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    Clinical Trial Results:
    Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study

    Summary
    EudraCT number
    		 2011-003448-28
    Trial protocol
    		 DE   CZ   ES   FI   NL   AT   GB   IT   BE   LT   PL   EE  
    Global end of trial date
    20 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IgPro20_3003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01545076
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CSL Behring GmbH
    Sponsor organisation address
    Emil-von-Behring-Strasse 76, Marburg, Germany,
    Public contact
    Trial Disclosure Manager, CSL Behring GmbH, clinicaltrials@cslbehring.com
    Scientific contact
    Trial Disclosure Manager, CSL Behring GmbH, clinicaltrials@cslbehring.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
    10 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of 2 different doses of IgPro20 (0.2 g/kg bw and/or 0.4 g/kg bw) in the maintenance treatment of CIDP in comparison to placebo.
    Protection of trial subjects
    This study was carried out in accordance with the ICH (International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) Good Clinical Practice (GCP) guidelines, the Declaration of Helsinki (version 2008), and standard operating procedures for clinical research and development at CSL Behring GmbH and the Contract Research Organizations (CROs) involved. The study was conducted under a protocol reviewed and approved by an IEC / IRB; the study was conducted by scientifically and medically qualified persons; the benefits of the study were in proportion to the risks; the rights and welfare of the subjects were respected; the physicians conducting the study did not find the hazards to outweigh the potential benefits; the results reported are accurate, and each subject or subject’s legal guardian gave his or her written informed consent before any protocol-driven tests or evaluations were performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Mar 2012
    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
    Netherlands: 10
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Czech Republic: 7
    Country: Number of subjects enrolled
    Estonia: 3
    Country: Number of subjects enrolled
    Finland: 1
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Germany: 65
    Country: Number of subjects enrolled
    Italy: 41
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    Canada: 25
    Country: Number of subjects enrolled
    Israel: 4
    Country: Number of subjects enrolled
    Japan: 17
    Country: Number of subjects enrolled
    United States: 42
    Worldwide total number of subjects
    276
    EEA total number of subjects
    180
    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)
    191
    From 65 to 84 years
    85
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of the 276 subjects screened, 31 were found not eligible. Therefore, 245 eligible subjects with CIDP entered the IgG Dependency Period during which time no IVIG was administered. Out of these, 208 subjects who experienced CIDP deterioration during the IgG Dependency Period qualified for the IgPro10 Restabilization Period.

    Period 1
    Period 1 title
    IgPro10 Restabilization
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 IgPro10
    Arm description
    		 Subjects who experienced CIDP deterioration during the IgG Dependency Period started up to 13 weeks of IVIG treatment with IgPro10 during the IgPro10 Restabilization Period. Of the 208 subjects that started this period, 207 received IgPro10.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IgPro10
    Investigational medicinal product code
    Other name
    Privigen
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks.

    Number of subjects in period 1
    		IgPro10
    Started
    208
    Completed
    172
    Not completed
    36
         Consent withdrawn by subject
    7
         Physician decision
    2
         Failure to meet randomization criteria
    22
         Adverse event, non-fatal
    4
         Protocol deviation
    1
    Period 2
    Period 2 title
    IgPro20 Subcutaneous (SC) Treatment
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IgPro20 (0.2)
    Arm description
    		 IgPro20 at a dose of 0.2 g/kg bw
    Arm type
    		 Experimental

    Investigational medicinal product name
    IgPro20
    Investigational medicinal product code
    Other name
    Hizentra
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Weekly subcutaneous (SC) infusion of IgPro20 at 0.2 g/kg bw for up to 24 weeks.

    Arm title
    		 IgPro20 (0.4)
    Arm description
    		 IgPro20 at a dose of 0.4 g/kg bw
    Arm type
    		 Experimental

    Investigational medicinal product name
    IgPro20
    Investigational medicinal product code
    Other name
    Hizentra
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Weekly subcutaneous (SC) infusion of IgPro20 at 0.4 g/kg bw for up to 24 weeks.

