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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis

    Summary
    EudraCT number
    2015-001758-14
    Trial protocol
    DE   ES   NL   BG   HU   BE   IT  
    Global end of trial date
    20 Mar 2018

    Results information
    Results version number
    v2(current)
    This version publication date
    02 Jun 2019
    First version publication date
    26 Apr 2019
    Other versions
    v1
    Version creation reason

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    201677
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GSK Response Center, 8664357343 1, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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
    29 Jul 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Mar 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of sirukumab (100 mg q2w for 12 months) as compared to placebo, each administered in addition to a 6-month prednisone treatment regimen
    Protection of trial subjects
    Not Applicable
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Oct 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Belgium: 14
    Country: Number of subjects enrolled
    Bulgaria: 4
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 42
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    New Zealand: 4
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    United States: 27
    Worldwide total number of subjects
    161
    EEA total number of subjects
    111
    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)
    42
    From 65 to 84 years
    112
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of sirukumab in treatment of participants with Giant Cell Arteritis (GCA). A total of 161 participants were enrolled.

    Pre-assignment
    Screening details
    This study was conducted in 2 distinct parts (Part A and Part B), Part A was a 52-week double-blind treatment phase and Part B was a 104-week long-term extension phase with the option to receive open-label sirukumab (SIR) (up to a 52-week duration of open-label treatment). This study was terminated early by sponsor.

    Period 1
    Period 1 title
    Part A (52 weeks)
    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
    Part A:SIR 100 mg SC q2w+6 month prednisone
    Arm description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
    Arm type
    Experimental

    Investigational medicinal product name
    Sirukumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1.0 milliliter Pre-filled syringe by subcutaneous route, every 2 weeks (treatment arms A & B) and subcutaneous, every 4 weeks (treatment arm C)

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

    Arm title
    Part A:SIR 100 mg SC q2w+3 month prednisone
    Arm description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
    Arm type
    Experimental

    Investigational medicinal product name
    Sirukumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1.0 milliliter Pre-filled syringe by subcutaneous route, every 2 weeks (treatment arms A & B) and subcutaneous, every 4 weeks (treatment arm C)

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

    Arm title
    Part A:SIR 50 mg SC q4w+6 month prednisone
    Arm description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
    Arm type
    Experimental

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

    Investigational medicinal product name
    Sirukumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1.0 milliliter Pre-filled syringe by subcutaneous route, every 2 weeks (treatment arms A & B) and subcutaneous, every 4 weeks (treatment arm C)

    Arm title
    Part A:Placebo SC q2w + 6 month prednisone
    Arm description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
    Arm type
    Placebo

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous every 2 weeks (treatment arms D & E)

    Arm title
    Part A:Placebo SC q2w+12 month prednisone
    Arm description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous every 2 weeks (treatment arms D & E)

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

    Number of subjects in period 1
    Part A:SIR 100 mg SC q2w+6 month prednisone Part A:SIR 100 mg SC q2w+3 month prednisone Part A:SIR 50 mg SC q4w+6 month prednisone Part A:Placebo SC q2w + 6 month prednisone Part A:Placebo SC q2w+12 month prednisone
    Started
    42
    39
    26
    27
    27
    Completed Part A and didn’t enter Part B
    1 [1]
    0 [2]
    1 [3]
    0 [4]
    0 [5]
    Completed
    8
    5
    4
    5
    4
    Not completed
    34
    34
    22
    22
    23
         Physician decision
    1
    4
    3
    1
    -
         Consent withdrawn by subject
    6
    6
    1
    3
    3
         Sponsor request
    24
    24
    18
    18
    19
         Unknown
    2
    -
    -
    -
    -
         Lost to follow-up
    -
    -
    -
    -
    1
         Protocol deviation
    1
    -
    -
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 2 Participants completed Part A then withdrew. They are counted again in withdrawals.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 2 Participants completed Part A then withdrew. They are counted again in withdrawals.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 2 Participants completed Part A then withdrew. They are counted again in withdrawals.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 2 Participants completed Part A then withdrew. They are counted again in withdrawals.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 2 Participants completed Part A then withdrew. They are counted again in withdrawals.
    Period 2
    Period 2 title
    Part B (104 weeks)
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part B:SIR 100 mg SC q2w+6 month prednisone
    Arm description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A
    Arm type
    Experimental

    Investigational medicinal product name
    Sirukumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1.0 milliliter Pre-filled syringe by subcutaneous route, every 2 weeks (treatment arms A & B) and subcutaneous, every 4 weeks (treatment arm C)

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

    Arm title
    Part B:SIR 100 mg SC q2w+3 month prednisone
    Arm description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A
    Arm type
    Experimental

    Investigational medicinal product name
    Sirukumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1.0 milliliter Pre-filled syringe by subcutaneous route, every 2 weeks (treatment arms A & B) and subcutaneous, every 4 weeks (treatment arm C)

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

    Arm title
    Part B:SIR 50 mg SC q4w+6 month prednisone
    Arm description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A
    Arm type
    Experimental

    Investigational medicinal product name
    Sirukumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1.0 milliliter Pre-filled syringe by subcutaneous route, every 2 weeks (treatment arms A & B) and subcutaneous, every 4 weeks (treatment arm C)

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

    Arm title
    Part B:Placebo SC q2w + 6 month prednisone
    Arm description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A
    Arm type
    Experimental

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous every 2 weeks (treatment arms D & E)

    Arm title
    Part B:Placebo SC q2w + 12 month prednisone
    Arm description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous every 2 weeks (treatment arms D & E)

    Number of subjects in period 2
    Part B:SIR 100 mg SC q2w+6 month prednisone Part B:SIR 100 mg SC q2w+3 month prednisone Part B:SIR 50 mg SC q4w+6 month prednisone Part B:Placebo SC q2w + 6 month prednisone Part B:Placebo SC q2w + 12 month prednisone
    Started
    8
    5
    4
    5
    4
    Completed
    0
    0
    0
    0
    0
    Not completed
    8
    5
    4
    5
    4
         Sponsor request
    8
    5
    3
    5
    4
         Lost to follow-up
    -
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A (52 weeks)
    Reporting group description
    -

    Reporting group values
    Part A (52 weeks) Total
    Number of subjects
    161 161
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    42 42
        From 65-84 years
    112 112
        85 years and over
    7 7
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    69.6 ( 7.85 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    124 124
        Male
    37 37
    Race, Customized
    Units: Subjects
        African American/African Heritage
    1 1
        White: Arabic/North African Heritage
    2 2
        White/Caucasian/European Heritage
    156 156
        Mixed Race
    2 2

    End points

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    End points reporting groups
    Reporting group title
    Part A:SIR 100 mg SC q2w+6 month prednisone
    Reporting group description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Reporting group title
    Part A:SIR 100 mg SC q2w+3 month prednisone
    Reporting group description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Reporting group title
    Part A:SIR 50 mg SC q4w+6 month prednisone
    Reporting group description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Reporting group title
    Part A:Placebo SC q2w + 6 month prednisone
    Reporting group description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Reporting group title
    Part A:Placebo SC q2w+12 month prednisone
    Reporting group description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
    Reporting group title
    Part B:SIR 100 mg SC q2w+6 month prednisone
    Reporting group description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A

    Reporting group title
    Part B:SIR 100 mg SC q2w+3 month prednisone
    Reporting group description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A

    Reporting group title
    Part B:SIR 50 mg SC q4w+6 month prednisone
    Reporting group description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A

    Reporting group title
    Part B:Placebo SC q2w + 6 month prednisone
    Reporting group description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A

    Reporting group title
    Part B:Placebo SC q2w + 12 month prednisone
    Reporting group description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A

    Subject analysis set title
    SIR100 mg SC q2w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    SIR 100 mg SC q2w+3 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    SIR 50 mg SC q4w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    Placebo SC q2w + 6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    Placebo SC q2w + 12 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

    Subject analysis set title
    PartA:SIR 100 mg SC q2w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    PartA:SIR 100 mg SC q2w+3 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartA:SIR 50 mg SC q4w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartA:Placebo SC q2w + 6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartA:Placebo SC q2w + 12 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    PartA:SIR 100 mg SC q2w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    PartA:SIR 100 mg SC q2w+3 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartA:SIR 50 mg SC q4w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartA:Placebo SC q2w + 6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartA:Placebo SC q2w + 12 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+3 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 50 mg SC q4w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartB:Placebo SC q2w + 6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartB:Placebo SC q2w + 12 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

    Subject analysis set title
    PartA:SIR 100 mg SC q2w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    PartA:SIR 100 mg SC q2w+6 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    PartA:SIR 100 mg SC q2w+3 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartA:SIR 50 mg SC q4w+6 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartA:Placebo SC q2w + 6 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartA:Placebo SC q2w + 12 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

    Subject analysis set title
    PartA:SIR 100 mg SC q2w+6 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    PartA:SIR 100 mg SC q2w+3 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartA:SIR 50 mg SC q4w+6 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartA:Placebo SC q2w + 6 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartA:Placebo SC q2w + 12 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+6 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+3 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 50 mg SC q4w+6 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartB:Placebo SC q2w + 6 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartB:Placebo SC q2w + 12 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+6 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+3 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 50 mg SC q4w+6 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartB:Placebo SC q2w + 6 month Prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+3 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartB:Placebo SC q2w + 6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartB:Placebo SC q2w + 12 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+3 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 50 mg SC q4w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartB:Placebo SC q2w + 6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartBSIR 100 mg SC q2w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    PartBSIR 100 mg SC q2w+3 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartBSIR 50 mg SC q4w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartBPlacebo SC q2w + 6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartBPlacebo SC q2w + 12 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+3 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 50 mg SC q4w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartB:Placebo SC q2w + 6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Subject analysis set title
    PartB:Placebo SC q2w + 12 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+3 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Subject analysis set title
    PartB:Placebo SC q2w + 12 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

    Subject analysis set title
    PartB:SIR 100 mg SC q2w+6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Subject analysis set title
    PartB:Placebo SC q2w + 6 month prednisone
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Primary: Part A: Number of participants in sustained remission at Week 52

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    End point title
    Part A: Number of participants in sustained remission at Week 52 [1]
    End point description
    Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) [<30 millimeters per hour] and C-reactive Protein (CRP) [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis.
    End point type
    Primary
    End point timeframe
    Week 52
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was performed.
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    17
    13
    9
    9
    7
    Units: Participants
    3
    2
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Part B: Number of participants who remained in sustained remission without requirement for rescue therapy or treatment change at Week 24

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    End point title
    Part B: Number of participants who remained in sustained remission without requirement for rescue therapy or treatment change at Week 24
    End point description
    Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30 millimeters per hour] and CRP [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Part B:SIR 100 mg SC q2w+6 month prednisone Part B:SIR 100 mg SC q2w+3 month prednisone Part B:SIR 50 mg SC q4w+6 month prednisone Part B:Placebo SC q2w + 6 month prednisone Part B:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone
    Number of subjects analysed
    2
    2
    1
    0 [2]
    0 [3]
    2
    Units: Participants
    99999
    99999
    99999
    99999
    Notes
    [2] - Data for number of participants in sustained remission over time for Part B is presented.
    [3] - Data for number of participants in sustained remission over time for Part B is presented.
    No statistical analyses for this end point

    Secondary: Part A: Cumulative prednisone dose over time

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    End point title
    Part A: Cumulative prednisone dose over time
    End point description
    Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on the participants who attended a scheduled or unscheduled visit mapped to that time point and received a total prednisone dose greater than 0 mg.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Milligrams
    arithmetic mean (standard deviation)
        Week 2, n= 40,39,26,27,26
    439.575 ( 237.8990 )
    464.923 ( 299.6445 )
    424.577 ( 270.2183 )
    432.815 ( 315.6851 )
    430.846 ( 241.3540 )
        Week 4,n=40,39,26,25,27
    701.100 ( 370.9798 )
    741.115 ( 436.4205 )
    701.192 ( 439.7251 )
    705.480 ( 601.9706 )
    751.407 ( 431.3442 )
        Week 8,n=37, 37,26,23,26
    1086.676 ( 600.7400 )
    987.730 ( 559.4458 )
    1014.731 ( 592.3515 )
    1161.391 ( 1202.8504 )
    1129.077 ( 546.8037 )
        Week 12,n=34,32,24,22,24
    1344.441 ( 779.6775 )
    1063.773 ( 619.4002 )
    1208.167 ( 650.6975 )
    1379.409 ( 1255.4397 )
    1462.917 ( 630.1717 )
        Week 16,n=32,30,24,22,22
    1545.602 ( 964.3264 )
    1182.288 ( 718.6186 )
    1348.750 ( 689.2484 )
    1672.795 ( 1261.7121 )
    1729.977 ( 701.3734 )
        Week 20,n=29,27,21,24,19
    1690.302 ( 1173.6005 )
    1339.546 ( 888.5007 )
    1475.786 ( 734.7667 )
    1646.177 ( 701.5240 )
    2041.632 ( 771.3504 )
        Week 24,n=30,25,19,18,17
    1878.458 ( 1333.1175 )
    1495.015 ( 1055.9615 )
    1626.342 ( 813.8284 )
    1917.444 ( 861.6887 )
    2299.471 ( 840.8758 )
        Week 28,n=24,23,15,17,15
    2000.813 ( 1594.5982 )
    1575.549 ( 1170.7294 )
    1797.533 ( 933.3753 )
    2141.294 ( 1082.2754 )
    2387.800 ( 741.1663 )
        Week 32,n=19,21,13,15,18
    2216.000 ( 1953.8211 )
    1716.863 ( 1328.1426 )
    1859.346 ( 858.5431 )
    2531.417 ( 1327.9125 )
    2404.500 ( 808.8642 )
        Week 36,n=19,17,14,13,14
    2321.711 ( 2090.2393 )
    1803.919 ( 1536.5304 )
    1705.214 ( 802.8858 )
    2617.817 ( 1636.2516 )
    2717.696 ( 897.0689 )
        Week 40,n=18,15,11,13,12
    2003.264 ( 1426.0271 )
    2023.342 ( 1651.4092 )
    1842.500 ( 904.4136 )
    2960.144 ( 1736.2249 )
    2963.865 ( 909.0195 )
        Week 44,n=17,13,10,12,13
    2051.603 ( 1588.9627 )
    1481.115 ( 1381.3957 )
    1980.733 ( 1444.8664 )
    2783.542 ( 1776.0608 )
    2954.760 ( 1022.5491 )
        Week 48,n=10,16,9,8,11
    1821.325 ( 1139.5986 )
    1601.656 ( 1362.9717 )
    1562.333 ( 828.5650 )
    2859.208 ( 1882.7422 )
    3167.898 ( 1195.4020 )
        Week 52,n=11,10,6,7,6
    2974.295 ( 2966.6259 )
    2418.213 ( 2085.2345 )
    2556.222 ( 1363.1832 )
    3157.054 ( 1988.0610 )
    3603.229 ( 1477.6777 )
    No statistical analyses for this end point

    Secondary: Part B: Number of participants in sustained remission over time

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    End point title
    Part B: Number of participants in sustained remission over time
    End point description
    Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30millimeters per hour] and CRP [<1milligram/deciliter]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. ITT-Part B Population. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    2
    1
    99999 [4]
    99999 [5]
    Units: Participants
        Week 4,n=1,1,1,0,0
    1
    1
    1
    99999
    99999
        Week 8,n=1,0,1,0,0
    1
    99999
    1
    99999
    99999
        Week 12,n=1,0,0,0,0
    1
    99999
    99999
    99999
    99999
    Notes
    [4] - Data for number of participants in sustained remission over time for Part B is presented.
    [5] - Data for number of participants in sustained remission over time for Part B is presented.
    No statistical analyses for this end point

    Secondary: Part A: Time to first disease flare after clinical remission

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    End point title
    Part A: Time to first disease flare after clinical remission
    End point description
    Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone PartA:SIR 100 mg SC q2w+6 month prednisone
    Number of subjects analysed
    39
    26
    27
    27
    40
    Units: Days
        median (inter-quartile range (Q1-Q3))
    99999 (-99999 to 99999)
    99999 (176.0 to 99999)
    99999 (99.0 to 99999)
    99999 (183.0 to 99999)
    99999 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Part B: Time to first disease flare for participants in sustained remission

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    End point title
    Part B: Time to first disease flare for participants in sustained remission
    End point description
    Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    2
    1
    0 [6]
    0 [7]
    Units: Days
        median (inter-quartile range (Q1-Q3))
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    ( to )
    ( to )
    Notes
    [6] - Data for number of participants in sustained remission over time for Part B is presented.
    [7] - Data for number of participants in sustained remission over time for Part B is presented.
    No statistical analyses for this end point

    Secondary: Part A: Number of disease flares over time

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    End point title
    Part A: Number of disease flares over time
    End point description
    This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Disease flares
        Week 2, n=38, 39,26,25,27
    1
    2
    2
    0
    2
        Week 4, n=37,37,25,23,27
    3
    4
    3
    0
    2
        Week 8, n=34,32,24,23,23
    2
    6
    3
    1
    5
        Week 12, n=32,29,24,22,22
    4
    9
    4
    4
    4
        Week 16, n=28,26,22,19,19
    4
    9
    5
    9
    4
        Week 20, n=26,23,19,18,16
    4
    9
    6
    10
    3
        Week 24, n=23,21,16,17,16
    6
    9
    8
    11
    5
        Week 28, n=19,18,12,14,14
    5
    8
    8
    11
    5
        Week 32, n=19,15,10,12,13
    5
    8
    5
    10
    6
        Week 36, n=15,13,10,12,13
    3
    8
    5
    10
    6
        Week 40, n=15,11,9,10,10
    2
    7
    5
    8
    5
        Week 44, n=11,11,6,8,9
    1
    8
    3
    6
    7
        Week 48, n=9,8,5,8,5
    1
    4
    1
    7
    3
        Week 52, n=9,5,5,5,4
    1
    2
    1
    7
    4
    No statistical analyses for this end point

    Secondary: Part A: Number of participants with at least one hospitalization for disease flare

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    End point title
    Part A: Number of participants with at least one hospitalization for disease flare
    End point description
    Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Participants
        Week 2, n=38, 39,26,25,27
    0
    0
    0
    0
    0
        Week 4, n=37,37,25,23,27
    0
    0
    0
    0
    0
        Week 8, n=34,32,24,23,23
    0
    0
    0
    0
    0
        Week 12, n=32,29,24,22,22
    1
    0
    0
    0
    0
        Week 16, n=28,26,22,19,19
    1
    0
    0
    0
    0
        Week 20, n=26,23,19,18,16
    1
    0
    1
    0
    0
        Week 24, n=23,21,16,17,16
    1
    0
    1
    0
    0
        Week 28, n=19,18,12,14,14
    0
    0
    1
    0
    0
        Week 32, n=19,15,10,12,13
    0
    0
    0
    0
    0
        Week 36, n=15,13,10,12,13
    0
    0
    0
    0
    0
        Week 40, n=15,11,9,10,10
    0
    0
    0
    0
    0
        Week 44, n=11,11,6,8,9
    0
    0
    0
    0
    0
        Week 48, n=9,8,5,8,5
    0
    0
    0
    0
    0
        Week 52, n=9,5,5,5,4
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part A: Number of hospitalizations for disease flare over time

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    End point title
    Part A: Number of hospitalizations for disease flare over time
    End point description
    Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Number of Hospitalizations
        Week 2, n=38, 39,26,25,27
    0
    0
    0
    0
    0
        Week 4, n=37,37,25,23,27
    0
    0
    0
    0
    0
        Week 8, n=34,32,24,23,23
    0
    0
    0
    0
    0
        Week 12, n=32,29,24,22,22
    2
    0
    0
    0
    0
        Week 16, n=28,26,22,19,19
    2
    0
    0
    0
    0
        Week 20, n=26,23,19,18,16
    2
    0
    1
    0
    0
        Week 24, n=23,21,16,17,16
    2
    0
    1
    0
    0
        Week 28, n=19,18,12,14,14
    0
    0
    1
    0
    0
        Week 32, n=19,15,10,12,13
    0
    0
    0
    0
    0
        Week 36, n=15,13,10,12,13
    0
    0
    0
    0
    0
        Week 40, n=15,11,9,10,10
    0
    0
    0
    0
    0
        Week 44, n=11,11,6,8,9
    0
    0
    0
    0
    0
        Week 48, n=9,8,5,8,5
    0
    0
    0
    0
    0
        Week 52, n=9,5,5,5,4
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part A: Mean 36-item Short Form health survey version 2 (SF-36 v2) acute score over time

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    End point title
    Part A: Mean 36-item Short Form health survey version 2 (SF-36 v2) acute score over time
    End point description
    SF-36v2 acute health survey questionnaire consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for Physical Component Summary (PCS), Mental Component Summary (MCS) scores was presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 12, 24, 36, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Scores on scale
    arithmetic mean (standard deviation)
        PCS,Baseline, n=42,38,25,23,27
    49.258 ( 11.7655 )
    43.271 ( 12.3169 )
    42.919 ( 11.7298 )
    49.240 ( 9.2759 )
    45.470 ( 12.8498 )
        PCS,Week 12, n=31,28,24,22,22
    51.519 ( 10.5352 )
    43.128 ( 11.4559 )
    43.655 ( 11.0324 )
    48.552 ( 10.4184 )
    47.007 ( 12.8749 )
        PCS,Week 24, n=23,20,15,17,16
    50.023 ( 11.4731 )
    45.677 ( 12.1192 )
    45.097 ( 15.0552 )
    46.911 ( 9.2901 )
    44.280 ( 11.4740 )
        PCS,Week 36, n=15,13,10,12,13
    51.989 ( 10.7521 )
    47.069 ( 12.7103 )
    46.005 ( 12.2496 )
    48.336 ( 10.0154 )
    44.946 ( 10.1921 )
        PCS,Week 52, n=9,5,5,5,4
    50.269 ( 10.8743 )
    53.690 ( 7.9049 )
    53.608 ( 7.7721 )
    52.026 ( 6.4892 )
    53.143 ( 12.8351 )
        MCS,Week 12, n=31,28,24,22,22
    43.955 ( 4.6164 )
    45.264 ( 5.7982 )
    46.393 ( 6.1792 )
    43.746 ( 5.3179 )
    43.182 ( 4.6707 )
        MCS,Week 24, n=23,20,15,17,16
    44.538 ( 5.6952 )
    45.954 ( 5.4884 )
    44.877 ( 6.5210 )
    45.372 ( 6.4561 )
    45.526 ( 5.8924 )
        MCS,Week 36, n=15,13,10,12,13
    45.258 ( 5.2429 )
    45.540 ( 4.8330 )
    44.550 ( 6.7199 )
    42.959 ( 4.8484 )
    46.755 ( 4.8284 )
        MCS,Week 52, n=9,5,5,5,4
    44.810 ( 6.4757 )
    45.008 ( 2.2373 )
    42.004 ( 5.5695 )
    42.258 ( 4.1002 )
    42.125 ( 1.9020 )
    No statistical analyses for this end point

    Secondary: Part A: Mean EuroQol – 5 dimensions, 5 levels (EQ-5D-5L) Index score over time

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    End point title
    Part A: Mean EuroQol – 5 dimensions, 5 levels (EQ-5D-5L) Index score over time
    End point description
    EuroQoL-5Dimensions essentially consists of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant’s health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 12, 24, 36, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Scores on scale
    arithmetic mean (standard deviation)
        Baseline, n=42,38,25,23,27
    0.7918 ( 0.20589 )
    0.6681 ( 0.31299 )
    0.6912 ( 0.19348 )
    0.7429 ( 0.22387 )
    0.7554 ( 0.16610 )
        Week 12, n=31,28,24,22,22
    0.7866 ( 0.22042 )
    0.7024 ( 0.22087 )
    0.7452 ( 0.17942 )
    0.7228 ( 0.16993 )
    0.7069 ( 0.22289 )
        Week 24, n=23,20,15,17,16
    0.7485 ( 0.20310 )
    0.7217 ( 0.21397 )
    0.7135 ( 0.24006 )
    0.7323 ( 0.10346 )
    0.7301 ( 0.11498 )
        Week 36, n=15,13,10,12,13
    0.8011 ( 0.13468 )
    0.7454 ( 0.22373 )
    0.7774 ( 0.11809 )
    0.6950 ( 0.15242 )
    0.7506 ( 0.17536 )
        Week 52, n=9,5,5,5,4
    0.8210 ( 0.13502 )
    0.7628 ( 0.15352 )
    0.8092 ( 0.04275 )
    0.7864 ( 0.05892 )
    0.8068 ( 0.06050 )
    No statistical analyses for this end point

    Secondary: Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) over time

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    End point title
    Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) over time
    End point description
    EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant’s health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1 (best score). The EQ VAS records the respondent’s self-rated health on a vertical line, VAS where the endpoints are ‘Best imaginable health state’ and ‘Worst imaginable health state’.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 12, 24, 36, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Scores on scale
    arithmetic mean (standard deviation)
        Baseline, n=42,38,25,23,27
    67.0 ( 17.83 )
    65.6 ( 21.43 )
    57.0 ( 17.61 )
    62.1 ( 23.81 )
    65.1 ( 16.00 )
        Week 12, n=31,28,24,22,22
    74.3 ( 19.77 )
    64.2 ( 22.89 )
    68.4 ( 19.39 )
    63.3 ( 22.61 )
    65.5 ( 21.33 )
        Week 24, n=23,20,15,17,16
    74.6 ( 16.26 )
    70.6 ( 24.05 )
    65.1 ( 23.11 )
    64.9 ( 19.03 )
    61.5 ( 19.71 )
        Week 36, n=15,13,10,12,13
    79.5 ( 9.55 )
    73.9 ( 24.55 )
    66.9 ( 20.72 )
    68.3 ( 18.66 )
    61.6 ( 21.29 )
        Week 52, n=9,5,5,5,4
    79.9 ( 9.74 )
    80.6 ( 16.50 )
    78.4 ( 14.77 )
    60.2 ( 26.33 )
    70.0 ( 27.41 )
    No statistical analyses for this end point

    Secondary: Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) scores over time

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    End point title
    Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) scores over time
    End point description
    The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Each negatively-worded item response was recoded so that 0 is a bad response and 4 is good response. All responses were added with equal weight to obtain the total score. The total score was calculated as the sum of all the individual items after recoding some of the items.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 12, 24, 36, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Scores on scale
    arithmetic mean (standard deviation)
        Baseline, n=42,38,25,23,27
    38.7 ( 10.72 )
    34.2 ( 12.25 )
    31.1 ( 9.89 )
    38.0 ( 8.37 )
    34.1 ( 13.32 )
        Week 12, n=31,28,24,22,22
    40.2 ( 8.83 )
    32.7 ( 11.25 )
    34.3 ( 11.12 )
    38.5 ( 9.82 )
    35.5 ( 13.34 )
        Week 24, n=23,20,15,17,16
    38.1 ( 10.48 )
    36.5 ( 13.22 )
    31.2 ( 13.09 )
    36.2 ( 6.15 )
    36.0 ( 9.18 )
        Week 36, n=15,13,10,12,13
    41.4 ( 9.41 )
    38.4 ( 9.95 )
    36.9 ( 10.88 )
    40.9 ( 6.49 )
    37.5 ( 10.02 )
        Week 52, n=9,5,5,5,4
    42.1 ( 6.72 )
    43.0 ( 6.48 )
    40.4 ( 5.22 )
    44.0 ( 5.48 )
    41.0 ( 12.25 )
    No statistical analyses for this end point

    Secondary: Part A: Mean Pain Numeric Rating Scale (NRS) scores over time

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    End point title
    Part A: Mean Pain Numeric Rating Scale (NRS) scores over time
    End point description
    The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain on a 11-point numeric rating scale ranging from 0, “no pain” to 10, “the worst pain imaginable”. Data for NRS scores over time for part A is reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Scores on scale
    arithmetic mean (standard deviation)
        Baseline, n=42,38,25,23,27
    1.8 ( 2.31 )
    2.5 ( 2.97 )
    3.1 ( 2.27 )
    2.6 ( 2.09 )
    2.6 ( 2.39 )
        Week 2, n=38,38,25,21,27
    1.3 ( 1.55 )
    2.8 ( 3.08 )
    2.8 ( 1.96 )
    2.6 ( 2.13 )
    2.6 ( 2.63 )
        Week 4, n=36,37,24,22,27
    1.7 ( 2.16 )
    3.1 ( 3.13 )
    3.3 ( 2.20 )
    2.4 ( 2.28 )
    1.8 ( 1.72 )
        Week 8, n=34,30,24,21,23
    1.8 ( 2.42 )
    2.9 ( 2.73 )
    3.0 ( 2.54 )
    2.1 ( 1.96 )
    3.3 ( 2.82 )
        Week 12, n=31,28,24,22,22
    1.7 ( 2.30 )
    3.6 ( 3.05 )
    3.3 ( 2.42 )
    2.3 ( 2.50 )
    2.0 ( 2.08 )
        Week 16, n=27,25,22,19,19
    1.4 ( 2.22 )
    3.3 ( 2.84 )
    3.0 ( 2.60 )
    2.4 ( 2.06 )
    2.7 ( 2.16 )
        Week 20, n=26,23,19,18,15
    1.7 ( 2.27 )
    2.9 ( 2.70 )
    3.6 ( 2.63 )
    1.4 ( 1.54 )
    2.7 ( 2.02 )
        Week 24, n=23,20,15,17,16
    2.4 ( 2.82 )
    2.5 ( 2.42 )
    3.3 ( 2.94 )
    2.4 ( 1.84 )
    3.5 ( 2.22 )
        Week 28, n=18,17,11,13,14
    2.6 ( 2.38 )
    2.8 ( 3.03 )
    3.6 ( 2.87 )
    2.3 ( 2.14 )
    2.9 ( 2.40 )
        Week 32, n=19,14,9,12,12
    2.1 ( 2.57 )
    1.9 ( 2.67 )
    2.9 ( 1.90 )
    2.6 ( 2.15 )
    3.1 ( 2.35 )
        Week 36, n=15,13,10,12,13
    1.6 ( 1.88 )
    2.0 ( 2.55 )
    2.9 ( 2.02 )
    2.3 ( 2.42 )
    1.9 ( 1.93 )
        Week 40, n=15,11,9,10,10
    2.0 ( 2.54 )
    2.0 ( 2.57 )
    3.1 ( 2.09 )
    1.9 ( 1.91 )
    2.6 ( 2.07 )
        Week 44, n=11,11,6,8,8
    2.1 ( 2.74 )
    1.9 ( 2.47 )
    2.2 ( 1.72 )
    1.3 ( 0.71 )
    3.0 ( 2.39 )
        Week 48, n=9,8,5,7,5
    1.9 ( 2.42 )
    0.8 ( 1.04 )
    2.6 ( 0.89 )
    1.6 ( 1.27 )
    4.0 ( 3.74 )
        Week 52, n=9,5,5,5,4
    1.3 ( 1.66 )
    0.8 ( 0.84 )
    2.8 ( 2.28 )
    2.2 ( 0.84 )
    1.0 ( 0.82 )
    No statistical analyses for this end point

    Secondary: Part A: Mean Health Assessment Questionnaire – Disability Index (HAQDI) Score over Time

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    End point title
    Part A: Mean Health Assessment Questionnaire – Disability Index (HAQDI) Score over Time
    End point description
    Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 12, 24, 36 and 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Scores on scale
    arithmetic mean (standard deviation)
        Baseline, n=19,14,13,9,12
    0.6776 ( 0.65658 )
    1.1250 ( 0.75479 )
    0.9615 ( 0.84376 )
    0.8889 ( 0.80875 )
    0.8646 ( 0.62034 )
        Week 12, n=12,8,12,9,9
    0.3229 ( 0.41785 )
    1.0938 ( 0.91063 )
    0.7292 ( 0.87392 )
    0.5694 ( 0.54526 )
    0.9306 ( 0.66764 )
        Week 24, n=10, 7,7,7,9
    0.5875 ( 0.58940 )
    0.8750 ( 0.78395 )
    0.9821 ( 0.92823 )
    0.9107 ( 0.83452 )
    0.9583 ( 0.70986 )
        Week 36, n=6,5,4,4,7
    0.5208 ( 0.70007 )
    0.8250 ( 0.80816 )
    0.6250 ( 0.51031 )
    0.5625 ( 0.58184 )
    1.0000 ( 0.91287 )
        Week 52, n=5,2,3,1,2
    0.3000 ( 0.41079 )
    0.3125 ( 0.44194 )
    0.1667 ( 0.14434 )
    0.0000 ( 99999 )
    0.1875 ( 0.26517 )
    No statistical analyses for this end point

    Secondary: Part A: Number of participants with Patient Global Impression of Change (PGIC) Score over time

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    End point title
    Part A: Number of participants with Patient Global Impression of Change (PGIC) Score over time
    End point description
    Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual’s response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24 and 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Participants
        Week 12,Much Better, n=31,28,24,22,22
    11
    7
    2
    5
    5
        Week 12,Better, n=31,28,24,22,22
    11
    10
    11
    4
    11
        Week 12, Slightly Better, n=31,28,24,22,22
    3
    5
    4
    8
    3
        Week 12,No Change, n=31,28,24,22,22
    3
    3
    4
    0
    3
        Week 12,Slightly Worse, n=31,28,24,22,22
    1
    1
    2
    4
    0
        Week 12,Worse, n=31,28,24,22,22
    2
    2
    1
    1
    0
        Week 12,Much Worse, n=31,28,24,22,22
    0
    0
    0
    0
    0
        Week 24,Much Better, n=23,20,15,17,16
    11
    6
    6
    5
    6
        Week 24,Better, n=23,20,15,17,16
    7
    8
    4
    6
    6
        Week 24, Slightly Better,n=23,20,15,17,16
    2
    2
    0
    4
    1
        Week 24,No Change, n=23,20,15,17,16
    1
    2
    2
    1
    1
        Week 24,Slightly Worse, n=23,20,15,17,16
    2
    1
    2
    1
    1
        Week 24, Worse,n=23,20,15,17,16
    0
    1
    1
    0
    1
        Week 24, Much Worse,n=23,20,15,17,16
    0
    0
    0
    0
    0
        Week 52,Much Better, n=9,5,5,5,4
    6
    3
    3
    2
    3
        Week 52,Better, n=9,5,5,5,4
    2
    2
    1
    2
    0
        Week 52,Slightly Better, n=9,5,5,5,4
    0
    0
    1
    1
    1
        Week 52,No Change, n=9,5,5,5,4
    1
    0
    0
    0
    0
        Week 52,Slightly Worse, n=9,5,5,5,4
    0
    0
    0
    0
    0
        Week 52,Worse, n=9,5,5,5,4
    0
    0
    0
    0
    0
        Week 52,Much Worse, n=9,5,5,5,4
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Part A: Mean Patient Global Assessment of disease activity (PtGA) score over time

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    End point title
    Part A: Mean Patient Global Assessment of disease activity (PtGA) score over time
    End point description
    The Patient’s Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS) of 10 centimeter (cm) ranging from 0 (“very well) to 10 (“very poor”).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Scores on scale
    arithmetic mean (standard deviation)
        Baseline, n=42,39,25,26,27
    2.96 ( 2.148 )
    3.72 ( 2.649 )
    4.24 ( 2.049 )
    3.60 ( 2.133 )
    3.64 ( 2.732 )
        Week 2, n=38,38,25,21,27
    2.59 ( 1.923 )
    3.51 ( 2.389 )
    3.73 ( 1.911 )
    3.45 ( 2.247 )
    3.52 ( 2.177 )
        Week 4, n=36,37,24,22,27
    2.43 ( 2.138 )
    3.75 ( 2.770 )
    3.81 ( 1.737 )
    3.01 ( 1.997 )
    2.62 ( 1.762 )
        Week 8, n=34,30,24,21,23
    1.97 ( 2.076 )
    3.87 ( 2.322 )
    3.44 ( 1.763 )
    2.85 ( 1.769 )
    2.90 ( 2.230 )
        Week 12, n=31,28,24,22,22
    1.97 ( 1.567 )
    3.80 ( 2.557 )
    3.95 ( 2.200 )
    3.20 ( 2.340 )
    2.75 ( 2.056 )
        Week 16, n=27,25,22,19,19
    1.95 ( 2.237 )
    3.82 ( 2.615 )
    3.39 ( 2.523 )
    2.86 ( 1.809 )
    2.76 ( 1.777 )
        Week 20, n=26,23,19,18,15
    2.60 ( 2.089 )
    3.20 ( 2.663 )
    4.17 ( 2.334 )
    2.45 ( 1.697 )
    2.90 ( 1.869 )
        Week 24, n=23,20,15,17,16
    2.63 ( 2.140 )
    2.33 ( 1.975 )
    3.83 ( 2.447 )
    2.85 ( 2.256 )
    3.34 ( 1.791 )
        Week 28, n=18,17,11,13,14
    2.44 ( 2.094 )
    3.09 ( 2.915 )
    4.18 ( 2.169 )
    2.68 ( 2.106 )
    2.74 ( 1.791 )
        Week 32, n=19,14,9,12,12
    2.01 ( 1.781 )
    2.22 ( 2.564 )
    3.02 ( 1.199 )
    2.43 ( 2.385 )
    2.88 ( 2.541 )
        Week 36, n=15,13,10,12,13
    1.46 ( 1.253 )
    2.66 ( 2.982 )
    2.79 ( 2.013 )
    2.68 ( 2.490 )
    2.62 ( 1.990 )
        Week 40, n=15,11,9,10,10
    2.05 ( 1.809 )
    2.35 ( 2.495 )
    3.20 ( 2.329 )
    2.24 ( 1.883 )
    3.00 ( 2.658 )
        Week 44, n=11,11,6,8,8
    2.28 ( 2.872 )
    2.19 ( 2.429 )
    2.17 ( 1.824 )
    2.18 ( 1.835 )
    3.49 ( 2.322 )
        Week 48, n=9,8,5,7,5
    1.81 ( 1.934 )
    1.03 ( 1.253 )
    2.30 ( 1.515 )
    1.86 ( 1.586 )
    4.48 ( 3.545 )
        Week 52, n=9,5,5,5,4
    1.10 ( 0.857 )
    0.46 ( 0.358 )
    2.76 ( 2.668 )
    2.44 ( 1.716 )
    2.13 ( 2.651 )
    No statistical analyses for this end point

    Secondary: Part A: Mean Physician Global Assessment of disease activity (PhGA) score over time

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    End point title
    Part A: Mean Physician Global Assessment of disease activity (PhGA) score over time
    End point description
    The Physician's Global Assessments of Disease Activity was recorded on a VAS of 10 cm ranging from 0 (“none”) to 10 (“extremely active”).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Scores on scale
    arithmetic mean (standard deviation)
        Baseline, n=42,39,25,26,27
    2.33 ( 2.101 )
    2.95 ( 2.208 )
    2.94 ( 2.374 )
    3.05 ( 2.501 )
    3.25 ( 2.823 )
        Week 2, n=36,35,25,20,26
    1.09 ( 1.373 )
    1.52 ( 1.822 )
    1.83 ( 1.558 )
    1.85 ( 1.879 )
    1.76 ( 2.094 )
        Week 4, n=33,32,23,21,25
    0.81 ( 1.191 )
    1.44 ( 1.904 )
    1.55 ( 1.236 )
    0.92 ( 1.125 )
    1.02 ( 1.090 )
        Week 8, n=33,28,23,20,21
    1.09 ( 1.508 )
    1.30 ( 1.723 )
    1.35 ( 1.229 )
    0.79 ( 0.798 )
    1.14 ( 1.226 )
        Week 12, n=29,25,23,18,21
    1.08 ( 1.486 )
    1.81 ( 2.183 )
    1.64 ( 1.908 )
    1.28 ( 1.629 )
    1.47 ( 2.151 )
        Week 16, n=26,23,21,16,19
    0.74 ( 0.895 )
    1.54 ( 1.793 )
    1.87 ( 2.078 )
    1.39 ( 1.830 )
    0.67 ( 0.779 )
        Week 20, n=25,23,18,17,15
    0.71 ( 1.189 )
    1.42 ( 1.808 )
    1.16 ( 1.628 )
    0.83 ( 0.882 )
    1.27 ( 1.622 )
        Week 24, n=20,20,15,15,15
    0.82 ( 1.089 )
    0.68 ( 0.869 )
    1.50 ( 1.690 )
    1.48 ( 2.003 )
    1.37 ( 1.551 )
        Week 28, n=17,17,11,12,13
    0.76 ( 1.068 )
    1.43 ( 1.986 )
    1.18 ( 2.116 )
    0.88 ( 0.586 )
    0.85 ( 1.440 )
        Week 32, n=19,14,8,11,12
    0.83 ( 1.320 )
    0.67 ( 0.841 )
    1.40 ( 1.516 )
    1.26 ( 1.546 )
    0.89 ( 1.672 )
        Week 36, n=13,11,10,11,13
    0.48 ( 0.660 )
    1.12 ( 1.589 )
    0.61 ( 0.792 )
    0.56 ( 0.408 )
    0.75 ( 0.906 )
        Week 40, n=13,9,8,9,10
    0.38 ( 0.395 )
    0.77 ( 1.417 )
    0.36 ( 0.283 )
    0.52 ( 0.531 )
    0.57 ( 0.566 )
        Week 44, n=10,9,6,8,7
    0.31 ( 0.228 )
    1.07 ( 1.574 )
    0.43 ( 0.547 )
    0.58 ( 0.740 )
    0.87 ( 1.404 )
        Week 48, n=7,7,5,6,5
    0.27 ( 0.446 )
    0.31 ( 0.540 )
    0.30 ( 0.316 )
    0.78 ( 1.482 )
    1.60 ( 2.164 )
        Week 52, n=9,5,5,4,4
    0.31 ( 0.434 )
    0.10 ( 0.141 )
    0.32 ( 0.311 )
    1.35 ( 0.947 )
    1.80 ( 3.082 )
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in serum C Reactive Protein (CRP) over time

