    1
        Blood potassium decreased
    0
    1
    1
    0
        Low density lipoprotein increased
    0
    1
    1
    0
        Blood albumin decreased
    0
    0
    1
    0
        Blood alkaline phosphatase decreased
    1
    0
    0
    1
        Blood calcium increased
    1
    0
    1
    0
        Blood cholesterol increased
    0
    0
    1
    0
        Blood homocysteine increased
    0
    0
    1
    0
        Liver function test abnormal
    1
    0
    1
    0
        Hyperlipidaemia
    0
    0
    0
    1
        Hypoalbuminaemia
    2
    0
    1
    0
        Hypoglycaemia
    0
    0
    0
    1
        Blood bilirubin increased
    1
    0
    0
    0
        Hypocalcaemia
    1
    0
    0
    0
        Blood triglycerides increased
    1
    0
    1
    0
        Hyperbilirubinaemia
    0
    0
    1
    0
        Hypertransaminasaemia
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
    End point description
    Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiratory rate. Vital signs abnormalities recorded as TEAEs were reported. The safety population included all participants who received any investigational product.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 61
    End point values
    		 Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
    Number of subjects analysed
    108
    108
    108
    107
    Units: participants
        Pyrexia
    3
    2
    6
    7
        Hypertension
    7
    4
    5
    4
        Weight increased
    0
    1
    2
    2
        Blood pressure increased
    1
    2
    1
    0
        Chills
    1
    2
    0
    1
        Hypertensive crisis
    0
    0
    0
    1
        Orthostatic hypotension
    1
    0
    0
    1
        Weight decreased
    1
    0
    0
    1
        Hypotension
    1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs

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    End point title
    		 Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs
    End point description
    The 12-lead ECG data were summarized and evaluated. Number of participants with clinically significant abnormal ECG findings as assessed by cardiologist were recorded and reported as TEAEs. The safety population included all participants who received any investigational product.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 56
    End point values
    		 Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
    Number of subjects analysed
    108
    108
    108
    107
    Units: participants
    2
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to Week 74
    Adverse event reporting additional description
    TEAE defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching to sifalimumab administered intravenously for 48 weeks (Day 337).

    Reporting group title
    Sifalimumab 200 milligram (mg)
    Reporting group description
    		 Sifalimumab 200 milligram (mg) administered intravenously for 48 weeks (Day 337).

    Reporting group title
    Sifalimumab 600 mg
    Reporting group description
    		 Sifalimumab 600 mg administered intravenously for 48 weeks (Day 337).

    Reporting group title
    Sifalimumab 1,200 mg
    Reporting group description
    		 Sifalimumab 1,200 mg administered intravenously for 48 weeks (Day 337).

    Serious adverse events
    		 Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 108 (17.59%)
    16 / 108 (14.81%)
    22 / 108 (20.37%)
    21 / 107 (19.63%)
         number of deaths (all causes)
    2
    0
    2
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Vascular disorders
    Hypertension
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Ischaemic limb pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Peripheral artery thrombosis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 107 (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
    Peripheral embolism
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 107 (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
    Surgical and medical procedures
    Abortion induced
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Abortion spontaneous incomplete
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Ectopic pregnancy
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Reproductive system and breast disorders
    Cervical dysplasia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Epistaxis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Laryngeal polyp
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Pulmonary embolism
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Pulmonary hypertension
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Injury, poisoning and procedural complications
    Fall
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Head injury
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Humerus fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Infusion related reaction
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Meniscus injury
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Muscle rupture
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Spinal compression fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Stab wound
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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 / 1
    Cardiac disorders
    Acute myocardial infarction
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    2 / 108 (1.85%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Cardiac arrest
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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 / 1