    Arm title
    		 Placebo
    Arm description
    		 2% human albumin solution
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Weekly SC infusion for up to 24 weeks.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The study was designed for IgPro20 SC randomization, therefore this is the subject population that should be used as the baseline.
    Number of subjects in period 2 [2]
    		IgPro20 (0.2) IgPro20 (0.4) Placebo
    Started
    57
    58
    57
    Completed
    36
    39
    21
    Not completed
    21
    19
    36
         Consent withdrawn by subject
    2
    8
    3
         Physician decision
    -
    -
    1
         Adverse event, non-fatal
    1
    1
    -
         Lack of efficacy
    18
    10
    32
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The study was designed for IgPro20 SC randomization, therefore this is the subject population that should be used as the baseline.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IgPro20 (0.2)
    Reporting group description
    		 IgPro20 at a dose of 0.2 g/kg bw

    Reporting group title
    IgPro20 (0.4)
    Reporting group description
    		 IgPro20 at a dose of 0.4 g/kg bw

    Reporting group title
    Placebo
    Reporting group description
    		 2% human albumin solution

    Reporting group values
    		 IgPro20 (0.2) IgPro20 (0.4) Placebo Total
    Number of subjects
    		 57 58 57 172
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 41 40 41 122
        From 65-84 years
    		 16 18 16 50
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.5 ( 12.02 ) 56.6 ( 13.62 ) 55.9 ( 12.64 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 27 20 62
        Male
    		 42 31 37 110

    End points

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    End points reporting groups
    Reporting group title
    IgPro10
    Reporting group description
    		 Subjects who experienced CIDP deterioration during the IgG Dependency Period started up to 13 weeks of IVIG treatment with IgPro10 during the IgPro10 Restabilization Period. Of the 208 subjects that started this period, 207 received IgPro10.
    Reporting group title
    IgPro20 (0.2)
    Reporting group description
    		 IgPro20 at a dose of 0.2 g/kg bw

    Reporting group title
    IgPro20 (0.4)
    Reporting group description
    		 IgPro20 at a dose of 0.4 g/kg bw

    Reporting group title
    Placebo
    Reporting group description
    		 2% human albumin solution

    Subject analysis set title
    ITTS
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention-to-treat Set (ITTS): The ITTS consists of all randomized subjects who received at least 1 dose of IgPro20 / placebo and satisfied inclusion criterion #1 (diagnosis of CIDP).

    Subject analysis set title
    SDS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Data Set (SDS): The SDS consists of all randomized subjects who received at least 1 dose of IgPro20 or placebo.

    Subject analysis set title
    PSDS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Pre-randomization Safety Data Set (PSDS): The PSDS was based on all subjects enrolled into the study who received at least 1 dose of IgPro10 before randomization.

    Subject analysis set title
    RSDS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Rescue Medication Safety Data Set (RSDS): The RSDS consists of subjects of the SDS who received at least 1 dose of IgPro10 rescue medication.

    Primary: Percentage (%) of subjects who relapse or are withdrawn for any other reason during the SC treatment period (ITTS)

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    End point title
    		 Percentage (%) of subjects who relapse or are withdrawn for any other reason during the SC treatment period (ITTS)
    End point description
    Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score). The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (“No upper limb problems”) to 5 (“Inability to use either arm for any purposeful movement”), and scores for leg disability range from 0 (“Walking not affected”) to 5 (“Restricted to wheelchair, unable to stand and walk a few steps with help”). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the “adjusted” INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
    End point type
    Primary
    End point timeframe
    Up to 25 weeks
    End point values
    		 IgPro20 (0.2) IgPro20 (0.4) Placebo
    Number of subjects analysed
    57
    58
    57
    Units: Percent of subjects
        number (not applicable)
    38.6
    32.8
    63.2
    Statistical analysis title
    		 CIDP Relapse or Withdrawal (IgPro20, 0.2)
    Comparison groups
    IgPro20 (0.2) v Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.007
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -24.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.7
         upper limit
    		 -6.21
    Statistical analysis title
    		 CIDP Relapse or Withdrawal (IgPro20, 0.4)
    Comparison groups
    IgPro20 (0.4) v Placebo
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -30.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46
         upper limit
    		 -12.2

    Secondary: Change from baseline in Inflammatory Neuropathy Cause and Treatment (INCAT) total scores during the SC treatment period (ITTS)