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    End point title
    Part A: Change from Baseline in serum C Reactive Protein (CRP) over time
    End point description
    Blood samples were collected for analysis of CRP. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in serum CRP over time for part A was reported. The Safety set comprised of all randomized participants who received at least 1 dose of SC IP.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Milligrams per liter
    arithmetic mean (standard deviation)
        Week 2,n=38,39,26,24,26
    -5.07 ( 6.616 )
    -8.81 ( 22.954 )
    -5.15 ( 8.436 )
    1.27 ( 13.155 )
    1.07 ( 6.794 )
        Week 4,n=37,38,25,23,27
    -4.39 ( 6.384 )
    -9.01 ( 23.327 )
    -4.09 ( 7.169 )
    4.91 ( 10.503 )
    0.76 ( 5.511 )
        Week 8,n=34,31,24,22,23
    -4.98 ( 6.583 )
    -9.94 ( 25.685 )
    -4.19 ( 7.197 )
    10.00 ( 14.652 )
    7.86 ( 25.894 )
        Week 12,n=32,28,24,21,21
    -5.08 ( 6.690 )
    -9.96 ( 26.849 )
    -4.22 ( 7.335 )
    14.81 ( 18.082 )
    4.04 ( 9.339 )
        Week 16,n=28,26,22,19,18
    -4.35 ( 5.648 )
    -10.43 ( 27.765 )
    -4.48 ( 7.621 )
    10.53 ( 17.303 )
    6.99 ( 15.503 )
        Week 20,n=26,23,19,18,16
    -4.50 ( 5.876 )
    -11.67 ( 29.422 )
    -4.78 ( 8.100 )
    5.32 ( 14.506 )
    2.35 ( 7.840 )
        Week 24,n=23,20,16,17,16
    -4.38 ( 4.640 )
    -13.19 ( 31.269 )
    -5.14 ( 8.837 )
    5.07 ( 13.815 )
    6.54 ( 20.711 )
        Week 28,n=19,18,12,14,14
    -5.28 ( 6.498 )
    -13.42 ( 33.182 )
    -6.33 ( 10.022 )
    1.87 ( 10.926 )
    0.22 ( 11.318 )
        Week 32,n=19,15,10,12,13
    -4.85 ( 7.259 )
    -14.47 ( 36.343 )
    -7.15 ( 10.875 )
    2.61 ( 9.835 )
    4.37 ( 16.277 )
        Week 36,n=15,12,10,12,13
    -4.72 ( 4.473 )
    -16.28 ( 40.531 )
    -7.08 ( 10.874 )
    5.73 ( 19.040 )
    1.64 ( 10.418 )
        Week 40,n=15,11,8,10,10
    -4.72 ( 4.374 )
    -17.67 ( 42.240 )
    -4.69 ( 8.510 )
    6.27 ( 21.164 )
    2.77 ( 13.101 )
        Week 44,n=11,11,6,8,9
    -5.35 ( 4.523 )
    -17.47 ( 42.350 )
    -1.90 ( 1.456 )
    2.80 ( 20.439 )
    5.13 ( 7.292 )
        Week 48,n=9,7,5,8,5
    -5.91 ( 4.993 )
    -23.39 ( 52.962 )
    -2.20 ( 1.562 )
    6.31 ( 20.952 )
    8.10 ( 18.084 )
        Week 52,n=9,5,5,5,4
    -6.00 ( 4.663 )
    -7.26 ( 9.461 )
    -2.20 ( 1.575 )
    0.64 ( 9.453 )
    -1.65 ( 4.561 )
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in Erythrocyte Sedimentation Rate (ESR) over time

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    End point title
    Part A: Change from Baseline in Erythrocyte Sedimentation Rate (ESR) over time
    End point description
    Blood samples were collected for analysis of ESR. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in ESR over time for part A was reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Millimeters per hour
    arithmetic mean (standard deviation)
        Week 2,n=37,39,26,24,26
    -13.05 ( 9.885 )
    -12.78 ( 15.560 )
    -14.62 ( 16.500 )
    -1.33 ( 9.323 )
    -9.96 ( 20.142 )
        Week 4,n=36,38,25,22,27
    -12.83 ( 9.346 )
    -17.41 ( 15.867 )
    -14.13 ( 12.419 )
    7.59 ( 15.308 )
    -5.30 ( 22.250 )
        Week 8,n=33,31,24,22,23
    -14.21 ( 9.927 )
    -18.76 ( 17.727 )
    -15.05 ( 14.030 )
    6.41 ( 12.105 )
    1.78 ( 27.361 )
        Week 12,n=32,28,24,22,22
    -14.97 ( 11.361 )
    -17.89 ( 17.846 )
    -14.30 ( 13.271 )
    20.36 ( 18.017 )
    -2.55 ( 21.498 )
        Week 16,n=28,26,22,19,19
    -12.50 ( 10.469 )
    -17.17 ( 17.693 )
    -15.37 ( 13.956 )
    14.21 ( 25.189 )
    -2.53 ( 20.839 )
        Week 20,n=26,23,18,18,16
    -13.19 ( 9.600 )
    -17.07 ( 18.498 )
    -14.33 ( 15.442 )
    10.00 ( 22.141 )
    -5.81 ( 23.063 )
        Week 24,n=23,19,16,17,16
    -13.63 ( 11.209 )
    -16.84 ( 15.378 )
    -14.89 ( 14.504 )
    7.59 ( 21.567 )
    -3.06 ( 22.389 )
        Week 28,n=19,18,11,14,14
    -15.26 ( 12.274 )
    -19.94 ( 20.069 )
    -16.84 ( 16.856 )
    1.50 ( 15.854 )
    -1.71 ( 29.148 )
        Week 32,n=19,15,10,12,13
    -13.26 ( 17.486 )
    -19.80 ( 19.266 )
    -14.52 ( 13.630 )
    -2.42 ( 20.129 )
    -2.85 ( 29.493 )
        Week 36,n=15,12,10,12, 13
    -14.47 ( 11.673 )
    -21.25 ( 20.855 )
    -14.42 ( 13.482 )
    0.67 ( 19.009 )
    0.92 ( 28.324 )
        Week 40,n=15,11,9,10,10
    -14.40 ( 12.070 )
    -22.27 ( 21.873 )
    -11.24 ( 13.277 )
    9.80 ( 28.840 )
    -2.60 ( 27.818 )
        Week 44,n=11,11,6,8,8
    -12.64 ( 10.347 )
    -22.18 ( 21.409 )
    -12.00 ( 13.520 )
    4.88 ( 18.256 )
    2.88 ( 21.860 )
        Week 48,n=9,8,5,8,5
    -15.33 ( 11.822 )
    -25.63 ( 24.372 )
    -14.00 ( 14.335 )
    4.50 ( 24.308 )
    8.60 ( 25.205 )
        Week 52,n=9,5,5,5,4
    -14.78 ( 11.692 )
    -24.60 ( 17.700 )
    -12.80 ( 15.385 )
    -4.60 ( 10.431 )
    1.25 ( 15.042 )
    No statistical analyses for this end point

    Secondary: Part A: Number of participants with adverse events (AEs), serious AEs (SAEs) and corticosteroid related AEs

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    End point title
    Part A: Number of participants with adverse events (AEs), serious AEs (SAEs) and corticosteroid related AEs
    End point description
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs have been reported.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Participants
        Any AE
    41
    36
    25
    26
    24
        Any SAE
    8
    6
    6
    5
    6
        Any Corticosteroid related AE
    18
    21
    15
    13
    12
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

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    End point title
    Part A: Change from Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
    End point description
    SBP and DBP were measured in semi-supine position after 5 minutes rest at indicated time points. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Millimeters of mercury
    arithmetic mean (standard deviation)
        SBP,Week 2,n=37,39,26,24,27
    -0.9 ( 13.11 )
    3.5 ( 13.97 )
    -2.1 ( 17.19 )
    5.7 ( 12.67 )
    -0.9 ( 15.63 )
        SBP,Week 4,n=37,37,25,23,27
    -0.9 ( 15.17 )
    0.2 ( 15.99 )
    -4.7 ( 15.00 )
    -2.2 ( 14.60 )
    -3.4 ( 14.25 )
        SBP,Week 8,n=34,32,24,22,23
    0.3 ( 14.33 )
    -3.9 ( 17.17 )
    -3.5 ( 15.73 )
    -0.8 ( 18.94 )
    -8.3 ( 21.05 )
        SBP,Week 12,n=32,29,24,22,22
    -2.3 ( 15.19 )
    -2.4 ( 17.15 )
    -6.2 ( 13.45 )
    1.4 ( 12.97 )
    -6.1 ( 19.31 )
        SBP,Week 16,n=28,26,22,19,19
    -6.0 ( 15.39 )
    -5.1 ( 18.28 )
    -3.0 ( 20.22 )
    1.9 ( 17.51 )
    -6.4 ( 12.73 )
        SBP,Week 20,n=26,23,19,18,16
    -6.7 ( 10.73 )
    -0.7 ( 14.09 )
    -3.4 ( 15.39 )
    -1.7 ( 17.16 )
    -9.4 ( 21.44 )
        SBP,Week 24,n=23,21,16,17,16
    -5.2 ( 12.65 )
    -2.5 ( 15.46 )
    -5.6 ( 16.55 )
    -2.6 ( 18.75 )
    -8.6 ( 15.65 )
        SBP,Week 28,n=19,18,12,14,14
    -8.8 ( 12.87 )
    -4.2 ( 20.49 )
    -0.1 ( 14.76 )
    6.4 ( 19.31 )
    -2.6 ( 17.71 )
        SBP,Week 32,n=19,15,10,12,13
    -10.7 ( 13.96 )
    -3.7 ( 15.03 )
    -7.4 ( 11.80 )
    3.4 ( 14.99 )
    -8.8 ( 14.80 )
        SBP,Week 36,n=15,13,10,12,13
    -6.2 ( 13.92 )
    -8.0 ( 15.80 )
    -6.8 ( 12.10 )
    -0.6 ( 20.46 )
    -2.5 ( 16.13 )
        SBP,Week 40,n=15,11,9,10,10
    -11.9 ( 11.75 )
    0.9 ( 13.14 )
    -4.8 ( 14.17 )
    2.1 ( 19.31 )
    -7.4 ( 20.14 )
        SBP,Week 44,n=11,11,6,8,9
    -12.7 ( 17.66 )
    -4.2 ( 19.22 )
    2.7 ( 13.26 )
    2.9 ( 15.99 )
    1.8 ( 13.91 )
        SBP,Week 48,n=9,8,5,8,5
    -13.6 ( 11.85 )
    -0.4 ( 9.44 )
    -3.6 ( 28.13 )
    8.8 ( 14.15 )
    4.8 ( 15.51 )
        SBP,Week 52,n=9,5,5,5,4
    -8.1 ( 15.85 )
    1.2 ( 14.46 )
    2.2 ( 19.52 )
    2.2 ( 18.46 )
    -3.8 ( 12.34 )
        DBP,Week 2,n=37,39,26,24,27
    0.3 ( 7.41 )
    1.2 ( 10.05 )
    -2.3 ( 14.00 )
    2.4 ( 9.85 )
    -2.2 ( 9.22 )
        DBP,Week 4,n=37,37,25,23,27
    1.8 ( 8.85 )
    1.5 ( 10.24 )
    -4.1 ( 13.22 )
    0.1 ( 11.66 )
    -3.0 ( 10.22 )
        DBP,Week 8,n=34,32,24,22,23
    2.1 ( 8.47 )
    -1.3 ( 7.62 )
    -4.0 ( 12.26 )
    2.6 ( 11.27 )
    -5.6 ( 11.83 )
        DBP,Week 12,n=32,29,24,22,22
    1.0 ( 9.60 )
    2.0 ( 12.35 )
    -4.7 ( 12.14 )
    1.3 ( 10.58 )
    -2.5 ( 11.16 )
        DBP,Week 16,n=28,26,22,19,19
    0.2 ( 7.48 )
    -2.5 ( 11.58 )
    -3.1 ( 12.80 )
    -1.3 ( 10.64 )
    -3.4 ( 7.97 )
        DBP,Week 20,n=26,23,19,18,16
    -0.9 ( 7.66 )
    1.4 ( 12.47 )
    -3.2 ( 16.21 )
    -2.0 ( 9.06 )
    -2.1 ( 10.98 )
        DBP,Week 24,n=23,21,16,17,16
    1.3 ( 8.72 )
    -0.6 ( 12.85 )
    -2.7 ( 11.77 )
    -3.3 ( 10.21 )
    -3.1 ( 9.27 )
        DBP,Week 28,n=19,18,12,14,14
    -3.1 ( 9.39 )
    -2.2 ( 10.05 )
    -4.3 ( 15.80 )
    0.1 ( 13.87 )
    -1.9 ( 10.37 )
        DBP,Week 32,n=19,15,10,12,13
    -4.2 ( 7.50 )
    -2.3 ( 12.92 )
    -6.9 ( 25.47 )
    -1.2 ( 11.17 )
    -5.8 ( 9.09 )
        DBP,Week 36,n=15,13,10,12,13
    -0.6 ( 8.92 )
    -5.1 ( 9.89 )
    -5.6 ( 17.02 )
    -1.2 ( 13.31 )
    -2.7 ( 13.05 )
        DBP,Week 40,n=15,11,9,10,10
    -6.9 ( 12.41 )
    2.6 ( 11.88 )
    -8.0 ( 21.60 )
    -2.0 ( 14.07 )
    -6.1 ( 11.97 )
        DBP,Week 44,n=11,11,6,8,9
    -2.7 ( 12.10 )
    -6.5 ( 14.56 )
    -2.5 ( 23.89 )
    -1.5 ( 8.28 )
    1.3 ( 11.36 )
        DBP,Week 48,n=9,8,5,8,5
    -5.6 ( 11.79 )
    -2.3 ( 11.42 )
    -2.0 ( 16.00 )
    -3.4 ( 12.75 )
    0.6 ( 8.47 )
        DBP,Week 52,n=9,5,5,5,4
    0.2 ( 12.55 )
    1.8 ( 10.23 )
    2.2 ( 3.35 )
    1.4 ( 11.89 )
    0.5 ( 5.92 )
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in Pulse Rate

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    End point title
    Part A: Change from Baseline in Pulse Rate
    End point description
    Pulse rate was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Week 2, ,n=37,39,25,24,27
    -1.9 ( 8.07 )
    -2.1 ( 8.93 )
    1.8 ( 10.40 )
    -0.4 ( 12.34 )
    -1.6 ( 9.79 )
        Week 4,n=37,37,25,22,27
    0.2 ( 8.82 )
    -1.4 ( 8.94 )
    -2.4 ( 9.42 )
    2.2 ( 13.39 )
    -1.9 ( 10.33 )
        Week 8,n=34,32,24,22,23
    -1.1 ( 10.23 )
    -3.2 ( 11.42 )
    -3.1 ( 8.80 )
    4.3 ( 12.36 )
    0.5 ( 11.06 )
        Week 12,n=32,29,23,22,22
    -3.8 ( 8.50 )
    -1.2 ( 13.62 )
    -0.8 ( 8.35 )
    4.5 ( 14.54 )
    -2.7 ( 10.95 )
        Week 16,n=28,26,22,19,19
    -3.4 ( 10.79 )
    0.3 ( 9.06 )
    -5.3 ( 10.32 )
    0.3 ( 15.04 )
    -2.2 ( 10.76 )
        Week 20,n=26,23,19,18,16
    -3.0 ( 9.75 )
    0.2 ( 11.35 )
    -0.7 ( 12.62 )
    1.0 ( 13.76 )
    -4.0 ( 12.54 )
        Week 24,n=23,21,16,17,16
    -2.1 ( 9.29 )
    -3.5 ( 11.18 )
    0.7 ( 14.13 )
    0.1 ( 12.76 )
    2.7 ( 8.27 )
        Week 28,n=19,18,12,14,14
    -1.4 ( 10.33 )
    -1.2 ( 9.21 )
    -3.5 ( 13.26 )
    0.1 ( 13.24 )
    0.5 ( 10.60 )
        Week 32,n=19,15,10,12,13
    -1.3 ( 8.20 )
    -4.7 ( 8.50 )
    -2.2 ( 10.78 )
    -0.8 ( 16.10 )
    -0.6 ( 12.58 )
        Week 36,n=15,13,10,12,13
    -5.9 ( 9.79 )
    -5.1 ( 9.06 )
    -4.5 ( 9.12 )
    -0.5 ( 12.22 )
    -3.2 ( 9.83 )
        Week 40,n=15,11,9,10,10
    -3.9 ( 5.64 )
    -3.0 ( 11.93 )
    -3.4 ( 10.57 )
    3.3 ( 12.83 )
    -3.8 ( 14.09 )
        Week 44,n=11,11,6,8,9
    -7.1 ( 8.01 )
    -3.4 ( 15.86 )
    -8.3 ( 13.41 )
    4.3 ( 15.34 )
    -3.4 ( 8.57 )
        Week 48,n=9,8,5,8,5
    -8.2 ( 7.36 )
    -9.3 ( 8.76 )
    -7.2 ( 10.47 )
    -1.9 ( 11.47 )
    0.0 ( 16.72 )
        Week 52,n=9,5,5,5,4
    -5.0 ( 12.97 )
    -11.0 ( 3.74 )
    -4.0 ( 15.89 )
    6.8 ( 6.34 )
    -5.3 ( 12.04 )
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in Temperature

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    End point title
    Part A: Change from Baseline in Temperature
    End point description
    Temperature was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month prednisone PartA:SIR 100 mg SC q2w+3 month prednisone PartA:SIR 50 mg SC q4w+6 month prednisone PartA:Placebo SC q2w + 6 month prednisone PartA:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Celsius
    arithmetic mean (standard deviation)
        Week 2, ,n=37,39,26,24,27
    -0.11 ( 0.269 )
    -0.04 ( 0.336 )
    0.03 ( 0.433 )
    -0.16 ( 0.421 )
    0.10 ( 0.449 )
        Week 4,n=37,37,25,23,27
    -0.12 ( 0.345 )
    0.01 ( 0.407 )
    0.04 ( 0.399 )
    -0.10 ( 0.387 )
    0.11 ( 0.340 )
        Week 8,n=34,32,23,22,23
    -0.04 ( 0.400 )
    -0.09 ( 0.432 )
    -0.07 ( 0.553 )
    0.04 ( 0.579 )
    0.19 ( 0.425 )
        Week 12,n=32,29,24,22,22
    -0.08 ( 0.461 )
    -0.11 ( 0.367 )
    0.01 ( 0.444 )
    -0.15 ( 0.494 )
    0.09 ( 0.450 )
        Week 16,n=28,26,22,19,19
    -0.08 ( 0.313 )
    -0.05 ( 0.392 )
    0.04 ( 0.316 )
    -0.21 ( 0.664 )
    0.09 ( 0.317 )
        Week 20,n=26,23,19,18,16
    0.03 ( 0.428 )
    -0.05 ( 0.483 )
    -0.12 ( 0.651 )
    -0.07 ( 0.355 )
    0.05 ( 0.395 )
        Week 24,n=23,21,16,17,16
    0.03 ( 0.389 )
    -0.11 ( 0.255 )
    -0.11 ( 0.558 )
    -0.26 ( 0.476 )
    0.04 ( 0.441 )
        Week 28,n=19,18,12,13,14
    0.03 ( 0.444 )
    -0.07 ( 0.517 )
    -0.09 ( 0.683 )
    -0.16 ( 0.479 )
    -0.06 ( 0.282 )
        Week 32,n=19,15,10,12,13
    -0.01 ( 0.515 )
    -0.07 ( 0.349 )
    0.28 ( 0.418 )
    -0.13 ( 0.367 )
    0.01 ( 0.364 )
        Week 36,n=15,13,9,12,13
    -0.09 ( 0.406 )
    -0.11 ( 0.569 )
    -0.10 ( 0.391 )
    -0.09 ( 0.390 )
    -0.08 ( 0.367 )
        Week 40,n=15,11,9,10,10
    0.08 ( 0.426 )
    -0.03 ( 0.454 )
    0.18 ( 0.438 )
    -0.05 ( 0.334 )
    -0.05 ( 0.306 )
        Week 44,n=11,11,6,8,9
    -0.14 ( 0.347 )
    -0.06 ( 0.391 )
    -0.03 ( 0.314 )
    0.00 ( 0.438 )
    -0.08 ( 0.396 )
        Week 48,n=9,8,5,8,5
    -0.22 ( 0.233 )
    -0.05 ( 0.510 )
    -0.14 ( 0.498 )
    -0.01 ( 0.280 )
    -0.08 ( 0.559 )
        Week 52,n=9,5,5,5,4
    -0.08 ( 0.291 )
    -0.32 ( 0.286 )
    0.14 ( 0.230 )
    0.02 ( 0.409 )
    -0.08 ( 0.814 )
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets

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    End point title
    Part A: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
    End point description
    Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Giga cells per liter
    arithmetic mean (standard deviation)
        Eosinophils,Week 2,n=37,36,24,23,25
    0.019 ( 0.0543 )
    0.001 ( 0.0690 )
    0.010 ( 0.0433 )
    0.015 ( 0.0557 )
    0.062 ( 0.2084 )
        Eosinophils,Week 4,n=36,37,24,22,26
    0.043 ( 0.0934 )
    0.035 ( 0.1238 )
    0.012 ( 0.0719 )
    0.023 ( 0.0617 )
    0.030 ( 0.1164 )
        Eosinophils,Week 8,n=34,29,22,22,21
    0.056 ( 0.0959 )
    0.102 ( 0.1634 )
    0.054 ( 0.1036 )
    0.048 ( 0.1498 )
    0.010 ( 0.0591 )
        Eosinophils,Week 12,n=31,28,23,22,22
    0.077 ( 0.1128 )
    0.155 ( 0.1971 )
    0.090 ( 0.0860 )
    0.090 ( 0.1684 )
    0.030 ( 0.0548 )
        Eosinophils,Week 16,n=27,26,20,19,19
    0.097 ( 0.1307 )
    0.162 ( 0.2170 )
    0.117 ( 0.1772 )
    0.067 ( 0.1148 )
    0.067 ( 0.1746 )
        Eosinophils,Week 20,n=25,22,18,17,16
    0.166 ( 0.2073 )
    0.114 ( 0.2085 )
    0.136 ( 0.1518 )
    0.094 ( 0.1743 )
    0.057 ( 0.0637 )
        Eosinophils,Week 24,n=22,21,16,16,16
    0.210 ( 0.4418 )
    0.109 ( 0.1590 )
    0.109 ( 0.1094 )
    0.089 ( 0.2392 )
    0.051 ( 0.0676 )
        Eosinophils,Week 28,n=18,18,11,14,13
    0.163 ( 0.2562 )
    0.068 ( 0.1340 )
    0.120 ( 0.1340 )
    0.046 ( 0.0714 )
    0.051 ( 0.0538 )
        Eosinophils,Week 32,n=19,15,10,12,13
    0.244 ( 0.3707 )
    0.069 ( 0.1580 )
    0.092 ( 0.1253 )
    0.038 ( 0.0597 )
    0.056 ( 0.0733 )
        Eosinophils,Week 36,n=15,12,10,12,12
    0.282 ( 0.3117 )
    0.076 ( 0.1753 )
    0.153 ( 0.1166 )
    0.049 ( 0.0720 )
    0.059 ( 0.0585 )
        Eosinophils,Week 40,n=14,11,8,10,10
    0.191 ( 0.2175 )
    0.075 ( 0.1924 )
    0.104 ( 0.1161 )
    0.065 ( 0.0737 )
    0.071 ( 0.1140 )
        Eosinophils,Week 44,n=11,10,6,7,9
    0.144 ( 0.1952 )
    0.045 ( 0.1329 )
    0.165 ( 0.1564 )
    0.024 ( 0.0541 )
    0.066 ( 0.0600 )
        Eosinophils,Week 48,n=9,8,4,8,5
    0.091 ( 0.0664 )
    0.059 ( 0.1561 )
    0.233 ( 0.2387 )
    0.028 ( 0.0489 )
    0.030 ( 0.0604 )
        Eosinophils,Week 52,n=8,5,5,5,4
    0.151 ( 0.1865 )
    0.192 ( 0.1839 )
    0.172 ( 0.1207 )
    0.108 ( 0.1139 )
    0.013 ( 0.0802 )
        Leukocytes,Week 2,n=37,38,24,24,25
    -3.12 ( 2.268 )
    -3.63 ( 1.971 )
    -3.32 ( 2.816 )
    -0.76 ( 2.145 )
    0.34 ( 2.238 )
        Leukocytes,Week 4,n=36,37,24,22,26
    -3.66 ( 2.621 )
    -4.76 ( 2.411 )
    -4.07 ( 2.157 )
    -1.64 ( 2.247 )
    -0.16 ( 2.330 )
        Leukocytes,Week 8,n=34,29,23,22,21
    -4.04 ( 2.481 )
    -5.65 ( 3.672 )
    -4.42 ( 2.469 )
    -1.79 ( 2.682 )
    -0.26 ( 1.880 )
        Leukocytes,Week 12,n=31,28,23,22,22
    -4.68 ( 2.666 )
    -5.67 ( 2.551 )
    -5.23 ( 2.581 )
    -2.66 ( 2.883 )
    -1.28 ( 1.810 )
        Leukocytes,Week 16,n=27,26,20,19,19
    -5.21 ( 2.244 )
    -5.61 ( 3.502 )
    -5.36 ( 2.309 )
    -2.98 ( 3.018 )
    -0.79 ( 3.018 )
        Leukocytes,Week 20,n=25,23,18,18,16
    -5.24 ( 1.950 )
    -5.20 ( 3.104 )
    -5.40 ( 2.414 )
    -3.24 ( 3.592 )
    -1.71 ( 2.840 )
        Leukocytes,Week 24,n=22,21,16,16,16
    -5.14 ( 3.559 )
    -6.39 ( 2.952 )
    -5.01 ( 1.884 )
    -2.89 ( 3.892 )
    -1.52 ( 2.738 )
        Leukocytes,Week 28,n=18,18,12,14,13
    -5.46 ( 2.619 )
    -6.04 ( 3.274 )
    -4.58 ( 2.143 )
    -3.01 ( 3.368 )
    -1.97 ( 3.461 )
        Leukocytes,Week 32,n=19,15,10,12,13
    -5.71 ( 2.419 )
    -5.61 ( 3.250 )
    -5.27 ( 1.696 )
    -3.43 ( 3.342 )
    -2.33 ( 3.011 )
        Leukocytes,Week 36,n=15,12,10,12,12
    -5.76 ( 2.106 )
    -6.82 ( 2.814 )
    -5.58 ( 1.757 )
    -3.36 ( 3.612 )
    -2.95 ( 3.635 )
        Leukocytes,Week 40,n=14,11,8,10,10
    -6.14 ( 1.987 )
    -7.10 ( 2.534 )
    -6.46 ( 2.130 )
    -3.18 ( 3.662 )
    -2.23 ( 3.142 )
        Leukocytes,Week 44,n=11,10,6,7,9
    -6.25 ( 2.300 )
    -6.95 ( 2.441 )
    -6.17 ( 1.726 )
    -2.83 ( 3.875 )
    -3.08 ( 3.056 )
        Leukocytes,Week 48,n=9,8,4,8,5
    -6.88 ( 2.436 )
    -7.35 ( 2.853 )
    -6.48 ( 2.887 )
    -2.69 ( 2.979 )
    -3.00 ( 3.045 )
        Leukocytes,Week 52,n=8,5,5,5,4
    -6.66 ( 2.654 )
    -7.36 ( 2.920 )
    -6.38 ( 2.262 )
    -3.84 ( 3.467 )
    -3.10 ( 4.090 )
        Lymphocytes,Week 2,n=37,36,24,23,25
    0.015 ( 1.1645 )
    0.002 ( 1.2620 )
    -0.041 ( 1.3241 )
    -0.159 ( 0.9064 )
    -0.209 ( 0.9381 )
        Lymphocytes,Week 4,n=36,37,24,22,26
    0.027 ( 1.2460 )
    -0.255 ( 1.2225 )
    0.057 ( 1.2338 )
    -0.002 ( 0.7340 )
    -0.382 ( 1.0808 )
        Lymphocytes,Week 8,n=34,29,22,22,21
    -0.191 ( 1.3361 )
    -0.411 ( 1.2086 )
    -0.067 ( 1.2814 )
    -0.049 ( 1.0832 )
    -0.516 ( 0.8562 )
        Lymphocytes,Week 12,n=31,28,23,22,22
    -0.215 ( 1.3052 )
    -0.437 ( 1.2479 )
    -0.081 ( 1.2018 )
    -0.128 ( 1.0505 )
    -0.344 ( 0.7846 )
        Lymphocytes,Week 16,n=27,26,20,19,19
    -0.450 ( 1.3450 )
    -0.704 ( 1.2994 )
    -0.153 ( 0.7804 )
    -0.327 ( 1.4269 )
    -0.635 ( 0.8037 )
        Lymphocytes,Week 20,n=25,22,18,17,16
    -0.616 ( 1.2793 )
    -0.313 ( 1.3011 )
    -0.439 ( 1.4363 )
    -0.385 ( 0.8819 )
    -0.533 ( 0.7432 )
        Lymphocytes,Week 24,n=22,21,16,16,16
    -0.399 ( 1.4276 )
    -0.179 ( 1.8386 )
    -0.073 ( 0.7890 )
    -0.401 ( 1.2030 )
    -0.386 ( 0.7504 )
        Lymphocytes,Week 28,n=18,18,11,14,13
    -0.614 ( 1.5450 )
    -0.273 ( 1.3296 )
    -0.192 ( 0.7271 )
    -0.258 ( 1.0211 )
    -0.565 ( 1.0397 )
        Lymphocytes,Week 32,n=19,15,10,12,13
    -0.602 ( 1.3438 )
    -0.407 ( 1.4002 )
    -0.476 ( 0.7997 )
    -0.402 ( 1.2625 )
    -0.492 ( 0.7877 )
        Lymphocytes,Week 36,n=15,12,10,12,12
    -0.625 ( 1.5738 )
    -0.672 ( 1.2263 )
    -0.430 ( 0.7690 )
    -0.417 ( 1.0538 )
    -0.078 ( 0.7182 )
        Lymphocytes,Week 40,n=14,11,8,10,10
    -0.929 ( 1.5351 )
    -0.845 ( 1.3603 )
    -0.570 ( 0.8261 )
    -0.519 ( 1.1491 )
    -0.681 ( 0.7363 )
        Lymphocytes,Week 44,n=11,10,6,7,9
    -0.915 ( 1.2235 )
    -1.047 ( 1.3375 )
    -0.198 ( 0.9783 )
    -1.029 ( 1.0293 )
    -0.343 ( 0.8113 )
        Lymphocytes,Week 48,n=9,8,4,8,5
    -1.258 ( 1.2063 )
    -0.923 ( 1.4811 )
    0.118 ( 1.0588 )
    -0.576 ( 1.1994 )
    -0.510 ( 1.1450 )
        Lymphocytes,Week 52,n=8,5,5,5,4
    -1.253 ( 1.2857 )
    -0.754 ( 1.0291 )
    -0.286 ( 1.0455 )
    0.194 ( 0.8800 )
    -0.128 ( 1.2618 )
        Neutrophils,Week 2,n=37,36,24,23,25
    -3.208 ( 2.5761 )
    -3.454 ( 2.2265 )
    -3.367 ( 2.5781 )
    -0.748 ( 2.2688 )
    0.387 ( 2.6156 )
        Neutrophils,Week 4,n=36,37,24,22,26
    -3.791 ( 2.5242 )
    -4.476 ( 2.3632 )
    -4.106 ( 2.4354 )
    -1.673 ( 1.9745 )
    0.089 ( 3.1611 )
        Neutrophils,Week 8,n=34,29,22,22,21
    -3.949 ( 2.5477 )
    -5.271 ( 3.2214 )
    -4.354 ( 2.4128 )
    -1.869 ( 3.2525 )
    0.192 ( 2.2180 )
        Neutrophils,Week 12,n=31,28,23,22,22
    -4.590 ( 2.6603 )
    -5.340 ( 2.6437 )
    -5.250 ( 2.1872 )
    -2.678 ( 3.1106 )
    -1.019 ( 2.1306 )
        Neutrophils,Week 16,n=27,26,20,19,19
    -4.933 ( 2.4430 )
    -4.929 ( 3.7907 )
    -5.358 ( 2.2367 )
    -2.766 ( 3.3212 )
    -0.263 ( 3.3610 )
        Neutrophils,Week 20,n=25,22,18,17,16
    -4.867 ( 2.3110 )
    -4.997 ( 3.0763 )
    -5.168 ( 2.4898 )
    -2.856 ( 4.0311 )
    -1.355 ( 3.3883 )
        Neutrophils,Week 24,n=22,21,16,16,16
    -4.985 ( 3.5051 )
    -6.257 ( 2.7551 )
    -5.030 ( 1.9579 )
    -2.570 ( 4.2089 )
    -1.342 ( 3.1038 )
        Neutrophils,Week 28,n=18,18,11,14,13
    -5.076 ( 2.3415 )
    -5.729 ( 3.1699 )
    -4.469 ( 2.1333 )
    -2.764 ( 3.5787 )
    -1.503 ( 4.3502 )
        Neutrophils,Week 32,n=19,15,10,12,13
    -5.357 ( 2.5525 )
    -5.153 ( 3.1939 )
    -4.840 ( 1.9387 )
    -3.006 ( 3.7915 )
    -2.018 ( 3.5674 )
        Neutrophils,Week 36,n=15,12,10,12,12
    -5.444 ( 2.1894 )
    -6.079 ( 3.0406 )
    -5.265 ( 1.8375 )
    -3.023 ( 3.9443 )
    -3.018 ( 4.1223 )
        Neutrophils,Week 40,n=14,11,8,10,10
    -5.416 ( 2.4371 )
    -6.179 ( 2.8859 )
    -5.916 ( 1.7172 )
    -2.705 ( 3.4469 )
    -1.663 ( 3.4090 )
        Neutrophils,Week 44,n=11,10,6,7,9
    -5.432 ( 2.5555 )
    -5.799 ( 3.1785 )
    -6.185 ( 1.3944 )
    -1.807 ( 4.5472 )
    -2.883 ( 3.8690 )
        Neutrophils,Week 48,n=9,8,4,8,5
    -5.628 ( 2.3471 )
    -6.396 ( 3.4832 )
    -6.790 ( 1.6060 )
    -2.160 ( 3.3843 )
    -2.650 ( 4.0017 )
        Neutrophils,Week 52,n=8,5,5,5,4
    -5.520 ( 2.7316 )
    -6.774 ( 2.6817 )
    -6.256 ( 1.8929 )
    -4.214 ( 3.6948 )
    -2.990 ( 4.8629 )
        Platelets,Week 2,n=37,38,24,23,25
    -39.0 ( 39.46 )
    -49.2 ( 52.77 )
    -41.1 ( 40.29 )
    -1.9 ( 37.57 )
    -4.3 ( 49.32 )
        Platelets,Week 4,n=36,37,24,22,26
    -45.9 ( 41.70 )
    -64.3 ( 56.21 )
    -49.0 ( 35.74 )
    2.1 ( 41.23 )
    -5.7 ( 43.51 )
        Platelets,Week 8,n=34,29,22,22,21
    -37.3 ( 31.22 )
    -72.2 ( 75.77 )
    -53.3 ( 37.10 )
    14.2 ( 45.62 )
    15.7 ( 57.21 )
        Platelets,Week 12,n=31,28,23,22,22
    -51.2 ( 33.25 )
    -74.0 ( 52.17 )
    -55.4 ( 38.89 )
    17.8 ( 50.58 )
    4.3 ( 55.14 )
        Platelets,Week 16,n=27,26,20,19,19
    -53.8 ( 33.54 )
    -69.9 ( 53.79 )
    -54.8 ( 39.71 )
    12.4 ( 52.98 )
    13.8 ( 60.11 )
        Platelets,Week 20,n=25,22,18,17,16
    -52.2 ( 54.64 )
    -69.5 ( 58.27 )
    -53.5 ( 38.00 )
    14.8 ( 44.55 )
    -0.1 ( 56.21 )
        Platelets,Week 24,n=22,21,16,16,16
    -58.0 ( 39.58 )
    -72.4 ( 64.56 )
    -57.5 ( 44.46 )
    6.3 ( 46.94 )
    20.1 ( 45.30 )
        Platelets,Week 28,n=18,18,11,14,13
    -70.2 ( 45.09 )
    -61.3 ( 54.34 )
    -50.6 ( 27.71 )
    15.4 ( 31.84 )
    13.1 ( 47.56 )
        Platelets,Week 32,n=19,15,10,12,13
    -57.6 ( 66.52 )
    -65.5 ( 51.20 )
    -50.8 ( 33.70 )
    -1.5 ( 45.26 )
    10.7 ( 53.95 )
        Platelets,Week 36,n=15,12,10,12,12
    -74.1 ( 32.84 )
    -70.6 ( 58.49 )
    -48.6 ( 23.64 )
    13.4 ( 32.69 )
    20.0 ( 85.28 )
        Platelets,Week 40,n=14,11,8,10,10
    -77.4 ( 41.72 )
    -66.9 ( 62.21 )
    -42.0 ( 21.33 )
    5.6 ( 45.38 )
    5.3 ( 54.71 )
        Platelets,Week 44,n=11,10,6,7,9
    -69.5 ( 36.62 )
    -76.7 ( 64.91 )
    -58.2 ( 19.28 )
    11.1 ( 48.18 )
    -3.3 ( 56.78 )
        Platelets,Week 48,n=9,8,4,8,5
    -68.3 ( 41.94 )
    -71.4 ( 57.71 )
    -80.8 ( 22.98 )
    14.4 ( 53.59 )
    0.4 ( 61.59 )
        Platelets,Week 52,n=8,5,5,5,4
    -81.9 ( 38.36 )
    -51.6 ( 43.90 )
    -58.6 ( 40.79 )
    -18.6 ( 55.44 )
    -17.5 ( 38.04 )
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in hematology parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin

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    End point title
    Part A: Change from Baseline in hematology parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
    End point description
    Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Grams per liter
    arithmetic mean (standard deviation)
        MCHC,Week 2,n=32,33,18,22,23
    -0.5 ( 6.21 )
    0.1 ( 9.47 )
    1.9 ( 5.11 )
    -1.1 ( 6.56 )
    1.2 ( 8.41 )
        MCHC,Week 4,n=31,31,19,20,25
    1.6 ( 7.36 )
    2.3 ( 11.94 )
    2.6 ( 9.46 )
    0.1 ( 5.17 )
    2.4 ( 9.32 )
        MCHC,Week 8,n=28,24,18,20,20
    6.1 ( 8.97 )
    6.7 ( 10.98 )
    6.4 ( 9.09 )
    0.6 ( 9.53 )
    6.7 ( 8.19 )
        MCHC,Week 12,n=25,23,18,20,20
    6.5 ( 9.77 )
    6.7 ( 9.03 )
    5.9 ( 14.20 )
    1.3 ( 9.55 )
    4.9 ( 7.81 )
        MCHC,Week 16,n=22,21,17,17,17
    8.3 ( 9.80 )
    8.9 ( 12.41 )
    10.2 ( 8.50 )
    0.9 ( 11.52 )
    4.5 ( 9.62 )
        MCHC,Week 20,n=19,18,14,16,14
    7.7 ( 8.43 )
    10.8 ( 9.53 )
    9.0 ( 8.60 )
    3.4 ( 10.38 )
    4.6 ( 12.48 )
        MCHC,Week 24,n=16,16,13,15,14
    4.7 ( 7.50 )
    14.6 ( 11.04 )
    4.9 ( 9.97 )
    3.0 ( 7.46 )
    4.9 ( 11.49 )
        MCHC,Week 28,n=13,14,10,12,11
    4.5 ( 7.78 )
    9.2 ( 11.52 )
    8.9 ( 11.41 )
    2.8 ( 13.57 )
    -0.4 ( 7.86 )
        MCHC,Week 32,n=13,11,8,10,11
    6.9 ( 9.33 )
    8.4 ( 10.45 )
    8.8 ( 9.05 )
    6.7 ( 8.88 )
    1.4 ( 8.58 )
        MCHC,Week 36,n=10,10,8,10,10
    6.9 ( 5.11 )
    6.7 ( 9.72 )
    13.5 ( 8.07 )
    7.9 ( 11.44 )
    4.2 ( 5.90 )
        MCHC,Week 40,n=10,9,7,8,9
    11.5 ( 9.89 )
    11.3 ( 7.75 )
    14.4 ( 12.45 )
    5.1 ( 15.30 )
    13.9 ( 12.39 )
        MCHC,Week 44,n=8,8,4,5,8
    12.5 ( 7.17 )
    9.9 ( 9.86 )
    13.5 ( 4.12 )
    5.2 ( 4.60 )
    12.1 ( 10.99 )
        MCHC,Week 48,n=6,7,2,6,4
    13.3 ( 9.07 )
    11.9 ( 9.84 )
    10.5 ( 13.44 )
    3.8 ( 11.48 )
    9.3 ( 9.32 )
        MCHC,Week 52,n=6,4,3,4,3
    16.5 ( 5.47 )
    18.8 ( 5.68 )
    24.0 ( 3.46 )
    11.3 ( 5.06 )
    5.0 ( 9.85 )
        Hemoglobin,Week 2,n=38,39,24,24,25
    1.2 ( 6.50 )
    2.5 ( 6.85 )
    1.3 ( 8.72 )
    -2.4 ( 7.08 )
    -0.9 ( 5.44 )
        Hemoglobin,Week 4,n=36,37,24,22,27
    3.0 ( 6.37 )
    2.8 ( 8.17 )
    2.5 ( 6.55 )
    -1.0 ( 8.45 )
    -2.1 ( 6.86 )
        Hemoglobin,Week 8,n=34,29,23,22,21
    5.9 ( 9.57 )
    4.7 ( 9.59 )
    3.1 ( 7.00 )
    -1.4 ( 10.54 )
    -2.8 ( 7.41 )
        Hemoglobin,Week 12,n=31,28,23,22,22
    5.8 ( 7.85 )
    8.4 ( 10.62 )
    4.7 ( 6.24 )
    -3.2 ( 11.11 )
    -1.4 ( 7.10 )
        Hemoglobin,Week 16,n=27,26,21,19,19
    2.6 ( 6.00 )
    5.8 ( 8.87 )
    4.2 ( 7.03 )
    -3.8 ( 10.55 )
    -1.7 ( 7.47 )
        Hemoglobin,Week 20,n=25,23,18,18,16
    2.0 ( 7.89 )
    7.4 ( 9.69 )
    3.3 ( 5.58 )
    -4.6 ( 11.32 )
    -0.6 ( 6.22 )
        Hemoglobin,Week 24,n=22,21,16,16,16
    2.2 ( 8.67 )
    7.0 ( 9.99 )
    5.4 ( 6.38 )
    -3.1 ( 12.05 )
    -0.9 ( 6.43 )
        Hemoglobin,Week 28,n=18,18,12,14,13
    0.3 ( 9.68 )
    5.8 ( 11.83 )
    2.8 ( 6.92 )
    -4.4 ( 11.45 )
    -1.5 ( 8.88 )
        Hemoglobin,Week 32,n=19,15,10,12,13
    0.9 ( 9.04 )
    5.1 ( 10.88 )
    2.0 ( 9.42 )
    -3.0 ( 10.05 )
    0.8 ( 9.64 )
        Hemoglobin,Week 36,n=15,12,10,12,12
    4.4 ( 7.97 )
    4.8 ( 11.91 )
    4.0 ( 7.26 )
    -2.6 ( 10.93 )
    1.3 ( 9.68 )
        Hemoglobin,Week 40,n=14,11,8,10,10
    1.3 ( 8.03 )
    3.8 ( 12.40 )
    6.3 ( 5.47 )
    -3.4 ( 11.24 )
    -0.4 ( 7.86 )
        Hemoglobin,Week 44,n=11,10,6,8,9
    0.0 ( 8.00 )
    6.7 ( 14.60 )
    2.3 ( 7.84 )
    -0.3 ( 11.70 )
    2.8 ( 12.85 )
        Hemoglobin,Week 48,n=9,8,4,8,5
    2.4 ( 7.57 )
    4.8 ( 12.62 )
    2.8 ( 12.69 )
    -4.6 ( 14.66 )
    7.6 ( 15.57 )
        Hemoglobin,Week 52,n=8,5,5,5,4
    2.9 ( 5.33 )
    8.6 ( 12.84 )
    10.4 ( 13.28 )
    4.4 ( 6.47 )
    2.8 ( 13.57 )
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in hematology parameter-Hematocrit