    Cardio-respiratory arrest
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    1 / 1
    0 / 0
    Mitral valve incompetence
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    1 / 1
    0 / 0
    Nervous system disorders
    Ischaemic stroke
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 107 (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
    Simple partial seizures
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Syncope
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Transient ischaemic attack
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    1 / 107 (0.93%)
         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
    Vasculitis cerebral
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 107 (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
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    2 / 107 (1.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Gastrointestinal disorders
    Ascites
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Diverticulum oesophageal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Gastritis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Gastritis haemorrhagic
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 107 (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
    Intussusception
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Irritable bowel syndrome
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Lip ulceration
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Salivary gland calculus
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Small intestinal perforation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Tongue oedema
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Skin and subcutaneous tissue disorders
    Skin ulcer
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Renal and urinary disorders
    Renal failure acute
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Musculoskeletal and connective tissue disorders
    Back pain
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Flank pain
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 107 (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
    Foot deformity
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Osteonecrosis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    2 / 108 (1.85%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic lupus erythematosus
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 108 (2.78%)
    4 / 108 (3.70%)
    7 / 108 (6.48%)
    3 / 107 (2.80%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    1 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 107 (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
    Cellulitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 108 (0.93%)
    1 / 108 (0.93%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corneal infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 107 (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
    Encephalitis viral
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Enterocolitis bacterial
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 107 (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
    Epiglottitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Erysipelas
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 107 (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
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Herpes zoster
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Infectious colitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Influenza
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 107 (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
    Lobar pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Lower respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Ludwig angina
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Meningitis bacterial
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Ophthalmic herpes zoster
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Parotitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 107 (0.93%)
         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
    Peritonitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    2 / 107 (1.87%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Progressive multifocal leukoencephalopathy
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Pyelonephritis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Pyelonephritis acute
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    2 / 108 (1.85%)
    0 / 108 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Sepsis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic embolus
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Septic shock
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    Soft tissue infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (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
    Upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    0 / 108 (0.00%)
    0 / 107 (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
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Sifalimumab 200 milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 108 (87.04%)
    97 / 108 (89.81%)
    97 / 108 (89.81%)
    93 / 107 (86.92%)
    Vascular disorders
    Hypertension
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 108 (6.48%)
    4 / 108 (3.70%)
    5 / 108 (4.63%)
    3 / 107 (2.80%)
         occurrences all number
    8
    4
    5
    3
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 108 (2.78%)
    2 / 108 (1.85%)