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    End point title
    		 Change from baseline in Inflammatory Neuropathy Cause and Treatment (INCAT) total scores during the SC treatment period (ITTS)
    End point description
    The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (“No upper limb problems”) to 5 (“Inability to use either arm for any purposeful movement”), and scores for leg disability range from 0 (“Walking not affected”) to 5 (“Restricted to wheelchair, unable to stand and walk a few steps with help”). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the “adjusted” INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 25 weeks
    End point values
    		 IgPro20 (0.2) IgPro20 (0.4) Placebo
    Number of subjects analysed
    56
    57
    57
    Units: Scores on scale
        median (full range (min-max))
    0 (-2 to 5)
    0 (-2 to 3)
    1 (-1 to 4)
    Statistical analysis title
    		 Median difference from Baseline (IgPro20, 0.2)
    Comparison groups
    IgPro20 (0.2) v Placebo
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.005
    Method
    		 Wilcoxon rank sum
    Parameter type
    		 Median difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0
    Statistical analysis title
    		 Median difference from Baseline (IgPro20, 0.4)
    Comparison groups
    IgPro20 (0.4) v Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Wilcoxon rank sum
    Parameter type
    		 Median difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0

    Secondary: Change from baseline in mean grip strength during the SC treatment period (ITTS)

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    End point title
    		 Change from baseline in mean grip strength during the SC treatment period (ITTS)
    End point description
    The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength of each hand was determined.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 25 weeks
    End point values
    		 IgPro20 (0.2) IgPro20 (0.4) Placebo
    Number of subjects analysed
    56
    57
    57
    Units: Kilopascal (kPa)
        median (full range (min-max))
    -0.6 (-80 to 55)
    -2.7 (-80 to 55)
    -6.6 (-51 to 22)
    Statistical analysis title
    		 Median difference from Baseline (IgPro20, 0.2)
    Comparison groups
    IgPro20 (0.2) v Placebo
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 Wilcoxon rank sum
    Parameter type
    		 Median difference (final values)
    Point estimate
    7.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 14
    Statistical analysis title
    		 Median difference from Baseline (IgPro20, 0.4)
    Comparison groups
    Placebo v IgPro20 (0.4)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.014
    Method
    		 Wilcoxon rank sum
    Parameter type
    		 Median difference (final values)
    Point estimate
    5.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 11.7

    Secondary: Change from baseline in Medical Research Council (MRC) sum scores during the SC treatment period (ITTS)

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    End point title
    		 Change from baseline in Medical Research Council (MRC) sum scores during the SC treatment period (ITTS)
    End point description
    An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
    End point type
    Secondary
    End point timeframe
    Baseline and up to 25 weeks
    End point values
    		 IgPro20 (0.2) IgPro20 (0.4) Placebo
    Number of subjects analysed
    56
    57
    57
    Units: scores on a scale
        median (full range (min-max))
    0 (-16 to 14)
    0 (-12 to 7)
    -2 (-19 to 6)
    Statistical analysis title
    		 Median difference from baseline (IgPro20, 0.2)
    Comparison groups
    Placebo v IgPro20 (0.2)
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 Wilcoxon rank sum
    Parameter type
    		 Median difference (final values)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 4
    Statistical analysis title
    		 Median difference from baseline (IgPro20, 0.4)
    Comparison groups
    Placebo v IgPro20 (0.4)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 Wilcoxon rank sum
    Parameter type
    		 Median difference (final values)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 4

    Secondary: Change from baseline in Rasch-built Overall Disability Scale (R-ODS) scores during the SC Treatment Period (ITTS)

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    End point title
    		 Change from baseline in Rasch-built Overall Disability Scale (R-ODS) scores during the SC Treatment Period (ITTS)
    End point description
    The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
    End point type
    Secondary
    End point timeframe
    Baseline and up to 25 weeks
    End point values
    		 IgPro20 (0.2) IgPro20 (0.4) Placebo
    Number of subjects analysed
    53
    53
    52
    Units: scores on a scale
        median (full range (min-max))
    -2 (-41 to 100)
    0 (-49 to 17)
    -3 (-43 to 13)
    Statistical analysis title
    		 Median difference from Baseline (IgPro20, 0.2)
    Comparison groups
    IgPro20 (0.2) v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.03
    Method
    		 Wilcoxon rank sum
    Parameter type
    		 Median difference (final values)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 9
    Statistical analysis title
    		 Median difference from Baseline (IgPro20, 0.4)
    Comparison groups
    IgPro20 (0.4) v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Wilcoxon rank sum
    Parameter type
    		 Median difference (final values)
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 9

    Secondary: Rate of adverse events per IgPro20 infusion during the SC treatment period (SDS)

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    End point title
    		 Rate of adverse events per IgPro20 infusion during the SC treatment period (SDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 28 weeks
    End point values
    		 IgPro20 (0.2) IgPro20 (0.4) Placebo
    Number of subjects analysed
    57
    58
    57
    Units: Rate/Infusion
        number (not applicable)
    0.079
    0.051
    0.034
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events during the SC Treatment Period (SDS)