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    End point title
    Part A: Change from Baseline in hematology parameter-Hematocrit
    End point description
    Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Proportion of red blood cells in blood
    arithmetic mean (standard deviation)
        Week 2,n=38,39,24,24,25
    0.0040 ( 0.01988 )
    0.0060 ( 0.02186 )
    0.0008 ( 0.02909 )
    -0.0063 ( 0.02491 )
    -0.0030 ( 0.01813 )
        Week 4,n=36,37,24,22,27
    0.0059 ( 0.01903 )
    0.0048 ( 0.02635 )
    0.0040 ( 0.01531 )
    -0.0035 ( 0.02676 )
    -0.0087 ( 0.02004 )
        Week 8,n=34,29,23,22,21
    0.0101 ( 0.02601 )
    0.0054 ( 0.03213 )
    0.0019 ( 0.02110 )
    -0.0054 ( 0.03286 )
    -0.0159 ( 0.01918 )
        Week 12,n=31,28,23,22,22
    0.0087 ( 0.02386 )
    0.0148 ( 0.03272 )
    0.0059 ( 0.01970 )
    -0.0118 ( 0.03281 )
    -0.0095 ( 0.02108 )
        Week 16,n=27,26,21,19,19
    -0.0037 ( 0.02187 )
    0.0049 ( 0.02833 )
    0.0008 ( 0.01961 )
    -0.0135 ( 0.02976 )
    -0.0095 ( 0.02347 )
        Week 20,n=25,23,18,18,16
    -0.0063 ( 0.02436 )
    0.0066 ( 0.03019 )
    -0.0015 ( 0.01398 )
    -0.0184 ( 0.02972 )
    -0.0062 ( 0.02076 )
        Week 24,n=22,21,16,16,16
    -0.0017 ( 0.02882 )
    0.0010 ( 0.02839 )
    0.0089 ( 0.01973 )
    -0.0133 ( 0.03478 )
    -0.0077 ( 0.01599 )
        Week 28,n=18,18,12,14,13
    -0.0089 ( 0.02917 )
    0.0039 ( 0.03455 )
    -0.0046 ( 0.01858 )
    -0.0186 ( 0.02814 )
    -0.0035 ( 0.02785 )
        Week 32,n=19,15,10,12,13
    -0.0076 ( 0.02782 )
    0.0027 ( 0.02994 )
    -0.0060 ( 0.03161 )
    -0.0176 ( 0.02473 )
    0.0025 ( 0.02741 )
        Week 36,n=15,12,10,12,12
    0.0012 ( 0.02603 )
    0.0036 ( 0.03232 )
    -0.0054 ( 0.01811 )
    -0.0198 ( 0.02570 )
    0.0018 ( 0.03090 )
        Week 40,n=14,11,8,10,10
    -0.0115 ( 0.03075 )
    -0.0052 ( 0.03398 )
    -0.0009 ( 0.01086 )
    -0.0193 ( 0.02157 )
    -0.0160 ( 0.02099 )
        Week 44,n=11,10,6,7,9
    -0.0185 ( 0.03039 )
    0.0054 ( 0.03463 )
    -0.0097 ( 0.02548 )
    -0.0126 ( 0.03225 )
    -0.0037 ( 0.03048 )
        Week 48,n=9,8,4,8,5
    -0.0136 ( 0.02709 )
    -0.0025 ( 0.03217 )
    -0.0053 ( 0.04366 )
    -0.0216 ( 0.03428 )
    0.0144 ( 0.04123 )
        Week 52,n=8,5,5,5,4
    -0.0135 ( 0.02112 )
    0.0016 ( 0.04082 )
    0.0058 ( 0.04370 )
    -0.0006 ( 0.01558 )
    0.0025 ( 0.03288 )
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume

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    End point title
    Part A: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume
    End point description
    Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Femtoliter
    arithmetic mean (standard deviation)
        Week 2,n=38,39,24,24,25
    0.5 ( 1.35 )
    0.5 ( 1.64 )
    0.5 ( 1.38 )
    0.6 ( 1.38 )
    0.4 ( 1.44 )
        Week 4,n=36,37,24,22,27
    0.9 ( 1.95 )
    1.1 ( 2.15 )
    1.0 ( 1.69 )
    0.6 ( 1.68 )
    0.6 ( 2.28 )
        Week 8,n=34,29,23,22,21
    1.2 ( 2.54 )
    1.8 ( 3.27 )
    1.9 ( 2.72 )
    1.7 ( 2.34 )
    -0.2 ( 2.91 )
        Week 12,n=31,28,23,22,22
    0.8 ( 3.41 )
    2.0 ( 4.29 )
    2.6 ( 3.14 )
    0.9 ( 3.16 )
    0.3 ( 4.07 )
        Week 16,n=27,26,21,19,19
    1.0 ( 4.14 )
    2.2 ( 4.36 )
    3.1 ( 3.37 )
    0.4 ( 4.03 )
    -0.3 ( 4.98 )
        Week 20,n=25,23,18,18,16
    1.2 ( 4.42 )
    1.8 ( 4.35 )
    2.1 ( 3.12 )
    -0.5 ( 4.72 )
    0.1 ( 3.54 )
        Week 24,n=22,21,16,16,16
    1.1 ( 4.20 )
    1.1 ( 3.91 )
    2.6 ( 3.36 )
    -1.0 ( 4.44 )
    -1.6 ( 4.84 )
        Week 28,n=18,18,12,14,13
    0.6 ( 4.02 )
    1.4 ( 4.19 )
    2.0 ( 2.26 )
    -0.4 ( 4.43 )
    -0.5 ( 3.95 )
        Week 32,n=19,15,10,12,13
    0.9 ( 4.42 )
    2.0 ( 4.44 )
    1.3 ( 3.13 )
    0.3 ( 4.89 )
    -0.5 ( 3.64 )
        Week 36,n=15,12,10,12,12
    1.8 ( 3.49 )
    1.6 ( 4.76 )
    0.9 ( 2.47 )
    -0.5 ( 4.93 )
    -0.2 ( 2.55 )
        Week 40,n=14,11,8,10,10
    0.6 ( 3.73 )
    1.8 ( 5.25 )
    2.0 ( 2.83 )
    0.4 ( 4.95 )
    -2.1 ( 3.00 )
        Week 44,n=11,10,6,8,9
    -0.5 ( 3.50 )
    2.5 ( 5.08 )
    1.7 ( 3.50 )
    -0.7 ( 6.87 )
    -0.7 ( 2.83 )
        Week 48,n=9,8,4,8,5
    -0.4 ( 3.50 )
    3.3 ( 4.95 )
    2.3 ( 4.50 )
    -1.1 ( 6.92 )
    2.0 ( 2.12 )
        Week 52,n=8,5,5,5,4
    -0.6 ( 3.02 )
    3.2 ( 5.12 )
    1.4 ( 4.16 )
    3.2 ( 5.72 )
    1.0 ( 2.58 )
    No statistical analyses for this end point

    Secondary: Part A:Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin

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    End point title
    Part A:Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin
    End point description
    Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Picograms
    arithmetic mean (standard deviation)
        Week 2,n=38,39,24,24,25
    0.13 ( 0.571 )
    0.29 ( 0.730 )
    0.42 ( 0.512 )
    0.12 ( 0.494 )
    0.22 ( 0.678 )
        Week 4,n=36,37,24,22,27
    0.53 ( 0.786 )
    0.58 ( 0.877 )
    0.55 ( 0.672 )
    0.25 ( 0.458 )
    0.36 ( 0.892 )
        Week 8,n=34,29,23,22,21
    0.96 ( 1.041 )
    1.20 ( 1.056 )
    1.16 ( 1.178 )
    0.60 ( 0.751 )
    0.49 ( 1.022 )
        Week 12,n=31,28,23,22,22
    0.94 ( 1.341 )
    1.43 ( 1.372 )
    1.38 ( 1.630 )
    0.44 ( 1.110 )
    0.47 ( 1.480 )
        Week 16,n=27,26,21,19,19
    1.16 ( 1.345 )
    1.59 ( 1.617 )
    1.83 ( 1.424 )
    0.24 ( 1.508 )
    0.22 ( 1.927 )
        Week 20,n=25,23,18,18,16
    1.24 ( 1.529 )
    1.69 ( 1.605 )
    1.48 ( 1.256 )
    0.14 ( 1.666 )
    0.39 ( 1.696 )
        Week 24,n=22,21,16,16,16
    0.97 ( 1.491 )
    1.80 ( 1.663 )
    1.34 ( 1.230 )
    -0.04 ( 1.727 )
    -0.08 ( 2.041 )
        Week 28,n=18,18,12,14,13
    0.91 ( 1.659 )
    1.48 ( 1.618 )
    1.47 ( 1.409 )
    0.21 ( 2.000 )
    -0.20 ( 1.493 )
        Week 32,n=19,15,10,12,13
    1.01 ( 1.498 )
    1.57 ( 1.694 )
    1.27 ( 1.111 )
    0.68 ( 2.103 )
    -0.14 ( 1.413 )
        Week 36,n=15,12,10,12,12
    1.42 ( 0.944 )
    1.29 ( 1.905 )
    1.39 ( 1.005 )
    0.68 ( 2.327 )
    0.15 ( 0.971 )
        Week 40,n=14,11,8,10,10
    1.30 ( 0.818 )
    1.75 ( 1.914 )
    1.91 ( 1.373 )
    0.71 ( 2.617 )
    0.44 ( 1.492 )
        Week 44,n=11,10,6,8,9
    1.16 ( 0.727 )
    1.83 ( 2.214 )
    1.63 ( 1.178 )
    0.30 ( 2.460 )
    0.77 ( 1.261 )
        Week 48,n=9,8,4,8,5
    1.36 ( 0.633 )
    2.25 ( 2.194 )
    1.73 ( 1.389 )
    0.14 ( 2.934 )
    1.32 ( 1.119 )
        Week 52,n=8,5,5,5,4
    1.44 ( 0.950 )
    2.70 ( 1.744 )
    2.24 ( 1.484 )
    1.84 ( 1.889 )
    0.80 ( 1.068 )
    No statistical analyses for this end point

    Secondary: Part A:Change from Baseline in hematology parameter- Erythrocytes

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    End point title
    Part A:Change from Baseline in hematology parameter- Erythrocytes
    End point description
    Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: trillion cells per liter
    arithmetic mean (standard deviation)
        Week 2,n=38,39,24,24,25
    0.01 ( 0.232 )
    0.02 ( 0.265 )
    -0.01 ( 0.303 )
    -0.10 ( 0.254 )
    -0.07 ( 0.221 )
        Week 4,n=36,37,24,22,27
    0.01 ( 0.208 )
    -0.01 ( 0.311 )
    -0.01 ( 0.202 )
    -0.09 ( 0.268 )
    -0.14 ( 0.248 )
        Week 8,n=34,29,23,22,21
    0.04 ( 0.249 )
    -0.04 ( 0.406 )
    -0.08 ( 0.300 )
    -0.16 ( 0.372 )
    -0.17 ( 0.219 )
        Week 12,n=31,28,23,22,22
    0.03 ( 0.255 )
    0.05 ( 0.417 )
    -0.07 ( 0.265 )
    -0.20 ( 0.379 )
    -0.11 ( 0.237 )
        Week 16,n=27,26,21,19,19
    -0.09 ( 0.238 )
    -0.07 ( 0.312 )
    -0.14 ( 0.282 )
    -0.19 ( 0.399 )
    -0.11 ( 0.303 )
        Week 20,n=25,23,18,18,16
    -0.13 ( 0.263 )
    -0.03 ( 0.305 )
    -0.12 ( 0.183 )
    -0.20 ( 0.461 )
    -0.08 ( 0.286 )
        Week 24,n=22,21,16,16,16
    -0.09 ( 0.270 )
    -0.06 ( 0.282 )
    -0.04 ( 0.234 )
    -0.11 ( 0.464 )
    -0.01 ( 0.289 )
        Week 28,n=18,18,12,14,13
    -0.14 ( 0.295 )
    -0.04 ( 0.327 )
    -0.16 ( 0.231 )
    -0.18 ( 0.377 )
    -0.02 ( 0.387 )
        Week 32,n=19,15,10,12,13
    -0.13 ( 0.292 )
    -0.09 ( 0.259 )
    -0.13 ( 0.330 )
    -0.22 ( 0.321 )
    0.04 ( 0.362 )
        Week 36,n=15,12,10,12,12
    -0.08 ( 0.262 )
    -0.04 ( 0.378 )
    -0.10 ( 0.183 )
    -0.21 ( 0.358 )
    0.03 ( 0.391 )
        Week 40,n=14,11,8,10,10
    -0.16 ( 0.234 )
    -0.16 ( 0.380 )
    -0.09 ( 0.189 )
    -0.22 ( 0.301 )
    -0.10 ( 0.330 )
        Week 44,n=11,10,6,7,9
    -0.18 ( 0.286 )
    -0.10 ( 0.333 )
    -0.17 ( 0.320 )
    -0.10 ( 0.216 )
    -0.03 ( 0.367 )
        Week 48,n=9,8,4,8,5
    -0.14 ( 0.240 )
    -0.23 ( 0.266 )
    -0.18 ( 0.457 )
    -0.20 ( 0.251 )
    0.04 ( 0.434 )
        Week 52,n=8,5,5,5,4
    -0.16 ( 0.283 )
    -0.18 ( 0.370 )
    -0.02 ( 0.531 )
    -0.18 ( 0.192 )
    -0.05 ( 0.332 )
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea

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    End point title
    Part A: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
    End point description
    Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea . Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        calcium,Week 2,n=38,39,26,24,26
    0.002 ( 0.1056 )
    0.006 ( 0.0853 )
    -0.008 ( 0.0817 )
    0.008 ( 0.1050 )
    0.013 ( 0.0812 )
        calcium,Week 4,n=37,38,25,23,27
    0.009 ( 0.0974 )
    0.008 ( 0.0968 )
    0.013 ( 0.0649 )
    -0.016 ( 0.0922 )
    -0.001 ( 0.0899 )
        calcium,Week 8,n=34,31,24,22,23
    0.032 ( 0.1114 )
    0.049 ( 0.0879 )
    0.005 ( 0.0764 )
    0.020 ( 0.0918 )
    0.013 ( 0.0615 )
        calcium,Week 12,n=32,28,24,22,21
    0.019 ( 0.1200 )
    0.072 ( 0.0789 )
    -0.001 ( 0.0750 )
    0.011 ( 0.0913 )
    0.016 ( 0.0851 )
        calcium,Week 16,n=28,26,22,19,18
    0.009 ( 0.0974 )
    0.050 ( 0.0808 )
    0.018 ( 0.0954 )
    -0.008 ( 0.0707 )
    0.044 ( 0.0768 )
        calcium,Week 20,n=25,23,19,18,16
    0.018 ( 0.1080 )
    0.070 ( 0.0987 )
    0.032 ( 0.0933 )
    0.000 ( 0.0884 )
    0.012 ( 0.0932 )
        calcium,Week 24,n=22,21,16,17,16
    0.008 ( 0.1029 )
    0.064 ( 0.0927 )
    0.032 ( 0.1077 )
    -0.002 ( 0.0748 )
    0.009 ( 0.0702 )
        calcium,Week 28,n=19,18,12,13,14
    0.006 ( 0.1102 )
    0.066 ( 0.1106 )
    0.054 ( 0.1232 )
    0.018 ( 0.0838 )
    0.076 ( 0.1108 )
        calcium,Week 32,n=19,15,10,12,13
    0.029 ( 0.1119 )
    0.044 ( 0.0923 )
    0.059 ( 0.0737 )
    -0.008 ( 0.0978 )
    0.075 ( 0.1271 )
        calcium,Week 36,n=15,12,10,12,13
    0.016 ( 0.0789 )
    0.055 ( 0.0773 )
    0.075 ( 0.0738 )
    -0.038 ( 0.1025 )
    0.053 ( 0.0957 )
        calcium,Week 40,n=15,11,9,10,10
    0.077 ( 0.1012 )
    0.016 ( 0.0662 )
    0.008 ( 0.0930 )
    -0.042 ( 0.0561 )
    0.037 ( 0.0589 )
        calcium,Week 44,n=11,11,6,8,9
    0.042 ( 0.1480 )
    0.025 ( 0.0908 )
    -0.002 ( 0.0475 )
    -0.035 ( 0.1638 )
    0.054 ( 0.1146 )
        calcium,Week 48,n=9,8,5,8,5
    -0.007 ( 0.1126 )
    0.028 ( 0.0956 )
    -0.018 ( 0.0769 )
    -0.035 ( 0.0769 )
    0.142 ( 0.0782 )
        calcium,Week 52,n=9,5,5,5,4
    0.013 ( 0.0907 )
    0.076 ( 0.1108 )
    0.026 ( 0.0747 )
    -0.056 ( 0.1161 )
    0.083 ( 0.0624 )
        Carbon Dioxide,Week 2,n=38,39,26,24,26
    0.7 ( 2.42 )
    0.6 ( 2.55 )
    0.5 ( 2.53 )
    -0.3 ( 2.31 )
    0.7 ( 2.24 )
        Carbon Dioxide,Week 4,n=37,38,25,23,27
    0.1 ( 2.03 )
    0.2 ( 2.68 )
    0.4 ( 2.69 )
    0.2 ( 1.75 )
    0.1 ( 2.83 )
        Carbon Dioxide,Week 8,n=34,31,24,22,23
    0.1 ( 3.39 )
    0.3 ( 2.89 )
    0.0 ( 2.69 )
    0.0 ( 2.01 )
    1.1 ( 2.24 )
        Carbon Dioxide,Week 12,n=32,28,24,22,21
    0.1 ( 2.66 )
    0.6 ( 2.53 )
    -0.4 ( 2.28 )
    0.0 ( 1.94 )
    1.2 ( 1.73 )
        Carbon Dioxide,Week 16,n=28,26,22,19,18
    0.1 ( 2.97 )
    0.5 ( 2.47 )
    0.8 ( 2.94 )
    -0.1 ( 1.88 )
    0.5 ( 2.55 )
        Carbon Dioxide,Week 20,n=25,23,19,18,16
    0.1 ( 2.98 )
    -0.1 ( 3.17 )
    -0.1 ( 2.70 )
    -0.3 ( 2.83 )
    0.5 ( 2.68 )
        Carbon Dioxide,Week 24,n=22,21,16,17,16
    0.4 ( 3.10 )
    0.4 ( 3.11 )
    -0.8 ( 2.65 )
    0.5 ( 2.29 )
    -0.2 ( 2.61 )
        Carbon Dioxide,Week 28,n=19,18,12,13,14
    -1.6 ( 2.83 )
    0.4 ( 3.63 )
    -1.0 ( 2.04 )
    -0.4 ( 2.36 )
    0.4 ( 3.08 )
        Carbon Dioxide,Week 32,n=19,15,10,12,13
    -1.0 ( 3.65 )
    0.8 ( 2.08 )
    -1.4 ( 2.17 )
    -0.6 ( 2.43 )
    0.2 ( 2.24 )
        Carbon Dioxide,Week 36,n=15,12,10,12,13
    -1.1 ( 2.28 )
    0.3 ( 3.72 )
    -0.9 ( 1.97 )
    -0.3 ( 3.63 )
    1.0 ( 2.16 )
        Carbon Dioxide,Week 40,n=15,11,6,10,10
    -1.5 ( 3.16 )
    0.9 ( 3.75 )
    -1.7 ( 2.35 )
    -0.8 ( 2.70 )
    0.4 ( 1.43 )
        Carbon Dioxide,Week 44,n=11,11,6,8,9
    -1.7 ( 2.72 )
    1.6 ( 3.50 )
    0.0 ( 3.03 )
    -1.6 ( 1.60 )
    -0.1 ( 2.47 )
        Carbon Dioxide,Week 48,n=9,8,5,8,5
    -2.6 ( 2.70 )
    0.5 ( 3.59 )
    -1.0 ( 2.65 )
    0.0 ( 1.77 )
    -0.2 ( 2.17 )
        Carbon Dioxide,Week 52,n=9,5,5,5,4
    -1.1 ( 1.76 )
    1.2 ( 2.68 )
    -1.2 ( 1.48 )
    -0.4 ( 1.34 )
    1.8 ( 2.87 )
        Chloride,Week 2,n=38,39,26,24,26
    1.1 ( 2.36 )
    0.6 ( 1.79 )
    0.7 ( 1.76 )
    1.0 ( 2.16 )
    0.8 ( 2.77 )
        Chloride,Week 4,n=37,38,25,23,27
    1.8 ( 2.34 )
    1.6 ( 2.10 )
    1.4 ( 1.87 )
    0.7 ( 2.14 )
    1.4 ( 2.79 )
        Chloride,Week 8,n=34,31,24,22,23
    2.5 ( 2.12 )
    2.4 ( 2.06 )
    2.0 ( 2.65 )
    1.0 ( 2.18 )
    2.1 ( 3.24 )
        Chloride,Week 12,n=32,28,24,22,21
    2.9 ( 2.54 )
    1.8 ( 3.03 )
    2.4 ( 2.30 )
    0.6 ( 2.06 )
    2.0 ( 2.36 )
        Chloride,Week 16,n=28,26,22,19,18
    3.0 ( 2.27 )
    2.3 ( 2.54 )
    2.2 ( 2.46 )
    1.1 ( 2.04 )
    2.4 ( 3.40 )
        Chloride,Week 20,n=25,23,19,18,16
    3.3 ( 2.88 )
    2.0 ( 2.11 )
    2.1 ( 2.49 )
    1.3 ( 2.22 )
    2.5 ( 3.12 )
        Chloride,Week 24,n=22,21,16,17,16
    3.4 ( 3.42 )
    2.7 ( 2.51 )
    1.6 ( 3.16 )
    1.0 ( 2.12 )
    2.3 ( 3.55 )
        Chloride,Week 28,n=19,18,12,13,14
    3.9 ( 3.13 )
    2.8 ( 2.80 )
    2.8 ( 2.49 )
    0.2 ( 3.49 )
    2.9 ( 3.63 )
        Chloride,Week 32,n=19,15,10,12,13
    3.4 ( 2.73 )
    1.9 ( 2.59 )
    2.0 ( 2.26 )
    -0.1 ( 4.17 )
    3.4 ( 3.43 )
        Chloride,Week 36,n=15,12,10,12,13
    3.8 ( 1.74 )
    2.4 ( 2.78 )
    1.9 ( 2.47 )
    1.1 ( 1.88 )
    2.8 ( 3.37 )
        Chloride,Week 40,n=15,11,9,10,10
    3.3 ( 2.49 )
    3.6 ( 1.12 )
    1.4 ( 1.94 )
    1.9 ( 1.45 )
    3.9 ( 3.03 )
        Chloride,Week 44,n=11,11,6,8,9
    3.8 ( 2.23 )
    3.4 ( 1.91 )
    0.2 ( 2.14 )
    1.1 ( 2.03 )
    2.2 ( 4.52 )
        Chloride,Week 48,n=9,8,5,8,5
    4.6 ( 1.88 )
    2.1 ( 2.23 )
    2.0 ( 1.58 )
    1.8 ( 1.58 )
    2.8 ( 3.11 )
        Chloride,Week 52,n=9,5,5,5,4
    4.8 ( 1.09 )
    2.2 ( 1.64 )
    0.2 ( 3.83 )
    3.6 ( 1.95 )
    3.8 ( 4.11 )
        Glucose,Week 2,n=38,39,26,24,26
    -0.03 ( 2.568 )
    -0.46 ( 1.671 )
    0.01 ( 1.237 )
    0.29 ( 1.358 )
    -0.44 ( 3.578 )
        Glucose,Week 4,n=37,38,25,23,27
    -0.10 ( 2.676 )
    -0.35 ( 1.929 )
    0.38 ( 1.601 )
    0.31 ( 1.466 )
    -0.03 ( 4.387 )
        Glucose,Week 8,n=34,31,24,22,23
    -0.29 ( 2.507 )
    -0.58 ( 2.606 )
    -0.12 ( 1.265 )
    0.10 ( 1.579 )
    -1.15 ( 5.685 )
        Glucose,Week 12,n=32,28,24,22,21
    -0.64 ( 2.219 )
    -0.63 ( 2.134 )
    -0.33 ( 1.163 )
    -0.25 ( 1.164 )
    -1.76 ( 5.919 )
        Glucose,Week 16,n=28,26,22,19,18
    -0.71 ( 2.485 )
    0.33 ( 1.941 )
    -0.29 ( 1.113 )
    -0.12 ( 1.414 )
    -1.15 ( 6.411 )
        Glucose,Week 20,n=25,23,19,18,16
    -0.66 ( 2.701 )
    -0.46 ( 1.550 )
    0.46 ( 1.714 )
    -0.33 ( 1.435 )
    -1.96 ( 7.018 )
        Glucose,Week 24,n=22,21,16,17,16
    -0.72 ( 2.701 )
    -0.44 ( 1.632 )
    -0.23 ( 1.217 )
    -0.38 ( 1.290 )
    -2.08 ( 6.953 )
        Glucose,Week 28,n=19,18,12,13,14
    -0.91 ( 2.990 )
    -0.32 ( 1.510 )
    0.58 ( 1.627 )
    -0.25 ( 1.278 )
    -2.05 ( 7.699 )
        Glucose,Week 32,n=19,15,10,12,13
    -0.74 ( 3.492 )
    -0.48 ( 1.533 )
    0.72 ( 1.795 )
    -0.05 ( 1.363 )
    -3.12 ( 7.818 )
        Glucose,Week 36,n=15,12,10,12,13
    -1.14 ( 3.268 )
    -0.35 ( 1.861 )
    0.05 ( 1.019 )
    -0.50 ( 1.261 )
    -2.98 ( 7.786 )
        Glucose,Week 40,n=15,11,9,10,10
    -0.99 ( 3.465 )
    -0.33 ( 2.376 )
    0.22 ( 1.203 )
    -0.22 ( 1.192 )
    -0.94 ( 3.589 )
        Glucose,Week 44,n=11,11,6,8,9
    -1.39 ( 3.789 )
    -0.05 ( 1.954 )
    -0.27 ( 0.940 )
    0.30 ( 0.739 )
    -0.23 ( 2.001 )
        Glucose,Week 48,n=9,8,5,8,5
    -1.39 ( 4.249 )
    -0.93 ( 2.077 )
    -0.62 ( 1.441 )
    -0.88 ( 1.369 )
    -0.36 ( 2.196 )
        Glucose,Week 52,n=9,5,5,5,4
    -1.51 ( 4.466 )
    -0.94 ( 2.707 )
    -0.26 ( 1.316 )
    -0.72 ( 1.308 )
    0.45 ( 2.353 )
        Phosphate,Week 2,n=38,39,26,24,26
    0.056 ( 0.2249 )
    -0.004 ( 0.1930 )
    0.017 ( 0.1886 )
    -0.025 ( 0.1622 )
    0.005 ( 0.1601 )
        Phosphate,Week 4,n=37,38,25,23,27
    0.071 ( 0.1944 )
    -0.011 ( 0.2501 )
    0.093 ( 0.1848 )
    0.006 ( 0.1883 )
    0.008 ( 0.2087 )
        Phosphate,Week 8,n=34,31,24,22,23
    0.088 ( 0.1786 )
    0.091 ( 0.2098 )
    0.112 ( 0.1588 )
    0.045 ( 0.1971 )
    0.055 ( 0.1746 )
        Phosphate,Week 12,n=32,28,24,22,21
    0.122 ( 0.2404 )
    0.154 ( 0.2377 )
    0.190 ( 0.1725 )
    0.067 ( 0.1873 )
    0.079 ( 0.1946 )
        Phosphate,Week 16,n=28,26,22,19,18
    0.113 ( 0.1976 )
    0.139 ( 0.2315 )
    0.146 ( 0.1612 )
    0.025 ( 0.1589 )
    0.039 ( 0.2238 )
        Phosphate,Week 20,n=25,23,19,18,16
    0.070 ( 0.1860 )
    0.160 ( 0.2436 )
    0.141 ( 0.2257 )
    0.043 ( 0.1854 )
    0.060 ( 0.2183 )
        Phosphate,Week 24,n=22,21,16,17,16
    0.132 ( 0.2066 )
    0.163 ( 0.2383 )
    0.181 ( 0.1778 )
    0.055 ( 0.1728 )
    0.101 ( 0.1811 )
        Phosphate,Week 28,n=19,18,12,13,14
    0.156 ( 0.1873 )
    0.090 ( 0.2543 )
    0.191 ( 0.1980 )
    0.073 ( 0.2017 )
    0.190 ( 0.3143 )
        Phosphate,Week 32,n=19,15,10,12,13
    0.164 ( 0.1166 )
    0.101 ( 0.2160 )
    0.214 ( 0.2086 )
    0.048 ( 0.1677 )
    0.155 ( 0.2713 )
        Phosphate,Week 36,n=15,12,10,12,13
    0.111 ( 0.1786 )
    0.068 ( 0.2204 )
    0.304 ( 0.2112 )
    0.098 ( 0.1939 )
    0.151 ( 0.2114 )
        Phosphate,Week 40,n=15,11,6,10,10
    0.221 ( 0.1902 )
    -0.007 ( 0.2007 )
    0.104 ( 0.1948 )
    0.073 ( 0.1849 )
    0.206 ( 0.2151 )
        Phosphate,Week 44,n=11,11,6,8,9
    0.142 ( 0.2117 )
    0.025 ( 0.1874 )
    0.090 ( 0.2131 )
    -0.065 ( 0.2267 )
    0.218 ( 0.2184 )
        Phosphate,Week 48,n=9,8,5,8,5
    0.029 ( 0.2136 )
    -0.054 ( 0.2203 )
    0.028 ( 0.2611 )
    -0.015 ( 0.1561 )
    0.132 ( 0.1972 )
        Phosphate,Week 52,n=9,5,5,5,4
    0.049 ( 0.2235 )
    -0.036 ( 0.2779 )
    0.208 ( 0.1583 )
    0.036 ( 0.0865 )
    0.115 ( 0.1434 )
        Potassium,Week 2,n=38,39,26,24,26
    0.03 ( 0.372 )
    -0.03 ( 0.437 )
    -0.02 ( 0.401 )
    0.18 ( 0.336 )
    0.08 ( 0.375 )
        Potassium,Week 4,n=37,38,25,23,27
    -0.13 ( 0.319 )
    -0.04 ( 0.412 )
    -0.10 ( 0.453 )
    0.06 ( 0.329 )
    -0.03 ( 0.343 )
        Potassium,Week 8,n=34,31,24,22,23
    0.01 ( 0.364 )
    0.05 ( 0.437 )
    -0.11 ( 0.422 )
    0.10 ( 0.333 )
    0.06 ( 0.399 )
        Potassium,Week 12,n=32,28,24,22,21
    -0.12 ( 0.333 )
    0.15 ( 0.810 )
    -0.10 ( 0.346 )
    0.06 ( 0.336 )
    0.04 ( 0.446 )
        Potassium,Week 16,n=28,26,22,19,18
    0.01 ( 0.376 )
    0.03 ( 0.439 )
    -0.02 ( 0.358 )
    0.15 ( 0.345 )
    0.15 ( 0.279 )
        Potassium,Week 20,n=25,23,19,18,16
    0.04 ( 0.394 )
    0.07 ( 0.556 )
    0.02 ( 0.417 )
    0.10 ( 0.287 )
    0.16 ( 0.390 )
        Potassium,Week 24,n=22,21,16,17,16
    0.05 ( 0.447 )
    -0.01 ( 0.403 )
    -0.13 ( 0.368 )
    0.15 ( 0.371 )
    0.16 ( 0.411 )
        Potassium,Week 28,n=19,18,12,13,14
    0.12 ( 0.288 )
    0.07 ( 0.470 )
    0.17 ( 0.414 )
    0.08 ( 0.297 )
    0.23 ( 0.418 )
        Potassium,Week 32,n=19,15,10,12,13
    0.16 ( 0.437 )
    0.01 ( 0.448 )
    0.17 ( 0.333 )
    0.19 ( 0.365 )
    0.25 ( 0.443 )
        Potassium,Week 36,n=15,12,10,12,13
    0.16 ( 0.429 )
    -0.07 ( 0.475 )
    0.18 ( 0.408 )
    0.18 ( 0.341 )
    0.21 ( 0.403 )
        Potassium,Week 40,n=15,11,9,10,10
    0.24 ( 0.534 )
    -0.03 ( 0.476 )
    0.01 ( 0.276 )
    0.03 ( 0.450 )
    0.28 ( 0.355 )
        Potassium,Week 44,n=11,11,6,8,9
    0.16 ( 0.287 )
    -0.13 ( 0.478 )
    -0.13 ( 0.288 )
    0.15 ( 0.385 )
    0.16 ( 0.488 )
        Potassium,Week 48,n=9,8,5,8,5
    0.21 ( 0.352 )
    0.06 ( 0.644 )
    -0.04 ( 0.182 )
    0.16 ( 0.283 )
    0.52 ( 0.432 )
        Potassium,Week 52,n=9,5,5,5,4
    0.22 ( 0.186 )
    -0.16 ( 0.434 )
    -0.10 ( 0.418 )
    0.06 ( 0.445 )
    0.20 ( 0.365 )
        Sodium,Week 2,n=38,39,26,24,26
    0.3 ( 2.11 )
    0.0 ( 2.33 )
    -0.8 ( 2.37 )
    -0.2 ( 1.52 )
    0.9 ( 2.92 )
        Sodium,Week 4,n=37,38,25,23,27
    0.7 ( 2.15 )
    0.4 ( 2.11 )
    0.2 ( 2.29 )
    0.0 ( 1.43 )
    0.6 ( 2.65 )
        Sodium,Week 8,n=34,31,24,22,23
    1.1 ( 2.10 )
    0.9 ( 3.12 )
    0.1 ( 2.32 )
    0.5 ( 1.50 )
    1.7 ( 2.91 )
        Sodium,Week 12,n=32,28,24,22,21
    1.8 ( 2.46 )
    0.5 ( 3.90 )
    0.6 ( 1.76 )
    0.5 ( 1.79 )
    2.1 ( 2.37 )
        Sodium,Week 16,n=28,26,22,19,18
    1.0 ( 2.28 )
    0.6 ( 3.09 )
    -0.2 ( 2.25 )
    -0.3 ( 1.37 )
    2.3 ( 3.59 )
        Sodium,Week 20,n=25,23,19,18,16
    1.0 ( 2.23 )
    0.6 ( 2.79 )
    -0.3 ( 2.60 )
    -0.6 ( 0.92 )
    2.3 ( 3.52 )
        Sodium,Week 24,n=22,21,16,17,16
    0.9 ( 2.31 )
    1.0 ( 1.83 )
    -0.4 ( 2.00 )
    0.4 ( 1.50 )
    1.9 ( 2.96 )
        Sodium,Week 28,n=19,18,12,13,14
    0.9 ( 2.27 )
    1.2 ( 2.75 )
    0.5 ( 1.93 )
    -0.8 ( 3.22 )
    2.4 ( 3.54 )
        Sodium,Week 32,n=19,15,10,12,13
    0.7 ( 2.31 )
    -0.3 ( 2.63 )
    -0.2 ( 2.04 )
    -0.8 ( 3.16 )
    3.2 ( 4.13 )
        Sodium,Week 36,n=15,12,10,12,13
    0.5 ( 1.96 )
    0.6 ( 2.43 )
    -0.4 ( 2.07 )
    -0.2 ( 1.85 )
    2.8 ( 3.60 )
        Sodium,Week 40,n=15,11,9,10,10
    0.1 ( 2.17 )
    1.2 ( 2.23 )
    -1.2 ( 2.49 )
    0.5 ( 1.58 )
    2.9 ( 3.07 )
        Sodium,Week 44,n=11,11,6,8,9
    0.5 ( 1.97 )
    0.4 ( 2.58 )
    -2.0 ( 2.53 )
    -0.8 ( 1.28 )
    1.8 ( 3.77 )
        Sodium,Week 48,n=9,8,5,8,5
    -0.3 ( 1.87 )
    0.8 ( 2.76 )
    -0.6 ( 2.07 )
    0.3 ( 1.91 )
    1.6 ( 2.70 )
        Sodium,Week 52,n=9,5,5,5,4
    0.7 ( 1.66 )
    0.4 ( 2.51 )
    -0.8 ( 3.11 )
    1.6 ( 1.14 )
    3.5 ( 3.32 )
        Urea,Week 2,n=38,39,26,24,26
    0.05 ( 1.210 )
    -0.16 ( 1.776 )
    0.28 ( 1.439 )
    -0.31 ( 1.458 )
    -0.32 ( 1.240 )
        Urea,Week 4,n=37,38,25,23,27
    -0.09 ( 1.592 )
    -0.61 ( 1.514 )
    -0.06 ( 1.277 )
    -0.22 ( 1.022 )
    -0.27 ( 1.700 )
        Urea,Week 8,n=34,31,24,22,23
    -0.36 ( 1.938 )
    -0.99 ( 1.826 )
    -0.40 ( 1.574 )
    -0.91 ( 0.970 )
    -0.34 ( 0.965 )
        Urea,Week 12,n=32,28,24,22,21
    -0.65 ( 1.617 )
    -1.20 ( 1.778 )
    -0.62 ( 1.501 )
    -1.12 ( 1.457 )
    -0.35 ( 1.316 )
        Urea,Week 16,n=28,26,22,19,18
    -0.56 ( 2.009 )
    -0.52 ( 1.612 )
    -0.72 ( 1.232 )
    -0.40 ( 1.580 )
    -0.07 ( 1.701 )
        Urea,Week 20,n=25,23,19,18,16
    -0.30 ( 1.675 )
    -0.70 ( 1.379 )
    -0.70 ( 1.197 )
    -0.31 ( 1.470 )
    -0.77 ( 1.900 )
        Urea,Week 24,n=22,21,16,17,16
    -0.48 ( 1.901 )
    -0.22 ( 2.044 )
    -0.80 ( 1.717 )
    -0.65 ( 1.457 )
    -0.64 ( 2.019 )
        Urea,Week 28,n=19,18,12,13,14
    -0.45 ( 1.745 )
    -0.42 ( 1.510 )
    -0.73 ( 1.317 )
    0.23 ( 1.111 )
    -0.31 ( 1.495 )
        Urea,Week 32,n=19,15,10,12,13
    -0.16 ( 2.086 )
    -0.64 ( 1.479 )
    -0.83 ( 1.382 )
    -0.76 ( 1.071 )
    0.17 ( 2.609 )
        Urea,Week 36,n=15,12,10,12,13
    0.06 ( 1.967 )
    -1.43 ( 1.828 )
    -0.93 ( 1.113 )
    -0.01 ( 0.973 )
    -0.22 ( 2.297 )
        Urea,Week 40,n=15,11,9,10,10
    -0.17 ( 1.775 )
    -0.78 ( 0.603 )
    -0.98 ( 1.237 )
    -0.76 ( 1.552 )
    0.32 ( 1.886 )
        Urea,Week 44,n=11,11,6,8,9
    -0.46 ( 3.119 )
    -1.05 ( 1.234 )
    -0.63 ( 1.359 )
    -0.76 ( 1.274 )
    -1.09 ( 1.727 )
        Urea,Week 48,n=9,8,5,8,5
    -0.18 ( 3.535 )
    -1.58 ( 1.450 )
    -0.06 ( 1.311 )
    -0.51 ( 1.225 )
    0.44 ( 1.282 )
        Urea,Week 52,n=9,5,5,5,4
    -0.26 ( 2.508 )
    -1.22 ( 1.671 )
    -0.76 ( 1.647 )
    -0.82 ( 0.782 )
    -0.45 ( 1.475 )
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in clinical chemistry parameters: Albumin and Protein

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    End point title
    Part A: Change from Baseline in clinical chemistry parameters: Albumin and Protein
    End point description
    Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Albumin,Week 2,n=38,39,26,24,26
    0.3 ( 2.29 )
    0.9 ( 1.79 )
    0.8 ( 1.88 )
    -0.9 ( 2.64 )
    -0.7 ( 2.24 )
        Albumin,Week 4,n=37,38,25,23,27
    0.9 ( 2.41 )
    2.0 ( 2.84 )
    1.6 ( 1.50 )
    -1.4 ( 2.46 )
    -0.9 ( 2.46 )
        Albumin,Week 8,n=34,31,24,22,23
    1.9 ( 2.76 )
    3.1 ( 2.35 )
    2.1 ( 1.85 )
    -1.1 ( 2.35 )
    -0.6 ( 1.80 )
        Albumin,Week 12,n=32,28,24,22,21
    2.0 ( 2.26 )
    3.4 ( 2.50 )
    3.1 ( 1.54 )
    -0.5 ( 2.81 )
    0.2 ( 1.87 )
        Albumin,Week 16,n=28,26,22,19,18
    1.7 ( 2.29 )
    2.8 ( 2.52 )
    2.8 ( 2.44 )
    -1.2 ( 2.41 )
    0.6 ( 2.48 )
        Albumin,Week 20,n=25,23,19,18,16
    1.8 ( 2.46 )
    3.9 ( 2.68 )
    2.8 ( 2.15 )
    -0.9 ( 2.70 )
    0.3 ( 2.11 )
        Albumin,Week 24,n=22,21,16,17,16
    1.6 ( 2.77 )
    3.8 ( 2.36 )
    3.7 ( 1.85 )
    0.0 ( 2.83 )
    0.3 ( 1.88 )
        Albumin,Week 28,n=19,18,12,13,14
    1.5 ( 1.61 )
    3.5 ( 3.38 )
    2.4 ( 2.78 )
    -0.5 ( 2.82 )
    0.4 ( 2.98 )
        Albumin,Week 32,n=19,15,10,12,13
    2.2 ( 2.03 )
    3.6 ( 3.68 )
    2.2 ( 2.66 )
    -0.7 ( 3.20 )
    1.1 ( 2.93 )
        Albumin,Week 36,n=15,12,10,12,13
    3.1 ( 2.61 )
    4.3 ( 3.75 )
    2.9 ( 2.08 )
    -1.3 ( 3.25 )
    0.2 ( 3.02 )
        Albumin,Week 40,n=15,11,9,10,10
    3.2 ( 1.97 )
    3.9 ( 3.78 )
    2.4 ( 2.07 )
    -1.1 ( 2.96 )
    -0.5 ( 2.27 )
        Albumin,Week 44,n=11,11,6,8,9
    3.2 ( 2.36 )
    4.1 ( 3.36 )
    2.2 ( 2.23 )
    0.4 ( 3.07 )
    0.6 ( 2.19 )
        Albumin,Week 48,n=9,8,5,8,5
    3.4 ( 2.13 )
    4.4 ( 3.20 )
    1.6 ( 2.70 )
    -0.8 ( 3.28 )
    2.0 ( 2.92 )
        Albumin,Week 52,n=9,5,5,5,4
    3.7 ( 2.45 )
    5.2 ( 1.64 )
    4.0 ( 2.55 )
    -1.2 ( 0.84 )
    1.5 ( 4.12 )
        Protein,Week 2,n=38,39,26,24,26
    -2.6 ( 3.68 )
    -2.4 ( 3.13 )
    -1.9 ( 2.73 )
    -1.7 ( 3.31 )
    -1.7 ( 3.16 )
        Protein,Week 4,n=37,38,25,23,27
    -2.5 ( 3.49 )
    -2.4 ( 4.39 )
    -1.8 ( 2.81 )
    -2.0 ( 3.64 )
    -2.0 ( 4.05 )
        Protein,Week 8,n=34,31,24,22,23
    -1.9 ( 3.53 )
    -1.6 ( 4.16 )
    -2.2 ( 3.67 )
    -0.7 ( 3.10 )
    -0.7 ( 3.30 )
        Protein,Week 12,n=32,28,24,22,21
    -1.7 ( 3.19 )
    -1.3 ( 3.72 )
    -0.8 ( 3.06 )
    1.0 ( 3.68 )
    0.9 ( 3.67 )
        Protein,Week 16,n=28,26,22,19,18
    -2.3 ( 3.43 )
    -2.0 ( 3.67 )
    -1.9 ( 3.70 )
    0.2 ( 3.20 )
    1.0 ( 3.68 )
        Protein,Week 20,n=25,23,19,18,16
    -1.9 ( 3.44 )
    -0.4 ( 4.69 )
    -1.3 ( 2.84 )
    0.6 ( 3.45 )
    0.4 ( 2.63 )
        Protein,Week 24,n=22,21,16,17,16
    -1.1 ( 3.64 )
    -0.9 ( 4.39 )
    0.0 ( 2.85 )
    1.5 ( 4.86 )
    0.8 ( 3.09 )
        Protein,Week 28,n=19,18,12,13,14
    -2.4 ( 3.30 )
    -0.8 ( 5.27 )
    -2.7 ( 2.67 )
    -0.2 ( 4.39 )
    1.6 ( 4.20 )
        Protein,Week 32,n=19,15,10,12,13
    -1.4 ( 3.52 )
    -1.5 ( 4.67 )
    -2.1 ( 4.07 )
    -0.3 ( 4.45 )
    2.6 ( 3.78 )
        Protein,Week 36,n=15,12,10,12,13
    -0.3 ( 3.48 )
    -0.8 ( 4.69 )
    -0.5 ( 2.51 )
    -0.3 ( 4.11 )
    1.8 ( 3.51 )
        Protein,Week 40,n=15,11,9,10,10
    -0.5 ( 3.38 )
    -1.5 ( 4.93 )
    -2.1 ( 1.76 )
    -0.4 ( 3.27 )
    1.4 ( 3.03 )
        Protein,Week 44,n=11,11,6,8,9
    0.3 ( 2.65 )
    -0.4 ( 4.06 )
    -2.0 ( 3.52 )
    2.3 ( 5.50 )
    1.7 ( 2.60 )
        Protein,Week 48,n=9,8,5,8,5
    0.3 ( 4.69 )
    -0.1 ( 3.76 )
    -1.8 ( 4.49 )
    1.4 ( 4.98 )
    3.2 ( 2.28 )
        Protein,Week 52,n=9,5,5,5,4
    -0.4 ( 3.54 )
    1.0 ( 4.69 )
    0.6 ( 4.88 )
    -1.0 ( 3.54 )
    1.8 ( 4.43 )
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in clinical chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)

