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    Clinical Trial Results:
    Rotterdam Observational Study in CIDP of Pharmacokinetics of Intravenous γ-globulin

    Summary
    EudraCT number
    		 2013-004988-32
    Trial protocol
    		 NL  
    Global end of trial date
    25 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions
    Summary report(s)
    		 PKPD_IVIg_CIDP

    Trial information

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    Trial identification
    Sponsor protocol code
    NL46993.078.13
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Erasmus MC
    Sponsor organisation address
    Dr. Molewaterplein 50, Rotterdam, Netherlands, PO 2040 3000CA
    Public contact
    GBS workgroup Erasmus MC, Erasmus University Medical Center, 0031 0107043430,
    Scientific contact
    GBS workgroup Erasmus MC, Erasmus University Medical Center, 0031 0107043430,
    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
    30 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to determine the PK and PD of IVIg during maintenance treatment in patients with CIDP. These data will be used to conduct a NONMEM analysis in relation to the dosage, frequency and batch of IVIg used.
    Protection of trial subjects
    The canula for IV administration was left in place longer to obtain serum samples shortly after infusion in order to minimize blood drawings.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    5
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening criteria were: must be diagnosed with CIDP (EFNS/PNS), EMG findings compatible with this diagnosis, age 18 and older, be on maintenance treatment with IVIg, agree on and sign the informed consent.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kiovig
    Investigational medicinal product code
    J06BA02
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Highly variable and patient dependent: ranges from 15 to 60 (g). g gram(s)

    Number of subjects in period 1
    		Overall trial
    Started
    15
    Completed
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 15 15
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 69 (37 to 79) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Primary: Serum IgG levels

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    End point title
    		 Serum IgG levels [1]
    End point description
    End point type
    Primary
    End point timeframe
    From first sample collected (30-04-214) until last sample collected (25-10-2015)
    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: Primary and secondary pharmacokinetic parameters were calculated using PKSolver’s version 2.0 noncompartmental analysis tool for infusion (Linear up – Log down) or the two-compartmental option. There are no arms to compare, yet adding a statistical analysis with one arm keeps getting flagged as an error (despite the option is given). Hence to complete this form no statistical analyses were specified. For an overwie of statistical analyses used please see the linked and/or enclosed publication.
    End point values
    		 Overall trial
    Number of subjects analysed
    15
    Units: g/L
        number (not applicable)
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From start of the trial (30-04-2014) until the last blood sample was collected (25-10-2015).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Excel
    Dictionary version
    2010
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 -

    Serious adverse events
    		 All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: SAEs during or after treatment with IVIg in general are rare, given all these patients were on maintenance treatment with IVIg before inclusion in the trial the ocurrence of any AE was a priori very limited. After completion of the last blood sample collection no AE was objectified and/or reported.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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