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    End point title
    		 Number of subjects with adverse events during the SC Treatment Period (SDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 28 weeks
    End point values
    		 IgPro20 (0.2) IgPro20 (0.4) Placebo
    Number of subjects analysed
    57
    58
    57
    Units: Subjects
        number (not applicable)
    33
    30
    21
    No statistical analyses for this end point

    Secondary: Percentage of subjects with adverse events during the SC Treatment Period (SDS)

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    End point title
    		 Percentage of subjects with adverse events during the SC Treatment Period (SDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 28 weeks
    End point values
    		 IgPro20 (0.2) IgPro20 (0.4) Placebo
    Number of subjects analysed
    57
    58
    57
    Units: Percent of Subjects
        number (not applicable)
    57.9
    51.7
    36.8
    No statistical analyses for this end point

    Secondary: Time to improvement during IgPro10 Re-stabilization Therapy (PSDS)

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    End point title
    		 Time to improvement during IgPro10 Re-stabilization Therapy (PSDS)
    End point description
    Improvement is defined as an INCAT score decrease by 1 point (except for the decrease from 1 to 0 in the upper limb score), R-ODS improvement by at least 4 points, or Mean Grip strength improvement by at least 8 kPa in one hand.
    End point type
    Secondary
    End point timeframe
    Up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    207
    Units: Days
        median (confidence interval 95%)
    23 (22 to 23)
    No statistical analyses for this end point

    Secondary: Change in mean grip strength during IgPro10 Re-stabilization Therapy (PSDS)

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    End point title
    		 Change in mean grip strength during IgPro10 Re-stabilization Therapy (PSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Reference Visit and up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    202
    Units: kPa
        arithmetic mean (standard deviation)
    11.27 ( 16.89 )
    No statistical analyses for this end point

    Secondary: Change in MRC sum score during IgPro10 Re-stabilization Therapy (PSDS)

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    End point title
    		 Change in MRC sum score during IgPro10 Re-stabilization Therapy (PSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Reference Visit and up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    203
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    3.4 ( 4.9 )
    No statistical analyses for this end point

    Secondary: Change in R-ODS during IgPro10 Re-stabilization Therapy (PSDS)

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    End point title
    		 Change in R-ODS during IgPro10 Re-stabilization Therapy (PSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Reference Visit and up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    166
    Units: Scores on acale
        arithmetic mean (standard deviation)
    4.7 ( 14.14 )
    No statistical analyses for this end point

    Secondary: Change in INCAT during IgPro10 Re-stabilization Therapy (PSDS)

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    End point title
    		 Change in INCAT during IgPro10 Re-stabilization Therapy (PSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Reference Visit and up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    205
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -1.1 ( 1.2 )
    No statistical analyses for this end point

    Secondary: Rate of adverse events per IgPro10 infusion during Re-stabilization Therapy (PSDS)

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    End point title
    		 Rate of adverse events per IgPro10 infusion during Re-stabilization Therapy (PSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    207
    Units: Rate/Infusion
        number (not applicable)
    0.175
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events during IgPro10 Re-stabilization Therapy (PSDS)

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    End point title
    		 Number of subjects with adverse events during IgPro10 Re-stabilization Therapy (PSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    207
    Units: Subjects
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Percent of subjects with adverse events during IgPro10 Re-stabilization Therapy (PSDS)

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    End point title
    		 Percent of subjects with adverse events during IgPro10 Re-stabilization Therapy (PSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    207
    Units: Percent of Subjects
        number (not applicable)
    48.3
    No statistical analyses for this end point

    Secondary: Change in mean grip strength during IgPro10 Rescue Therapy (RSDS)

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    End point title
    		 Change in mean grip strength during IgPro10 Rescue Therapy (RSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Before first rescue IgPro10 infusion and up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    35
    Units: kPa
        arithmetic mean (standard deviation)
    16.3 ( 17.58 )
    No statistical analyses for this end point

    Secondary: Change in MRC sum score during IgPro10 Rescue Therapy (RSDS)

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    End point title
    		 Change in MRC sum score during IgPro10 Rescue Therapy (RSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Before first rescue IgPro10 infusion and up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    35
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    6.8 ( 5.28 )
    No statistical analyses for this end point

