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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, Data analyst, Carer, 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
         Consent withdrawn by subject
    6
    6
    1
    3
    3
         Physician decision
    1
    4
    3
    1
    -
         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