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    End point title
    Part A: Change from Baseline in clinical chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
    End point description
    Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: International units per liter
    arithmetic mean (standard deviation)
        ALT,Week 2,n=38,39,26,24,26
    8.2 ( 17.71 )
    5.3 ( 14.63 )
    10.1 ( 23.12 )
    -0.6 ( 3.27 )
    1.8 ( 15.16 )
        ALT,Week 4,n=37,38,25,23,27
    6.6 ( 11.17 )
    6.6 ( 16.09 )
    5.2 ( 6.10 )
    -1.2 ( 4.20 )
    -3.1 ( 9.80 )
        ALT,Week 8,n=34,31,24,22,23
    6.0 ( 14.70 )
    9.5 ( 12.71 )
    4.7 ( 8.25 )
    -2.8 ( 4.19 )
    -6.8 ( 12.81 )
        ALT,Week 12,n=32,28,24,22,21
    4.7 ( 6.91 )
    4.4 ( 10.82 )
    4.0 ( 6.85 )
    -3.3 ( 5.39 )
    -7.0 ( 11.88 )
        ALT,Week 16,n=28,26,22,19,18
    4.1 ( 8.11 )
    2.2 ( 9.86 )
    5.2 ( 10.08 )
    -3.5 ( 5.23 )
    -6.6 ( 14.22 )
        ALT,Week 20,n=25,23,19,18,16
    16.1 ( 51.67 )
    4.9 ( 15.83 )
    8.6 ( 11.73 )
    2.3 ( 22.33 )
    -8.1 ( 14.38 )
        ALT,Week 24,n=22,21,16,17,16
    8.3 ( 13.62 )
    2.5 ( 14.71 )
    16.4 ( 33.68 )
    -2.8 ( 6.58 )
    -9.4 ( 13.61 )
        ALT,Week 28,n=19,18,12,13,14
    6.7 ( 8.75 )
    2.9 ( 14.59 )
    12.1 ( 23.96 )
    -1.9 ( 3.95 )
    -8.9 ( 12.65 )
        ALT,Week 32,n=19,15,10,12,13
    6.6 ( 11.06 )
    5.0 ( 14.05 )
    5.1 ( 9.45 )
    -2.0 ( 4.45 )
    -10.0 ( 12.40 )
        ALT,Week 36,n=15,12,10,12,13
    8.7 ( 13.58 )
    6.0 ( 15.22 )
    4.5 ( 8.44 )
    -2.8 ( 2.77 )
    -10.0 ( 13.87 )
        ALT,Week 40,n=15,11,9,10,10
    5.3 ( 8.85 )
    7.3 ( 19.52 )
    5.4 ( 5.61 )
    0.1 ( 11.82 )
    -2.1 ( 6.77 )
        ALT,Week 44,n=11,11,6,8,9
    1.8 ( 5.51 )
    5.5 ( 15.53 )
    2.7 ( 7.09 )
    -0.4 ( 7.15 )
    -7.0 ( 4.42 )
        ALT,Week 48,n=9,8,5,8,5
    2.3 ( 6.54 )
    4.5 ( 16.52 )
    3.6 ( 10.48 )
    -3.5 ( 3.12 )
    0.2 ( 11.50 )
        ALT,Week 52,n=9,5,5,5,4
    1.3 ( 5.98 )
    1.6 ( 19.63 )
    8.8 ( 10.03 )
    -4.4 ( 1.52 )
    5.3 ( 20.81 )
        ALP,Week 2,n=38,39,26,24,26
    -9.3 ( 15.76 )
    -11.4 ( 7.46 )
    -11.4 ( 8.50 )
    -3.0 ( 5.88 )
    -2.6 ( 5.81 )
        ALP,Week 4,n=37,38,25,23,27
    -15.5 ( 13.96 )
    -13.4 ( 12.75 )
    -14.2 ( 10.17 )
    -2.2 ( 8.83 )
    5.3 ( 27.51 )
        ALP,Week 8,n=34,31,24,22,23
    -16.8 ( 11.61 )
    -10.4 ( 13.73 )
    -15.3 ( 7.14 )
    2.9 ( 9.95 )
    1.6 ( 33.37 )
        ALP,Week 12,n=32,28,24,22,21
    -19.2 ( 15.60 )
    -7.0 ( 10.15 )
    -15.0 ( 8.06 )
    6.6 ( 13.21 )
    -5.3 ( 16.83 )
        ALP,Week 16,n=28,26,22,19,18
    -18.2 ( 15.36 )
    -8.0 ( 12.61 )
    -14.6 ( 8.56 )
    1.1 ( 12.90 )
    -0.3 ( 14.43 )
        ALP,Week 20,n=25,23,19,18,16
    -14.4 ( 21.82 )
    -4.4 ( 12.89 )
    -13.3 ( 9.58 )
    5.9 ( 19.44 )
    -1.0 ( 12.41 )
        ALP,Week 24,n=22,21,16,17,16
    -16.3 ( 20.32 )
    -6.2 ( 13.76 )
    -12.5 ( 9.08 )
    6.9 ( 16.34 )
    -1.8 ( 20.27 )
        ALP,Week 28,n=19,18,12,13,14
    -17.6 ( 23.06 )
    -4.3 ( 14.99 )
    -17.5 ( 6.56 )
    1.6 ( 13.28 )
    2.9 ( 19.72 )
        ALP,Week 32,n=19,15,10,12,13
    -15.9 ( 22.94 )
    -6.1 ( 11.89 )
    -12.6 ( 6.93 )
    -2.3 ( 17.00 )
    5.2 ( 18.44 )
        ALP,Week 36,n=15,12,10,12,13
    -20.3 ( 24.22 )
    -7.3 ( 11.18 )
    -9.6 ( 12.51 )
    -1.8 ( 15.49 )
    7.3 ( 20.95 )
        ALP,Week 40,n=15,11,9,10,10
    -14.5 ( 22.71 )
    -7.4 ( 10.16 )
    -9.9 ( 11.35 )
    -0.2 ( 15.17 )
    12.3 ( 24.69 )
        ALP,Week 44,n=11,11,6,8,9
    -19.4 ( 24.30 )
    -6.2 ( 13.48 )
    -4.0 ( 10.86 )
    2.8 ( 19.93 )
    11.9 ( 24.93 )
        ALP,Week 48,n=9,8,5,8,5
    -24.4 ( 28.77 )
    -6.5 ( 8.45 )
    -4.4 ( 12.82 )
    1.5 ( 18.31 )
    7.2 ( 17.06 )
        ALP,Week 52,n=9,5,5,5,4
    -26.0 ( 29.20 )
    -8.0 ( 9.14 )
    -3.6 ( 7.60 )
    1.0 ( 19.34 )
    -1.5 ( 11.00 )
        AST,Week 2,n=38,39,26,24,26
    6.1 ( 8.07 )
    3.7 ( 4.81 )
    4.5 ( 7.11 )
    -0.3 ( 2.66 )
    0.4 ( 6.18 )
        AST,Week 4,n=37,38,25,23,27
    5.4 ( 8.43 )
    5.9 ( 6.74 )
    5.0 ( 3.96 )
    -1.0 ( 2.75 )
    -0.7 ( 7.10 )
        AST,Week 8,n=34,31,24,22,23
    6.4 ( 6.43 )
    10.6 ( 8.90 )
    6.7 ( 7.90 )
    0.1 ( 2.74 )
    -1.6 ( 7.72 )
        AST,Week 12,n=32,28,24,22,21
    7.6 ( 9.02 )
    9.0 ( 5.64 )
    6.5 ( 5.24 )
    0.5 ( 3.62 )
    0.1 ( 8.74 )
        AST,Week 16,n=28,26,22,19,18
    8.5 ( 8.94 )
    7.0 ( 5.79 )
    8.0 ( 7.28 )
    0.2 ( 4.45 )
    1.0 ( 11.88 )
        AST,Week 20,n=25,23,19,18,16
    14.6 ( 27.52 )
    7.7 ( 7.24 )
    9.0 ( 7.46 )
    4.3 ( 20.22 )
    1.4 ( 12.10 )
        AST,Week 24,n=22,21,16,17,16
    9.8 ( 8.52 )
    7.6 ( 6.75 )
    10.5 ( 10.02 )
    0.6 ( 4.40 )
    -1.3 ( 8.29 )
        AST,Week 28,n=19,18,12,13,14
    9.0 ( 7.23 )
    8.1 ( 7.30 )
    9.4 ( 10.61 )
    1.1 ( 3.88 )
    -0.1 ( 9.01 )
        AST,Week 32,n=19,15,10,12,13
    8.8 ( 7.63 )
    9.2 ( 7.72 )
    8.0 ( 4.94 )
    0.6 ( 3.65 )
    1.2 ( 9.49 )
        AST,Week 36,n=15,12,10,12,13
    10.6 ( 8.85 )
    10.8 ( 8.09 )
    7.6 ( 5.02 )
    1.3 ( 2.56 )
    0.2 ( 9.27 )
        AST,Week 40,n=15,11,9,10,10
    8.9 ( 4.56 )
    8.7 ( 10.82 )
    9.1 ( 4.11 )
    4.7 ( 13.17 )
    6.7 ( 11.36 )
        AST,Week 44,n=11,11,6,8,9
    8.1 ( 3.56 )
    9.2 ( 8.91 )
    8.3 ( 5.09 )
    3.5 ( 4.81 )
    2.3 ( 3.24 )
        AST,Week 48,n=9,8,5,8,5
    8.1 ( 4.04 )
    11.8 ( 12.63 )
    9.8 ( 7.29 )
    1.3 ( 4.68 )
    6.4 ( 5.59 )
        AST,Week 52,n=9,5,5,5,4
    7.1 ( 3.33 )
    9.2 ( 4.97 )
    11.6 ( 5.68 )
    -0.2 ( 3.63 )
    4.3 ( 6.85 )
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin

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    End point title
    Part A: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
    End point description
    Blood samples were collected to analyze the chemistry parameters including bilirubin, creatinine, direct bilirubin and indirect bilirubin. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    42
    39
    26
    27
    27
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        Bilirubin,Week 2,n=38,39,26,24,26
    1.8 ( 2.73 )
    1.5 ( 3.12 )
    1.9 ( 3.73 )
    -1.1 ( 1.94 )
    -1.0 ( 3.45 )
        Bilirubin,Week 4,n=37,38,25,23,27
    2.4 ( 5.05 )
    1.9 ( 3.10 )
    1.8 ( 2.76 )
    -1.8 ( 2.52 )
    -1.5 ( 5.22 )
        Bilirubin,Week 8,n=34,31,24,22,23
    3.0 ( 3.58 )
    2.8 ( 4.81 )
    0.9 ( 2.95 )
    -2.3 ( 2.50 )
    -3.2 ( 5.31 )
        Bilirubin,Week 12,n=32,28,24,22,21
    4.3 ( 8.49 )
    2.8 ( 3.58 )
    2.7 ( 3.44 )
    -1.0 ( 2.40 )
    -2.9 ( 4.52 )
        Bilirubin,Week 16,n=28,26,22,19,18
    2.7 ( 4.68 )
    4.4 ( 4.53 )
    3.9 ( 3.50 )
    -0.9 ( 1.85 )
    -3.3 ( 4.25 )
        Bilirubin,Week 20,n=25,23,19,18,16
    4.7 ( 9.09 )
    4.3 ( 4.36 )
    3.6 ( 3.58 )
    -1.4 ( 2.20 )
    -3.1 ( 4.67 )
        Bilirubin,Week 24,n=22,21,16,17,16
    4.9 ( 6.29 )
    3.0 ( 4.41 )
    4.8 ( 3.60 )
    -1.1 ( 1.80 )
    -1.7 ( 3.34 )
        Bilirubin,Week 28,n=19,18,12,13,14
    4.4 ( 5.86 )
    3.7 ( 3.77 )
    3.1 ( 3.18 )
    -0.8 ( 1.92 )
    -3.2 ( 3.72 )
        Bilirubin,Week 32,n=19,15,10,12,13
    4.2 ( 4.95 )
    4.0 ( 4.54 )
    2.7 ( 2.91 )
    -0.8 ( 2.53 )
    -3.0 ( 3.74 )
        Bilirubin,Week 36,n=15,12,10,12,13
    5.2 ( 4.66 )
    5.3 ( 5.42 )
    2.3 ( 2.91 )
    -0.9 ( 1.88 )
    -2.1 ( 4.91 )
        Bilirubin,Week 40,n=15,11,6,10,10
    5.1 ( 4.18 )
    2.9 ( 4.13 )
    2.6 ( 2.07 )
    -1.1 ( 2.02 )
    -1.9 ( 4.18 )
        Bilirubin,Week 44,n=11,11,6,8,9
    4.4 ( 6.14 )
    1.8 ( 3.52 )
    2.5 ( 2.17 )
    -0.1 ( 2.03 )
    -1.2 ( 3.23 )
        Bilirubin,Week 48,n=9,8,5,8,5
    6.7 ( 6.22 )
    3.8 ( 3.62 )
    2.2 ( 1.79 )
    -1.1 ( 1.96 )
    -1.8 ( 2.49 )
        Bilirubin,Week 52,n=9,5,5,5,4
    4.8 ( 5.09 )
    1.6 ( 3.58 )
    5.0 ( 4.36 )
    -1.0 ( 2.00 )
    1.8 ( 6.85 )
        Direct Bilirubin,Week 2,n=38,39,26,24,26
    0.1 ( 1.03 )
    -0.1 ( 0.92 )
    0.1 ( 0.82 )
    0.0 ( 0.59 )
    -0.3 ( 0.75 )
        Direct Bilirubin,Week 4,n=37,38,25,23,27
    0.3 ( 0.97 )
    0.1 ( 0.73 )
    0.1 ( 0.76 )
    -0.2 ( 0.83 )
    -0.6 ( 1.31 )
        Direct Bilirubin,Week 8,n=34,31,24,22,23
    0.2 ( 1.01 )
    0.1 ( 0.72 )
    0.0 ( 0.29 )
    -0.1 ( 0.75 )
    -0.8 ( 1.31 )
        Direct Bilirubin,Week 12,n=32,28,24,22,21
    0.3 ( 1.12 )
    0.1 ( 0.66 )
    0.2 ( 0.96 )
    -0.1 ( 0.75 )
    -0.6 ( 1.29 )
        Direct Bilirubin,Week 16,n=28,26,22,19,18
    0.3 ( 1.19 )
    0.4 ( 0.98 )
    0.3 ( 0.63 )
    -0.1 ( 0.46 )
    -0.8 ( 1.40 )
        Direct Bilirubin,Week 20,n=25,23,19,18,16
    1.4 ( 3.29 )
    0.1 ( 1.12 )
    0.4 ( 0.77 )
    -0.2 ( 0.65 )
    -0.9 ( 1.45 )
        Direct Bilirubin,Week 24,n=22,21,16,17,16
    1.0 ( 1.59 )
    0.0 ( 0.89 )
    0.4 ( 0.81 )
    -0.4 ( 0.79 )
    -0.8 ( 1.24 )
        Direct Bilirubin,Week 28,n=19,18,12,13,14
    0.7 ( 1.34 )
    -0.1 ( 1.08 )
    0.1 ( 0.90 )
    -0.5 ( 0.88 )
    -1.0 ( 1.52 )
        Direct Bilirubin,Week 32,n=19,15,10,12,13
    0.5 ( 1.26 )
    0.3 ( 1.03 )
    0.1 ( 0.32 )
    -0.2 ( 0.58 )
    -1.2 ( 1.54 )
        Direct Bilirubin,Week 36,n=15,12,10,12,13
    0.7 ( 1.22 )
    0.3 ( 1.44 )
    -0.1 ( 0.74 )
    -0.2 ( 0.58 )
    -1.2 ( 1.54 )
        Direct Bilirubin,Week 40,n=15,11,6,10,10
    0.6 ( 1.18 )
    -0.4 ( 0.81 )
    -0.3 ( 0.71 )
    0.0 ( 0.00 )
    -1.4 ( 1.35 )
        Direct Bilirubin,Week 44,n=11,11,6,8,9
    0.8 ( 0.98 )
    -0.4 ( 0.81 )
    0.2 ( 0.41 )
    0.0 ( 0.00 )
    -0.7 ( 1.00 )
        Direct Bilirubin,Week 48,n=9,8,5,8,5
    1.2 ( 0.97 )
    -0.3 ( 0.71 )
    -0.6 ( 1.34 )
    0.0 ( 0.00 )
    -1.2 ( 1.10 )
        Direct Bilirubin,Week 52,n=9,5,5,5,4
    1.0 ( 1.00 )
    -0.8 ( 1.10 )
    -0.2 ( 1.10 )
    -0.4 ( 0.89 )
    -0.5 ( 1.00 )
        Indirect Bilirubin,Week 2,n=38,39,26,24,26
    1.7 ( 2.51 )
    1.6 ( 2.84 )
    1.8 ( 3.18 )
    -1.1 ( 1.75 )
    -0.7 ( 3.19 )
        Indirect Bilirubin,Week 4,n=37,38,25,23,27
    2.1 ( 4.93 )
    1.9 ( 2.86 )
    1.8 ( 2.31 )
    -1.6 ( 2.19 )
    -0.9 ( 4.27 )
        Indirect Bilirubin,Week 8,n=34,31,24,22,23
    2.8 ( 3.37 )
    2.7 ( 4.37 )
    0.9 ( 2.90 )
    -2.2 ( 2.47 )
    -2.4 ( 4.34 )
        Indirect Bilirubin,Week 12,n=32,28,24,22,21
    4.0 ( 7.94 )
    2.7 ( 3.28 )
    2.5 ( 2.87 )
    -1.0 ( 2.63 )
    -2.3 ( 3.79 )
        Indirect Bilirubin,Week 16,n=28,26,22,19,18
    2.4 ( 4.29 )
    4.0 ( 3.88 )
    3.6 ( 3.22 )
    -0.8 ( 1.84 )
    -2.5 ( 3.00 )
        Indirect Bilirubin,Week 20,n=25,23,19,18,16
    3.3 ( 6.22 )
    4.2 ( 3.66 )
    3.2 ( 3.21 )
    -1.2 ( 2.23 )
    -2.2 ( 3.47 )
        Indirect Bilirubin,Week 24,n=22,21,16,17,16
    4.0 ( 5.52 )
    3.0 ( 3.88 )
    4.4 ( 3.03 )
    -0.8 ( 1.64 )
    -0.9 ( 2.62 )
        Indirect Bilirubin,Week 28,n=19,18,12,13,14
    3.7 ( 5.05 )
    3.8 ( 3.42 )
    3.0 ( 3.02 )
    -0.3 ( 1.80 )
    -2.2 ( 2.55 )
        Indirect Bilirubin,Week 32,n=19,15,10,12,13
    3.7 ( 4.24 )
    3.7 ( 3.77 )
    2.6 ( 2.99 )
    -0.6 ( 2.35 )
    -1.8 ( 2.52 )
        Indirect Bilirubin,Week 36,n=15,12,10,12,13
    4.5 ( 4.02 )
    5.0 ( 4.47 )
    2.4 ( 2.63 )
    -0.8 ( 1.66 )
    -0.8 ( 3.83 )
        Indirect Bilirubin,Week 40,n=15,11,6,10,10
    4.5 ( 3.94 )
    3.3 ( 3.61 )
    2.9 ( 2.03 )
    -1.1 ( 2.02 )
    -0.5 ( 2.95 )
        Indirect Bilirubin,Week 44,n=11,11,6,8,9
    3.5 ( 5.43 )
    2.2 ( 3.03 )
    2.3 ( 2.34 )
    -0.1 ( 2.03 )
    -0.6 ( 2.88 )
        Indirect Bilirubin,Week 48,n=9,8,5,8,5
    5.4 ( 5.68 )
    4.0 ( 3.21 )
    2.8 ( 2.28 )
    -1.1 ( 1.96 )
    -0.6 ( 2.19 )
        Indirect Bilirubin,Week 52,n=9,5,5,5,4
    3.8 ( 4.52 )
    2.4 ( 2.61 )
    5.2 ( 5.02 )
    -0.6 ( 1.95 )
    2.3 ( 6.13 )
        Creatinine,Week 2,n=38,39,26,24,26
    4.96 ( 9.319 )
    4.10 ( 12.030 )
    0.71 ( 5.170 )
    -1.65 ( 6.165 )
    0.28 ( 7.485 )
        Creatinine,,Week 4,n=37,38,25,23,27
    4.00 ( 11.061 )
    3.03 ( 12.685 )
    2.56 ( 6.760 )
    -0.64 ( 5.781 )
    0.48 ( 7.222 )
        Creatinine,Week 8,n=34,31,24,22,23
    3.26 ( 10.522 )
    1.48 ( 14.285 )
    0.95 ( 6.027 )
    -2.93 ( 7.703 )
    2.43 ( 8.688 )
        Creatinine,,Week 12,n=32,28,24,22,21
    2.88 ( 11.590 )
    -0.84 ( 16.780 )
    3.28 ( 6.334 )
    -3.09 ( 7.615 )
    1.46 ( 6.093 )
        Creatinine,,Week 16,n=28,26,22,19,18
    3.87 ( 9.387 )
    1.16 ( 12.971 )
    1.27 ( 6.604 )
    -0.14 ( 9.654 )
    3.37 ( 15.068 )
        Creatinine,,Week 20,n=25,23,19,18,16
    -0.87 ( 8.652 )
    0.33 ( 9.278 )
    -0.09 ( 5.721 )
    -0.18 ( 6.991 )
    4.73 ( 12.179 )
        Creatinine,Week 24,n=22,21,16,17,16
    1.58 ( 9.671 )
    -0.45 ( 20.542 )
    1.86 ( 9.364 )
    -1.14 ( 8.093 )
    2.63 ( 7.834 )
        Creatinine,,Week 28,n=19,18,12,13,14
    5.00 ( 12.803 )
    0.46 ( 17.574 )
    -1.33 ( 5.372 )
    -0.28 ( 4.970 )
    4.07 ( 7.431 )
        Creatinine, Week 32,n=19,15,10,12,13
    3.88 ( 11.182 )
    -2.52 ( 20.459 )
    -1.33 ( 7.598 )
    0.59 ( 7.911 )
    4.10 ( 7.264 )
        Creatinine,,Week 36,n=15,12,10,12,13
    1.09 ( 11.330 )
    -3.82 ( 22.270 )
    0.88 ( 7.151 )
    4.56 ( 9.011 )
    3.62 ( 11.433 )
        Creatinine,,Week 40,n=15,11,6,10,10
    4.87 ( 11.617 )
    -1.45 ( 10.674 )
    -0.88 ( 9.831 )
    1.67 ( 9.527 )
    1.55 ( 10.630 )
        Creatinine, Week 44,n=11,11,6,8,9
    0.03 ( 14.182 )
    -7.06 ( 19.793 )
    -2.38 ( 7.847 )
    0.23 ( 7.876 )
    3.96 ( 14.656 )
        Creatinine,,Week 48,n=9,8,5,8,5
    7.21 ( 14.144 )
    -7.15 ( 26.680 )
    2.80 ( 8.917 )
    1.43 ( 5.646 )
    5.72 ( 18.804 )
        Creatinine,,Week 52,n=9,5,5,5,4
    3.56 ( 6.903 )
    -5.10 ( 30.563 )
    4.20 ( 9.195 )
    1.78 ( 9.836 )
    12.23 ( 16.814 )
    No statistical analyses for this end point

    Secondary: Part A: Mean Serum concentrations of sirukumab

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    End point title
    Part A: Mean Serum concentrations of sirukumab
    End point description
    Blood samples for Pharmacokinetic analysis of sirukumab serum concentrations were planned to be collected at specified time points. Data was not collected due to early termination of the study
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 44 and 52
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    0 [12]
    Units: Milligrams per milliliter
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [8] - Data was not collected due to early termination of the study
    [9] - Data was not collected due to early termination of the study
    [10] - Data was not collected due to early termination of the study
    [11] - Data was not collected due to early termination of the study
    [12] - Data was not collected due to early termination of the study
    No statistical analyses for this end point

    Secondary: Part A: Mean Serum anti-sirukumab antibodies

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    End point title
    Part A: Mean Serum anti-sirukumab antibodies
    End point description
    Blood samples for Pharmacokinetic analysis of Serum anti-sirukumab antibodies were planned to be collected at specified time points. Data was not collected due to early termination of the study
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and up to 52 weeks
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    Units: Micrograms per milliliter
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [13] - Data was not collected due to early termination of the study
    [14] - Data was not collected due to early termination of the study
    [15] - Data was not collected due to early termination of the study
    [16] - Data was not collected due to early termination of the study
    [17] - Data was not collected due to early termination of the study
    No statistical analyses for this end point

    Secondary: Part A: Change from Baseline in free and total interleukin-6 (IL-6) over time

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    End point title
    Part A: Change from Baseline in free and total interleukin-6 (IL-6) over time
    End point description
    Blood samples for Pharmacodynamic analysis were planned but not collected due to early termination of study.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and up to 52 weeks
    End point values
    PartA:SIR 100 mg SC q2w+6 month Prednisone PartA:SIR 100 mg SC q2w+3 month Prednisone PartA:SIR 50 mg SC q4w+6 month Prednisone PartA:Placebo SC q2w + 6 month Prednisone PartA:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    0 [22]
    Units: Picograms per milliliter
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [18] - Data was not collected due to early termination of the study
    [19] - Data was not collected due to early termination of the study
    [20] - Data was not collected due to early termination of the study
    [21] - Data was not collected due to early termination of the study
    [22] - Data was not collected due to early termination of the study
    No statistical analyses for this end point

    Secondary: Part B: Number of participants with AEs, SAEs and corticosteroid related AEs who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Number of participants with AEs, SAEs and corticosteroid related AEs who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.
    End point type
    Secondary
    End point timeframe
    Up to 120 weeks
    End point values
    PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone PartB:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Participants
    number (not applicable)
        All AEs
    2
    1
    1
    2
    2
        All SAEs
    0
    0
    0
    0
    0
        Corticosteroid related AEs
    0
    0
    0
    1
    1
    No statistical analyses for this end point

    Secondary: Part B: Number of participants with AEs, SAEs and corticosteroid related AEs who never received 100mg OL Sirukumab in Part B