    Secondary: Change in R-ODS during IgPro10 Rescue Therapy (RSDS)

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    End point title
    		 Change in R-ODS during IgPro10 Rescue Therapy (RSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Before first rescue IgPro10 infusion and up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    29
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    14 ( 14.69 )
    No statistical analyses for this end point

    Secondary: Change in INCAT during IgPro10 Rescue Therapy (RSDS)

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    End point title
    		 Change in INCAT during IgPro10 Rescue Therapy (RSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Before first rescue IgPro10 infusion and up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    45
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -1.3 ( 1.31 )
    No statistical analyses for this end point

    Secondary: Time to improvement after CIDP relapse during IgPro10 Rescue Therapy (RSDS)

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    End point title
    		 Time to improvement after CIDP relapse during IgPro10 Rescue Therapy (RSDS)
    End point description
    Improvement is defined as a decrease in INCAT score (except for the decrease from 1 to 0 in the upper limb score) back to or below the baseline score
    End point type
    Secondary
    End point timeframe
    Up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    60
    Units: Days
        median (confidence interval 95%)
    23 (22 to 49)
    No statistical analyses for this end point

    Secondary: Rate of adverse events per IgPro10 infusion during Rescue Therapy (RSDS)

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    End point title
    		 Rate of adverse events per IgPro10 infusion during Rescue Therapy (RSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    60
    Units: Rate/Infusion
        number (not applicable)
    0.142
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events during IgPro10 Rescue Therapy (RSDS)

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    End point title
    		 Number of subjects with adverse events during IgPro10 Rescue Therapy (RSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    60
    Units: Subjects
        number (not applicable)
    17
    No statistical analyses for this end point

    Secondary: Percent of subjects with adverse events during IgPro10 Rescue Therapy (RSDS)

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    End point title
    		 Percent of subjects with adverse events during IgPro10 Rescue Therapy (RSDS)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 13 weeks
    End point values
    		 IgPro10
    Number of subjects analysed
    60
    Units: Percent of Subjects
        number (not applicable)
    28.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    4.5 years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    IgPro10 Restabilization
    Reporting group description
    		 PSDS

    Reporting group title
    IgPro20 (0.2)
    Reporting group description
    		 SDS

    Reporting group title
    IgPro20 (0.4)
    Reporting group description
    		 SDS

    Reporting group title
    Placebo
    Reporting group description
    		 SDS

    Reporting group title
    IgPro10 Rescue
    Reporting group description
    		 RSDS