    6 / 108 (5.56%)
    7 / 107 (6.54%)
         occurrences all number
    4
    3
    10
    10
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 108 (6.48%)
    7 / 108 (6.48%)
    5 / 108 (4.63%)
    6 / 107 (5.61%)
         occurrences all number
    7
    7
    5
    6
    Epistaxis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    4 / 108 (3.70%)
    2 / 108 (1.85%)
    2 / 107 (1.87%)
         occurrences all number
    1
    4
    3
    2
    Oropharyngeal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 108 (3.70%)
    4 / 108 (3.70%)
    1 / 108 (0.93%)
    0 / 107 (0.00%)
         occurrences all number
    5
    4
    1
    0
    Psychiatric disorders
    Anxiety
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 108 (2.78%)
    6 / 108 (5.56%)
    2 / 108 (1.85%)
    7 / 107 (6.54%)
         occurrences all number
    3
    6
    2
    8
    Insomnia
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 108 (3.70%)
    7 / 108 (6.48%)
    3 / 108 (2.78%)
    1 / 107 (0.93%)
         occurrences all number
    4
    8
    3
    1
    Investigations
    Alanine aminotransferase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 108 (4.63%)
    1 / 108 (0.93%)
    1 / 108 (0.93%)
    3 / 107 (2.80%)
         occurrences all number
    7
    1
    1
    5
    Gamma-glutamyltransferase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 108 (4.63%)
    0 / 108 (0.00%)
    1 / 108 (0.93%)
    4 / 107 (3.74%)
         occurrences all number
    7
    0
    2
    5
    White blood cell count increased
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 108 (2.78%)
    1 / 108 (0.93%)
    2 / 108 (1.85%)
    3 / 107 (2.80%)
         occurrences all number
    4
    1
    4
    5
    Injury, poisoning and procedural complications
    Contusion
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 108 (2.78%)
    2 / 108 (1.85%)
    3 / 108 (2.78%)
    1 / 107 (0.93%)
         occurrences all number
    4
    2
    3
    1
    Infusion related reaction
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 108 (4.63%)
    8 / 108 (7.41%)
    7 / 108 (6.48%)
    5 / 107 (4.67%)
         occurrences all number
    10
    17
    9
    10
    Nervous system disorders
    Dizziness
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 108 (4.63%)
    5 / 108 (4.63%)
    2 / 108 (1.85%)
    5 / 107 (4.67%)
         occurrences all number
    5
    6
    2
    5
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    15 / 108 (13.89%)
    16 / 108 (14.81%)
    15 / 108 (13.89%)
    12 / 107 (11.21%)
         occurrences all number
    24
    18
    37
    13
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    3 / 108 (2.78%)
    4 / 108 (3.70%)
    1 / 107 (0.93%)
         occurrences all number
    1
    3
    4
    1
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 108 (0.00%)
    6 / 108 (5.56%)
    4 / 107 (3.74%)
         occurrences all number
    2
    0
    7
    4
    Abdominal pain upper
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 108 (3.70%)
    1 / 108 (0.93%)
    5 / 108 (4.63%)
    4 / 107 (3.74%)
         occurrences all number
    5
    1
    5
    4
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 108 (0.93%)
    2 / 108 (1.85%)
    5 / 107 (4.67%)
         occurrences all number
    2
    1
    2
    5
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 108 (7.41%)
    7 / 108 (6.48%)
    9 / 108 (8.33%)
    5 / 107 (4.67%)
         occurrences all number
    9
    7
    9
    5
    Dyspepsia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 108 (2.78%)
    3 / 108 (2.78%)
    1 / 108 (0.93%)
    4 / 107 (3.74%)
         occurrences all number
    3
    3
    1
    4
    Gastritis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 108 (0.00%)
    3 / 108 (2.78%)
    3 / 108 (2.78%)
    3 / 107 (2.80%)
         occurrences all number
    0
    3
    5
    3
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 108 (7.41%)
    4 / 108 (3.70%)
    7 / 108 (6.48%)
    5 / 107 (4.67%)
         occurrences all number
    12
    5
    11
    7
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 108 (4.63%)
    1 / 108 (0.93%)
    6 / 108 (5.56%)
    3 / 107 (2.80%)
         occurrences all number
    5
    1
    8
    3
    Skin and subcutaneous tissue disorders
    Rash
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 108 (0.93%)
    2 / 108 (1.85%)
    6 / 107 (5.61%)
         occurrences all number
    1
    1
    2
    6
    Pruritus
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 108 (1.85%)
    7 / 108 (6.48%)
    3 / 108 (2.78%)
    5 / 107 (4.67%)
         occurrences all number
    2
    8
    3
    8
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 108 (2.78%)
    2 / 108 (1.85%)
    9 / 108 (8.33%)
    5 / 107 (4.67%)
         occurrences all number
    6
    3
    11
    5
    Back pain
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 108 (2.78%)
    3 / 108 (2.78%)
    8 / 108 (7.41%)
    5 / 107 (4.67%)
         occurrences all number
    3
    3
    8
    5
    Systemic lupus erythematosus
    alternative assessment type: Systematic
         subjects affected / exposed
    35 / 108 (32.41%)
    34 / 108 (31.48%)
    31 / 108 (28.70%)
    26 / 107 (24.30%)
         occurrences all number
    56
    42
    46
    46
    Infections and infestations
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 108 (7.41%)
    11 / 108 (10.19%)
    4 / 108 (3.70%)
    15 / 107 (14.02%)
         occurrences all number
    8
    15
    7
    20
    Conjunctivitis
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 108 (3.70%)