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    End point title
    Part B: Number of participants with AEs, SAEs and corticosteroid related AEs who never received 100mg OL Sirukumab in Part B
    End point description
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.
    End point type
    Secondary
    End point timeframe
    Up to 120 weeks
    End point values
    PartB:Placebo SC q2w + 12 month Prednisone PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Participants
    number (not applicable)
        All AEs
    0
    4
    3
    2
    1
        All SAEs
    0
    0
    0
    0
    0
        Corticosteroid related AEs
    1
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in SBP and DBP for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in SBP and DBP for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
    End point values
    PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone PartB:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Millimeters of mercury
    arithmetic mean (standard deviation)
        SBP,Week 2,n=1,1,0,1,2
    2.0 ( 99999 )
    15.0 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    6.5 ( 19.09 )
        SBP,Week 4,n=2,1,1,2,2
    5.0 ( 21.21 )
    0.0 ( 99999 )
    6.0 ( 99999 )
    -1.5 ( 3.54 )
    1.5 ( 0.71 )
        SBP,Week 8,n=2,1,1,2,1
    14.0 ( 8.49 )
    18.0 ( 99999 )
    -12.0 ( 99999 )
    -11.5 ( 10.61 )
    5.0 ( 99999 )
        SBP,Week 12,n=2,1,1,1,0
    7.0 ( 1.41 )
    14.0 ( 99999 )
    8.0 ( 99999 )
    2.0 ( 99999 )
    99999 ( 99999 )
        SBP,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    9.0 ( 99999 )
    99999 ( 99999 )
        SBP,Week 16,n=2,0,0,1,0
    0.0 ( 0.00 )
    99999 ( 99999 )
    99999 ( 99999 )
    11.0 ( 99999 )
    99999 ( 99999 )
        SBP,Week 24,n=2,0,0,0,0
    8.0 ( 0.00 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        SBP,Week 36,n=2,0,0,0,0
    11.0 ( 9.90 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        SBP,Week 38,n=1,0,0,0,0
    -6.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        SBP,Week 40,n=1,0,0,0,0
    -10.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        SBP,Week follow up,n=2,1,0,1,1
    3.0 ( 18.38 )
    -1.0 ( 99999 )
    99999 ( 99999 )
    22.0 ( 99999 )
    12.0 ( 99999 )
        DBP,Week 2,n=1,1,0,1,2
    -10.0 ( 99999 )
    -8.0 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    7.0 ( 9.90 )
        DBP,Week 4,n=2,1,1,2,2
    -3.0 ( 12.73 )
    -15.0 ( 99999 )
    6.0 ( 99999 )
    2.0 ( 5.66 )
    4.5 ( 3.54 )
        DBP,Week 8,n=2,1,1,2,1
    3.0 ( 4.24 )
    -5.0 ( 99999 )
    -4.0 ( 99999 )
    4.0 ( 2.83 )
    -1.0 ( 99999 )
        DBP,Week 12,n=2,1,1,1,0
    -5.0 ( 7.07 )
    -5.0 ( 99999 )
    1.0 ( 99999 )
    4.0 ( 99999 )
    99999 ( 99999 )
        DBP,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    7.0 ( 99999 )
    99999 ( 99999 )
        DBP,Week 16,n=2,0,0,1,0
    -5.0 ( 7.07 )
    99999 ( 99999 )
    99999 ( 99999 )
    15.0 ( 99999 )
    99999 ( 99999 )
        DBP,Week 24,n=2,0,0,0,0
    1.0 ( 1.41 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        DBP,Week 36,n=2,0,0,0,0
    -2.0 ( 2.83 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        DBP,Week 38,n=1,0,0,0,0
    -8.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        DBP,Week 40,n=1,0,0,0,0
    -10.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        DBP,Week follow up,n=2,1,0,1,1
    -2.0 ( 5.66 )
    -7.0 ( 99999 )
    99999 ( 99999 )
    21.0 ( 99999 )
    3.0 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in SBP and DBP for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in SBP and DBP for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
    End point values
    PartB:Placebo SC q2w + 12 month Prednisone PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Millimeters of mercury
    arithmetic mean (standard deviation)
        SBP,Week 4,n=3,3,3,1,2
    -2.0 ( 8.49 )
    -23.7 ( 4.73 )
    -6.3 ( 5.51 )
    7.0 ( 25.36 )
    10.0 ( 99999 )
        SBP,Week 8,n=2,1,2,0,2
    -1.5 ( 0.71 )
    -32.5 ( 14.85 )
    -6.0 ( 99999 )
    -7.5 ( 17.68 )
    99999 ( 99999 )
        SBP,Week 12,n=1,1,1,1,1
    -2.0 ( 99999 )
    -59.0 ( 99999 )
    -4.0 ( 99999 )
    15.0 ( 99999 )
    13.0 ( 99999 )
        SBP,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -8.0 ( 99999 )
    25.0 ( 99999 )
    -8.0 ( 99999 )
        SBP,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    4.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        SBP,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -26.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        SBP,Week follow up,n=5,4,2,3,2
    5.0 ( 1.41 )
    -7.4 ( 19.62 )
    -3.3 ( 8.54 )
    -17.5 ( 31.82 )
    10.7 ( 10.07 )
        DBP,Week 4,n=3,3,3,1,2
    -11.0 ( 11.31 )
    -8.3 ( 14.29 )
    0.3 ( 4.51 )
    7.7 ( 8.74 )
    -4.0 ( 99999 )
        DBP,Week 8,n=2,1,2,0,2
    -6.0 ( 8.49 )
    -9.0 ( 2.83 )
    -10.0 ( 99999 )
    16.5 ( 2.12 )
    99999 ( 99999 )
        DBP,Week 12,n=1,1,1,1,1
    -9.0 ( 99999 )
    -22.0 ( 99999 )
    -6.0 ( 99999 )
    15.0 ( 99999 )
    8.0 ( 99999 )
        DBP,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    15.0 ( 99999 )
    -17.0 ( 99999 )
        DBP,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -10.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        DBP,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -10.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        DBP,Week follow up,n=5,4,2,3,2
    -2.0 ( 4.24 )
    3.4 ( 12.34 )
    -2.8 ( 99999 )
    12.5 ( 10.61 )
    6.0 ( 4.36 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in Pulse Rate for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in Pulse Rate for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
    End point values
    PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone PartB:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: beats per minute
    arithmetic mean (standard deviation)
        Week 2,n=1,1,0,1,2
    4.0 ( 99999 )
    7.0 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    4.0 ( 8.49 )
        Week 4,n=2,1,1,2,2
    -2.0 ( 8.49 )
    6.0 ( 99999 )
    -10.0 ( 99999 )
    -17.0 ( 2.83 )
    -5.5 ( 9.19 )
        Week 8,n=2,1,1,2,1
    0.0 ( 5.66 )
    3.0 ( 999999 )
    4.0 ( 99999 )
    -12.5 ( 9.19 )
    -4.0 ( 99999 )
        Week 12,n=2,1,1,1,0
    -2.0 ( 2.83 )
    2.0 ( 999999 )
    4.0 ( 99999 )
    -12.0 ( 99999 )
    99999 ( 99999 )
        Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -24.0 ( 99999 )
    99999 ( 99999 )
        Week 16,n=2,0,0,1,0
    2.0 ( 2.83 )
    99999 ( 99999 )
    99999 ( 99999 )
    -14.0 ( 99999 )
    99999 ( 99999 )
        Week 24,n=2,0,0,0,0
    5.0 ( 1.41 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 36,n=2,0,0,0,0
    -2.0 ( 8.49 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 38,n=1,0,0,0,0
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 40,n=1,0,0,0,0
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week follow up,n=2,1,0,1,1
    5.0 ( 12.73 )
    -3.0 ( 99999 )
    99999 ( 99999 )
    -22.0 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in Pulse Rate for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in Pulse Rate for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Pulse rate was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
    End point values
    PartB:Placebo SC q2w + 12 month Prednisone PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: beats per minute
    arithmetic mean (standard deviation)
        Week 4,n=3,3,3,1,2
    -1.5 ( 6.36 )
    3.7 ( 1.53 )
    0.3 ( 3.51 )
    -14.7 ( 2.31 )
    -29.0 ( 99999 )
        Week 8,n=2,1,2,0,2
    -0.5 ( 0.71 )
    8.0 ( 4.24 )
    4.0 ( 99999 )
    -5.5 ( 2.12 )
    99999 ( 99999 )
        Week 12,n=1,1,1,1,1
    99999 ( 99999 )
    11.0 ( 99999 )
    -4.0 ( 99999 )
    4.0 ( 99999 )
    6.0 ( 99999 )
        Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -4.0 ( 99999 )
    -4.0 ( 99999 )
    6.0 ( 99999 )
        Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week follow up,n=5,4,2,3,2
    7.5 ( 4.95 )
    1.4 ( 10.11 )
    4.0 ( 99999 )
    -1.5 ( 2.12 )
    -7.7 ( 17.62 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in Temperature for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in Temperature for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
    End point values
    PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone PartB:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Celsius
    arithmetic mean (standard deviation)
        Week 2,n=1,1,0,1,2
    0.20 ( 99999 )
    0.50 ( 99999 )
    99999 ( 99999 )
    -0.40 ( 99999 )
    -0.65 ( 0.071 )
        Week 4,n=2,1,1,2,2
    0.15 ( 0.071 )
    -0.50 ( 99999 )
    -0.30 ( 99999 )
    -0.10 ( 0.141 )
    0.30 ( 1.414 )
        Week 8,n=2,1,1,2,1
    -0.15 ( 0.212 )
    0.00 ( 99999 )
    0.10 ( 99999 )
    -0.20 ( 0.000 )
    -0.50 ( 99999 )
        Week 12,n=2,1,1,1,0
    -0.25 ( 0.071 )
    0.90 ( 99999 )
    0.50 ( 99999 )
    0.00 ( 99999 )
    99999 ( 99999 )
        Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.20 ( 99999 )
    99999 ( 99999 )
        Week 16,n=2,0,0,1,0
    -0.05 ( 0.071 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.10 ( 99999 )
    99999 ( 99999 )
        Week 24,n=2,0,0,0,0
    -0.42 ( 0.163 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 36,n=2,0,0,0,0
    -0.25 ( 0.071 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 38,n=1,0,0,0,0
    0.00 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 40,n=1,0,0,0,0
    0.00 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week follow up,n=2,1,0,1,1
    0.15 ( 0.071 )
    0.00 ( 99999 )
    99999 ( 99999 )
    0.50 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in Temperature for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in Temperature for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
    End point values
    PartB:Placebo SC q2w + 12 month Prednisone PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Celsius
    arithmetic mean (standard deviation)
        Week 4,n=3,3,3,1,2
    0.10 ( 0.283 )
    0.10 ( 0.458 )
    0.07 ( 0.115 )
    0.00 ( 0.300 )
    -0.20 ( 99999 )
        Week 8,n=2,1,2,0,2
    0.05 ( 0.354 )
    -0.10 ( 0.566 )
    0.00 ( 99999 )
    -0.10 ( 0.283 )
    99999 ( 99999 )
        Week 12,n=1,1,1,1,1
    -0.50 ( 99999 )
    -0.30 ( 99999 )
    0.40 ( 99999 )
    0.00 ( 99999 )
    0.00 ( 99999 )
        Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.20 ( 99999 )
    0.00 ( 99999 )
    -0.10 ( 99999 )
        Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.00 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.00 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week follow up,n=5,4,2,3,2
    0.20 ( 0.283 )
    0.06 ( 0.305 )
    0.15 ( 0.265 )
    0.00 ( 0.283 )
    -0.13 ( 0.252 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone PartB:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Giga cells per liter
    arithmetic mean (standard deviation)
        Eosinophils,Week 2,n=1,1,0,1,2
    -0.010 ( 99999 )
    -0.110 ( 99999 )
    99999 ( 99999 )
    0.000 ( 99999 )
    -0.010 ( 0.0141 )
        Eosinophils,Week 4,n=2,1,1,2,2
    -0.015 ( 0.0212 )
    -0.210 ( 99999 )
    -0.010 ( 99999 )
    -0.030 ( 0.0283 )
    0.035 ( 0.0495 )
        Eosinophils,Week 8,n=2,1,1,2,1
    -0.010 ( 0.0424 )
    -0.180 ( 99999 )
    0.040 ( 99999 )
    -0.120 ( 0.1838 )
    0.045 ( 0.0636 )
        Eosinophils,Week 12,n=2,0,1,1,0
    -0.030 ( 0.0000 )
    99999 ( 99999 )
    0.030 ( 99999 )
    -0.160 ( 99999 )
    99999 ( 99999 )
        Eosinophils,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.290 ( 99999 )
    99999 ( 99999 )
        Eosinophils,Week 16,n=2,0,0,1,0
    0.030 ( 0.0141 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.270 ( 99999 )
    99999 ( 99999 )
        Eosinophils,Week 24,n=2,0,0,0,0
    -0.015 ( 0.0212 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Eosinophils,Week 36,n=2,0,0,0,0
    -0.010 ( 0.0566 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Eosinophils,Week 38,n=1,0,0,0,0
    0.020 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Eosinophils,Week 40,n=1,0,0,0,0
    -0.030 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Leukocytes,Week 2,n=1,1,0,1,2
    -0.20 ( 99999 )
    0.30 ( 99999 )
    99999 ( 99999 )
    2.60 ( 99999 )
    -2.30 ( 0.424 )
        Leukocytes,Week 4,n=2,1,1,2,2
    0.25 ( 0.778 )
    -0.30 ( 99999 )
    0.20 ( 99999 )
    0.60 ( 1.697 )
    -1.45 ( 0.071 )
        Leukocytes,Week 8,n=2,1,1,2,1
    -0.25 ( 1.061 )
    0.00 ( 99999 )
    0.60 ( 99999 )
    0.10 ( 0.000 )
    -0.95 ( 2.333 )
        Leukocytes,Week 12,n=2,0,1,1,0
    -0.10 ( 0.990 )
    99999 ( 99999 )
    0.90 ( 99999 )
    -0.60 ( 99999 )
    99999 ( 99999 )
        Leukocytes,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.40 ( 99999 )
    99999 ( 99999 )
        Leukocytes,Week 16,n=2,0,0,1,0
    -0.45 ( 0.778 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.30 ( 99999 )
    99999 ( 99999 )
        Leukocytes,Week 24,n=2,0,0,0,0
    -0.20 ( 0.424 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Leukocytes,Week 36,n=2,0,0,0,0
    0.65 ( 0.354 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Leukocytes,Week 38,n=1,0,0,0,0
    -0.50 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Leukocytes,Week 40,n=1,0,0,0,0
    -1.30 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Lymphocytes,Week 2,n=1,1,0,1,2
    -0.170 ( 99999 )
    0.000 ( 99999 )
    99999 ( 99999 )
    -0.400 ( 99999 )
    -0.160 ( 0.0990 )
        Lymphocytes,Week 4,n=2,1,1,2,2
    0.110 ( 0.0566 )
    -0.340 ( 99999 )
    -0.010 ( 99999 )
    -0.035 ( 0.2051 )
    -0.115 ( 0.5162 )
        Lymphocytes,Week 8,n=2,1,1,2,1
    -0.120 ( 0.0283 )
    0.160 ( 99999 )
    0.050 ( 99999 )
    -0.185 ( 0.3323 )
    -0.275 ( 0.4172 )
        Lymphocytes,Week 12,n=2,0,1,1,0
    -0.030 ( 0.0283 )
    99999 ( 99999 )
    0.300 ( 99999 )
    -0.190 ( 99999 )
    99999 ( 99999 )
        Lymphocytes,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.490 ( 99999 )
    99999 ( 99999 )
        Lymphocytes,Week 16,n=2,0,0,1,0
    -0.230 ( 0.2828 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.540 ( 99999 )
    99999 ( 99999 )
        Lymphocytes,Week 24,n=2,0,0,0,0
    -0.320 ( 0.1697 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Lymphocytes,Week 36,n=2,0,0,0,0
    0.195 ( 0.1768 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        LymphocytesWeek 38,n=1,0,0,0,0
    0.010 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Lymphocytes,Week 40,n=1,0,0,0,0
    -0.160 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Neutrophils ,Week 2,n=1,1,0,1,2
    -0.040 ( 99999 )
    0.510 ( 99999 )
    99999 ( 99999 )
    3.010 ( 99999 )
    -2.210 ( 0.5233 )
        Neutrophils ,Week 4,n=2,1,1,2,2
    0.205 ( 0.5728 )
    0.400 ( 99999 )
    0.230 ( 99999 )
    0.740 ( 1.8950 )
    -1.420 ( 0.4950 )
        Neutrophils ,Week 8,n=2,1,1,2,2
    -0.265 ( 0.6435 )
    0.060 ( 99999 )
    0.620 ( 99999 )
    0.485 ( 0.1909 )
    -0.790 ( 1.8385 )
        Neutrophils ,Week 12,n=2,0,1,1,0
    0.020 ( 0.8061 )
    99999 ( 99999 )
    0.630 ( 99999 )
    -0.320 ( 99999 )
    99999 ( 99999 )
        Neutrophils ,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.590 ( 99999 )
    99999 ( 99999 )
        Neutrophils ,Week 16,n=2,0,0,1,0
    -0.235 ( 0.4879 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.050 ( 99999 )
    99999 ( 99999 )
        Neutrophils ,Week 24,n=2,0,0,0,0
    0.085 ( 0.6859 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Neutrophils ,Week 36,n=2,0,0,0,0
    0.540 ( 0.6788 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Neutrophils ,Week 38,n=1,0,0,0,0
    -0.460 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Neutrophils,Week 40,n=1,0,0,0,0
    -0.770 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Platelets ,Week 2,n=1,1,0,1,2
    5.0 ( 99999 )
    4.0 ( 99999 )
    99999 ( 99999 )
    -27.0 ( 99999 )
    -20.5 ( 57.28 )
        Platelets,Week 4,n=2,1,1,2,2
    -1.0 ( 4.24 )
    6.0 ( 99999 )
    -1.0 ( 99999 )
    -33.5 ( 30.41 )
    -42.0 ( 11.31 )
        Platelets,Week 8,n=2,1,1,2,1
    7.0 ( 11.31 )
    -6.0 ( 99999 )
    2.0 ( 99999 )
    -20.5 ( 28.99 )
    -40.0 ( 0.00 )
        Platelets,Week 12,n=2,0,1,1,0
    7.0 ( 7.07 )
    99999 ( 99999 )
    52.0 ( 99999 )
    12.0 ( 99999 )
    99999 ( 99999 )
        Platelets,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -31.0 ( 99999 )
    99999 ( 99999 )
        Platelets,Week 16,n=2,0,0,1,0
    2.0 ( 1.41 )
    99999 ( 99999 )
    99999 ( 99999 )
    -97.0 ( 99999 )
    99999 ( 99999 )
        Platelets,Week 24,n=2,0,0,0,0
    -18.5 ( 9.19 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Platelets,Week 36,n=2,0,0,0,0
    10.0 ( 21.21 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Platelets,Week 38,n=1,0,0,0,0
    -15.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Platelets,Week 40,n=1,0,0,0,0
    -6.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
    End point values
    PartB:Placebo SC q2w + 12 month Prednisone PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Giga cells per liter
    arithmetic mean (standard deviation)
        Eosinophils,Week 4,n=3,3,2,1,2
    0.415 ( 0.5869 )
    -0.110 ( 0.1735 )
    -0.013 ( 0.0551 )
    -0.050 ( 0.0849 )
    -0.030 ( 99999 )
        Eosinophils,Week 8,n=2,1,2,0,2
    0.330 ( 0.4101 )
    -0.070 ( 0.0707 )
    0.020 ( 99999 )
    0.020 ( 0.2546 )
    99999 ( 99999 )
        Eosinophils,Week 12,n=1,1,1,1,1
    0.030 ( 99999 )
    -0.120 ( 99999 )
    -0.120 ( 99999 )
    -0.190 ( 99999 )
    0.070 ( 99999 )
        Eosinophils,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.200 ( 99999 )
    -0.180 ( 99999 )
    -0.050 ( 99999 )
        Eosinophils,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.100 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Eosinophils,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.240 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Leukocytes,Week 4,n=3,3,2,1,2
    1.30 ( 0.990 )
    0.40 ( 0.500 )
    0.30 ( 1.229 )
    0.50 ( 0.000 )
    -0.40 ( 99999 )
        Leukocytes,Week 8,n=2,1,2,0,2
    0.65 ( 0.071 )
    0.25 ( 0.071 )
    0.10 ( 99999 )
    0.90 ( 0.424 )
    99999 ( 99999 )
        Leukocytes,Week 12,n=1,1,1,1,1
    -0.70 ( 99999 )
    -1.30 ( 99999 )
    -1.60 ( 99999 )
    0.80 ( 99999 )
    -1.50 ( 99999 )
        Leukocytes,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.50 ( 99999 )
    0.30 ( 99999 )
    -1.30 ( 99999 )
        Leukocytes,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.60 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Leukocytes,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -1.10 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Lymphocytes,Week 4,n=3,3,2,1,2
    0.015 ( 0.2475 )
    0.293 ( 0.2136 )
    0.077 ( 0.2442 )
    0.370 ( 0.0990 )
    -0.960 ( 99999 )
        Lymphocytes,Week 8,n=2,1,2,0,2
    -0.180 ( 0.4243 )
    0.470 ( 0.0707 )
    0.090 ( 99999 )
    0.205 ( 0.0495 )
    99999 ( 99999 )
        Lymphocytes,Week 12,n=1,1,1,1,1
    -0.610 ( 99999 )
    -0.210 ( 99999 )
    0.140 ( 99999 )
    0.190 ( 99999 )
    0.380 ( 99999 )
        Lymphocytes,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.040 ( 99999 )
    0.340 ( 99999 )
    -0.520 ( 99999 )
        Lymphocytes,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.000 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Lymphocytes,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.240 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Neutrophils ,Week 4,n=3,3,2,1,2
    0.815 ( 0.0212 )
    0.183 ( 0.4196 )
    0.333 ( 1.0108 )
    0.180 ( 0.1414 )
    0.390 ( 99999 )
        Neutrophils ,Week 8,n=2,1,2,0,2
    0.500 ( 0.8627 )
    -0.205 ( 0.1909 )
    0.010 ( 99999 )
    0.600 ( 0.0283 )
    99999 ( 99999 )
        Neutrophils ,Week 12,n=1,1,1,1,1
    -0.140 ( 99999 )
    -0.750 ( 99999 )
    -1.440 ( 99999 )
    0.820 ( 99999 )
    -1.770 ( 99999 )
        Neutrophils ,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.220 ( 99999 )
    0.230 ( 99999 )
    -0.210 ( 99999 )
        Neutrophils ,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.350 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Neutrophils ,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.420 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Platelets,Week 4,n=3,3,2,1,2
    -14.0 ( 4.24 )
    15.0 ( 31.43 )
    -6.0 ( 9.64 )
    10.5 ( 3.54 )
    26.0 ( 99999 )
        Platelets,Week 8,n=2,1,2,0,2
    31.5 ( 4.95 )
    17.5 ( 23.33 )
    -25.0 ( 99999 )
    10.0 ( 22.63 )
    99999 ( 99999 )
        Platelets,Week 12,n=1,1,1,1,1
    14.0 ( 99999 )
    27.0 ( 99999 )
    -20.0 ( 99999 )
    14.0 ( 99999 )
    -8.0 ( 99999 )
        Platelets,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -4.0 ( 99999 )
    15.0 ( 99999 )
    -19.0 ( 99999 )
        Platelets,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -20.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Platelets,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -16.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in hematology parameters- MCHC and Hemoglobin for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in hematology parameters- MCHC and Hemoglobin for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone PartB:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Grams per liter
    arithmetic mean (standard deviation)
        MCHC,Week 2,n=1,1,0,1,1
    -3.0 ( 99999 )
    -1.0 ( 99999 )
    99999 ( 99999 )
    -3.0 ( 99999 )
    20.0 ( 99999 )
        MCHC,Week 4,n=2,1,0,2,1
    -1.5 ( 3.54 )
    1.0 ( 99999 )
    99999 ( 99999 )
    3.5 ( 2.12 )
    23.0 ( 99999 )
        MCHC,Week 8,n=2,1,0,2,1
    0.0 ( 12.73 )
    16.0 ( 99999 )
    99999 ( 99999 )
    3.5 ( 14.85 )
    9.0 ( 99999 )
        MCHC,Week 12,n=2,0,0,1,0
    -5.5 ( 0.71 )
    99999 ( 99999 )
    99999 ( 99999 )
    19.0 ( 99999 )
    99999 ( 99999 )
        MCHC,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    5.0 ( 99999 )
    99999 ( 99999 )
        MCHC,Week 16,n=2,0,0,1,0
    0.0 ( 1.41 )
    99999 ( 99999 )
    99999 ( 99999 )
    11.0 ( 99999 )
    99999 ( 99999 )
        MCHC,Week 24,n=2,0,0,0,0
    -3.0 ( 2.83 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        MCHC,Week 36,n=2,0,0,0,0
    -4.0 ( 4.24 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        MCHC,Week 38,n=1,0,0,0,0
    -3.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        MCHC,Week 40,n=1,0,0,0,0
    4.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Hemoglobin,Week 2,n=1,1,0,1,2
    -4.0 ( 99999 )
    -2.0 ( 99999 )
    99999 ( 99999 )
    7.0 ( 99999 )
    10.0 ( 4.24 )
        Hemoglobin,Week 4,n=2,1,1,2,2
    0.5 ( 0.71 )
    -2.0 ( 99999 )
    -9.0 ( 99999 )
    -0.5 ( 10.61 )
    8.0 ( 8.49 )
        Hemoglobin,Week 8,n=2,1,1,2,1
    4.0 ( 1.41 )
    3.0 ( 99999 )
    0.0 ( 99999 )
    -0.5 ( 10.61 )
    9.0 ( 4.24 )
        Hemoglobin,Week 12,n=2,0,1,1,0
    1.5 ( 3.54 )
    99999 ( 99999 )
    0.0 ( 99999 )
    -6.0 ( 99999 )
    99999 ( 99999 )
        Hemoglobin,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
        Hemoglobin,Week 16,n=2,0,0,1,0
    0.0 ( 0.00 )
    99999 ( 99999 )
    99999 ( 99999 )
    8.0 ( 99999 )
    99999 ( 99999 )
        Hemoglobin,Week 24,n=2,0,0,0,0
    -0.5 ( 7.78 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Hemoglobin,Week 36,n=2,0,0,0,0
    -1.5 ( 3.54 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Hemoglobin,Week 38,n=1,0,0,0,0
    -3.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Hemoglobin,Week 40,n=1,0,0,0,0
    -3.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in hematology parameters- MCHC and Hemoglobin for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in hematology parameters- MCHC and Hemoglobin for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
    End point values
    PartB:Placebo SC q2w + 12 month Prednisone PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Grams per liter
    arithmetic mean (standard deviation)
        MCHC,Week 4,n=3,3,2,1,2
    -7.0 ( 11.31 )
    -18.0 ( 99999 )
    -14.0 ( 4.24 )
    -3.0 ( 1.41 )
    0.0 ( 99999 )
        MCHC,Week 8,n=0,1,2,0,2
    8.0 ( 19.80 )
    99999 ( 99999 )
    -8.0 ( 99999 )
    -0.5 ( 16.26 )
    99999 ( 99999 )
        MCHC,Week 12,n=0,1,1,1,1
    11.0 ( 99999 )
    99999 ( 99999 )
    -10.0 ( 99999 )
    11.0 ( 99999 )
    21.0 ( 99999 )
        MCHC,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -9.0 ( 99999 )
    -1.0 ( 99999 )
    8.0 ( 99999 )
        MCHC,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -17.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        MCHC,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -15.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Hemoglobin,Week 4,n=3,3,2,1,2
    -5.5 ( 3.54 )
    -4.0 ( 5.29 )
    -6.3 ( 3.51 )
    2.0 ( 9.90 )
    -2.0 ( 99999 )
        Hemoglobin,Week 8,n=2,1,2,0,2
    -1.5 ( 10.61 )
    -6.0 ( 14.14 )
    -4.0 ( 99999 )
    4.0 ( 12.73 )
    99999 ( 99999 )
        Hemoglobin,Week 12,n=1,1,1,1,1
    5.0 ( 99999 )
    -5.0 ( 99999 )
    -1.0 ( 99999 )
    20.0 ( 99999 )
    8.0 ( 99999 )
        Hemoglobin,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    19.0 ( 99999 )
    2.0 ( 99999 )
        Hemoglobin,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -4.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Hemoglobin,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in hematology parameter-Hematocrit for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in hematology parameter-Hematocrit for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone PartB:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Proportion of red blood cells in blood
    arithmetic mean (standard deviation)
        Hematocrit,Week 2,n=1,1,0,1,2
    -0.0080 ( 99999 )
    -0.0060 ( 99999 )
    99999 ( 99999 )
    0.0250 ( 99999 )
    0.0235 ( 0.01202 )
        Hematocrit,Week 4,n=2,1,1,2,2
    0.0030 ( 0.00141 )
    -0.0080 ( 99999 )
    -0.0250 ( 99999 )
    -0.0060 ( 0.03111 )
    0.0105 ( 0.00354 )
        Hematocrit,Week 8,n=2,1,1,2,2
    0.0115 ( 0.01909 )
    -0.0110 ( 99999 )
    -0.0030 ( 99999 )
    -0.0040 ( 0.01414 )
    0.0260 ( 0.02546 )
        Hematocrit,Week 12,n=2,0,1,1,0
    0.0125 ( 0.01202 )
    99999 ( 99999 )
    -0.0060 ( 99999 )
    -0.0420 ( 99999 )
    99999 ( 99999 )
        Hematocrit,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.0080 ( 99999 )
    99999 ( 99999 )
        Hematocrit,Week 16,n=2,0,0,1,0
    0.0000 ( 0.00141 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.0080 ( 99999 )
    99999 ( 99999 )
        Hematocrit,Week 24,n=2,0,0,0,0
    0.0040 ( 0.02687 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Hematocrit,Week 36,n=2,0,0,0,0
    0.0005 ( 0.01626 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Hematocrit,Week 38,n=1,0,0,0,0
    -0.0050 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Hematocrit,Week 40,n=1,0,0,0,0
    -0.0140 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in hematology parameter-Hematocrit for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in hematology parameter-Hematocrit for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
    End point values
    PartB:Placebo SC q2w + 12 month Prednisone PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Proportion of red blood cells in blood
    arithmetic mean (standard deviation)
        Hematocrit,Week 4,n=3,3,2,1,2
    -0.0070 ( 0.00849 )
    -0.0047 ( 0.02570 )
    -0.0057 ( 0.01834 )
    0.0115 ( 0.02616 )
    -0.0040 ( 99999 )
        Hematocrit,Week 8,n=2,1,2,0,2
    -0.0120 ( 0.00424 )
    -0.0185 ( 0.04879 )
    0.0000 ( 99999 )
    0.0135 ( 0.01768 )
    99999 ( 99999 )
        Hematocrit,Week 12,n=1,1,1,1,1
    0.0030 ( 99999 )
    -0.0120 ( 99999 )
    0.0080 ( 99999 )
    0.0470 ( 99999 )
    -0.0010 ( 99999 )
        Hematocrit,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.0060 ( 99999 )
    0.0610 ( 99999 )
    -0.0030 ( 99999 )
        Hematocrit,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.0100 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Hematocrit,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.0280 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone PartB:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Femtoliter
    arithmetic mean (standard deviation)
        Week 2,n=1,1,0,1,2
    -2.0 ( 99999 )
    1.0 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    0.5 ( 3.54 )
        Week 4,n=2,1,1,2,2
    1.5 ( 0.71 )
    1.0 ( 99999 )
    1.0 ( 99999 )
    -1.5 ( 0.71 )
    0.5 ( 2.12 )
        Week 8,n=2,1,1,2,1
    1.5 ( 2.12 )
    -1.0 ( 99999 )
    0.0 ( 99999 )
    -2.5 ( 0.71 )
    2.0 ( 2.83 )
        Week 12,n=2,0,1,1,0
    2.5 ( 0.71 )
    99999 ( 99999 )
    0.0 ( 99999 )
    -6.0 ( 99999 )
    99999 ( 99999 )
        Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -5.0 ( 99999 )
    99999 ( 99999 )
        Week 16,n=2,0,0,1,0
    0.5 ( 0.71 )
    99999 ( 99999 )
    99999 ( 99999 )
    -4.0 ( 99999 )
    99999 ( 99999 )
        Week 24,n=2,0,0,0,0
    1.5 ( 0.71 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 36,n=2,0,0,0,0
    2.5 ( 2.12 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 38,n=1,0,0,0,0
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 40,n=1,0,0,0,0
    -2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
    End point values
    PartB:Placebo SC q2w + 12 month Prednisone PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Femtoliter
    arithmetic mean (standard deviation)
        Week 4,n=3,3,2,1,2
    2.0 ( 1.41 )
    0.7 ( 1.15 )
    1.3 ( 1.53 )
    0.0 ( 0.00 )
    -3.0 ( 99999 )
        Week 8,n=2,1,2,0,2
    1.5 ( 0.71 )
    -0.5 ( 0.71 )
    1.0 ( 99999 )
    0.0 ( 1.41 )
    99999 ( 99999 )
        Week 12,n=1,1,1,1,1
    2.0 ( 99999 )
    0.0 ( 99999 )
    2.0 ( 99999 )
    -1.0 ( 99999 )
    1.0 ( 99999 )
        Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    1.0 ( 99999 )
    0.0 ( 99999 )
    2.0 ( 99999 )
        Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    3.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    4.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone PartB:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Picograms
    arithmetic mean (standard deviation)
        Week 2,n=1,1,0,1,2
    -1.10 ( 99999 )
    0.20 ( 99999 )
    99999 ( 99999 )
    -0.20 ( 99999 )
    0.60 ( 0.990 )
        Week 4,n=2,1,1,2,2
    0.30 ( 0.000 )
    0.60 ( 99999 )
    0.20 ( 99999 )
    -0.05 ( 0.354 )
    1.00 ( 1.273 )
        Week 8,n=2,1,1,2,2
    0.30 ( 0.424 )
    1.30 ( 99999 )
    0.30 ( 99999 )
    -0.45 ( 0.919 )
    0.70 ( 0.141 )
        Week 12,n=2,1,1,1,0
    0.25 ( 0.212 )
    99999 ( 99999 )
    0.30 ( 99999 )
    0.00 ( 99999 )
    99999 ( 99999 )
        Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.90 ( 99999 )
    99999 ( 99999 )
        Week 16,n=2,0,0,1,0
    0.00 ( 0.00 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.10 ( 99999 )
    99999 ( 99999 )
        Week 24,n=2,0,0,0,0
    0.10 ( 0.141 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 36,n=2,0,0,0,0
    0.25 ( 0.354 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 38,n=1,0,0,0,0
    -0.40 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 40,n=1,0,0,0,0
    0.40 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
    End point values
    PartB:Placebo SC q2w + 12 month Prednisone PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Picograms
    arithmetic mean (standard deviation)
        Week 4,n=3,3,2,1,2
    0.00 ( 0.849 )
    -0.33 ( 0.757 )
    -0.47 ( 0.451 )
    -0.25 ( 0.354 )
    -1.00 ( 99999 )
        Week 8,n=2,1,2,0,2
    1.10 ( 2.121 )
    -0.15 ( 0.354 )
    -0.60 ( 99999 )
    0.00 ( 1.273 )
    99999 ( 99999 )
        Week 12,n=1,1,1,1,1
    1.80 ( 99999 )
    -0.10 ( 99999 )
    -0.50 ( 99999 )
    0.70 ( 99999 )
    2.20 ( 99999 )
        Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.80 ( 99999 )
    -0.20 ( 99999 )
    1.30 ( 99999 )
        Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.80 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.20 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in hematology parameter- Erythrocytes for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in hematology parameter- Erythrocytes for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone PartB:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Trillion cells per liter
    arithmetic mean (standard deviation)
        Week 2,n=1,1,0,1,2
    0.00 ( 99999 )
    -0.10 ( 99999 )
    99999 ( 99999 )
    0.30 ( 99999 )
    0.25 ( 0.071 )
        Week 4,n=2,1,1,2,2
    0.00 ( 0.000 )
    -0.10 ( 99999 )
    -0.30 ( 99999 )
    0.00 ( 0.283 )
    0.10 ( 0.141 )
        Week 8,n=2,1,1,2,2
    0.10 ( 0.141 )
    0.00 ( 99999 )
    0.00 ( 99999 )
    0.05 ( 0.212 )
    0.15 ( 0.071 )
        Week 12,n=2,1,1,1,0
    0.10 ( 0.141 )
    99999 ( 99999 )
    0.00 ( 99999 )
    -0.20 ( 99999 )
    99999 ( 99999 )
        Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.10 ( 99999 )
    99999 ( 99999 )
        Week 16,n=2,0,0,1,0
    0.00 ( 0.00 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.20 ( 99999 )
    99999 ( 99999 )
        Week 24,n=2,0,0,0,0
    0.00 ( 0.283 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 36,n=2,0,0,0,0
    -0.05 ( 0.071 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 38,n=1,0,0,0,0
    0.00 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 40,n=1,0,0,0,0
    0.00 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in hematology parameter- Erythrocytes for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in hematology parameter- Erythrocytes for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
    End point values
    PartB:Placebo SC q2w + 12 month Prednisone PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Trillion cells per liter
    arithmetic mean (standard deviation)
        Week 4,n=3,3,2,1,2
    -0.20 ( 0.000 )
    -0.03 ( 0.252 )
    -0.10 ( 0.173 )
    0.10 ( 0.283 )
    0.10 ( 99999 )
        Week 8,n=2,1,2,0,2
    -0.20 ( 0.000 )
    -0.15 ( 0.495 )
    0.00 ( 99999 )
    0.10 ( 0.283 )
    99999 ( 99999 )
        Week 12,n=1,1,1,1,1
    -0.10 ( 99999 )
    -0.10 ( 99999 )
    0.10 ( 99999 )
    0.60 ( 99999 )
    0.00 ( 99999 )
        Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.10 ( 99999 )
    0.70 ( 99999 )
    -0.10 ( 99999 )
        Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.00 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.10 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

    Close Top of page
    End point title
    Part B: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone PartB:Placebo SC q2w + 12 month Prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        Calcium,Week 2,n=1,1,0,1,2
    0.060 ( 99999 )
    0.000 ( 99999 )
    99999 ( 99999 )
    0.100 ( 99999 )
    0.040 ( 0.0000 )
        Calcium,Week 4,n=2,1,1,2,2
    0.070 ( 0.0707 )
    -0.100 ( 99999 )
    -0.080 ( 99999 )
    0.050 ( 0.1273 )
    0.000 ( 0.0566 )
        Calcium,Week 8,n=2,1,1,2,1
    0.120 ( 0.0283 )
    -0.140 ( 99999 )
    0.000 ( 99999 )
    -0.020 ( 0.0849 )
    0.020 ( 99999 )
        Calcium,Week 12,n=2,1,1,1,0
    0.110 ( 0.0990 )
    99999 ( 99999 )
    0.000 ( 99999 )
    -0.040 ( 99999 )
    99999 ( 99999 )
        Calcium,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.000 ( 99999 )
    99999 ( 99999 )
        Calcium,Week 16,n=2,0,0,1,0
    0.000 ( 0.1131 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.140 ( 99999 )
    99999 ( 99999 )
        Calcium,Week 24,n=2,0,0,0,0
    0.040 ( 0.0566 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Calcium,Week 36,n=2,0,0,0,0
    -0.050 ( 0.0707 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Calcium,Week 38,n=1,0,0,0,0
    -0.020 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Calcium,Week 40,n=1,0,0,0,0
    -0.020 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Carbon Dioxide,Week 2,n=1,1,0,1,2
    3.0 ( 99999 )
    -5.0 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    -1.0 ( 0.00 )
        Carbon Dioxide,Week 4,n=2,1,1,2,2
    3.5 ( 3.54 )
    -3.0 ( 99999 )
    2.0 ( 99999 )
    -1.5 ( 2.12 )
    -3.5 ( 2.12 )
        Carbon Dioxide,Week 8,n=2,1,1,2,1
    2.5 ( 2.12 )
    -4.0 ( 99999 )
    1.0 ( 99999 )
    -1.0 ( 0.00 )
    -1.0 ( 99999 )
        Carbon Dioxide,Week 12,n=2,1,1,1,0
    3.5 ( 2.12 )
    99999 ( 99999 )
    2.0 ( 99999 )
    -3.0 ( 99999 )
    99999 ( 99999 )
        Carbon Dioxide,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.0 ( 99999 )
    99999 ( 99999 )
        Carbon Dioxide,Week 16,n=2,0,0,1,0
    0.5 ( 0.71 )
    99999 ( 99999 )
    99999 ( 99999 )
    -1.0 ( 99999 )
    99999 ( 99999 )
        Carbon Dioxide,Week 24,n=2,0,0,0,0
    3.0 ( 0.00 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Carbon Dioxide,Week 36,n=2,0,0,0,0
    1.5 ( 4.95 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Carbon Dioxide,Week 38,n=1,0,0,0,0
    1.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Carbon Dioxide,Week 40,n=1,0,0,0,0
    -2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Chloride,Week 2,n=1,1,0,1,2
    -1.0 ( 99999 )
    2.0 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    1.0 ( 1.41 )
        Chloride,Week 4,n=2,1,1,2,2
    -2.5 ( 0.71 )
    1.0 ( 99999 )
    6.0 ( 99999 )
    0.5 ( 2.12 )
    1.5 ( 0.71 )
        Chloride,Week 8,n=2,1,1,2,1
    -3.0 ( 1.41 )
    0.0 ( 99999 )
    2.0 ( 99999 )
    1.0 ( 1.41 )
    3.0 ( 99999 )
        Chloride,Week 12,n=2,1,1,1,0
    -2.5 ( 0.71 )
    99999 ( 99999 )
    -1.0 ( 99999 )
    1.0 ( 99999 )
    99999 ( 99999 )
        Chloride,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.0 ( 99999 )
    99999 ( 99999 )
        Chloride,Week 16,n=2,0,0,1,0
    -1.0 ( 0.00 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
        Chloride,Week 24,n=2,0,0,0,0
    -2.0 ( 1.41 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Chloride,Week 36,n=2,0,0,0,0
    0.5 ( 0.71 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Chloride,Week 38,n=1,0,0,0,0
    -1.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Chloride,Week 40,n=1,0,0,0,0
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Glucose,Week 2,n=1,1,0,1,2
    0.80 ( 99999 )
    0.20 ( 99999 )
    99999 ( 99999 )
    1.30 ( 99999 )
    1.25 ( 1.202 )
        Glucose,Week 4,n=2,1,1,2,2
    0.95 ( 1.202 )
    0.40 ( 99999 )
    -0.70 ( 99999 )
    -0.05 ( 2.192 )
    -0.05 ( 0.212 )
        Glucose,Week 8,n=2,1,1,2,1
    0.70 ( 0.424 )
    0.00 ( 99999 )
    0.10 ( 99999 )
    0.30 ( 1.414 )
    0.20 ( 99999 )
        Glucose,Week 12,n=2,1,1,1,0
    0.60 ( 0.566 )
    0.00 ( 99999 )
    0.00 ( 99999 )
    -0.10 ( 99999 )
    99999 ( 99999 )
        Glucose,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.10 ( 99999 )
    99999 ( 99999 )
        Glucose,Week 16,n=2,0,0,1,0
    0.55 ( 0.071 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.20 ( 99999 )
    99999 ( 99999 )
        Glucose,Week 24,n=2,0,0,0,0
    0.65 ( 0.354 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Glucose,Week 36,n=2,0,0,0,0
    0.35 ( 0.071 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Glucose,Week 38,n=1,0,0,0,0
    0.50 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Glucose,Week 40,n=1,0,0,0,0
    3.60 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Phosphate,Week 2,n=1,1,0,1,2
    0.050 ( 99999 )
    -0.100 ( 99999 )
    99999 ( 99999 )
    -0.300 ( 99999 )
    0.000 ( 0.0707 )
        Phosphate,Week 4,n=2,1,1,2,2
    -0.125 ( 0.1768 )
    -0.250 ( 99999 )
    0.000 ( 99999 )
    0.050 ( 0.2828 )
    -0.050 ( 0.1414 )
        Phosphate,Week 8,n=2,1,1,2,1
    0.025 ( 0.1061 )
    -0.200 ( 99999 )
    0.150 ( 99999 )
    -0.075 ( 0.3182 )
    -0.050 ( 99999 )
        Phosphate,Week 12,n=2,1,1,1,0
    -0.025 ( 0.1768 )
    99999 ( 99999 )
    0.050 ( 99999 )
    0.200 ( 99999 )
    99999 ( 99999 )
        Phosphate,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.250 ( 99999 )
    99999 ( 99999 )
        Phosphate,Week 16,n=2,0,0,1,0
    -0.050 ( 0.0707 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.300 ( 99999 )
    99999 ( 99999 )
        Phosphate,Week 24,n=2,0,0,0,0
    0.050 ( 0.0000 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Phosphate,Week 36,n=2,0,0,0,0
    -0.025 ( 0.0354 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Phosphate,Week 38,n=1,0,0,0,0
    0.000 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Phosphate,Week 40,n=1,0,0,0,0
    0.000 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Potassium,Week 2,n=1,1,0,1,2
    0.10 ( 99999 )
    -0.20 ( 99999 )
    99999 ( 99999 )
    0.00 ( 99999 )
    0.10 ( 0.283 )
        Potassium,Week 4,n=2,1,1,2,2
    0.20 ( 0.283 )
    -0.20 ( 99999 )
    0.20 ( 99999 )
    -0.30 ( 0.141 )
    0.00 ( 0.141 )
        Potassium,Week 8,n=2,1,1,2,1
    0.10 ( 0.424 )
    0.00 ( 99999 )
    0.50 ( 99999 )
    -0.30 ( 0.424 )
    0.10 ( 99999 )
        Potassium,Week 12,n=2,1,1,1,0
    0.25 ( 0.636 )
    99999 ( 99999 )
    0.30 ( 99999 )
    0.10 ( 99999 )
    99999 ( 99999 )
        Potassium,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.00 ( 99999 )
    99999 ( 99999 )
        Potassium,Week 16,n=2,0,0,1,0
    0.00 ( 0.141 )
    99999 ( 99999 )
    99999 ( 99999 )
    -0.10 ( 99999 )
    99999 ( 99999 )
        Potassium,Week 24,n=2,0,0,0,0
    0.40 ( 0.283 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Potassium,Week 36,n=2,0,0,0,0
    0.20 ( 0.424 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Potassium,Week 38,n=1,0,0,0,0
    0.00 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Potassium,Week 40,n=1,0,0,0,0
    -0.30 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Sodium,Week 2,n=1,1,0,1,2
    0.0 ( 99999 )
    -2.0 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    1.0 ( 0.00 )
        Sodium,Week 4,n=2,1,1,2,2
    -0.5 ( 0.71 )
    -1.0 ( 99999 )
    3.0 ( 99999 )
    0.5 ( 4.95 )
    0.5 ( 0.71 )
        Sodium,Week 8,n=2,1,1,2,1
    -2.0 ( 1.41 )
    -1.0 ( 99999 )
    0.0 ( 99999 )
    -0.5 ( 3.54 )
    2.0 ( 99999 )
        Sodium,Week 12,n=2,1,1,1,0
    -1.0 ( 1.41 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    2.0 ( 99999 )
    99999 ( 99999 )
        Sodium,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2.0 ( 99999 )
    99999 ( 99999 )
        Sodium,Week 16,n=2,0,0,1,0
    -1.5 ( 0.71 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
        Sodium,Week 24,n=2,0,0,0,0
    -0.5 ( 0.71 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Sodium,Week 36,n=2,0,0,0,0
    2.0 ( 0.00 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Sodium,Week 38,n=1,0,0,0,0
    -1.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Sodium,Week 40,n=1,0,0,0,0
    2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Urea,Week 2,n=1,1,0,1,2
    -1.00 ( 99999 )
    -2.50 ( 99999 )
    99999 ( 99999 )
    0.50 ( 99999 )
    0.75 ( 0.354 )
        Urea,Week 4,n=2,1,1,2,2
    1.25 ( 0.354 )
    -1.00 ( 99999 )
    1.50 ( 99999 )
    1.50 ( 0.707 )
    0.25 ( 0.354 )
        Urea,Week 8,n=2,1,1,2,1
    2.00 ( 2.121 )
    -2.00 ( 99999 )
    3.00 ( 99999 )
    -0.25 ( 0.354 )
    0.50 ( 99999 )
        Urea,Week 12,n=2,1,1,1,0
    -0.50 ( 2.121 )
    99999 ( 99999 )
    1.50 ( 99999 )
    0.00 ( 99999 )
    99999 ( 99999 )
        Urea,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.00 ( 99999 )
    99999 ( 99999 )
        Urea,Week 16,n=2,0,0,1,0
    1.25 ( 1.768 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.50 ( 99999 )
    99999 ( 99999 )
        Urea,Week 24,n=2,0,0,0,0
    0.00 ( 0.000 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Urea,Week 36,n=2,0,0,0,0
    0.00 ( 0.707 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Urea,Week 38,n=1,0,0,0,0
    1.50 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Urea,Week 40,n=1,0,0,0,0
    1.50 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for participants who never received 100 mg open label Sirukumab in Part B