    Serious adverse events
    		 IgPro10 Restabilization IgPro20 (0.2) IgPro20 (0.4) Placebo IgPro10 Rescue
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 207 (5.31%)
    3 / 57 (5.26%)
    2 / 58 (3.45%)
    1 / 57 (1.75%)
    2 / 60 (3.33%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Investigations
    Blood pressure diastolic increased
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    0 / 207 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic inflammatory demyelinating polyradiculoneuropathy
         subjects affected / exposed
    2 / 207 (0.97%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 207 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 207 (0.00%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 207 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    1 / 57 (1.75%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 207 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 207 (0.00%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 207 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 57 (1.75%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthropathy
         subjects affected / exposed
    0 / 207 (0.00%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 57 (1.75%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture nonunion
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 57 (1.75%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 207 (0.00%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 57 (1.75%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 57 (1.75%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IgPro10 Restabilization IgPro20 (0.2) IgPro20 (0.4) Placebo IgPro10 Rescue
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 207 (24.15%)
    22 / 57 (38.60%)
    20 / 58 (34.48%)
    15 / 57 (26.32%)
    7 / 60 (11.67%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    5 / 207 (2.42%)
    3 / 57 (5.26%)
    1 / 58 (1.72%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    5
    8
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    34 / 207 (16.43%)
    4 / 57 (7.02%)
    4 / 58 (6.90%)
    2 / 57 (3.51%)
    4 / 60 (6.67%)
         occurrences all number
    53
    5
    4
    2
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 207 (2.42%)
    5 / 57 (8.77%)
    0 / 58 (0.00%)
    1 / 57 (1.75%)
    0 / 60 (0.00%)
         occurrences all number
    11
    5
    0
    1
    0
    Infusion site erythema
         subjects affected / exposed
    0 / 207 (0.00%)
    5 / 57 (8.77%)
    10 / 58 (17.24%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    11
    28
    0
    0
    Infusion site swelling
         subjects affected / exposed
    0 / 207 (0.00%)
    5 / 57 (8.77%)
    6 / 58 (10.34%)
    2 / 57 (3.51%)
    0 / 60 (0.00%)
         occurrences all number
    0
    8
    8
    2
    0
    Infusion site induration
         subjects affected / exposed
    0 / 207 (0.00%)
    2 / 57 (3.51%)
    3 / 58 (5.17%)
    1 / 57 (1.75%)
    0 / 60 (0.00%)
         occurrences all number
    0
    10
    3
    1
    0
    Infusion site pain
         subjects affected / exposed
    0 / 207 (0.00%)
    3 / 57 (5.26%)
    2 / 58 (3.45%)
    2 / 57 (3.51%)
    0 / 60 (0.00%)
         occurrences all number
    0
    15
    2
    2
    0
    Infusion site warmth
         subjects affected / exposed
    0 / 207 (0.00%)
    0 / 57 (0.00%)
    3 / 58 (5.17%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    10 / 207 (4.83%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    2 / 57 (3.51%)
    4 / 60 (6.67%)
         occurrences all number
    12
    0
    1
    2
    4
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    3 / 207 (1.45%)
    1 / 57 (1.75%)
    3 / 58 (5.17%)
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    1
    3
    0
    0
    Arthralgia
         subjects affected / exposed
    3 / 207 (1.45%)
    3 / 57 (5.26%)
    1 / 58 (1.72%)
    1 / 57 (1.75%)
    0 / 60 (0.00%)
         occurrences all number
    3
    3
    1
    1
    0
    Back pain
         subjects affected / exposed
    5 / 207 (2.42%)
    3 / 57 (5.26%)
    1 / 58 (1.72%)
    1 / 57 (1.75%)
    1 / 60 (1.67%)
         occurrences all number
    5
    4
    1
    1
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 207 (5.80%)
    4 / 57 (7.02%)
    2 / 58 (3.45%)
    1 / 57 (1.75%)
    1 / 60 (1.67%)
         occurrences all number
    12
    6
    2
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 207 (0.48%)
    1 / 57 (1.75%)
    0 / 58 (0.00%)
    3 / 57 (5.26%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    0
    3
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 207 (0.97%)
    3 / 57 (5.26%)
    2 / 58 (3.45%)
    2 / 57 (3.51%)
    0 / 60 (0.00%)
         occurrences all number
    2
    3
    2
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Nov 2011
    -Updated with regard to measurements and information on the occurrence of hemolysis -Changes in timing of SC treatment: allowed to be performed on 1 or 2 consecutive days each study week -A change in dosing for loading and rescue with IVIG: a total dose of ≤ 200 g was to be administered for subjects with a body weight greater than 100 kg
    12 Apr 2013
    -‘IVIG Withdrawal Period’ was changed to the ‘IgG Dependency Test Period’. Daily self-assessments (R-ODS score and grip strength) were added to prove subjects´ ongoing need for IVIG -The schedule and loading / maintenance dosing for the IgPro10 Rescue Period was revised to match the IgPro10 Restabilization Period. The dosing was continued until the I-NCAT score was back to the result at the Rescue Reference Visit -Additional safety assessment at 4 weeks after final administration of IgPro20 -Addition of laboratory parameters (blood urea nitrogen, gamma-glutamyltransferase)
    11 Sep 2014
    -Number of SC infusion sites in parallel no longer specified, focus on maximum rate and volume per site allowed per protocol; volume per infusion site increased to 50 mL -Addition of new post-marketing adverse reactions and precautions for IgPro20 (Thrombotic Events and Aseptic Meningitis Syndrome) -Addition of interim safety analysis (March 2014) summary, which revealed no additional safety issue -Deletion of inclusion criterion #2, reducing the length of time required for pre-study IVIG to 8 weeks -Addition of Screening Period details: assessments could now be performed over > 1 visit; eligibility had to be determined before Screening efficacy measurements were performed and Screening IVIG was administered
    08 Dec 2015
    -Adverse reactions and precautions were updated per current safety information for IgPro10 (Transfusion-related Acute Lung Injury) -Definition of “CIDP relapse” was clarified to be applicable to IgPro10 Restabilization as well as when it occurs during the SC Treatment Period

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    For endpoint, "Time to CIDP relapse or withdrawal due to any other reason during the SC treatment period (ITTS)", for the Placebo group the median time was 79.0 days (95% CI: 57.0 to 125.0). Other median times could not be calculated.
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