    4 / 108 (3.70%)
    1 / 108 (0.93%)
    2 / 107 (1.87%)
         occurrences all number
    5
    5
    1
    2
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 108 (4.63%)
    5 / 108 (4.63%)
    5 / 108 (4.63%)
    4 / 107 (3.74%)
         occurrences all number
    6
    6
    6
    4
    Herpes zoster
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 108 (0.93%)
    5 / 108 (4.63%)
    4 / 108 (3.70%)
    8 / 107 (7.48%)
         occurrences all number
    1
    6
    4
    8
    Influenza
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 108 (3.70%)
    3 / 108 (2.78%)
    1 / 108 (0.93%)
    5 / 107 (4.67%)
         occurrences all number
    4
    3
    1
    5
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 108 (9.26%)
    12 / 108 (11.11%)
    13 / 108 (12.04%)
    9 / 107 (8.41%)
         occurrences all number
    17
    14
    15
    12
    Oral herpes
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 108 (4.63%)
    3 / 108 (2.78%)
    3 / 108 (2.78%)
    4 / 107 (3.74%)
         occurrences all number
    6
    7
    4
    5
    Pharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 108 (3.70%)
    3 / 108 (2.78%)
    6 / 108 (5.56%)
    12 / 107 (11.21%)
         occurrences all number
    5
    3
    9
    12
    Respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 108 (2.78%)
    1 / 108 (0.93%)
    3 / 108 (2.78%)
    3 / 107 (2.80%)
         occurrences all number
    5
    1
    3
    4
    Sinusitis
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 108 (2.78%)
    2 / 108 (1.85%)
    4 / 108 (3.70%)
    5 / 107 (4.67%)
         occurrences all number
    3
    2
    4
    7
    Upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 108 (8.33%)
    10 / 108 (9.26%)
    17 / 108 (15.74%)
    15 / 107 (14.02%)
         occurrences all number
    12
    16
    27
    23
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 108 (12.96%)
    22 / 108 (20.37%)
    17 / 108 (15.74%)
    18 / 107 (16.82%)
         occurrences all number
    19
    25
    22
    25
    Metabolism and nutrition disorders
    Diabetes mellitus
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 108 (1.85%)
    2 / 108 (1.85%)
    3 / 108 (2.78%)
    2 / 107 (1.87%)
         occurrences all number
    2
    2
    4
    2
    Hypokalaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 108 (3.70%)
    1 / 108 (0.93%)
    4 / 108 (3.70%)
    5 / 107 (4.67%)
         occurrences all number
    5
    1
    5
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jun 2011
    The overall reason for the amendment was to include the following changes: Changes in eligibility criteria. Added instruction for participants who entered the study with indeterminate QuantiFERON-TB Gold blood test results. Changes in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level required to qualify and remain in the study from “<=300 copies/mL” to “HBV DNA detected by reflex testing by the central lab at screening or at any time for the duration of the study.” Also specified that the frequency of HBV DNA testing in isolated Hepatitis B core positive participants was to be done. Text to clarify that body temperature should be taken orally, removed text regarding the collection of serum samples for the assessment of safety biomarkers during infusion, hypersensitivity, and anaphylactic reactions and text to clarify corticosteroid tapering due to decreased SLE activity after Day 85. Changes in flow cytometry sample collection due to extension of the follow-up period from 90 to 180 days. An additional Clinical Evaluation Questionnaire (CEQ) assessment was to be performed. Amended to include only 200 participants would participate in sample collection for acute phase reactants/biomarkers, all flow cytometry data would remain blinded until the end of the study, and only plasma samples were to be collected for optional biomarker repository samples. To characterize proteomic sample collection, to characterize IFN bioassay sample collection, to reflect the new estimated volume of blood that was to be collected. To clarify that skin photographs would not be obtained from participants who did not present with active skin disease at screening or day 1, to define and describe the method of collection for Adverse Events of Interest (AESIs), sulfasalazine to the list of restricted medications.
    28 Aug 2012
    The overall reason for the amendment was to include the following changes: Change in description of sifalimumab dosing, text to reduce overall sample size from 544 participants to 400 participants based on a 20 percent (%) improvement of sifalimumab over placebo in the SRI. Participants were in screening at the time of the 400th subject was randomized, if eligible participants would have been allowed to be randomized into the study. Change in serum sample collection time points. The number of diagnostic test-positive participants per treatment group was revised to 60 participants and the minimum detectable difference was also revised.
    23 Jan 2013
    The overall reason for the amendment was to include the following changes: To describe an unblinded interim analysis was planned for the study, which was performed by a limited number of sponsor personnel. To describe the collection of optional urine biomarker samples from eligible participants. To describe that Farr assay testing was to be performed on Day 169. Sample size of diagnostic test-positive participants per treatment group was increased from 60 to 80.

    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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