    Close Top of page
    End point title
    Part B: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
    End point values
    PartB:Placebo SC q2w + 12 month Prednisone PartB:SIR 100 mg SC q2w+6 month Prednisone PartB:SIR 100 mg SC q2w+3 month Prednisone PartB:SIR 50 mg SC q4w+6 month Prednisone PartB:Placebo SC q2w + 6 month Prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        Calcium,Week 4,n=3,3,2,1,2
    -0.040 ( 0.0566 )
    0.067 ( 0.0643 )
    -0.093 ( 0.0462 )
    0.060 ( 0.1414 )
    0.120 ( 99999 )
        Calcium,Week 8,n=2,1,2,0,2
    0.020 ( 0.0000 )
    0.010 ( 0.0707 )
    -0.060 ( 99999 )
    0.050 ( 0.0707 )
    99999 ( 99999 )
        Calcium,Week 12,n=1,1,1,1,1
    0.000 ( 99999 )
    0.020 ( 99999 )
    0.040 ( 99999 )
    0.160 ( 99999 )
    0.000 ( 99999 )
        Calcium,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.040 ( 99999 )
    0.180 ( 99999 )
    0.060 ( 99999 )
        Calcium,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.040 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Calcium,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.020 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Carbon Dioxide,Week 4,n=3,3,2,1,2
    -3.0 ( 0.00 )
    0.0 ( 2.00 )
    -2.7 ( 1.15 )
    0.0 ( 2.83 )
    -1.0 ( 99999 )
        Carbon Dioxide,Week 8,n=2,1,2,0,2
    -1.5 ( 0.71 )
    -0.5 ( 0.71 )
    -4.0 ( 99999 )
    0.5 ( 3.54 )
    99999 ( 99999 )
        Carbon Dioxide,Week 12,n=1,1,1,1,1
    -3.0 ( 99999 )
    1.0 ( 99999 )
    -2.0 ( 99999 )
    0.0 ( 99999 )
    0.0 ( 99999 )
        Carbon Dioxide,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    1.0 ( 99999 )
    0.0 ( 99999 )
        Carbon Dioxide,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    1.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Carbon Dioxide,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Chloride,Week 4,n=3,3,2,1,2
    0.5 ( 0.71 )
    0.7 ( 1.15 )
    0.3 ( 3.06 )
    -2.5 ( 4.95 )
    -4.0 ( 99999 )
        Chloride,Week 8,n=2,1,2,0,2
    0.5 ( 2.12 )
    -2.0 ( 0.00 )
    -1.0 ( 99999 )
    -2.5 ( 2.12 )
    99999 ( 99999 )
        Chloride,Week 12,n=1,1,1,1,1
    -2.0 ( 99999 )
    -2.0 ( 99999 )
    0.0 ( 99999 )
    -4.0 ( 99999 )
    -2.0 ( 99999 )
        Chloride,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    1.0 ( 99999 )
    -5.0 ( 99999 )
    -1.0 ( 99999 )
        Chloride,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    1.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Chloride,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Glucose,Week 4,n=3,3,2,1,2
    -0.40 ( 0.707 )
    -0.10 ( 0.608 )
    0.33 ( 1.115 )
    -0.80 ( 0.849 )
    0.70 ( 99999 )
        Glucose,Week 8,n=2,1,2,0,2
    0.55 ( 0.354 )
    0.15 ( 1.061 )
    0.60 ( 99999 )
    -0.85 ( 0.071 )
    99999 ( 99999 )
        Glucose,Week 12,n=1,1,1,1,1
    0.20 ( 99999 )
    0.00 ( 99999 )
    2.80 ( 99999 )
    0.30 ( 99999 )
    -0.50 ( 99999 )
        Glucose,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    1.40 ( 99999 )
    0.30 ( 99999 )
    2.10 ( 99999 )
        Glucose,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    1.10 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Glucose,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    2.10 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Phosphate,Week 4,n=3,3,2,1,2
    -0.025 ( 0.1061 )
    0.050 ( 0.2646 )
    -0.033 ( 0.1155 )
    -0.125 ( 0.1768 )
    0.050 ( 99999 )
        Phosphate,Week 8,n=2,1,2,0,2
    -0.075 ( 0.0354 )
    0.150 ( 0.1414 )
    -0.100 ( 99999 )
    -0.250 ( 0.2121 )
    99999 ( 99999 )
        Phosphate,Week 12,n=1,1,1,1,1
    -0.100 ( 99999 )
    0.050 ( 99999 )
    -0.250 ( 99999 )
    0.000 ( 99999 )
    0.250 ( 99999 )
        Phosphate,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.100 ( 99999 )
    0.000 ( 99999 )
    0.000 ( 99999 )
        Phosphate,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.050 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Phosphate,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.150 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Potassium,Week 4,n=3,3,2,1,2
    -0.10 ( 0.141 )
    -0.27 ( 0.289 )
    0.03 ( 0.321 )
    0.10 ( 0.141 )
    0.40 ( 99999 )
        Potassium,Week 8,n=2,1,2,0,2
    -0.10 ( 0.283 )
    -0.25 ( 0.212 )
    -0.30 ( 99999 )
    0.00 ( 0.424 )
    99999 ( 99999 )
        Potassium,Week 12,n=1,1,1,1,1
    -0.40 ( 99999 )
    -0.20 ( 99999 )
    -0.20 ( 99999 )
    0.40 ( 99999 )
    0.00 ( 99999 )
        Potassium,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.10 ( 99999 )
    -0.10 ( 99999 )
    -0.20 ( 99999 )
        Potassium,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.10 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Potassium,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.20 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Sodium,Week 4,n=3,3,2,1,2
    -1.0 ( 1.41 )
    0.3 ( 1.53 )
    -1.0 ( 2.65 )
    -3.0 ( 2.83 )
    -3.0 ( 99999 )
        Sodium,Week 8,n=2,1,2,0,2
    -1.0 ( 1.41 )
    -2.5 ( 0.71 )
    2.0 ( 99999 )
    -3.5 ( 3.54 )
    99999 ( 99999 )
        Sodium,Week 12,n=1,1,1,1,1
    -4.0 ( 99999 )
    -2.0 ( 99999 )
    1.0 ( 99999 )
    -4.0 ( 99999 )
    0.0 ( 99999 )
        Sodium,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    -4.0 ( 99999 )
    0.0 ( 99999 )
        Sodium,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    3.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Sodium,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    1.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Urea,Week 4,n=3,3,2,1,2
    -0.25 ( 1.061 )
    -0.83 ( 0.577 )
    -0.50 ( 1.323 )
    -0.50 ( 0.707 )
    0.00 ( 99999 )
        Urea,Week 8,n=2,1,2,0,2
    0.50 ( 0.707 )
    -0.50 ( 0.707 )
    0.00 ( 99999 )
    -0.75 ( 0.354 )
    99999 ( 99999 )
        Urea,Week 12,n=1,1,1,1,1
    -2.50 ( 99999 )
    -0.50 ( 99999 )
    -1.50 ( 99999 )
    0.00 ( 99999 )
    -1.00 ( 99999 )
        Urea,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.00 ( 99999 )
    -0.50 ( 99999 )
    0.50 ( 99999 )
        Urea,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -0.50 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Urea,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -1.00 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in clinical chemistry parameters: Albumin and Protein for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in clinical chemistry parameters: Albumin and Protein for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Albumin,Week 2,n=1,1,0,1,2
    -1.0 ( 99999 )
    99999 ( 99999 )
    -1.0 ( 99999 )
    5.0 ( 99999 )
    3.5 ( 0.71 )
        Albumin,Week 4,n=2,1,1,2,2
    0.0 ( 1.41 )
    -1.0 ( 99999 )
    0.0 ( 99999 )
    0.0 ( 2.83 )
    3.0 ( 1.41 )
        Albumin,Week 8,n=2,1,1,2,1
    1.0 ( 2.83 )
    0.0 ( 99999 )
    0.0 ( 99999 )
    -2.0 ( 2.83 )
    2.0 ( 99999 )
        Albumin,Week 12,n=2,0,1,1,0
    1.0 ( 0.00 )
    1.0 ( 99999 )
    99999 ( 99999 )
    -4.0 ( 99999 )
    99999 ( 99999 )
        Albumin,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
        Albumin,Week 16,n=2,0,0,1,0
    -0.5 ( 2.12 )
    99999 ( 99999 )
    99999 ( 99999 )
    2.0 ( 99999 )
    99999 ( 99999 )
        Albumin,Week 24,n=2,0,0,0,0
    -0.5 ( 3.54 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Albumin,Week 36,n=2,0,0,0,0
    -1.0 ( 2.83 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Albumin,Week 38,n=1,0,0,0,0
    -2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Albumin,Week 40,n=1,0,0,0,0
    -2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Protein,Week 2,n=1,1,0,1,2
    0.0 ( 99999 )
    99999 ( 99999 )
    -1.0 ( 99999 )
    8.0 ( 99999 )
    1.5 ( 2.12 )
        Protein,Week 4,n=2,1,1,2,2
    1.0 ( 1.41 )
    -2.0 ( 99999 )
    0.0 ( 99999 )
    -0.5 ( 4.95 )
    -0.5 ( 2.12 )
        Protein,Week 8,n=2,1,1,2,1
    3.0 ( 1.41 )
    2.0 ( 99999 )
    0.0 ( 99999 )
    -2.5 ( 4.95 )
    0.0 ( 99999 )
        Protein,Week 12,n=2,0,1,1,0
    2.5 ( 2.12 )
    2.0 ( 99999 )
    99999 ( 99999 )
    -4.0 ( 99999 )
    99999 ( 99999 )
        Protein,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -5.0 ( 99999 )
    99999 ( 99999 )
        Protein,Week 16,n=2,0,0,1,0
    1.0 ( 1.41 )
    99999 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    99999 ( 99999 )
        Protein,Week 24,n=2,0,0,0,0
    0.5 ( 3.54 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Protein,Week 36,n=2,0,0,0,0
    1.5 ( 0.71 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Protein,Week 38,n=1,0,0,0,0
    1.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Protein,Week 40,n=1,0,0,0,0
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in clinical chemistry parameters: Albumin and Protein for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in clinical chemistry parameters: Albumin and Protein for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
    End point values
    PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Albumin,Week 4,n=3,3,2,1,2
    -2.5 ( 0.71 )
    -0.3 ( 1.53 )
    -1.3 ( 0.58 )
    1.0 ( 1.41 )
    0.0 ( 99999 )
        Albumin,Week 8,n=2,1,2,0,2
    -1.5 ( 0.71 )
    1.5 ( 2.12 )
    -2.0 ( 99999 )
    1.0 ( 2.83 )
    99999 ( 99999 )
        Albumin,Week 12,n=1,1,1,1,1
    0.0 ( 99999 )
    3.0 ( 99999 )
    -1.0 ( 99999 )
    5.0 ( 99999 )
    3.0 ( 99999 )
        Albumin,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    5.0 ( 99999 )
    0.0 ( 99999 )
        Albumin,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -1.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Albumin,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Protein,Week 4,n=3,3,2,1,2
    -5.0 ( 2.83 )
    -0.3 ( 3.21 )
    -2.7 ( 1.53 )
    1.0 ( 5.66 )
    0.0 ( 99999 )
        Protein,Week 8,n=2,1,2,0,2
    -1.5 ( 3.54 )
    1.5 ( 3.54 )
    -2.0 ( 99999 )
    2.5 ( 4.95 )
    99999 ( 99999 )
        Protein,Week 12,n=1,1,1,1,1
    2.0 ( 99999 )
    3.0 ( 99999 )
    -2.0 ( 99999 )
    9.0 ( 99999 )
    1.0 ( 99999 )
        Protein,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    12.0 ( 99999 )
    -1.0 ( 99999 )
        Protein,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -1.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Protein,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in clinical chemistry parameters: ALT, ALP and AST for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in clinical chemistry parameters: ALT, ALP and AST for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: International units per liter
    arithmetic mean (standard deviation)
        ALT,Week 2,n=1,1,0,1,2
    1.0 ( 99999 )
    99999 ( 99999 )
    4.0 ( 99999 )
    3.0 ( 99999 )
    72.5 ( 101.12 )
        ALT,Week 4,n=2,1,1,2,2
    -1.5 ( 3.54 )
    0.0 ( 99999 )
    4.0 ( 99999 )
    4.0 ( 9.90 )
    51.5 ( 64.35 )
        ALT,Week 8,n=2,1,1,2,2
    2.5 ( 4.95 )
    1.0 ( 99999 )
    2.0 ( 99999 )
    4.5 ( 7.78 )
    31.5 ( 24.75 )
        ALT,Week 12,n=2,0,1,1,0
    -3.0 ( 7.07 )
    4.0 ( 99999 )
    99999 ( 99999 )
    -3.0 ( 99999 )
    99999 ( 99999 )
        ALT,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2.0 ( 99999 )
    99999 ( 99999 )
        ALT,Week 16,n=2,0,0,1,0
    -1.0 ( 2.83 )
    99999 ( 99999 )
    99999 ( 99999 )
    2.0 ( 99999 )
    99999 ( 99999 )
        ALT,Week 24,n=2,0,0,0,0
    -2.5 ( 6.36 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ALT,Week 36,n=2,0,0,0,0
    -4.5 ( 9.19 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ALT,Week 38,n=1,0,0,0,0
    -9.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ALT,Week 40,n=1,0,0,0,0
    -9.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ALP,Week 2,n=1,1,0,1,2
    7.0 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    -17.0 ( 99999 )
    -5.0 ( 5.66 )
        ALP,Week 4,n=2,1,1,2,2
    5.5 ( 0.71 )
    -4.0 ( 99999 )
    -9.0 ( 99999 )
    -9.0 ( 14.14 )
    -7.0 ( 5.66 )
        ALP,Week 8,n=2,1,1,2,2
    7.0 ( 1.41 )
    -3.0 ( 99999 )
    -16.0 ( 99999 )
    -4.5 ( 26.16 )
    -12.0 ( 5.66 )
        ALP,Week 12,n=2,0,1,1,0
    5.0 ( 1.41 )
    2.0 ( 99999 )
    99999 ( 99999 )
    8.0 ( 99999 )
    99999 ( 99999 )
        ALP,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -15.0 ( 99999 )
    99999 ( 99999 )
        ALP,Week 16,n=2,0,0,1,0
    -0.5 ( 0.71 )
    99999 ( 99999 )
    99999 ( 99999 )
    -9.0 ( 99999 )
    99999 ( 99999 )
        ALP,Week 24,n=2,0,0,0,0
    2.5 ( 2.12 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ALP,Week 36,n=2,0,0,0,0
    2.0 ( 5.66 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ALP,Week 38,n=1,0,0,0,0
    7.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ALP,Week 40,n=1,0,0,0,0
    18.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        AST,Week 2,n=1,1,0,1,2
    0.0 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    3.0 ( 99999 )
    44.5 ( 57.28 )
        AST,Week 4,n=2,1,1,2,2
    -4.5 ( 0.71 )
    0.0 ( 99999 )
    0.0 ( 99999 )
    -0.5 ( 3.54 )
    23.0 ( 25.46 )
        AST,Week 8,n=2,1,1,2,2
    1.5 ( 0.71 )
    -3.0 ( 99999 )
    -2.0 ( 99999 )
    2.0 ( 4.24 )
    14.0 ( 5.66 )
        AST,Week 12,n=2,0,1,1,0
    -4.0 ( 1.41 )
    -1.0 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    99999 ( 99999 )
        AST,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
        AST,Week 16,n=2,0,0,1,0
    -3.0 ( 2.83 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.0 ( 99999 )
    99999 ( 99999 )
        AST,Week 24,n=2,0,0,0,0
    -3.5 ( 2.12 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        AST,Week 36,n=2,0,0,0,0
    -4.5 ( 4.95 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        AST,Week 38,n=1,0,0,0,0
    -7.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        AST,Week 40,n=1,0,0,0,0
    -7.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in clinical chemistry parameters: ALT, ALP and AST for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in clinical chemistry parameters: ALT, ALP and AST for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
    End point values
    PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: International units per liter
    arithmetic mean (standard deviation)
        ALT,Week 4,n=3,3,2,1,2
    1.0 ( 0.00 )
    2.3 ( 1.15 )
    2.7 ( 7.23 )
    -8.0 ( 4.24 )
    103.0 ( 99999 )
        ALT,Week 8,n=2,1,2,0,2
    -1.5 ( 3.54 )
    9.0 ( 7.07 )
    13.0 ( 99999 )
    -9.5 ( 9.19 )
    99999 ( 99999 )
        ALT,Week 12,n=1,1,1,1,1
    2.0 ( 99999 )
    3.0 ( 99999 )
    8.0 ( 99999 )
    -4.0 ( 99999 )
    0.0 ( 99999 )
        ALT,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -5.0 ( 99999 )
    -6.0 ( 99999 )
    1.0 ( 99999 )
        ALT,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ALT,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -4.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ALP,Week 4,n=3,3,2,1,2
    0.0 ( 14.14 )
    -0.7 ( 3.79 )
    0.0 ( 4.36 )
    0.5 ( 3.54 )
    81.0 ( 99999 )
        ALP,Week 8,n=2,1,2,0,2
    -3.0 ( 0.00 )
    1.5 ( 2.12 )
    -1.0 ( 99999 )
    -1.0 ( 4.24 )
    99999 ( 99999 )
        ALP,Week 12,n=1,1,1,1,1
    -10.0 ( 99999 )
    -1.0 ( 99999 )
    0.0 ( 99999 )
    17.0 ( 99999 )
    -11.0 ( 99999 )
        ALP,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    4.0 ( 99999 )
    3.0 ( 99999 )
    -10.0 ( 99999 )
        ALP,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        ALP,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    4.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        AST,Week 4,n=3,3,2,1,2
    -1.5 ( 3.54 )
    0.7 ( 1.53 )
    2.0 ( 3.00 )
    -5.0 ( 1.41 )
    24.0 ( 99999 )
        AST,Week 8,n=2,1,2,0,2
    0.0 ( 5.66 )
    10.5 ( 9.19 )
    7.0 ( 99999 )
    -6.0 ( 2.83 )
    99999 ( 99999 )
        AST,Week 12,n=1,1,1,1,1
    2.0 ( 99999 )
    1.0 ( 99999 )
    -1.0 ( 99999 )
    2.0 ( 99999 )
    0.0 ( 99999 )
        AST,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    -4.0 ( 99999 )
    0.0 ( 99999 )
    2.0 ( 99999 )
        AST,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -1.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        AST,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    -3.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        Bilirubin,Week 2,n=1,1,0,1,2
    0.0 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    2.0 ( 99999 )
    -1.0 ( 1.41 )
        Bilirubin,Week 4,n=2,1,1,2,2
    5.0 ( 1.41 )
    0.0 ( 99999 )
    -2.0 ( 99999 )
    1.0 ( 1.41 )
    1.0 ( 1.41 )
        Bilirubin,Week 8,n=2,1,1,2,2
    -1.0 ( 4.24 )
    2.0 ( 99999 )
    0.0 ( 99999 )
    1.0 ( 4.24 )
    2.0 ( 0.00 )
        Bilirubin,Week 12,n=2,0,1,1,0
    0.0 ( 8.49 )
    0.0 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    99999 ( 99999 )
        Bilirubin,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
        Bilirubin,Week 16,n=2,0,0,1,0
    5.0 ( 4.24 )
    99999 ( 99999 )
    99999 ( 99999 )
    2.0 ( 99999 )
    99999 ( 99999 )
        Bilirubin,Week 24,n=2,0,0,0,0
    -2.0 ( 5.66 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Bilirubin,Week 36,n=2,0,0,0,0
    1.0 ( 7.07 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Bilirubin,Week 38,n=1,0,0,0,0
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Bilirubin,Week 40,n=1,0,0,0,0
    2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Direct Bilirubin,Week 2,n=1,1,0,1,2
    0.0 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    2.0 ( 99999 )
    0.0 ( 0.00 )
        Direct Bilirubin,Week 4,n=2,1,1,2,2
    1.0 ( 1.41 )
    0.0 ( 99999 )
    0.0 ( 99999 )
    1.0 ( 1.41 )
    0.0 ( 0.00 )
        Direct Bilirubin,Week 8,n=2,1,1,2,1
    0.0 ( 2.83 )
    0.0 ( 99999 )
    0.0 ( 99999 )
    1.0 ( 1.41 )
    0.0 ( 99999 )
        Direct Bilirubin,Week 12,n=2,0,1,1,0
    0.0 ( 2.83 )
    0.0 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
        Direct Bilirubin,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
        Direct Bilirubin,Week 16,n=2,0,0,1,0
    1.0 ( 1.41 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
        Direct Bilirubin,Week 24,n=2,0,0,0,0
    0.0 ( 0.00 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Direct Bilirubin,Week 36,n=2,0,0,0,0
    -1.0 ( 1.41 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Direct Bilirubin,Week 38,n=1,0,0,0,0
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Direct Bilirubin,Week 40,n=1,0,0,0,0
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Indirect Bilirubin,Week 2,n=1,1,0,1,2
    0.0 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    0.0 ( 99999 )
    -1.0 ( 1.41 )
        Indirect Bilirubin,Week 4,n=2,1,1,2,2
    4.0 ( 0.00 )
    0.0 ( 99999 )
    -2.0 ( 99999 )
    0.0 ( 0.00 )
    1.0 ( 1.41 )
        Indirect Bilirubin,Week 8,n=2,1,1,2,1
    -1.0 ( 1.41 )
    2.0 ( 99999 )
    0.0 ( 99999 )
    0.0 ( 2.83 )
    2.0 ( 99999 )
        Indirect Bilirubin,Week 12,n=2,0,1,1,0
    0.0 ( 5.66 )
    0.0 ( 99999 )
    99999 ( 99999 )
    -2.0 ( 99999 )
    99999 ( 99999 )
        Indirect Bilirubin,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
        Indirect Bilirubin,Week 16,n=2,0,0,1,0
    4.0 ( 5.66 )
    99999 ( 99999 )
    99999 ( 99999 )
    2.0 ( 99999 )
    99999 ( 99999 )
        Indirect Bilirubin,Week 24,n=2,0,0,0,0
    -2.0 ( 5.66 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Indirect Bilirubin,Week 36,n=2,0,0,0,0
    2.0 ( 8.49 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Indirect Bilirubin,Week 38,n=1,0,0,0,0
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Indirect Bilirubin,Week 40,n=1,0,0,0,0
    2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Creatinine,Week 2,n=1,1,0,1,2
    -3.50 ( 99999 )
    99999 ( 99999 )
    -6.20 ( 99999 )
    1.80 ( 99999 )
    3.10 ( 1.838 )
        Creatinine,Week 4,n=2,1,1,2,2
    -11.05 ( 9.405 )
    2.70 ( 99999 )
    -12.40 ( 99999 )
    -1.30 ( 0.566 )
    2.20 ( 4.384 )
        Creatinine,Week 8,n=2,1,1,2,1
    -8.40 ( 6.930 )
    9.70 ( 99999 )
    -8.00 ( 99999 )
    0.45 ( 5.728 )
    0.00 ( 99999 )
        Creatinine,Week 12,n=2,0,1,1,0
    -11.90 ( 11.879 )
    4.40 ( 99999 )
    99999 ( 99999 )
    -0.90 ( 99999 )
    99999 ( 99999 )
        Creatinine,Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.80 ( 99999 )
    99999 ( 99999 )
        Creatinine,Week 16,n=2,0,0,1,0
    -12.80 ( 5.657 )
    99999 ( 99999 )
    99999 ( 99999 )
    4.40 ( 99999 )
    99999 ( 99999 )
        Creatinine,Week 24,n=2,0,0,0,0
    -9.75 ( 12.516 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Creatinine,Week 36,n=2,0,0,0,0
    -15.05 ( 9.970 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Creatinine,Week 38,n=1,0,0,0,0
    -19.40 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Creatinine,Week 40,n=1,0,0,0,0
    -20.30 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
    End point values
    PartBSIR 100 mg SC q2w+6 month prednisone PartBSIR 100 mg SC q2w+3 month prednisone PartBSIR 50 mg SC q4w+6 month prednisone PartBPlacebo SC q2w + 6 month prednisone PartBPlacebo SC q2w + 12 month prednisone
    Number of subjects analysed
    6
    4
    3
    3
    2
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        Bilirubin,Week 4,n=3,3,2,1,2
    0.7 ( 3.06 )
    1.3 ( 3.06 )
    -5.0 ( 1.41 )
    0.0 ( 99999 )
    -8.0 ( 2.83 )
        Bilirubin,Week 8,n=2,1,2,0,2
    3.0 ( 4.24 )
    2.0 ( 99999 )
    -4.0 ( 2.83 )
    99999 ( 99999 )
    -6.0 ( 5.66 )
        Bilirubin,Week 12,n=1,1,1,1,1
    4.0 ( 99999 )
    -2.0 ( 99999 )
    2.0 ( 99999 )
    4.0 ( 99999 )
    -8.0 ( 99999 )
        Bilirubin,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    -2.0 ( 99999 )
    -2.0 ( 99999 )
    4.0 ( 99999 )
    99999 ( 99999 )
        Bilirubin,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    -2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Bilirubin,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    -4.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Direct Bilirubin,Week 4,n=3,3,2,1,2
    0.0 ( 0.00 )
    0.0 ( 0.00 )
    0.0 ( 0.00 )
    0.0 ( 99999 )
    -2.0 ( 0.00 )
        Direct Bilirubin,Week 8,n=2,1,2,0,2
    1.0 ( 1.41 )
    2.0 ( 99999 )
    0.0 ( 0.00 )
    99999 ( 99999 )
    -2.0 ( 0.00 )
        Direct Bilirubin,Week 12,n=1,1,1,1,1
    2.0 ( 99999 )
    2.0 ( 99999 )
    0.0 ( 99999 )
    0.0 ( 99999 )
    -2.0 ( 99999 )
        Direct Bilirubin,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    0.0 ( 99999 )
    0.0 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
        Direct Bilirubin,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Direct Bilirubin,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    0.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Indirect Bilirubin,Week 4,n=3,3,2,1,2
    0.7 ( 3.06 )
    1.3 ( 3.06 )
    -5.0 ( 1.41 )
    0.0 ( 99999 )
    -6.0 ( 2.83 )
        Indirect Bilirubin,Week 8,n=2,1,2,0,2
    2.0 ( 2.83 )
    0.0 ( 99999 )
    -4.0 ( 2.83 )
    99999 ( 99999 )
    -4.0 ( 5.66 )
        Indirect Bilirubin,Week 12,n=1,1,1,1,1
    2.0 ( 99999 )
    -4.0 ( 99999 )
    2.0 ( 99999 )
    4.0 ( 99999 )
    -6.0 ( 99999 )
        Indirect Bilirubin,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    -2.0 ( 99999 )
    -2.0 ( 99999 )
    4.0 ( 99999 )
    99999 ( 99999 )
        Indirect Bilirubin,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    -2.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Indirect Bilirubin,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    -4.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Creatinine,Week 4,n=3,3,2,1,2
    -7.07 ( 7.887 )
    -0.63 ( 4.842 )
    -1.30 ( 9.334 )
    -0.90 ( 99999 )
    3.95 ( 19.445 )
        Creatinine,Week 8,n=2,1,2,0,2
    -8.40 ( 0.566 )
    -18.60 ( 99999 )
    -5.25 ( 3.748 )
    99999 ( 99999 )
    -5.75 ( 5.728 )
        Creatinine,Week 12,n=1,1,1,1,1
    -6.20 ( 99999 )
    -27.40 ( 99999 )
    5.30 ( 99999 )
    9.70 ( 99999 )
    -19.50 ( 99999 )
        Creatinine,Week 16,n=0,1,1,1,0
    99999 ( 99999 )
    -19.50 ( 99999 )
    5.30 ( 99999 )
    5.30 ( 99999 )
    99999 ( 99999 )
        Creatinine,Week 24,n=0,1,0,0,0
    99999 ( 99999 )
    -27.40 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Creatinine,Week 36,n=0,1,0,0,0
    99999 ( 99999 )
    -21.20 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Cumulative prednisone dose over time for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

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    End point title
    Part B: Cumulative prednisone dose over time for participants who received at least one dose of 100 mg open-label Sirukumab in Part B
    End point description
    Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Milligrams
    arithmetic mean (standard deviation)
        Week 2, n=0,0,0,1,1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    561.000 ( 99999 )
    550.000 ( 99999 )
        Week 4,n=0,0,0,2,1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    596.125 ( 586.7219 )
    775.000 ( 99999 )
        Week 8,n=0,0,0,2,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    956.125 ( 851.8869 )
    99999 ( 99999 )
        Week 12,n=0,0,0,2,1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1201.125 ( 1000.3793 )
    1600.000 ( 99999 )
        Week 14,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    843.750 ( 99999 )
    99999 ( 99999 )
        Week 16,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1233.750 ( 99999 )
    99999 ( 99999 )
        Week 24,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1853.750 ( 99999 )
    99999 ( 99999 )
        Week 28,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1908.500 ( 99999 )
    99999 ( 99999 )
        Week 32,n=0,0,0,0,1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1600.000 ( 99999 )
        Week 38,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2153.750 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Cumulative prednisone dose over time for participants who never received 100 mg open label Sirukumab in Part B

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    End point title
    Part B: Cumulative prednisone dose over time for participants who never received 100 mg open label Sirukumab in Part B
    End point description
    Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented. 99999 indicates data was not available due to insufficient number of participants to analyze the data.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38
    End point values
    PartBSIR 100 mg SC q2w+6 month prednisone PartBSIR 100 mg SC q2w+3 month prednisone PartBSIR 50 mg SC q4w+6 month prednisone PartBPlacebo SC q2w + 6 month prednisone PartBPlacebo SC q2w + 12 month prednisone
    Number of subjects analysed
    6
    4
    3
    3
    2
    Units: Milligrams
    arithmetic mean (standard deviation)
        Week 2, n=0,0,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 4,n=0,0,0,1,1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    203.750 ( 99999 )
    325.000 ( 99999 )
        Week 8,n=0,0,0,1,1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    357.500 ( 99999 )
    596.250 ( 99999 )
        Week 12,n=0,0,0,0,1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    830.000 ( 99999 )
        Week 14,n=0,0,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 16,n=0,0,0,0,1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1020.000 ( 99999 )
        Week 24,n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    397.500 ( 99999 )
    99999 ( 99999 )
        Week 28,n= 0,0,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 32,n=0,0,0,0,1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1211.250 ( 99999 )
        Week 38,n=0,0,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Number of disease flares over time

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    End point title
    Part B: Number of disease flares over time
    End point description
    This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented. 99999 indicates data was not available due to insufficient number of participants to analyze the data.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    8
    5
    4
    5
    4
    Units: Disease flares
        Week 2, n=1,1,0,1,2
    0
    0
    99999
    0
    0
        Week 4, n=5,4,4,3,4
    0
    0
    0
    0
    0
        Week 8, n=4,2,3,2,3
    0
    0
    1
    0
    0
        Week 12, n=3,2,2,2,1
    0
    0
    1
    0
    0
        Week 14, n=0,0,0,1,0
    99999
    99999
    99999
    1
    99999
        Week 16, n=2,1,1,2,0
    0
    0
    0
    1
    99999
        Week 24, n=2,1,0,0,0
    0
    0
    99999
    99999
    99999
        Week 36, n=2,1,0,0,0
    0
    0
    99999
    99999
    99999
        Week 38, n=1,0,0,0,0
    2
    99999
    99999
    99999
    99999
        Week 40, n=1,0,0,0,0
    2
    99999
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Part B: Number of participants requiring at least one hospitalization for disease flare

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    End point title
    Part B: Number of participants requiring at least one hospitalization for disease flare
    End point description
    Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: “Severe Flare including Hospitalizations”. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    8
    5
    4
    5
    4
    Units: Participants
    9999999
    9999999
    9999999
    9999999
    9999999
    No statistical analyses for this end point

    Secondary: Part B: Number of hospitalizations for disease flare over time

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    End point title
    Part B: Number of hospitalizations for disease flare over time
    End point description
    Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: “Severe Flare including Hospitalizations”. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.
    End point type
    Secondary
    End point timeframe
    Up to Week 104
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    8
    5
    4
    5
    4
    Units: Number of hospitalizations
    9999999
    9999999
    9999999
    9999999
    9999999
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in 36-item SF-36 v2 acute score over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in 36-item SF-36 v2 acute score over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B
    End point description
    SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who received at least one dose of 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Scores on scale
    number (not applicable)
        Par 1, Week 12, Physical Functioning
    10
    99999
    99999
    99999
    99999
        Par 1, Week 12, Role Physical
    12.5
    99999
    99999
    99999
    99999
        Par 1, Week 12, Bodily Pain
    -39
    99999
    99999
    99999
    99999
        Par 1, Week 12, General Health
    0
    99999
    99999
    99999
    99999
        Par 1, Week 12, Vitality
    -6.25
    99999
    99999
    99999
    99999
        Par 1, Week 12, Social Functioning
    0
    99999
    99999
    99999
    99999
        Par 1, Week 12, Role Emotional
    -8.33
    99999
    99999
    99999
    99999
        Par 1, Week 12, Mental Health
    10
    99999
    99999
    99999
    99999
        Par 1, Week 12, Physical Component Summary
    -8.76
    99999
    99999
    99999
    99999
        Par 1, Week 12, Mental Component Summary
    3.29
    99999
    99999
    99999
    99999
        Par 1, Week 24, Physical Functioning
    -4.99
    99999
    99999
    99999
    99999
        Par 1, Week 24, Role Physical
    -12.5
    99999
    99999
    99999
    99999
        Par 1, Week 24, Bodily Pain
    1
    99999
    99999
    99999
    99999
        Par 1, Week 24, General Health
    -5
    99999
    99999
    99999
    99999
        Par 1, Week 24, Vitality
    0
    99999
    99999
    99999
    99999
        Par 1, Week 24, Social Functioning
    0
    99999
    99999
    99999
    99999
        Par 1, Week 24, Role Emotional
    -16.67
    99999
    99999
    99999
    99999
        Par 1, Week 24, Mental Health
    5
    99999
    99999
    99999
    99999
        Par 1, Week 24, Physical Component Summary
    -2.09
    99999
    99999
    99999
    99999
        Par 1, Week 24, Mental Component Summary
    -0.76
    99999
    99999
    99999
    99999
        Par 1, Day 339, Physical Functioning
    9.99
    99999
    99999
    99999
    99999
        Par 1, Day 339, Role Physical
    37.5
    99999
    99999
    99999
    99999
        Par 1, Day 339, Bodily Pain
    23
    99999
    99999
    99999
    99999
        Par 1, Day 339, General Health
    5
    99999
    99999
    99999
    99999
        Par 1, Day 339, Vitality
    6.25
    99999
    99999
    99999
    99999
        Par 1, Day 339, Social Functioning
    0
    99999
    99999
    99999
    99999
        Par 1, Day 339, Role Emotional
    0
    99999
    99999
    99999
    99999
        Par 1, Day 339, Mental Health
    0
    99999
    99999
    99999
    99999
        Par 1, Day 339, Physical Component Summary
    9.98
    99999
    99999
    99999
    99999
        Par 1, Day 339, Mental Component Summary
    -2.78
    99999
    99999
    99999
    99999
        Par 2, Week 12, Physical Functioning
    4.99
    99999
    99999
    99999
    99999
        Par 2, Week 12, Role Physical
    50
    99999
    99999
    99999
    99999
        Par 2, Week 12, Bodily Pain
    49
    99999
    99999
    99999
    99999
        Par 2, Week 12, General Health
    10
    99999
    99999
    99999
    99999
        Par 2, Week 12, Vitality
    0
    99999
    99999
    99999
    99999
        Par 2, Week 12, Social Functioning
    12.5
    99999
    99999
    99999
    99999
        Par 2, Week 12, Role Emotional
    99999
    99999
    99999
    99999
    99999
        Par 2, Week 12, Mental Health
    -10
    99999
    99999
    99999
    99999
        Par 2, Week 12, Physical Component Summary
    15.7
    99999
    99999
    99999
    99999
        Par 2, Week 12, Mental Component Summary
    -5.84
    99999
    99999
    99999
    99999
        Par 2, Week 24, Physical Functioning
    24.99
    99999
    99999
    99999
    99999
        Par 2, Week 24, Role Physical
    50
    99999
    99999
    99999
    99999
        Par 2, Week 24, Bodily Pain
    33
    99999
    99999
    99999
    99999
        Par 2, Week 24, General Health
    5
    99999
    99999
    99999
    99999
        Par 2, Week 24, Vitality
    -6.25
    99999
    99999
    99999
    99999
        Par 2, Week 24, Social Functioning
    12.5
    99999
    99999
    99999
    99999
        Par 2, Week 24, Role Emotional
    0
    99999
    99999
    99999
    99999
        Par 2, Week 24, Mental Health
    -20
    99999
    99999
    99999
    99999
        Par 2, Week 24, Physical Component Summary
    17.37
    99999
    99999
    99999
    99999
        Par 2, Week 24, Mental Component Summary
    -10.18
    99999
    99999
    99999
    99999
        Par 2, Day 344, Physical Functioning
    -5.01
    99999
    99999
    99999
    99999
        Par 2, Day 344, Role Physical
    37.5
    99999
    99999
    99999
    99999
        Par 2, Day 344, Bodily Pain
    11
    99999
    99999
    99999
    99999
        Par 2, Day 344, General Health
    10
    99999
    99999
    99999
    99999
        Par 2, Day 344, Vitality
    -6.25
    99999
    99999
    99999
    99999
        Par 2, Day 344, Social Functioning
    12.5
    99999
    99999
    99999
    99999
        Par 2, Day 344, Role Emotional
    0
    99999
    99999
    99999
    99999
        Par 2, Day 344, Mental Health
    -15
    99999
    99999
    99999
    99999
        Par 2, Day 344, Physical Component Summary
    8.12
    99999
    99999
    99999
    99999
        Par 2, Day 344, Mental Component Summary
    -4.89
    99999
    99999
    99999
    99999
        Par 3, Day 113, Physical Functioning
    99999
    99999
    -10
    99999
    99999
        Par 3, Day 113, Role Physical
    99999
    99999
    0
    99999
    99999
        Par 3, Day 113, Bodily Pain
    99999
    99999
    0
    99999
    99999
        Par 3, Day 113, General Health
    99999
    99999
    -5
    99999
    99999
        Par 3, Day 113, Vitality
    99999
    99999
    -6.25
    99999
    99999
        Par 3, Day 113, Social Functioning
    99999
    99999
    99999
    99999
    99999
        Par 3, Day 113, Role Emotional
    99999
    99999
    0
    99999
    99999
        Par 3, Day 113, Mental Health
    99999
    99999
    -5
    99999
    99999
        Par 3, Day 113, Physical Component Summary
    99999
    99999
    -1.72
    99999
    99999
        Par 3, Day 113, Mental Component Summary
    99999
    99999
    -1.05
    99999
    99999
        Par 4, Week 12, Physical Functioning
    99999
    15
    99999
    99999
    99999
        Par 4, Week 12, Role Physical
    99999
    6.25
    99999
    99999
    99999
        Par 4, Week 12, Bodily Pain
    99999
    33
    99999
    99999
    99999
        Par 4, Week 12, General Health
    99999
    -5
    99999
    99999
    99999
        Par 4, Week 12, Vitality
    99999
    0
    99999
    99999
    99999
        Par 4, Week 12, Social Functioning
    99999
    0
    99999
    99999
    99999
        Par 4, Week 12, Role Emotional
    99999
    0
    99999
    99999
    99999
        Par 4, Week 12, Mental Health
    99999
    5
    99999
    99999
    99999
        Par 4, Week 12, Physical Component Summary
    99999
    6.28
    99999
    99999
    99999
        Par 4, Week 12, Mental Component Summary
    99999
    -1.59
    99999
    99999
    99999
        Par 5, Week 12, Physical Functioning
    99999
    99999
    99999
    5
    99999
        Par 5, Week 12, Role Physical
    99999
    99999
    99999
    -18.75
    99999
        Par 5, Week 12, Bodily Pain
    99999
    99999
    99999
    -16
    99999
        Par 5, Week 12, General Health
    99999
    99999
    99999
    10
    10
        Par 5, Week 12, Vitality
    99999
    99999
    99999
    6.25
    99999
        Par 5, Week 12, Social Functioning
    99999
    99999
    99999
    -25
    99999
        Par 5, Week 12, Role Emotional
    99999
    99999
    99999
    -16.66
    99999
        Par 5, Week 12, Mental Health
    99999
    99999
    99999
    -5
    99999
        Par 5, Week 12, Physical Component Summary
    99999
    99999
    99999
    -0.34
    99999
        Par 5, Week 12, Mental Component Summary
    99999
    99999
    99999
    -5.35
    99999
        Par 5, Day 162, Physical Functioning
    99999
    99999
    99999
    10.01
    99999
        Par 5, Day 162, Role Physical
    99999
    99999
    99999
    -18.75
    99999
        Par 5, Day 162, Bodily Pain
    99999
    99999
    99999
    -16
    99999
        Par 5, Day 162, General Health
    99999
    99999
    99999
    -7
    99999
        Par 5, Day 162, Vitality
    99999
    99999
    99999
    -12.5
    99999
        Par 5, Day 162, Social Functioning
    99999
    99999
    99999
    -25
    99999
        Par 5, Day 162, Role Emotional
    99999
    99999
    99999
    -33.33
    99999
        Par 5, Day 162, Mental Health
    99999
    99999
    99999
    5
    99999
        Par 5, Day 162, Physical Component Summary
    168
    99999
    99999
    -1.62
    99999
        Par 5, Day 162, Mental Component Summary
    99999
    99999
    99999
    -8.24
    99999
        Par 6, Day 91, Physical Functioning
    99999
    99999
    99999
    -15
    99999
        Par 6, Day 91, Role Physical
    99999
    99999
    99999
    -25
    99999
        Par 6, Day 91, Bodily Pain
    99999
    99999
    99999
    22
    99999
        Par 6, Day 91, General Health
    99999
    99999
    99999
    0
    99999
        Par 6, Day 91, Vitality
    99999
    99999
    99999
    -6.25
    99999
        Par 6, Day 91, Social Functioning
    99999
    99999
    99999
    0
    99999
        Par 6, Day 91, Role Emotional
    99999
    99999
    99999
    0
    99999
        Par 6, Day 91, Mental Health
    99999
    99999
    99999
    20
    99999
        Par 6, Day 91, Physical Component Summary
    99999
    99999
    99999
    -5.17
    99999
        Par 6, Day 91, Mental Component Summary
    99999
    99999
    99999
    5.95
    99999
        Par 7, Day 85, Physical Functioning
    99999
    99999
    99999
    99999
    -10.01
        Par 7, Day 85, Role Physical
    99999
    99999
    99999
    99999
    -6.25
        Par 7, Day 85, Bodily Pain
    99999
    99999
    99999
    99999
    -22
        Par 7, Day 85, General Health
    99999
    99999
    99999
    99999
    10
        Par 7, Day 85, Vitality
    99999
    99999
    99999
    99999
    -12.5
        Par 7, Day 85, Social Functioning
    99999
    99999
    99999
    99999
    99999
        Par 7, Day 85, Role Emotional
    99999
    99999
    99999
    99999
    99999
        Par 7, Day 85, Mental Health
    99999
    99999
    99999
    99999
    5
        Par 7, Day 85, Physical Component Summary
    99999
    99999
    99999
    99999
    -4.79
        Par 7, Day 85, Mental Component Summary
    99999
    99999
    99999
    99999
    1.82
        Par 8, Day 87, Physical Functioning
    99999
    99999
    99999
    99999
    0
        Par 8, Day 87, Role Physical
    99999
    99999
    99999
    99999
    6.25
        Par 8, Day 87, Bodily Pain
    99999
    99999
    99999
    99999
    21
        Par 8, Day 87, General Health
    99999
    99999
    99999
    99999
    0
        Par 8, Day 87, Vitality
    99999
    99999
    99999
    99999
    0
        Par 8, Day 87, Social Functioning
    99999
    99999
    99999
    99999
    12.5
        Par 8, Day 87, Role Emotional
    99999
    99999
    99999
    99999
    16.66
        Par 8, Day 87, Mental Health
    99999
    99999
    99999
    99999
    5
        Par 8, Day 87, Physical Component Summary
    99999
    99999
    99999
    99999
    1.52
        Par 8, Day 87, Mental Component Summary
    99999
    99999
    99999
    99999
    4.54
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in 36-item SF-36 v2 acute score over time for participants who never received 100 mg OL Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in 36-item SF-36 v2 acute score over time for participants who never received 100 mg OL Sirukumab in Part B
    End point description
    SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who never received 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Day 23, Day 29, Day 30, Day 57, Day 59, Day 64, Day 65 , Day 85, Day 112, Day 113, Day 163, Day 169, Day 373, Week 8 and Week 12
    End point values
    PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone
    Number of subjects analysed
    2
    2
    6
    4
    3
    Units: Scores on scale
    number (not applicable)
        Par 1, Day 30, Physical Functioning
    99999
    99999
    -5
    99999
    99999
        Par 1, Day 30, Role Physical
    99999
    99999
    0
    99999
    99999
        Par 1, Day 30, Bodily Pain
    99999
    99999
    -16
    99999
    99999
        Par 1, Day 30, General health
    99999
    99999
    10
    99999
    99999
        Par 1, Day 30, Vitality
    99999
    99999
    0
    99999
    99999
        Par 1, Day 30, Social Functioning
    99999
    99999
    0
    99999
    99999
        Par 1, Day 30, Role emotional
    99999
    99999
    0
    99999
    99999
        Par 1, Day 30, Mental health
    99999
    99999
    5
    99999
    99999
        Par 1, Day 30, Physical Component Summary
    99999
    99999
    -2.26
    99999
    99999
        Par 1, Day 30, Mental Component Summary
    99999
    99999
    2.26
    99999
    99999
        Par 2, Day 29, Physical Functioning
    99999
    99999
    0
    99999
    99999
        Par 2, Day 29, Role Physical
    99999
    99999
    0
    99999
    99999
        Par 2, Day 29, Bodily Pain
    99999
    99999
    0
    99999
    99999
        Par 2, Day 29, General health
    99999
    99999
    8
    99999
    99999
        Par 2, Day 29, Vitality
    99999
    99999
    6.25
    99999
    99999
        Par 2, Day 29, Social Functioning
    99999
    99999
    0
    99999
    99999
        Par 2, Day 29, Role emotional
    99999
    99999
    0
    99999
    99999
        Par 2, Day 29, Mental health
    99999
    99999
    10
    99999
    99999
        Par 2, Day 29, Physical Component Summary
    99999
    99999
    -0.12
    99999
    99999
        Par 2, Day 29, Mental Component Summary
    99999
    99999
    3.18
    99999
    99999
        Par 3, Day 23, Physical Functioning
    99999
    99999
    25
    99999
    99999
        Par 3, Day 23, Role Physical
    99999
    99999
    6.25
    99999
    99999
        Par 3, Day 23, Bodily Pain
    99999
    99999
    49
    99999
    99999
        Par 3, Day 23, General health
    99999
    99999
    10
    99999
    99999
        Par 3, Day 23, Vitality
    99999
    99999
    0
    99999
    99999
        Par 3, Day 23, Social Functioning
    99999
    99999
    0
    99999
    99999
        Par 3, Day 23, Role emotional
    99999
    99999
    0
    99999
    99999
        Par 3, Day 23, Mental health
    99999
    99999
    -5
    99999
    99999
        Par 3, Day 23, Physical Component Summary
    99999
    99999
    12.88
    99999
    99999
        Par 3, Day 23, Mental Component Summary
    99999
    99999
    -5.75
    99999
    99999
        Par 4, Week 12, Physical Functioning
    99999
    99999
    15
    99999
    99999
        Par 4, Week 12, Role Physical
    99999
    99999
    18.75
    99999
    99999
        Par 4, Week 12, Bodily Pain
    99999
    99999
    0
    99999
    99999
        Par 4, Week 12, General health
    99999
    99999
    0
    99999
    99999
        Par 4, Week 12, Vitality
    99999
    99999
    6.25
    99999
    99999
        Par 4, Week 12, Social Functioning
    99999
    99999
    0
    99999
    99999
        Par 4, Week 12, Role emotional
    99999
    99999
    0
    99999
    99999
        Par 4, Week 12, Mental health
    99999
    99999
    0
    99999
    99999
        Par 4, Week 12, Physical Component Summary
    99999
    99999
    4.88
    99999
    99999
        Par 4, Week 12, Mental Component Summary
    99999
    99999
    -1.45
    99999
    99999
        Par 4, Day 113, Physical Functioning
    99999
    99999
    15
    99999
    99999
        Par 4, Day 113, Role Physical
    99999
    99999
    0
    99999
    99999
        Par 4, Day 113, Bodily Pain
    99999
    99999
    0
    99999
    99999
        Par 4, Day 113, General health
    99999
    99999
    10
    99999
    99999
        Par 4, Day 113, Vitality
    99999
    99999
    0
    99999
    99999
        Par 4, Day 113, Social Functioning
    99999
    99999
    -12.5
    99999
    99999
        Par 4, Day 113, Role emotional
    99999
    99999
    0
    99999
    99999
        Par 4, Day 113, Mental health
    99999
    99999
    25
    99999
    99999
        Par 4, Day 113, Physical Component Summary
    99999
    99999
    0.77
    99999
    99999
        Par 4, Day 113, Mental Component Summary
    99999
    99999
    3.61
    99999
    99999
        Par 5, Week 8, Physical Functioning
    99999
    99999
    -5
    99999
    99999
        Par 5, Week 8, Role Physical
    99999
    99999
    0
    99999
    99999
        Par 5, Week 8, Bodily Pain
    99999
    99999
    10
    99999
    99999
        Par 5, Week 8, General health
    99999
    99999
    -10
    99999
    99999
        Par 5, Week 8, Vitality
    99999
    99999
    -6.25
    99999
    99999
        Par 5, Week 8, Social Functioning
    99999
    99999
    -12.5
    99999
    99999
        Par 5, Week 8, Role emotional
    99999
    99999
    16.67
    99999
    99999
        Par 5, Week 8, Mental health
    99999
    99999
    0
    99999
    99999
        Par 5, Week 8, Physical Component Summary
    99999
    99999
    -2.1
    99999
    99999
        Par 5, Week 8, Mental Component Summary
    99999
    99999
    1.1
    99999
    99999
        Par 5, Day 85, Physical Functioning
    99999
    99999
    5
    99999
    99999
        Par 5, Day 85, Role Physical
    99999
    99999
    -6.25
    99999
    99999
        Par 5, Day 85, Bodily Pain
    99999
    99999
    10
    99999
    99999
        Par 5, Day 85, General health
    99999
    99999
    -22
    99999
    99999
        Par 5, Day 85, Vitality
    99999
    99999
    -6.25
    99999
    99999
        Par 5, Day 85, Social Functioning
    99999
    99999
    -12.5
    99999
    99999
        Par 5, Day 85, Role emotional
    99999
    99999
    8.33
    99999
    99999
        Par 5, Day 85, Mental health
    99999
    99999
    10
    99999
    99999
        Par 5, Day 85, Physical Component Summary
    99999
    99999
    -3.17
    99999
    99999
        Par 5, Day 85, Mental Component Summary
    99999
    99999
    1.62
    99999
    99999
        Par 6, Day 65, Physical Functioning
    99999
    99999
    0
    99999
    99999
        Par 6, Day 65, Role Physical
    99999
    99999
    6.25
    99999
    99999
        Par 6, Day 65, Bodily Pain
    99999
    99999
    0
    99999
    99999
        Par 6, Day 65, General health
    99999
    99999
    0
    99999
    99999
        Par 6, Day 65, Vitality
    99999
    99999
    -6.25
    99999
    99999
        Par 6, Day 65, Social Functioning
    99999
    99999
    12.5
    99999
    99999
        Par 6, Day 65, Role emotional
    99999
    99999
    8.33
    99999
    99999
        Par 6, Day 65, Mental health
    99999
    99999
    0
    99999
    99999
        Par 6, Day 65, Physical Component Summary
    99999
    99999
    -0.01
    99999
    99999
        Par 6, Day 65, Mental Component Summary
    99999
    99999
    1.88
    99999
    99999
        Par 7, Week 12, Physical Functioning
    99999
    99999
    99999
    0
    99999
        Par 7, Week 12, Role Physical
    99999
    99999
    99999
    6.25
    99999
        Par 7, Week 12, Bodily Pain
    99999
    99999
    99999
    16
    99999
        Par 7, Week 12, General health
    99999
    99999
    99999
    0
    99999
        Par 7, Week 12, Vitality
    99999
    99999
    99999
    -6.25
    99999
        Par 7, Week 12, Social Functioning
    99999
    99999
    99999
    0
    99999
        Par 7, Week 12, Role emotional
    99999
    99999
    99999
    0
    99999
        Par 7, Week 12, Mental health
    99999
    99999
    99999
    -5
    99999
        Par 7, Week 12, Physical Component Summary
    99999
    99999
    99999
    -3.33
    99999
        Par 7, Week 12, Mental Component Summary
    99999
    99999
    99999
    -2.88
    99999
        Par 7, Day 373, Physical Functioning
    99999
    99999
    99999
    15
    99999
        Par 7, Day 373, Role Physical
    99999
    99999
    99999
    6.25
    99999
        Par 7, Day 373, Bodily Pain
    99999
    99999
    99999
    16
    99999
        Par 7, Day 373, General health
    99999
    99999
    99999
    8
    99999
        Par 7, Day 373, Vitality
    99999
    99999
    99999
    0
    99999
        Par 7, Day 373, Social Functioning
    99999
    99999
    99999
    0
    99999
        Par 7, Day 373, Role emotional
    99999
    99999
    99999
    0
    99999
        Par 7, Day 373, Mental health
    99999
    99999
    99999
    -15
    99999
        Par 7, Day 373, Physical Component Summary
    99999
    99999
    99999
    7.95
    99999
        Par 7, Day 373, Mental Component Summary
    99999
    99999
    99999
    -6.1
    99999
        Par 8, Day 64, Physical Functioning
    99999
    99999
    99999
    5
    99999
        Par 8, Day 64, Role Physical
    99999
    99999
    99999
    -6.25
    99999
        Par 8, Day 64, Bodily Pain
    99999
    99999
    99999
    -22
    99999
        Par 8, Day 64, General health
    99999
    99999
    99999
    0
    99999
        Par 8, Day 64, Vitality
    99999
    99999
    99999
    -12.5
    99999
        Par 8, Day 64, Social Functioning
    99999
    99999
    99999
    0
    99999
        Par 8, Day 64, Role emotional
    99999
    99999
    99999
    25
    99999
        Par 8, Day 64, Mental health
    99999
    99999
    99999
    -15
    99999
        Par 8, Day 64, Physical Component Summary
    99999
    99999
    99999
    -3.24
    99999
        Par 8, Day 64, Mental Component Summary
    99999
    99999
    99999
    0.02
    99999
        Par 9, Day 29, Physical Functioning
    99999
    99999
    99999
    10
    99999
        Par 9, Day 29, Role Physical
    99999
    99999
    99999
    6.25
    99999
        Par 9, Day 29, Bodily Pain
    99999
    99999
    99999
    0
    99999
        Par 9, Day 29, General health
    99999
    99999
    99999
    -3
    99999
        Par 9, Day 29, Vitality
    99999
    99999
    99999
    0
    99999
        Par 9, Day 29, Social Functioning
    99999
    99999
    99999
    0
    99999
        Par 9, Day 29, Role emotional
    99999
    99999
    99999
    0
    99999
        Par 9, Day 29, Mental health
    99999
    99999
    99999
    -10
    99999
        Par 9, Day 29, Physical Component Summary
    99999
    99999
    99999
    3.22
    99999
        Par 9, Day 29, Mental Component Summary
    99999
    99999
    99999
    -3.68
    99999
        Par 10, Day 57, Physical Functioning
    99999
    99999
    99999
    0
    99999
        Par 10, Day 57, Role Physical
    99999
    99999
    99999
    12.5
    99999
        Par 10, Day 57, Bodily Pain
    99999
    99999
    99999
    0
    99999
        Par 10, Day 57, General health
    99999
    99999
    99999
    -5
    99999
        Par 10, Day 57, Vitality
    99999
    99999
    99999
    0
    99999
        Par 10, Day 57, Social Functioning
    99999
    99999
    99999
    12.5
    99999
        Par 10, Day 57, Role emotional
    99999
    99999
    99999
    0
    99999
        Par 10, Day 57, Mental health
    99999
    99999
    99999
    0
    99999
        Par 10, Day 57, Physical Component Summary
    99999
    99999
    99999
    0.95
    99999
        Par 10, Day 57, Mental Component Summary
    99999
    99999
    99999
    0.83
    99999
        Par 11, Week 12, Physical Functioning
    99999
    99999
    99999
    99999
    -29.99
        Par 11, Week 12, Role Physical
    99999
    99999
    99999
    99999
    -18.75
        Par 11, Week 12, Bodily Pain
    99999
    99999
    99999
    99999
    0
        Par 11, Week 12, General health
    99999
    99999
    99999
    99999
    -13
        Par 11, Week 12, Vitality
    99999
    99999
    99999
    99999
    -6.25
        Par 11, Week 12, Social Functioning
    99999
    99999
    99999
    99999
    -25
        Par 11, Week 12, Role emotional
    99999
    99999
    99999
    99999
    0
        Par 11, Week 12, Mental health
    99999
    99999
    99999
    99999
    5
        Par 11, Week 12, Physical Component Summary
    99999
    99999
    99999
    99999
    -9.37
        Par 11, Week 12, Mental Component Summary
    99999
    99999
    99999
    99999
    1.44
        Par 11, Day 163, Physical Functioning
    99999
    99999
    99999
    99999
    -15.01
        Par 11, Day 163, Role Physical
    99999
    99999
    99999
    99999
    6.25
        Par 11, Day 163, Bodily Pain
    99999
    99999
    99999
    99999
    0
        Par 11, Day 163, General health
    99999
    99999
    99999
    99999
    -8
        Par 11, Day 163, Vitality
    99999
    99999
    99999
    99999
    0
        Par 11, Day 163, Social Functioning
    99999
    99999
    99999
    99999
    -37.5
        Par 11, Day 163, Role emotional
    99999
    99999
    99999
    99999
    9
        Par 11, Day 163, Mental health
    99999
    99999
    99999
    99999
    10
        Par 11, Day 163, Physical Component Summary
    99999
    99999
    99999
    99999
    -3.64
        Par 11, Day 163, Mental Component Summary
    99999
    99999
    99999
    99999
    -0.4
        Par 12, Day 85, Physical Functioning
    99999
    99999
    99999
    99999
    -5
        Par 12, Day 85, Role Physical
    99999
    99999
    99999
    99999
    -6.25
        Par 12, Day 85, Bodily Pain
    99999
    99999
    99999
    99999
    -11
        Par 12, Day 85, General health
    99999
    99999
    99999
    99999
    -5
        Par 12, Day 85, Vitality
    99999
    99999
    99999
    99999
    6.25
        Par 12, Day 85, Social Functioning
    99999
    99999
    99999
    99999
    0
        Par 12, Day 85, Role emotional
    99999
    99999
    99999
    99999
    -16.67
        Par 12, Day 85, Mental health
    99999
    99999
    99999
    99999
    5
        Par 12, Day 85, Physical Component Summary
    99999
    99999
    99999
    99999
    -2.76
        Par 12, Day 85, Mental Component Summary
    99999
    99999
    99999
    99999
    0.13
        Par 13, Day 59, Physical Functioning
    99999
    99999
    99999
    99999
    5
        Par 13, Day 59, Role Physical
    99999
    99999
    99999
    99999
    -12.5
        Par 13, Day 59, Bodily Pain
    99999
    99999
    99999
    99999
    0
        Par 13, Day 59, General health
    99999
    99999
    99999
    99999
    0
        Par 13, Day 59, Vitality
    99999
    99999
    99999
    99999
    0
        Par 13, Day 59, Social Functioning
    99999
    99999
    99999
    99999
    -12.5
        Par 13, Day 59, Role emotional
    99999
    99999
    99999
    99999
    0
        Par 13, Day 59, Mental health
    99999
    99999
    99999
    99999
    -25
        Par 13, Day 59, Physical Component Summary
    99999
    99999
    99999
    99999
    2.16
        Par 13, Day 59, Mental Component Summary
    99999
    99999
    99999
    99999
    -7.59
        Par 14, Day 57, Physical Functioning
    -5.01
    99999
    99999
    99999
    99999
        Par 14, Day 57, Role Physical
    -18.75
    99999
    99999
    99999
    99999
        Par 14, Day 57, Bodily Pain
    -32
    99999
    99999
    99999
    99999
        Par 14, Day 57, General health
    10
    99999
    99999
    99999
    99999
        Par 14, Day 57, Vitality
    12.5
    99999
    99999
    99999
    99999
        Par 14, Day 57, Social Functioning
    -37.5
    99999
    99999
    99999
    99999
        Par 14, Day 57, Role emotional
    0
    99999
    99999
    99999
    99999
        Par 14, Day 57, Mental health
    15
    99999
    99999
    99999
    99999
        Par 14, Day 57, Physical Component Summary
    -7.54
    99999
    99999
    99999
    99999
        Par 14, Day 57, Mental Component Summary
    3.62
    99999
    99999
    99999
    99999
        Par 15, Day 169, Physical Functioning
    4.99
    99999
    99999
    99999
    99999
        Par 15, Day 169, Role Physical
    50
    99999
    99999
    99999
    99999
        Par 15, Day 169, Bodily Pain
    33
    99999
    99999
    99999
    99999
        Par 15, Day 169, General health
    5
    99999
    99999
    99999
    99999
        Par 15, Day 169, Vitality
    6.25
    99999
    99999
    99999
    99999
        Par 15, Day 169, Social Functioning
    25
    99999
    99999
    99999
    99999
        Par 15, Day 169, Role emotional
    50
    99999
    99999
    99999
    99999
        Par 15, Day 169, Mental health
    0
    99999
    99999
    99999
    99999
        Par 15, Day 169, Physical Component Summary
    7.93
    99999
    99999
    99999
    99999
        Par 15, Day 169, Mental Component Summary
    8.48
    99999
    99999
    99999
    99999
        Par 16, Week 12, Physical Functioning
    99999
    5
    99999
    99999
    99999
        Par 16, Week 12, Role Physical
    99999
    6.25
    99999
    99999
    99999
        Par 16, Week 12, Bodily Pain
    99999
    28
    99999
    99999
    99999
        Par 16, Week 12, General health
    99999
    0
    99999
    99999
    99999
        Par 16, Week 12, Vitality
    99999
    -6.25
    99999
    99999
    99999
        Par 16, Week 12, Social Functioning
    99999
    0
    99999
    99999
    99999
        Par 16, Week 12, Role emotional
    99999
    0
    99999
    99999
    99999
        Par 16, Week 12, Mental health
    99999
    0
    99999
    99999
    99999
        Par 16, Week 12, Physical Component Summary
    99999
    5.1
    99999
    99999
    99999
        Par 16, Week 12, Mental Component Summary
    99999
    -2.52
    99999
    99999
    99999
        Par 16, Day 112, Physical Functioning
    99999
    0
    99999
    99999
    99999
        Par 16, Day 112, Role Physical
    99999
    12.5
    99999
    99999
    99999
        Par 16, Day 112, Bodily Pain
    99999
    28
    99999
    99999
    99999
        Par 16, Day 112, General health
    99999
    -20
    99999
    99999
    99999
        Par 16, Day 112, Vitality
    99999
    -6.25
    99999
    99999
    99999
        Par 16, Day 112, Social Functioning
    99999
    0
    99999
    99999
    99999
        Par 16, Day 112, Role emotional
    99999
    0
    99999
    99999
    99999
        Par 16, Day 112, Mental health
    99999
    0
    99999
    99999
    99999
        Par 16, Day 112, Physical Component Summary
    99999
    2.71
    99999
    99999
    99999
        Par 16, Day 112, Mental Component Summary
    99999
    -2.21
    99999
    99999
    99999
        Par 17, Day 85, Physical Functioning
    99999
    -10
    99999
    99999
    99999
        Par 17, Day 85, Role Physical
    99999
    -25
    99999
    99999
    99999
        Par 17, Day 85, Bodily Pain
    99999
    -10
    99999
    99999
    99999
        Par 17, Day 85, General health
    99999
    0
    99999
    99999
    99999
        Par 17, Day 85, Vitality
    99999
    6.25
    99999
    99999
    99999
        Par 17, Day 85, Social Functioning
    99999
    -12.5
    99999
    99999
    99999
        Par 17, Day 85, Role emotional
    99999
    0
    99999
    99999
    99999
        Par 17, Day 85, Mental health
    99999
    5
    99999
    99999
    99999
        Par 17, Day 85, Physical Component Summary
    99999
    -6.51
    99999
    99999
    99999
        Par 17, Day 85, Mental Component Summary
    99999
    3.01
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in EQ-5D-5L Index score over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

    Close Top of page
    End point title
    Part B: Change from Baseline in EQ-5D-5L Index score over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B
    End point description
    EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant’s health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from UK population was used for conversion, regardless of origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Scores on scale
    number (not applicable)
        Par 1, Week 12
    -0.127
    99999
    99999
    99999
    99999
        Par 1, Week 24
    -0.098
    99999
    99999
    99999
    99999
        Par 1, Day 339
    -0.070
    99999
    99999
    99999
    99999
        Par 2, Week 12
    0.204
    99999
    99999
    99999
    99999
        Par 2, Week 24
    0.041
    99999
    99999
    99999
    99999
        Par 2, Day 344
    0.110
    99999
    99999
    99999
    99999
        Par 3, Day 113
    99999
    99999
    0.000
    99999
    99999
        Par 4, Week 12
    99999
    0.097
    99999
    99999
    99999
        Par 5, Week 12
    99999
    99999
    99999
    0.028
    99999
        Par 5, Day 162
    99999
    99999
    99999
    0.028
    99999
        Par 6, Day 91
    99999
    99999
    99999
    0.000
    99999
        Par 7, Day 85
    99999
    99999
    99999
    99999
    0.000
        Par 8, Day 87
    99999
    99999
    99999
    99999
    0.012
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in EQ-5D-5L Index score over time for participants who never received 100mg OL Sirukumab in Part B

    Close Top of page
    End point title
    Part B: Change from Baseline in EQ-5D-5L Index score over time for participants who never received 100mg OL Sirukumab in Part B
    End point description
    EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12
    End point values
    PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Scores on scale
    number (not applicable)
        Par 1, Day 30
    99999
    -0.248
    99999
    99999
    99999
        Par 2, Day 29
    99999
    0.000
    99999
    99999
    99999
        Par 3, Day 29
    99999
    0.233
    99999
    99999
    99999
        Par 4, Week 12
    99999
    0.000
    99999
    99999
    99999
        Par 4, Day 113
    99999
    0.000
    99999
    99999
    99999
        Par 5, Day 85
    99999
    -0.015
    99999
    99999
    99999
        Par 6, Day 65
    99999
    0.163
    99999
    99999
    99999
        Par 7, Week 12
    99999
    99999
    0.163
    99999
    99999
        Par 7, Day 373
    99999
    99999
    0.163
    99999
    99999
        Par 8, Day 64
    99999
    99999
    -0.016
    99999
    99999
        Par 9, Day 29
    99999
    99999
    0.212
    99999
    99999
        Par 10, Day 57
    99999
    99999
    0.000
    99999
    99999
        Par 11, Week 12
    99999
    99999
    99999
    -0.069
    99999
        Par 11, Day 163
    99999
    99999
    99999
    0.042
    99999
        Par 12, Day 85
    99999
    99999
    99999
    -0.059
    99999
        Par 13, Day 59
    99999
    99999
    99999
    0.000
    99999
        Par 14, Day 57
    99999
    99999
    99999
    99999
    0.000
        Par 16, Day 169
    99999
    99999
    99999
    99999
    0.232
        Par 17,Week 12
    0.163
    99999
    99999
    99999
    99999
        Par 17, Day 112
    0.163
    99999
    99999
    99999
    99999
        Par 18, Day 85
    -0.042
    99999
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in FACIT-Fatigue scores over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

    Close Top of page
    End point title
    Part B: Change from Baseline in FACIT-Fatigue scores over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B
    End point description
    The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Scores on scale
    number (not applicable)
        Par 1, Week 12, I Feel Fatigued
    -3
    99999
    99999
    99999
    99999
        Par 1, Week 24, I Feel Fatigued
    -4
    99999
    99999
    99999
    99999
        Par 1, Day 339, I Feel Fatigued
    3
    99999
    99999
    99999
    99999
        Par 2, Week 12, I Feel Fatigued
    8
    99999
    99999
    99999
    99999
        Par 2, Week 24, I Feel Fatigued
    2
    99999
    99999
    99999
    99999
        Par 2, Day 344, I Feel Fatigued
    6
    99999
    99999
    99999
    99999
        Par 3, Day 113, I Feel Fatigued
    99999
    99999
    2
    99999
    99999
        Par 4, Week 12, I Feel Fatigued
    99999
    2
    99999
    99999
    99999
        Par 5, Week 12, I Feel Fatigued
    99999
    99999
    99999
    -5
    99999
        Par 5, Day 162, I Feel Fatigued
    99999
    99999
    99999
    -4
    99999
        Par 6, Day 91, I Feel Fatigued
    99999
    99999
    99999
    -12
    99999
        Par 7, Day 85, I Feel Fatigued
    99999
    99999
    99999
    99999
    -7
        Par 8, Day 87, I Feel Fatigued
    99999
    99999
    99999
    99999
    -10
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in FACIT-Fatigue scores over time for participants who never received 100mg OL Sirukumab in Part B

    Close Top of page
    End point title
    Part B: Change from Baseline in FACIT-Fatigue scores over time for participants who never received 100mg OL Sirukumab in Part B
    End point description
    The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
    End point values
    PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Scores on scale
    number (not applicable)
        Par 1, Day 30, I Feel Fatigued
    99999
    -3
    99999
    99999
    99999
        Par 2, Day 29, I Feel Fatigued
    99999
    -1
    99999
    99999
    99999
        Par 3, Day 23, I Feel Fatigued
    99999
    0
    99999
    99999
    99999
        Par 4, Week 12, I Feel Fatigued
    99999
    2
    99999
    99999
    99999
        Par 4, Day 113, I Feel Fatigued
    99999
    -16
    99999
    99999
    99999
        Par 5, Week 8, I Feel Fatigued
    99999
    -1
    99999
    99999
    99999
        Par 5, Day 85, I Feel Fatigued
    99999
    -3
    99999
    99999
    99999
        Par 6, Day 65, I Feel Fatigued
    99999
    -1
    99999
    99999
    99999
        Par 7, Week 12, I Feel Fatigued
    99999
    99999
    0
    99999
    99999
        Par 7, Day 373, I Feel Fatigued
    99999
    99999
    5
    99999
    99999
        Par 8, Day 64, I Feel Fatigued
    99999
    99999
    -3
    99999
    99999
        Par 9, Day 29, I Feel Fatigued
    99999
    99999
    0
    99999
    99999
        Par 10, Day 57, I Feel Fatigued
    99999
    99999
    13
    99999
    99999
        Par 11, Week 12, I Feel Fatigued
    99999
    99999
    99999
    5
    99999
        Par 11, Day 163, I Feel Fatigued
    99999
    99999
    99999
    6
    99999
        Par 12, Day 85, I Feel Fatigued
    99999
    99999
    99999
    -1
    99999
        Par 13, Day 59, I Feel Fatigued
    99999
    99999
    99999
    7
    99999
        Par 14, Day 57, I Feel Fatigued
    99999
    99999
    99999
    99999
    -11
        Par 16, Day 169, I Feel Fatigued
    99999
    99999
    99999
    99999
    0
        Par 17, Week 12, I Feel Fatigued
    6
    99999
    99999
    99999
    99999
        Par 17, Day112, I Feel Fatigued
    6
    99999
    99999
    99999
    99999
        Par 18, Day 85, I Feel Fatigued
    -1
    99999
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in Pain NRS scores over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

    Close Top of page
    End point title
    Part B: Change from Baseline in Pain NRS scores over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B
    End point description
    The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, “no pain” to 10, “the worst pain imaginable”. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Scores on scale
    number (not applicable)
        Par 1, Week 2
    4
    99999
    99999
    99999
    99999
        Par 1, Week 4
    -1
    99999
    99999
    99999
    99999
        Par 1, Week 8
    -1
    99999
    99999
    99999
    99999
        Par 1, Week 12
    4
    99999
    99999
    99999
    99999
        Par 1, Week 24
    0
    99999
    99999
    99999
    99999
        Par 1, Day 339
    -2
    99999
    99999
    99999
    99999
        Par 2, Week 4
    0
    99999
    99999
    99999
    99999
        Par 2, Week 8
    0
    99999
    99999
    99999
    99999
        Par 2, Week 12
    1
    99999
    0
    99999
    99999
        Par 2, Week 24
    0
    99999
    99999
    99999
    99999
        Par 2, Week 38
    1
    99999
    99999
    99999
    99999
        Par 2, Week 40
    1
    99999
    99999
    99999
    99999
        Par 2, Day 344
    0
    99999
    99999
    99999
    99999
        Par 3, Day 113
    99999
    99999
    -2
    99999
    99999
        Par 4, Week 4
    99999
    -2
    99999
    99999
    99999
        Par 4, Week 8
    99999
    0
    99999
    99999
    99999
        Par 4, Week 12
    99999
    -3
    99999
    99999
    99999
        Par 5, Week 4
    99999
    99999
    99999
    0
    99999
        Par 5, Week 8
    99999
    99999
    99999
    1
    99999
        Par 5, Week 12
    99999
    99999
    99999
    0
    99999
        Par 5, Week 14
    99999
    99999
    99999
    1
    99999
        Par 5, Week 16
    99999
    99999
    99999
    0
    99999
        Par 5, Day 162
    99999
    99999
    99999
    1
    99999
        Par 6, Week 2
    99999
    99999
    99999
    2
    99999
        Par 6, Week 4
    99999
    99999
    99999
    -2
    99999
        Par 6, Week 8
    99999
    99999
    99999
    -2
    99999
        Par 6, Day 91
    99999
    99999
    99999
    -1
    99999
        Par 7, Week 2
    99999
    99999
    99999
    99999
    -1
        Par 7, Week 4
    99999
    99999
    99999
    99999
    0
        Par 7, Week 8
    99999
    99999
    99999
    99999
    1
        Par 7, Day 85
    99999
    99999
    99999
    99999
    0
        Par 8, Week 2
    99999
    99999
    99999
    99999
    2
        Par 8, Week 4
    99999
    99999
    99999
    99999
    0
        Par 8, Day 87
    99999
    99999
    99999
    99999
    0
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in Pain NRS scores over time for participants who never received at least one dose of 100mg OL Sirukumab in Part B

    Close Top of page
    End point title
    Part B: Change from Baseline in Pain NRS scores over time for participants who never received at least one dose of 100mg OL Sirukumab in Part B
    End point description
    The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, “no pain” to 10, “the worst pain imaginable”. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
    End point values
    PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Scores on scale
    number (not applicable)
        Par 1, Day 30
    99999
    0
    99999
    99999
    99999
        Par 2, Day 29
    99999
    0
    99999
    99999
    99999
        Par 3, Day 23
    99999
    -1
    99999
    99999
    99999
        Par 4, Week 4
    99999
    0
    99999
    99999
    99999
        Par 4, Week 8
    99999
    0
    99999
    99999
    99999
        Par 4, Week 12
    99999
    0
    99999
    99999
    99999
        Par 4, Day 113
    99999
    0
    99999
    99999
    99999
        Par 5, Week 4
    99999
    0
    99999
    99999
    99999
        Par 5, Week 8
    99999
    0
    99999
    99999
    99999
        Par 5, Day 85
    99999
    2
    99999
    99999
    99999
        Par 6, Week 4
    99999
    0
    99999
    99999
    99999
        Par 6, Day 65
    99999
    0
    99999
    99999
    99999
        Par 7, Week 4
    99999
    99999
    1
    99999
    99999
        Par 7, Week 8
    99999
    99999
    0
    99999
    99999
        Par 7, Week 12
    99999
    99999
    0
    99999
    99999
        Par 7, Day 373
    99999
    99999
    0
    99999
    99999
        Par 8, Week 4
    99999
    99999
    0
    99999
    99999
        Par 8, Day 64
    99999
    99999
    -1
    99999
    99999
        Par 9, Day 29
    99999
    99999
    0
    99999
    99999
        Par 10, Week 4
    99999
    99999
    0
    99999
    99999
        Par 10, Day 57
    99999
    99999
    -1
    99999
    99999
        Par 11, Week 4
    99999
    99999
    99999
    0
    99999
        Par 11, Week 8
    99999
    99999
    99999
    0
    99999
        Par 11, Week 12
    99999
    99999
    99999
    1
    99999
        Par 11, Day 163
    99999
    99999
    99999
    1
    99999
        Par 12, Week 4
    99999
    99999
    99999
    0
    99999
        Par 12, Week 8
    99999
    99999
    99999
    -1
    99999
        Par 12, Day 85
    99999
    99999
    99999
    0
    99999
        Par 13, Week 4
    99999
    99999
    99999
    0
    99999
        Par 13, Day 59
    99999
    99999
    99999
    0
    99999
        Par 14, Week 4
    99999
    99999
    99999
    99999
    0
        Par 14, Day 57
    99999
    99999
    99999
    99999
    -1
        Par 16, Day 169
    99999
    99999
    99999
    99999
    -3
        Par 17, Week 4
    -2
    99999
    99999
    99999
    99999
        Par 17, Week 12
    -2
    99999
    99999
    99999
    99999
        Par 17, Day 112
    -2
    99999
    99999
    99999
    99999
        Par 18, Week 8
    1
    99999
    99999
    99999
    99999
        Par 18, Day 85
    0
    99999
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Part B: HAQDI Score over Time for participants who received at least one Dose of 100 mg OL Sirukumab in Part B

    Close Top of page
    End point title
    Part B: HAQDI Score over Time for participants who received at least one Dose of 100 mg OL Sirukumab in Part B
    End point description
    Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability.
    End point type
    Secondary
    End point timeframe
    Day 87, 339, 344, Week 12, 24
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    0 [23]
    0 [24]
    1 [25]
    Units: Scores on scale
    number (not applicable)
        Par 1, Week 12, Able to Do Chores
    1
    99999
    99999
        Par 1, Week 12, Get In and Out of a car
    0
    99999
    99999
        Par 1, Week 12, Run Errands and Shop
    0
    99999
    99999
        Par 1, Week 12, Get In and Out of Bed
    0
    99999
    99999
        Par 1, Week 12, Stand Up From a Straight
    1
    99999
    99999
        Par 1, Week 12, Dress yourself
    1
    99999
    99999
        Par 1, Week 12, Shampoo your hair
    0
    99999
    99999
        Par 1, Week 12, Cut your meat
    0
    99999
    99999
        Par 1, Week 12, Lift a Full Cup/Glass to mouth
    0
    99999
    99999
        Par 1, Week 12, Open a New Milk Carton
    1
    99999
    99999
        Par 1, Week 12, Open car doors
    0
    99999
    99999
        Par 1, Week 12, Open Jars Previously Opened
    1
    99999
    99999
        Par 1, Week 12, Turn Faucets On And Off
    1
    99999
    99999
        Par 1, Week 12, Get On and Off The Toilet
    0
    99999
    99999
        Par 1, Week 12, Take a Tub Bath
    3
    99999
    99999
        Par 1, Week 12, Wash and Dry Your Body
    0
    99999
    99999
        Par 1, Week 12, Bend Down Pick Up Clothing-Floor
    1
    99999
    99999
        Par 1, Week 12, Reach-Get Down 5 Lb Obj Above Head
    1
    99999
    99999
        Par 1, Week 12, Climb Up Five Steps
    0
    99999
    99999
        Par 1, Week 12, Walk Outdoors on Flat Ground
    0
    99999
    99999
        Par 1, Week 24, Able to Do Chores
    0
    99999
    99999
        Par 1, Week 24, Get In and Out of a car
    0
    99999
    99999
        Par 1, Week 24, Run Errands and Shop
    0
    99999
    99999
        Par 1, Week 24, Get In and Out of Bed
    0
    99999
    99999
        Par 1, Week 24, Stand Up From a Straight
    0
    99999
    99999
        Par 1, Week 24, Dress yourself
    0
    99999
    99999
        Par 1, Week 24, Shampoo your hair
    0
    99999
    99999
        Par 1, Week 24, Cut your meat
    0
    99999
    99999
        Par 1, Week 24, Lift a Full Cup/Glass to mouth
    0
    99999
    99999
        Par 1, Week 24, Open a New Milk Carton
    0
    99999
    99999
        Par 1, Week 24, Open car doors
    0
    99999
    99999
        Par 1, Week 24, Open Jars Previously Opened
    1
    99999
    99999
        Par 1, Week 24, Turn Faucets On And Off
    1
    99999
    99999
        Par 1, Week 24, Get On and Off The Toilet
    0
    99999
    99999
        Par 1, Week 24, Take a Tub Bath
    3
    99999
    99999
        Par 1, Week 24, Wash and Dry Your Body
    0
    99999
    99999
        Par 1, Week 24, Bend Down Pick Up Clothing-Floor
    0
    99999
    99999
        Par 1, Week 24, Reach-Get Down 5 Lb Obj Above Head
    0
    99999
    99999
        Par 1, Week 24, Climb Up Five Steps
    0
    99999
    99999
        Par 1, Week 24, Walk Outdoors on Flat Ground
    0
    99999
    99999
        Par 1, Day 339, Able to Do Chores
    0
    99999
    99999
        Par 1, Day 339, Get In and Out of a car
    0
    99999
    99999
        Par 1, Day 339, Run Errands and Shop
    0
    99999
    99999
        Par 1, Day 339, Get In and Out of Bed
    0
    99999
    99999
        Par 1, Day 339, Stand Up From a Straight
    0
    99999
    99999
        Par 1, Day 339, Dress yourself
    0
    99999
    99999
        Par 1, Day 339, Shampoo your hair
    0
    99999
    99999
        Par 1, Day 339, Cut your meat
    0
    99999
    99999
        Par 1, Day 339, Lift a Full Cup/Glass to mouth
    0
    99999
    99999
        Par 1, Day 339, Open a New Milk Carton
    1
    99999
    99999
        Par 1, Day 339, Open car doors
    0
    99999
    99999
        Par 1, Day 339, Open Jars Previously Opened
    0
    99999
    99999
        Par 1, Day 339, Turn Faucets On And Off
    0
    99999
    99999
        Par 1, Day 339, Get On and Off The Toilet
    0
    99999
    99999
        Par 1, Day 339, Take a Tub Bath
    3
    99999
    99999
        Par 1, Day 339, Wash and Dry Your Body
    0
    99999
    99999
        Par 1, Day 339, Bend Down Pick Up Clothing-Floor
    0
    99999
    99999
        Par 1, Day 339, Reach-Get Down 5 Lb Obj Above Head
    0
    99999
    99999
        Par 1, Day 339, Climb Up Five Steps
    0
    99999
    99999
        Par 1, Day 339, Walk Outdoors on Flat Ground
    0
    99999
    99999
        Par 2, Week 12, Able to Do Chores
    1
    99999
    99999
        Par 2, Week 12, Get In and Out of a car
    0
    99999
    99999
        Par 2, Week 12, Run Errands and Shop
    0
    99999
    99999
        Par 2, Week 12, Get In and Out of Bed
    0
    99999
    99999
        Par 2, Week 12, Stand Up From a Straight
    0
    99999
    99999
        Par 2, Week 12, Dress yourself
    0
    99999
    99999
        Par 2, Week 12, Shampoo your hair
    0
    99999
    99999
        Par 2, Week 12, Cut your meat
    0
    99999
    99999
        Par 2, Week 12, Lift a Full Cup/Glass to mouth
    0
    99999
    99999
        Par 2, Week 12, Open a New Milk Carton
    1
    99999
    99999
        Par 2, Week 12, Open car doors
    0
    99999
    99999
        Par 2, Week 12, Open Jars Previously Opened
    0
    99999
    99999
        Par 2, Week 12, Turn Faucets On And Off
    0
    99999
    99999
        Par 2, Week 12, Get On and Off The Toilet
    0
    99999
    99999
        Par 2, Week 12, Take a Tub Bath
    3
    99999
    99999
        Par 2, Week 12, Wash and Dry Your Body
    0
    99999
    99999
        Par 2, Week 12, Bend Down Pick Up Clothing-Floor
    1
    99999
    99999
        Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head
    2
    99999
    99999
        Par 2, Week 12, Climb Up Five Steps
    0
    99999
    99999
        Par 2, Week 12, Walk Outdoors on Flat Ground
    0
    99999
    99999
        Par 2, Week 24, Able to Do Chores
    0
    99999
    99999
        Par 2, Week 24, Get In and Out of a car
    0
    99999
    99999
        Par 2, Week 24, Run Errands and Shop
    0
    99999
    99999
        Par 2, Week 24, Get In and Out of Bed
    0
    99999
    99999
        Par 2, Week 24, Stand Up From a Straight
    0
    99999
    99999
        Par 2, Week 24, Dress yourself
    0
    99999
    99999
        Par 2, Week 24, Shampoo your hair
    0
    99999
    99999
        Par 2, Week 24, Cut your meat
    0
    99999
    99999
        Par 2, Week 24, Lift a Full Cup/Glass to mouth
    0
    99999
    99999
        Par 2, Week 24, Open a New Milk Carton
    0
    99999
    99999
        Par 2, Week 24, Open car doors
    0
    99999
    99999
        Par 2, Week 24, Open Jars Previously Opened
    0
    99999
    99999
        Par 2, Week 24, Turn Faucets On And Off
    0
    99999
    99999
        Par 2, Week 24, Get On and Off The Toilet
    0
    99999
    99999
        Par 2, Week 24, Take a Tub Bath
    0
    99999
    99999
        Par 2, Week 24, Wash and Dry Your Body
    0
    99999
    99999
        Par 2, Week 24, Bend Down Pick Up Clothing-Floor
    0
    99999
    99999
        Par 2, Week 24, Reach-Get Down 5 Lb Obj Above Head
    1
    99999
    99999
        Par 2, Week 24, Climb Up Five Steps
    0
    99999
    99999
        Par 2, Week 24, Walk Outdoors on Flat Ground
    0
    99999
    99999
        Par 2, Day 344, Able to Do Chores
    1
    99999
    99999
        Par 2, Day 344, Get In and Out of a car
    0
    99999
    99999
        Par 2, Day 344, Run Errands and Shop
    0
    99999
    99999
        Par 2, Day 344, Get In and Out of Bed
    0
    99999
    99999
        Par 2, Day 344, Stand Up From a Straight
    0
    99999
    99999
        Par 2, Day 344, Dress yourself
    0
    99999
    99999
        Par 2, Day 344, Shampoo your hair
    0
    99999
    99999
        Par 2, Day 344, Cut your meat
    0
    99999
    99999
        Par 2, Day 344, Lift a Full Cup/Glass to mouth
    0
    99999
    99999
        Par 2, Day 344, Open a New Milk Carton
    1
    99999
    99999
        Par 2, Day 344, Open car doors
    0
    99999
    99999
        Par 2, Day 344,Open Jars Previously Opened
    0
    99999
    99999
        Par 2, Day 344, Turn Faucets On And Off
    0
    99999
    99999
        Par 2, Day 344, Get On and Off The Toilet
    0
    99999
    99999
        Par 2, Day 344, Take a Tub Bath
    3
    99999
    99999
        Par 2, Day 344, Wash and Dry Your Body
    0
    99999
    99999
        Par 2, Day 344, Bend Down Pick Up Clothing-Floor
    0
    99999
    99999
        Par 2, Day 344, Reach-Get Down 5 Lb Obj Above Head
    1
    99999
    99999
        Par 2, Day 344, Climb Up Five Steps
    0
    99999
    99999
        Par 2, Day 344, Walk Outdoors on Flat Ground
    0
    99999
    99999
        Par 3, Week 12, Able to Do Chores
    99999
    0
    99999
        Par 3, Week 12, Get In and Out of a car
    99999
    0
    99999
        Par 3, Week 12, Run Errands and Shop
    99999
    0
    99999
        Par 3, Week 12, Get In and Out of Bed
    99999
    0
    99999
        Par 3, Week 12, Stand Up From a Straight
    99999
    0
    99999
        Par 3, Week 12, Dress yourself
    99999
    0
    99999
        Par 3, Week 12, Shampoo your hair
    99999
    0
    99999
        Par 3, Week 12, Cut your meat
    99999
    0
    99999
        Par 3, Week 12, Lift a Full Cup/Glass to mouth
    99999
    0
    99999
        Par 3, Week 12, Open a New Milk Carton
    99999
    0
    99999
        Par 3, Week 12, Open car doors
    99999
    0
    99999
        Par 3, Week 12, Open Jars Previously Opened
    99999
    0
    99999
        Par 3, Week 12, Turn Faucets On And Off
    99999
    0
    99999
        Par 3, Week 12, Get On and Off The Toilet
    99999
    0
    99999
        Par 3, Week 12, Take a Tub Bath
    99999
    0
    99999
        Par 3, Week 12, Wash and Dry Your Body
    99999
    0
    99999
        Par 3, Week 12, Bend Down Pick Up Clothing-Floor
    99999
    0
    99999
        Par 3, Week 12, Reach-Get Down 5 Lb Obj Above Head
    99999
    0
    99999
        Par 3, Week 12, Climb Up Five Steps
    99999
    0
    99999
        Par 3, Week 12, Walk Outdoors on Flat Ground
    99999
    0
    99999
        Par 4, Day 87, Able to Do Chores
    99999
    99999
    1
        Par 4, Day 87, Get In and Out of a car
    99999
    99999
    0
        Par 4, Day 87, Run Errands and Shop
    99999
    99999
    0
        Par 4, Day 87, Get In and Out of Bed
    99999
    99999
    0
        Par 4, Day 87, Stand Up From a Straight
    99999
    99999
    0
        Par 4, Day 87, Dress yourself
    99999
    99999
    0
        Par 4, Day 87, Shampoo your hair
    99999
    99999
    0
        Par 4, Day 87, Cut your meat
    99999
    99999
    0
        Par 4, Day 87, Lift a Full Cup/Glass to mouth
    99999
    99999
    0
        Par 4, Day 87, Open a New Milk Carton
    99999
    99999
    0
        Par 4, Day 87, Open Jars Previously Opened
    99999
    99999
    0
        Par 4, Day 87, Turn Faucets On And Off
    99999
    99999
    0
        Par 4, Day 87, Get On and Off The Toilet
    99999
    99999
    0
        Par 4, Day 87, Take a Tub Bath
    99999
    99999
    0
        Par 4, Day 87, Wash and Dry Your Body
    99999
    99999
    1
        Par 4, Day 87, Bend Down Pick Up Clothing-Floor
    99999
    99999
    0
        Par 4, Day 87, Reach-Get Down 5 Lb Obj Above Head
    99999
    99999
    1
        Par 4, Day 87, Climb Up Five Steps
    99999
    99999
    0
        Par 4, Day 87, Walk Outdoors on Flat Ground
    99999
    99999
    0
    Notes
    [23] - Data for number of participants in sustained remission over time for Part B is presented.
    [24] - Data for number of participants in sustained remission over time for Part B is presented.
    [25] - Data for number of participants in sustained remission over time for Part B is presented.
    No statistical analyses for this end point

    Secondary: Part B: HAQDI Score over time for participants who never received 100 mg OL Sirukumab in Part B

    Close Top of page
    End point title
    Part B: HAQDI Score over time for participants who never received 100 mg OL Sirukumab in Part B
    End point description
    Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability.
    End point type
    Secondary
    End point timeframe
    Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12
    End point values
    PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone
    Number of subjects analysed
    2
    1
    1
    3
    1
    Units: Scores on scale
    number (not applicable)
        Par 1, Day 29, Able to Do Chores
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Get In and Out of a car
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Run Errands and Shop
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Get In and Out of Bed
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Stand Up From a Straight Chair
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Dress yourself
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Shampoo your hair
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Cut your meat
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Lift a Full Cup or Glass to Mouth
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Open a New Milk Carton
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Open car doors
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Open Jars Previously Opened
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Turn Faucets On And Off
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Get On and Off The Toilet
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Take a Tub Bath
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Wash and Dry Your Body
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Bend Down Pick Up Clothing- Floor
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Reach-Get Down 5 Lb Obj Above Head
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Climb Up Five Steps
    99999
    99999
    99999
    0
    99999
        Par 1, Day 29, Walk Outdoors on Flat Ground
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Able to Do Chores
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Get In and Out of a car
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Run Errands and Shop
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Get In and Out of Bed
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Stand Up From a Straight Chair
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Dress yourself
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Shampoo your hair
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Cut your meat
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Lift a Full Cup or Glass to Mouth
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Open a New Milk Carton
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Open r car doors
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Open Jars Previously Opened
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Turn Faucets On And Off
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Get On and Off The Toilet
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Take a Tub Bath
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Wash and Dry Your Body
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Bend Down Pick Up Clothing- Floor
    99999
    99999
    99999
    1
    99999
        Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head
    99999
    99999
    99999
    1
    99999
        Par 2, Week 12, Climb Up Five Steps
    99999
    99999
    99999
    0
    99999
        Par 2, Week 12, Walk Outdoors on Flat Ground
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Able to Do Chores
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Get In and Out of a car
    99999
    99999
    99999
    1
    99999
        Par 2, Day 113, Run Errands and Shop
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Get In and Out of Bed
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Stand Up From a Straight Chair
    99999
    99999
    99999
    1
    99999
        Par 2, Day 113, Dress yourself
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Shampoo your hair
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Cut your meat
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Lift a Full Cup or Glass to Mouth
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Open a New Milk Carton
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Open car doors
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Open Jars Previously Opened
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Turn Faucets On And Off
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Get On and Off The Toilet
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Take a Tub Bath
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Wash and Dry Your Body
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Bend Down Pick Up Clothing- Floor
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Reach-Get Down 5 Lb Obj Above Head
    99999
    99999
    99999
    1
    99999
        Par 2, Day 113, Climb Up Five Steps
    99999
    99999
    99999
    0
    99999
        Par 2, Day 113, Walk Outdoors on Flat Ground
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Able to Do Chores
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Get In and Out of a car
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Run Errands and Shop
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Get In and Out of Bed
    99999
    99999
    99999
    1
    99999
        Par 3, Day 65, Stand Up From a Straight Chair
    99999
    99999
    99999
    1
    99999
        Par 3, Day 65, Dress yourself
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Shampoo your hair
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Cut your meat
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Lift a Full Cup or Glass to Mouth
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Open a New Milk Carton
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Open car doors
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Open Jars Previously Opened
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Turn Faucets On And Off
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Get On and Off The Toilet
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Take a Tub Bath
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Wash and Dry Your Body
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Bend Down Pick Up Clothing- Floor
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Reach-Get Down 5 Lb Obj Above Head
    99999
    99999
    99999
    1
    99999
        Par 3, Day 65, Climb Up Five Steps
    99999
    99999
    99999
    0
    99999
        Par 3, Day 65, Walk Outdoors on Flat Ground
    99999
    99999
    99999
    0
    99999
        Par 4, Week 12, Able to Do Chores
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Get In and Out of a car
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Run Errands and Shop
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Get In and Out of Bed
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Stand Up From a Straight Chair
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Dress yourself
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Shampoo your hair
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Cut your meat
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Lift a Full Cup or Glass to Mouth
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Open a New Milk Carton
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Open car doors
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Open Jars Previously Opened
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Turn Faucets On And Off
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Get On and Off The Toilet
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12,Take a Tub Bath
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Wash and Dry Your Body
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Bend Down Pick Up Clothing- Floor
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Reach-Get Down 5 Lb Obj Above Head
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Climb Up Five Steps
    0
    99999
    99999
    99999
    99999
        Par 4, Week 12, Walk Outdoors on Flat Ground
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Able to Do Chores
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Get In and Out of a car
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Run Errands and Shop
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Get In and Out of Bed
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Stand Up From a Straight Chair
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Dress yourself
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Shampoo your hair
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Cut your meat
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Lift a Full Cup or Glass to Mouth
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Open a New Milk Carton
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Open car doors
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Open Jars Previously Opened
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Turn Faucets On And Off
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Get On and Off The Toilet
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373,Take a Tub Bath
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Wash and Dry Your Body
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Bend Down Pick Up Clothing- Floor
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Reach-Get Down 5 Lb Obj Above Head
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Climb Up Five Steps
    0
    99999
    99999
    99999
    99999
        Par 4, Day 373, Walk Outdoors on Flat Ground
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Able to Do Chores
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Get In and Out of a car
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Run Errands and Shop
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Get In and Out of Bed
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Stand Up From a Straight Chair
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Dress yourself
    1
    99999
    99999
    99999
    99999
        Par 5, Day 64, Shampoo your hair
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Cut your meat
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Lift a Full Cup or Glass to Mouth
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Open a New Milk Carton
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Open car doors
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Open Jars Previously Opened
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Turn Faucets On And Off
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Get On and Off The Toilet
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64,Take a Tub Bath
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Wash and Dry Your Body
    0
    99999
    99999
    99999
    99999
        Par 5, Day 64, Bend Down Pick Up Clothing- Floor
    1
    99999
    99999
    99999
    99999
        Par 5, Day 64, Reach-Get Down 5 Lb Obj Above Head
    1
    99999
    99999
    99999
    99999
        Par 5, Day 64, Climb Up Five Steps
    1
    99999
    99999
    99999
    99999
        Par 5, Day 64, Walk Outdoors on Flat Ground
    1
    99999
    99999
    99999
    99999
        Par 6, Day 85 Able to Do Chores
    99999
    1
    99999
    99999
    99999
        Par 6, Day 85, Get In and Out of a car
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Run Errands and Shop
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Get In and Out of Bed
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Stand Up From a Straight Chair
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Dress yourself
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85,Shampoo your hair
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Cut your meat
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Lift a Full Cup or Glass to Mouth
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Open a New Milk Carton
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Open car doors
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Open Jars Previously Opened
    99999
    1
    99999
    99999
    99999
        Par 6, Day 85, Turn Faucets On And Off
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Get On and Off The Toilet
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85,Take a Tub Bath
    99999
    1
    99999
    99999
    99999
        Par 6, Day 85, Wash and Dry Your Body
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Bend Down Pick Up Clothing- Floor
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Reach-Get Down 5 Lb Obj Above Head
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Climb Up Five Steps
    99999
    0
    99999
    99999
    99999
        Par 6, Day 85, Walk Outdoors on Flat Ground
    99999
    0
    99999
    99999
    99999
        Par 7, Day 169, Able to Do Chores
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Get In and Out of a car
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Run Errands and Shop
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Get In and Out of Bed
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Stand Up From a Straight Chair
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Dress yourself
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169,Shampoo your hair
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Cut your meat
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Lift a Full Cup or Glass to Mouth
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Open a New Milk Carton
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Open car doors
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Open Jars Previously Opened
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Turn Faucets On And Off
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Get On and Off The Toilet
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169,Take a Tub Bath
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Wash and Dry Your Body
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Bend Down Pick Up Clothing- Floor
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Reach-Get Down 5 Lb Obj Above Head
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Climb Up Five Steps
    99999
    99999
    99999
    99999
    0
        Par 7, Day 169, Walk Outdoors on Flat Ground
    99999
    99999
    99999
    99999
    0
        Par 8, Week 12, Able to Do Chores
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Get In and Out of a car
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Run Errands and Shop
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Get In and Out of Bed
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Stand Up From a Straight Chair
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Dress yourself
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12,Shampoo your hair
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Cut your meat
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Lift a Full Cup or Glass to Mouth
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Open a New Milk Carton
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Open car doors
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Open Jars Previously Opened
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Turn Faucets On And Off
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Get On and Off The Toilet
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12,Take a Tub Bath
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Wash and Dry Your Body
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Bend Down Pick Up Clothing- Floor
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12 Reach-Get Down 5 Lb Obj Above Head
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Climb Up Five Steps
    99999
    99999
    0
    99999
    99999
        Par 8, Week 12, Walk Outdoors on Flat Ground
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Able to Do Chores
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Get In and Out of a car
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Run Errands and Shop
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Get In and Out of Bed
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Stand Up From a Straight Chair
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Dress yourself
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Shampoo your hair
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Cut your meat
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Lift a Full Cup or Glass to Mout
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Open a New Milk Carton
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Open car doors
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Open Jars Previously Opened
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Turn Faucets On And Off
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Get On and Off The Toilet
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Take a Tub Bath
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Wash and Dry Your Body
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Bend Down Pick Up Clothing- Floor
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Reach-Get Down 5 Lb Obj Above Head
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Climb Up Five Steps
    99999
    99999
    0
    99999
    99999
        Par 8, Day 112, Walk Outdoors on Flat Ground
    99999
    99999
    0
    99999
    99999
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in PtGA score for participants who received at least one dose of 100 mg OL Sirukumab in Part B

    Close Top of page
    End point title
    Part B: Change from Baseline in PtGA score for participants who received at least one dose of 100 mg OL Sirukumab in Part B
    End point description
    The Patient’s Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (“very well) to 10 (“very poor”). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Scores on scale
    number (not applicable)
        Par 1, Week 2
    4.3
    99999
    99999
    99999
    99999
        Par 1, Week 4
    2.3
    99999
    99999
    99999
    99999
        Par 1, Week 8
    -0.2
    99999
    99999
    99999
    99999
        Par 1, Week 12
    4.0
    99999
    99999
    99999
    99999
        Par 1, Week 16
    4.7
    99999
    99999
    99999
    99999
        Par 1, Week 24
    2.2
    99999
    99999
    99999
    99999
        Par 1, Week 36
    0.4
    99999
    99999
    99999
    99999
        Par 1, Day 339
    -0.7
    99999
    99999
    99999
    99999
        Par 2, Week 4
    -1.0
    99999
    99999
    99999
    99999
        Par 2, Week 8
    -0.3
    99999
    99999
    99999
    99999
        Par 2, Week 12
    -0.6
    99999
    99999
    99999
    99999
        Par 2, Week 16
    -0.7
    99999
    99999
    99999
    99999
        Par 2, Week 24
    0.5
    99999
    99999
    99999
    99999
        Par 2, Week 36
    -0.6
    99999
    99999
    99999
    99999
        Par 2, Week 38
    0.9
    99999
    99999
    99999
    99999
        Par 2, Week 40
    -0.3
    99999
    99999
    99999
    99999
        Par 2, Day 344
    -0.7
    99999
    99999
    99999
    99999
        Par 3,Par 3,, Day 113
    99999
    99999
    2.1
    99999
    99999
        Par 4, Week 4
    99999
    -1.0
    99999
    99999
    99999
        Par 4, Week 8
    99999
    4.9
    99999
    99999
    99999
        Par 4, Week 12
    99999
    0.4
    99999
    99999
    99999
        Par 5, Week 4
    99999
    99999
    99999
    2.0
    99999
        Par 5, Week 8
    99999
    99999
    99999
    99999
    0.4
        Par 5, Week 12
    99999
    99999
    99999
    0.2
    99999
        Par 5, Week 14
    99999
    99999
    99999
    1.0
    99999
        Par 5, Week 16
    99999
    99999
    99999
    1.0
    99999
        Par 5, Day 162
    99999
    99999
    99999
    0.8
    99999
        Par 6, Week 4
    99999
    99999
    99999
    -3.1
    99999
        Par 6, Week 8
    99999
    99999
    99999
    -3.2
    99999
        Par 6, Day 91
    99999
    99999
    99999
    -3.5
    99999
        Par 7, Week 2
    99999
    99999
    99999
    99999
    -0.7
        Par 7, Week 4
    99999
    99999
    99999
    99999
    0.7
        Par 7, Week 8
    99999
    99999
    99999
    99999
    0.8
        Par 7, Day 85
    99999
    99999
    99999
    99999
    -0.4
        Par 8, Week 2
    99999
    99999
    99999
    99999
    -0.1
        Par 8, Week 4
    99999
    99999
    99999
    99999
    -3.7
        Par 8, Day 87
    99999
    99999
    99999
    99999
    -3.1
        Par 6, Week 2
    99999
    99999
    99999
    -0.1
    99999
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in PtGA score for participants who never received 100 mg OL Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in PtGA score for participants who never received 100 mg OL Sirukumab in Part B
    End point description
    The Patient’s Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (“very well) to 10 (“very poor”). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Weeks 2, 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85,112, 113, 115, 163, 169 and 373
    End point values
    PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone
    Number of subjects analysed
    2
    2
    6
    4
    3
    Units: Scores on scale
    number (not applicable)
        Par 1, Day 30
    99999
    99999
    0.2
    99999
    99999
        Par 2, Day 29
    99999
    99999
    -0.1
    99999
    99999
        Par 3, Day 23
    99999
    99999
    0.0
    99999
    99999
        Par 4, Week 4
    99999
    99999
    -0.2
    99999
    99999
        Par 4, Week 8
    99999
    99999
    0.1
    99999
    99999
        Par 4, Week 12
    99999
    99999
    0.0
    99999
    99999
        Par 4, Day 113
    99999
    99999
    0.0
    99999
    99999
        Par 5, Week 4
    99999
    99999
    0.1
    99999
    99999
        Par 5, Week 8
    99999
    99999
    0.4
    99999
    99999
        Par 5, Day 85
    99999
    99999
    2.3
    99999
    99999
        Par 6, Week 4
    99999
    99999
    -1.0
    99999
    99999
        Par 6, Day 65
    99999
    99999
    0.5
    99999
    99999
        Par 7, Week 4
    99999
    99999
    99999
    1.0
    99999
        Par 7, Week 8
    99999
    99999
    99999
    0.0
    99999
        Par 7, Week 12
    99999
    99999
    99999
    0.0
    99999
        Par 7, Week 16
    99999
    99999
    99999
    0.2
    99999
        Par 7, Week 36
    99999
    99999
    99999
    0.2
    99999
        Par 7, Day 373
    99999
    99999
    99999
    0.9
    99999
        Par 8, Week 4
    99999
    99999
    99999
    -0.2
    99999
        Par 8, Day 64
    99999
    99999
    99999
    -0.4
    99999
        Par 9, Day 29
    99999
    99999
    99999
    0.1
    99999
        Par 10, Week 4
    99999
    99999
    99999
    0.0
    99999
        Par 10, Day 57
    99999
    99999
    99999
    -0.3
    99999
        Par 11, Week 4
    99999
    99999
    99999
    99999
    -0.1
        Par 11, Week 8
    99999
    99999
    99999
    99999
    0.2
        Par 11, Week 12
    99999
    99999
    99999
    99999
    0.2
        Par 11, Week 16
    99999
    99999
    99999
    99999
    1.2
        Par 11, Day 163
    99999
    99999
    99999
    99999
    0.3
        Par 12, Day 4
    99999
    99999
    99999
    99999
    -0.8
        Par 12, Week 8
    99999
    99999
    99999
    99999
    -0.7
        Par 12, Day 85
    99999
    99999
    99999
    99999
    0.9
        Par 12, Week 4
    99999
    99999
    99999
    99999
    -0.7
        Par 12, Day 59
    99999
    99999
    99999
    99999
    1.0
        Par 13, Week 4
    -0.4
    99999
    99999
    99999
    99999
        Par 13, Day 57
    -0.9
    99999
    99999
    99999
    99999
        Par 14, Day 169
    -1.1
    99999
    99999
    99999
    99999
        Par 15, Week 4
    99999
    -0.3
    99999
    99999
    99999
        Par 15, Week 12
    99999
    -0.3
    99999
    99999
    99999
        Par 15, Day 112
    99999
    -0.1
    99999
    99999
    99999
        Par 16, Week 8
    99999
    0.2
    99999
    99999
    99999
        Par 16, Day 85
    99999
    -0.1
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in PhGA score for participants who received at least one dose of 100 mg OL Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in PhGA score for participants who received at least one dose of 100 mg OL Sirukumab in Part B
    End point description
    In PhGA was based on “What is physician's assessment of the participant's current disease activity”. PhGA used a 10 cm VAS ranging from 0 (“none”) to 10 (“extremely active”). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Day 85, Day 113, Day 162, Day 203, Day 339, Day 344, Week 2, Week 4, Week 8, Week 12, Week 14, Week 16, Week 24, Week 36, Week 38, Week 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Scores on scale
    number (not applicable)
        Par 1, Week 2
    0.0
    99999
    99999
    99999
    99999
        Par 1, Week 4
    -0.5
    99999
    99999
    99999
    99999
        Par 1, Week 8
    -1.2
    99999
    99999
    99999
    99999
        Par 1, Week 12
    -0.6
    99999
    99999
    99999
    99999
        Par 1, Week 16
    -0.9
    99999
    99999
    99999
    99999
        Par 1, Week 24
    -0.6
    99999
    99999
    99999
    99999
        Par 1, Week 36
    -1.1
    99999
    99999
    99999
    99999
        Par 1, Day 339
    -1.2
    99999
    99999
    99999
    99999
        Par 2, Week 4
    0.0
    99999
    99999
    99999
    99999
        Par 2, Week 8
    0.1
    99999
    99999
    99999
    99999
        Par 2, Week 12
    0.4
    99999
    99999
    99999
    99999
        Par 2, Week 16
    0.1
    99999
    99999
    99999
    99999
        Par 2, Week 24
    0.0
    99999
    99999
    99999
    99999
        Par 2, Week 36
    0.1
    99999
    99999
    99999
    99999
        Par 2, Week 38
    0.7
    99999
    99999
    99999
    99999
        Par 2, Week 40
    0.4
    99999
    99999
    99999
    99999
        Par 2, Day 344
    0.2
    99999
    99999
    99999
    99999
        Par 3, Day 113
    99999
    99999
    -0.2
    99999
    99999
        Par 4, Week 4
    99999
    -0.2
    99999
    99999
    99999
        Par 4, Week 12
    99999
    0.1
    99999
    99999
    99999
        Par 5, Week 4
    99999
    99999
    99999
    1.8
    99999
        Par 5, Week 8
    99999
    99999
    99999
    -1.1
    99999
        Par 5, Week 12
    99999
    99999
    99999
    -0.7
    99999
        Par 5, Week 14
    99999
    99999
    99999
    1.5
    99999
        Par 5, Week 16
    99999
    99999
    99999
    -1.1
    99999
        Par 5, Day 162
    99999
    99999
    99999
    -0.4
    99999
        Par 6, Day 203
    99999
    99999
    99999
    7.6
    99999
        Par 7, Week 2
    99999
    99999
    99999
    99999
    0.0
        Par 7, Week 4
    99999
    99999
    99999
    99999
    0.1
        Par 7, Week 8
    99999
    99999
    99999
    99999
    0.0
        Par 7, Day 85
    99999
    99999
    99999
    99999
    0.0
        Par 8, Week 2
    99999
    99999
    99999
    99999
    -6.0
        Par 8, Week 4
    99999
    99999
    99999
    99999
    -6.3
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in PhGA score for participants who never received 100 mg OL Sirukumab in Part B

    Close Top of page
    End point title
    Part B: Change from Baseline in PhGA score for participants who never received 100 mg OL Sirukumab in Part B
    End point description
    In PhGA was based on “What is physician's assessment of the participant's current disease activity”. PhGA used a 10 cm VAS ranging from 0 (“none”) to 10 (“extremely active”). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373
    End point values
    PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone
    Number of subjects analysed
    2
    2
    6
    4
    3
    Units: Scores on scale
    number (not applicable)
        Par 1, Day 30
    99999
    99999
    0.0
    99999
    99999
        Par 2, Day 29
    99999
    99999
    0.1
    99999
    99999
        Par 3, Day 23
    99999
    99999
    0.0
    99999
    99999
        Par 3, Week 12
    99999
    99999
    0.7
    99999
    99999
        Par 4, Day 113
    99999
    99999
    0.0
    99999
    99999
        Par 5, Week 4
    99999
    99999
    -0.3
    99999
    99999
        Par 5, Day 85
    99999
    99999
    0.3
    99999
    99999
        Par 6, Week 4
    99999
    99999
    -0.2
    99999
    99999
        Par 6, Day 65
    99999
    99999
    -0.3
    99999
    99999
        Par 7, Week 4
    99999
    99999
    99999
    0.2
    99999
        Par 7, Week 8
    99999
    99999
    99999
    0.0
    99999
        Par 7, Week 12
    99999
    99999
    99999
    0.2
    99999
        Par 7, Week 16
    99999
    99999
    99999
    0.4
    99999
        Par 7, Week 36
    99999
    99999
    99999
    0.2
    99999
        Par 7, Day 373
    99999
    99999
    99999
    0.0
    99999
        Par 8, Week 4
    99999
    99999
    99999
    0.4
    99999
        Par 8, Day 64
    99999
    99999
    99999
    0.1
    99999
        Par 9, Day 29
    99999
    99999
    99999
    0.2
    99999
        Par 10, Week 4
    99999
    99999
    99999
    0.0
    99999
        Par 10, Day 57
    99999
    99999
    99999
    0.1
    99999
        Par 11, Week 12
    99999
    99999
    99999
    99999
    0.9
        Par 11, Week 16
    99999
    99999
    99999
    99999
    0.9
        Par 11, Day 163
    99999
    99999
    99999
    99999
    0.4
        Par 12, Week 4
    99999
    99999
    99999
    99999
    -0.1
        Par 12, Week 8
    99999
    99999
    99999
    99999
    0.1
        Par 12, Day 85
    99999
    99999
    99999
    99999
    -0.1
        Par 13, Week 4
    99999
    99999
    99999
    99999
    -0.6
        Par 13, Day 59
    99999
    99999
    99999
    99999
    -0.3
        Par 14, Week 4
    -0.3
    99999
    99999
    99999
    99999
        Par 14, Day 57
    0.3
    99999
    99999
    99999
    99999
        Par 15, Day 169
    -0.5
    99999
    99999
    99999
    99999
        Par 16, Week 4
    99999
    -0.1
    99999
    99999
    99999
        Par 16, Week 12
    99999
    0.0
    99999
    99999
    99999
        Par 16, Day 112
    99999
    0.4
    99999
    99999
    99999
        Par 17, Week 8
    99999
    0.1
    99999
    99999
    99999
        Par 17, Day 85
    99999
    0.2
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Part B: Number of participants with PGIC Score over time who received at least one dose of 100 mg OL Sirukumab in Part B

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    End point title
    Part B: Number of participants with PGIC Score over time who received at least one dose of 100 mg OL Sirukumab in Part B
    End point description
    Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual’s response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Days 103 and 271
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Participants
    number (not applicable)
        Par 1, Day 1: Much Better
    1
    99999
    99999
    99999
    99999
        Par 2, Day 1: Much Better
    1
    99999
    99999
    99999
    99999
        Par 2, Day 271: Worse
    1
    99999
    99999
    99999
    99999
        Par 3, Day 1: Much Better
    99999
    99999
    1
    99999
    99999
        Par 4, Day 1: Much Better
    99999
    1
    99999
    99999
    99999
        Par 5,Day 1: Slightly Better
    99999
    99999
    99999
    1
    99999
        Par 5, Day 103: No change
    99999
    99999
    99999
    1
    99999
        Par 6, Day 1: Better
    99999
    99999
    99999
    1
    99999
        Par 7, Day 1: Much Better
    99999
    99999
    99999
    99999
    1
        Par 8, Day 1: Slightly Better
    99999
    99999
    99999
    99999
    1
    No statistical analyses for this end point

    Secondary: Part B: Number of participants with PGIC Score over time who never received 100 mg OL Sirukumab in Part B

    Close Top of page
    End point title
    Part B: Number of participants with PGIC Score over time who never received 100 mg OL Sirukumab in Part B
    End point description
    Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual’s response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1)
    End point values
    PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Participants
    number (not applicable)
        Par 1, Day 1: No change
    99999
    1
    99999
    99999
    99999
        Par 2, Day 1: Much Better
    99999
    1
    99999
    99999
    99999
        Par 3, Day 1: Much Better
    99999
    1
    99999
    99999
    99999
        Par 4, Day 1: Much Better
    99999
    1
    99999
    99999
    99999
        Par 5, Day 1: Better
    99999
    1
    99999
    99999
    99999
        Par 6, Day 1: Much Better
    99999
    1
    99999
    99999
    99999
        Par 7, Day 1: Much Better
    99999
    99999
    1
    99999
    99999
        Par 8, Day 1: Better
    99999
    99999
    1
    99999
    99999
        Par 9, Day 1: Much Better
    99999
    99999
    1
    99999
    99999
        Par 10, Day 1: Better
    99999
    99999
    1
    99999
    99999
        Par 11, Day 1: Much Better
    99999
    99999
    99999
    1
    99999
        Par 12, Day 1: Much Better
    99999
    99999
    99999
    1
    99999
        Par 13, Day 1: Better
    99999
    99999
    99999
    1
    99999
        Par 14, Day 1: Better
    99999
    99999
    99999
    99999
    1
        Par 15, Day 1: Much Better
    99999
    99999
    99999
    99999
    1
        Par 16, Day 1: Much Better
    99999
    99999
    99999
    99999
    1
        Par 17, Day 1: Much Better
    1
    99999
    99999
    99999
    99999
        Par 18, Day 1: Much Better
    1
    99999
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in CRP over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in CRP over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B
    End point description
    Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Milligram per liter (mg/L)
    arithmetic mean (standard deviation)
        Week 2, n=1,1,0,1,2
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 2.970 )
        Week 4, n=2,1,1,2,2
    99999 ( 0.000 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 1.909 )
    99999 ( 2.828 )
        Week 8, n=2,1,1,2,1
    99999 ( 0.000 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 6.010 )
    99999 ( 99999 )
        Week 12, n=2,1,1,1,0
    99999 ( 0.000 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 14, n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 16, n=2,0,0,1,0
    99999 ( 0.424 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 24, n=2,0,0,0,0
    99999 ( 2.546 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 36, n=2,0,0,0,0
    99999 ( 0.849 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 38, n=1,0,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 40, n=1,0,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in CRP over time for participants who never received 100 mg OL Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in CRP over time for participants who never received 100 mg OL Sirukumab in Part B
    End point description
    Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
    End point values
    PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: mg/L
    arithmetic mean (standard deviation)
        Week 4, n=3,3,2,1,2
    99999 ( 1.202 )
    99999 ( 0.361 )
    99999 ( 0.252 )
    99999 ( 0.071 )
    99999 ( 99999 )
        Week 8, n=2,1,2,0,2
    99999 ( 0.636 )
    99999 ( 0.778 )
    99999 ( 99999 )
    99999 ( 0.000 )
    99999 ( 99999 )
        Week 12, n=1,1,1,1,1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 16, n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 24, n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 36, n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in ESR over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in ESR over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B
    End point description
    Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Millimeter per hour (mm/h)
    arithmetic mean (standard deviation)
        Week 2, n=1,1,0,1,1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 4, n=2,1,1,2,2
    99999 ( 2.12 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 16.97 )
    99999 ( 31.82 )
        Week 8, n=2,1,0,2,1
    99999 ( 7.07 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 15.56 )
    99999 ( 99999 )
        Week 12, n=2,1,1,1,0
    99999 ( 1.41 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 14, n=0,0,0,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 16, n=2,0,0,1,0
    99999 ( 2.12 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 24, n=2,0,0,0,0
    ( 0.71 )
    ( 99999 )
    ( 99999 )
    ( 99999 )
    ( 99999 )
        Week 36, n=2,0,0,0,0
    99999 ( 11.31 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 38, n=1,0,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 40, n=1,0,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in ESR over time for participants who never received 100 mg OL Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in ESR over time for participants who never received 100 mg OL Sirukumab in Part B
    End point description
    Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
    End point values
    PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: mm/h
    arithmetic mean (standard deviation)
        Week 36, n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 5.03 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 4, n=3,3,3,1,2
    99999 ( 5.66 )
    99999 ( 5.03 )
    99999 ( 1.53 )
    99999 ( 1.00 )
    99999 ( 99999 )
        Week 8, n=2,1,3,0,2
    99999 ( 2.83 )
    99999 ( 7.07 )
    99999 ( 99999 )
    99999 ( 0.00 )
    99999 ( 99999 )
        Week 12, n=1,1,1,1,1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 16, n=0,1,1,1,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 24, n=0,1,0,0,0
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in EQ-5D-5L VAS over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in EQ-5D-5L VAS over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B
    End point description
    EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent’s self-rated health on a vertical line, VAS where the endpoints are ‘Best imaginable health state’ and ‘Worst imaginable health state’. Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24
    End point values
    PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:Placebo SC q2w + 6 month prednisone PartB:Placebo SC q2w + 12 month prednisone
    Number of subjects analysed
    2
    1
    1
    2
    2
    Units: Scores on scale
    number (not applicable)
        Par 2, Day 344
    -1
    99999
    99999
    99999
    99999
        Par 3, Day 113
    99999
    99999
    1
    99999
    99999
        Par 4, Week 12
    99999
    -4
    99999
    99999
    99999
        Par 5, Week 12
    99999
    99999
    99999
    9
    99999
        Par 5, Day 162
    99999
    99999
    99999
    -15
    99999
        Par 6, Day 91
    99999
    99999
    99999
    20
    99999
        Par 7, Day 85
    99999
    99999
    99999
    99999
    4
        Par 8, Day 87
    99999
    99999
    99999
    99999
    21
        Par 1, Week 12
    -12
    99999
    99999
    99999
    99999
        Par 1, Week 24
    1
    99999
    99999
    99999
    99999
        Par 1, Day 339
    8
    99999
    99999
    99999
    99999
        Par 2, Week 12
    3
    99999
    99999
    99999
    99999
        Par 2, Week 24
    14
    99999
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Part B: Change from Baseline in EQ-5D-5L VAS over time for participants who never received 100 mg OL Sirukumab in Part B

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    End point title
    Part B: Change from Baseline in EQ-5D-5L VAS over time for participants who never received 100 mg OL Sirukumab in Part B
    End point description
    EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent’s self-rated health on a vertical line, VAS where the endpoints are 100 (Best imaginable health state) and 0 (Worst imaginable health state). Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12
    End point values
    PartB:Placebo SC q2w + 12 month prednisone PartB:SIR 100 mg SC q2w+6 month prednisone PartB:SIR 100 mg SC q2w+3 month prednisone PartB:SIR 50 mg SC q4w+6 month prednisone PartB:Placebo SC q2w + 6 month prednisone
    Number of subjects analysed
    2
    6
    4
    3
    3
    Units: Scores on scale
    number (not applicable)
        Par 5, Day 85
    99999
    -1
    99999
    99999
    99999
        Par 6, Day 65
    99999
    20
    99999
    99999
    99999
        Par 7, Week 12
    99999
    99999
    4
    99999
    99999
        Par 7, Day 373
    99999
    99999
    8
    99999
    99999
        Par 8, Day 64
    99999
    99999
    -2
    99999
    99999
        Par 9, Day 29
    99999
    99999
    -1
    99999
    99999
        Par 10, Day 57
    99999
    99999
    5
    99999
    99999
        Par 11, Week 12
    99999
    99999
    99999
    -10
    99999
        Par 11, Day 163
    99999
    99999
    99999
    -12
    99999
        Par 12, Day 85
    99999
    99999
    99999
    -8
    99999
        Par 13, Day 59
    99999
    99999
    99999
    10
    99999
        Par 14, Day 57
    99999
    99999
    99999
    99999
    -42
        Par 16, Day 169
    99999
    99999
    99999
    99999
    62
        Par 17, Week 12
    9
    99999
    99999
    99999
    99999
        Par 17, Day 112
    7
    99999
    99999
    99999
    99999
        Par 18, Day 85
    -4
    99999
    99999
    99999
    99999
        Par 1, Day 30
    99999
    2
    99999
    99999
    99999
        Par 2, Day 29
    99999
    0
    99999
    99999
    99999
        Par 3, Day 23
    99999
    1
    99999
    99999
    99999
        Par 4, Week 12
    99999
    -2
    99999
    99999
    99999
        Par 4, Day 113
    99999
    -47
    99999
    99999
    99999
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 104 in Part B.
    Adverse event reporting additional description
    Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Part A:SIR 100 mg SC q2w+6 month prednisone
    Reporting group description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

    Reporting group title
    Part A:SIR 100 mg SC q2w+3 month prednisone
    Reporting group description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Reporting group title
    Part A: SIR 50 mg SC q4w+6 month prednisone
    Reporting group description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

    Reporting group title
    Part A:Placebo SC q2w + 6 month prednisone
    Reporting group description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

    Reporting group title
    Part A:Placebo SC q2w + 12 month prednisone
    Reporting group description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

    Reporting group title
    Part B:SIR 100 mg SC q2w+6 month Prednisone+100mg OL SIR
    Reporting group description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.

    Reporting group title
    Part B:SIR 100 mg SC q2w+3 month Prednisone+100mg OL SIR
    Reporting group description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.

    Reporting group title
    Part B:SIR 50 mg SC q4w+6 month Prednisone+100mg OL SIR
    Reporting group description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.

    Reporting group title
    Part B:Placebo SC q2w + 6 month Prednisone+100mg OL SIR
    Reporting group description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.

    Reporting group title
    Part B:Placebo SC q2w + 12 month Prednisone+100mg OL SIR
    Reporting group description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.

    Reporting group title
    Part B:SIR 100 mg SC q2w+6 month Prednisone/ No 100mg OL SIR
    Reporting group description
    Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.

    Reporting group title
    Part B:SIR 100 mg SC q2w+3 month Prednisone/ No 100mg OL SIR
    Reporting group description
    Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.

    Reporting group title
    Part B:SIR 50 mg SC q4w+6 month Prednisone/ No 100mg OL SIR
    Reporting group description
    Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.

    Reporting group title
    Part B:Placebo SC q2w + 6 month Prednisone/ No 100mg OL SIR
    Reporting group description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.

    Reporting group title
    Part B:Placebo SC q2w + 12 month Prednisone/ No 100mg OL SIR
    Reporting group description
    Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.

    Serious adverse events
    Part A:SIR 100 mg SC q2w+6 month prednisone Part A:SIR 100 mg SC q2w+3 month prednisone Part A: SIR 50 mg SC q4w+6 month prednisone Part A:Placebo SC q2w + 6 month prednisone Part A:Placebo SC q2w + 12 month prednisone Part B:SIR 100 mg SC q2w+6 month Prednisone+100mg OL SIR Part B:SIR 100 mg SC q2w+3 month Prednisone+100mg OL SIR Part B:SIR 50 mg SC q4w+6 month Prednisone+100mg OL SIR Part B:Placebo SC q2w + 6 month Prednisone+100mg OL SIR Part B:Placebo SC q2w + 12 month Prednisone+100mg OL SIR Part B:SIR 100 mg SC q2w+6 month Prednisone/ No 100mg OL SIR Part B:SIR 100 mg SC q2w+3 month Prednisone/ No 100mg OL SIR Part B:SIR 50 mg SC q4w+6 month Prednisone/ No 100mg OL SIR Part B:Placebo SC q2w + 6 month Prednisone/ No 100mg OL SIR Part B:Placebo SC q2w + 12 month Prednisone/ No 100mg OL SIR
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 42 (19.05%)
    6 / 39 (15.38%)
    6 / 26 (23.08%)
    5 / 27 (18.52%)
    6 / 27 (22.22%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Temporal arteritis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchiectasis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Brain contusion
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    2 / 26 (7.69%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal artery occlusion
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Large intestine polyp
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis cholestatic
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hypersensitivity vasculitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 26 (3.85%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Electrolyte imbalance
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Part A:SIR 100 mg SC q2w+6 month prednisone Part A:SIR 100 mg SC q2w+3 month prednisone Part A: SIR 50 mg SC q4w+6 month prednisone Part A:Placebo SC q2w + 6 month prednisone Part A:Placebo SC q2w + 12 month prednisone Part B:SIR 100 mg SC q2w+6 month Prednisone+100mg OL SIR Part B:SIR 100 mg SC q2w+3 month Prednisone+100mg OL SIR Part B:SIR 50 mg SC q4w+6 month Prednisone+100mg OL SIR Part B:Placebo SC q2w + 6 month Prednisone+100mg OL SIR Part B:Placebo SC q2w + 12 month Prednisone+100mg OL SIR Part B:SIR 100 mg SC q2w+6 month Prednisone/ No 100mg OL SIR Part B:SIR 100 mg SC q2w+3 month Prednisone/ No 100mg OL SIR Part B:SIR 50 mg SC q4w+6 month Prednisone/ No 100mg OL SIR Part B:Placebo SC q2w + 6 month Prednisone/ No 100mg OL SIR Part B:Placebo SC q2w + 12 month Prednisone/ No 100mg OL SIR
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 42 (97.62%)
    36 / 39 (92.31%)
    25 / 26 (96.15%)
    26 / 27 (96.30%)
    24 / 27 (88.89%)
    2 / 2 (100.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    2 / 2 (100.00%)
    2 / 2 (100.00%)
    4 / 6 (66.67%)
    3 / 4 (75.00%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 42 (9.52%)
    2 / 39 (5.13%)
    4 / 26 (15.38%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    5
    3
    4
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 39 (2.56%)
    1 / 26 (3.85%)
    1 / 27 (3.70%)
    2 / 27 (7.41%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    2
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 39 (7.69%)
    4 / 26 (15.38%)
    2 / 27 (7.41%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    41
    5
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Injection site erythema
         subjects affected / exposed
    9 / 42 (21.43%)
    4 / 39 (10.26%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    29
    4
    5
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 39 (7.69%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    3
    6
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site pruritus
         subjects affected / exposed
    3 / 42 (7.14%)
    4 / 39 (10.26%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    19
    7
    2
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    6 / 42 (14.29%)
    2 / 39 (5.13%)
    4 / 26 (15.38%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    9
    6
    13
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site swelling
         subjects affected / exposed
    4 / 42 (9.52%)
    4 / 39 (10.26%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    6
    4
    8
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site warmth
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    5 / 42 (11.90%)
    8 / 39 (20.51%)
    3 / 26 (11.54%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    5
    14
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 39 (2.56%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    11
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 42 (19.05%)
    2 / 39 (5.13%)
    2 / 26 (7.69%)
    2 / 27 (7.41%)
    3 / 27 (11.11%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    8
    3
    2
    3
    5
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 39 (5.13%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    8
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 39 (5.13%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 39 (2.56%)
    4 / 26 (15.38%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    4
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 39 (5.13%)
    2 / 26 (7.69%)
    1 / 27 (3.70%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    4
    2
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervousness
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    C-reactive protein abnormal
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    2 / 27 (7.41%)
    0 / 27 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Low density lipoprotein increased
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 39 (2.56%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 39 (2.56%)
    2 / 26 (7.69%)
    2 / 27 (7.41%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Fall
         subjects affected / exposed
    4 / 42 (9.52%)
    2 / 39 (5.13%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    3 / 27 (11.11%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    8
    2
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Joint dislocation
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    2 / 27 (7.41%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Limb injury
         subjects affected / exposed
    4 / 42 (9.52%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Road traffic accident
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tendon rupture
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Foot fracture
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Laceration
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Limb traumatic amputation
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Procedural pain
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 42 (7.14%)
    4 / 39 (10.26%)
    2 / 26 (7.69%)
    1 / 27 (3.70%)
    3 / 27 (11.11%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    5
    3
    1
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    13 / 42 (30.95%)
    7 / 39 (17.95%)
    8 / 26 (30.77%)
    7 / 27 (25.93%)
    8 / 27 (29.63%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    20
    14
    16
    7
    13
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    0 / 26 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    3
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tremor
         subjects affected / exposed
    3 / 42 (7.14%)
    3 / 39 (7.69%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Syncope
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 42 (2.38%)
    4 / 39 (10.26%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    5
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 39 (2.56%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cataract
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    1 / 26 (3.85%)
    1 / 27 (3.70%)
    2 / 27 (7.41%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    1
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye pain
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Chalazion
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    3 / 26 (11.54%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 39 (5.13%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    4
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    5 / 42 (11.90%)
    2 / 39 (5.13%)
    5 / 26 (19.23%)
    2 / 27 (7.41%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    5
    2
    12
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Faeces discoloured
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 26 (3.85%)
    2 / 27 (7.41%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    2 / 26 (7.69%)
    2 / 27 (7.41%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    2
    2
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    0 / 26 (0.00%)
    1 / 27 (3.70%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 39 (5.13%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    2
    2
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Toothache
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 39 (2.56%)
    1 / 26 (3.85%)
    2 / 27 (7.41%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal hernia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Eructation
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Noninfective gingivitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 39 (5.13%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    2
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    5 / 42 (11.90%)
    1 / 39 (2.56%)
    1 / 26 (3.85%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    5
    5
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Night sweats
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 39 (2.56%)
    2 / 26 (7.69%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    2 / 26 (7.69%)
    1 / 27 (3.70%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    2
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Swelling face
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 39 (2.56%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Macule
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Purpura
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    0 / 26 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 42 (11.90%)
    4 / 39 (10.26%)
    5 / 26 (19.23%)
    1 / 27 (3.70%)
    4 / 27 (14.81%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    7
    36
    6
    1
    6
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Back pain
         subjects affected / exposed
    7 / 42 (16.67%)
    3 / 39 (7.69%)
    3 / 26 (11.54%)
    2 / 27 (7.41%)
    4 / 27 (14.81%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    7
    9
    5
    2
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bursitis
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    3 / 42 (7.14%)
    5 / 39 (12.82%)
    3 / 26 (11.54%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    6
    6
    3
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 39 (7.69%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 39 (5.13%)
    2 / 26 (7.69%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    3
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 39 (5.13%)
    1 / 26 (3.85%)
    2 / 27 (7.41%)
    4 / 27 (14.81%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    7
    2
    2
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neck pain
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    5
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Osteoarthritis
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 39 (2.56%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 39 (5.13%)
    3 / 26 (11.54%)
    2 / 27 (7.41%)
    3 / 27 (11.11%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    6
    5
    2
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pain in jaw
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 39 (5.13%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    3
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 39 (2.56%)
    0 / 26 (0.00%)
    1 / 27 (3.70%)
    2 / 27 (7.41%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    1
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Synovial cyst
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 39 (7.69%)
    0 / 26 (0.00%)
    2 / 27 (7.41%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    3
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 39 (5.13%)
    3 / 26 (11.54%)
    1 / 27 (3.70%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    2
    4
    1
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Onychomycosis
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    1 / 26 (3.85%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    3 / 42 (7.14%)
    3 / 39 (7.69%)
    2 / 26 (7.69%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    3
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 42 (4.76%)
    8 / 39 (20.51%)
    2 / 26 (7.69%)
    4 / 27 (14.81%)
    1 / 27 (3.70%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    8
    2
    5
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 39 (5.13%)
    2 / 26 (7.69%)
    2 / 27 (7.41%)
    4 / 27 (14.81%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    2
    2
    2
    10
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Gout
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 26 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Oct 2015
    Amendment No. 1: Protocol has been updated to clarify the secondary objectives and endpoints of characterization of sustained remission in Parts A and B, collection of patient and physician reported outcomes, including correction of the version of the EQ-5D version that will be administered and pain assessment using a numeric rating scale. Further clarifications have been included in updates to the potential signs and symptoms of GCA, prednisone use during screening and taper initiation, participant eligibility for receiving open-label sirukumab in Part B and investigator consideration of the individual participant benefit-risk of continuing sirukumab in Part B. This amendment includes additional information on risk mitigation for GI perforations and serious allergic/hypersensitivity events. The inclusion criteria for GCA diagnostic criteria for temporal artery biopsy and imaging and symptoms of active GCA have been updated. Other changes include removal of restrictions on the use of NSAIDs, clarification of circumstances requiring discontinuation of study treatment but not study withdrawal, and circumstances in which subjects may withdraw from the study. The Time and Events table has been updated and corrections included. Other additions include guidance to investigators related to treatment of glucocorticoid-induced osteoporosis. Clarification of protocol-specified exploratory biomarkers and optional exploratory biomarkers, updated information on the study number for the exploratory imaging sub-study, randomization system and correction of typographical errors.
    30 Mar 2016
    Amendment No. 2: Amendment has been updated to include the assessment of the utility of ultrasound imaging as an indicator of disease activity in an exploratory cohort of participants. Other modifications include updates to the inclusion criteria for diagnosis of GCA to allow for diagnosis by ultrasound imaging in sites qualified to participate in the ultrasound imaging portion of the study, to further clarify features consistent with GCA or PMR flares, and to clarify requirements for the prednisone dose at Screening. The inclusion criteria have also been amended to include the acceptability of a single view of chest radiographs if consistent with local guidelines. Updated information on the pre-filled syringes has been included. Other modifications include the clarification that the daily prednisone dose should be taken in a single daily administration in the morning. Country-specific requirements have been included for Germany, the Netherlands, and Australia and New Zealand. These include a requirement to discontinue study drug administration in the event of a serious infection (Germany), a requirement for participants to discontinue the study at the conclusion of Part A after completing the 16-week follow up phase (the Netherlands) and a requirement to notify investigators when the value of the ESR result is > 40 mm/hr or has increased > 10 mm/hr from baseline or previous result (Australia and New Zealand).
    16 Nov 2016
    Amendment No. 3: Amendment has been updated to include the implementation of the Columbia-Suicide Severity Rating Scale to prospectively monitor suicidal ideation and behavior. Other modifications include revision of the endpoints for the exploratory imaging cohort, further clarifications regarding the initiation of the prednisone taper and prednisone sourcing information, and inclusion of malignancies as a potential risk of clinical significance. In addition, a requirement for male contraception and restrictions on sperm donation, amendment of QTc exclusion and stopping criteria, revision of criteria to allow prior anti-IL-6 use if not associated with intolerance or inadequate response, and addition of an exclusion criterion related to suicidality are included. Pregnancy testing is now required at 4-weekly intervals while participants are receiving study drug during Parts A and B and during the 16-week follow up period after drug discontinuation. Additional clarification of reflex testing for hepatitis and tuberculosis testing have been included. Updated information regarding database locks and unblinding and treatment comparisons has also been included.

    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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