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    Clinical Trial Results:
    Immune tolerance induction in MS patients with neutralizing antibodies against interferon-beta

    Summary
    EudraCT number
    		 2009-013284-19
    Trial protocol
    		 AT  
    Global end of trial date
    30 Sep 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Oct 2020
    First version publication date
    21 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HINABS-ITI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52 A, Innsbruck, Austria, 6020
    Public contact
    Priv.Doz. Dr. Harald Hegen, Medical University Innsbruck, University Hospital for Neurology, +43 (0)512- 504- 24279, harald.hegen@tirol-kliniken.at
    Scientific contact
    Priv.Doz. Dr. Harald Hegen, Medical University Innsbruck, University Hospital for Neurology, +43 (0)512- 504- 24279, harald.hegen@tirol-kliniken.at
    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 Sep 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    How many multiple slerosis patients show a reduction of the neutralizing antibodies < 100 neutralizing units after 3 months of weekly intravenous interferon-beta infusion.
    Protection of trial subjects
    To reduce side effects such as flu-like symptoms (FLS), 1000 mg paracetamol were administered intravenously prior to each IFNβ infusion.
    Background therapy
    		 All subjets received IFNβ before enrolled in the trial.
    Evidence for comparator
    		 No comparators were tested in this trial.
    Actual start date of recruitment
    10 Dec 2009
    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
    Austria: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were eligible if they were diagnosed as relapsing MS or clinically isolated syndrome (CIS) according to the revised McDonalds criteria 2005, received previous treatment with any IFNβ preparation and were NAb positive with a titer >500 TRU (10-fold reduction unit) at screening.

    Pre-assignment
    Screening details
    		 Previous IFNβ treatment had to be interrupted for at least 7 days before baseline visit. Patients, who did not show sufficient MxA gene expression after administration of the study dose of 1500μg IFNβ-1b at baseline or at week 1, were withdrawn from the study.

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 IFNβ-1b treatment
    Arm description
    		 We aimed to investigate whether the repeated high-dose intravenous IFNβ administration in patients with high NAb titers leads to a sustained reversion of NAbs and an increase of MxA expression
    Arm type
    		 Experimental

    Investigational medicinal product name
    Interferon Beta-1b
    Investigational medicinal product code
    Other name
    Betaferon
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received 1500μg IFNβ-1b reconstituted in 100 ml 0.9% NaCl intravenously once a week over 3 months (i.e. a total of 13 infusions).

    Number of subjects in period 1
    		IFNβ-1b treatment
    Started
    10
    Completed
    9
    Not completed
    1
         Lacking MxA induction
    1
    Period 2
    Period 2 title
    Follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 IFNβ-1b follow-up
    Arm description
    		 We aimed to investigate whether the repeated high-dose intravenous IFNβ administration in patients with high NAb titers leads to a sustained reversion of NAbs and an increase of MxA expression
    Arm type
    		 Experimental

    Investigational medicinal product name
    Interferon Beta-1b
    Investigational medicinal product code
    Other name
    Betaferon
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received 1500μg IFNβ-1b reconstituted in 100 ml 0.9% NaCl intravenously once a week over 3 months (i.e. a total of 13 infusions).

    Number of subjects in period 2
    		IFNβ-1b follow-up
    Started
    9
    Completed
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IFNβ-1b treatment
    Reporting group description
    		 We aimed to investigate whether the repeated high-dose intravenous IFNβ administration in patients with high NAb titers leads to a sustained reversion of NAbs and an increase of MxA expression

    Reporting group values
    		 IFNβ-1b treatment Total
    Number of subjects
    		 10 10
    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)
    		 10 10
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.4 ( 10.019 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    IFNβ-1b treatment
    Reporting group description
    		 We aimed to investigate whether the repeated high-dose intravenous IFNβ administration in patients with high NAb titers leads to a sustained reversion of NAbs and an increase of MxA expression
    Reporting group title
    IFNβ-1b follow-up
    Reporting group description
    		 We aimed to investigate whether the repeated high-dose intravenous IFNβ administration in patients with high NAb titers leads to a sustained reversion of NAbs and an increase of MxA expression

    Primary: NAb titer

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    End point title
    		 NAb titer
    End point description
    Blood collections were performed at screening, then monthly at baseline, week 4, 8 and 12, as well as at follow-up after 24 weeks. At baseline and weeks 4, 8 and12 blood samples were withdrawn immediately before and 4h after IFNβ administration.
    End point type
    Primary
    End point timeframe
    Day 0 (baseline)- week 24
    End point values
    		 IFNβ-1b treatment IFNβ-1b follow-up
    Number of subjects analysed
    9
    9
    Units: TRU
        median (inter-quartile range (Q1-Q3))
    1429 (902 to 2995)
    2175 (1803 to 2519)
    Statistical analysis title
    		 NAb titers
    Statistical analysis description
    Median NAb titer at follow-up was not significantly different compared to baseline.
    Comparison groups
    IFNβ-1b treatment v IFNβ-1b follow-up
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.23
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 0- week 24
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    IFNβ-1b treatment and follow-up
    Reporting group description
    		 We aimed to investigate whether the repeated high-dose intravenous IFNβ administration in patients with high NAb titers leads to a sustained reversion of NAbs and an increase of MxA expression

    Serious adverse events
    		 IFNβ-1b treatment and follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IFNβ-1b treatment and follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 10 (50.00%)
    Cardiac disorders
    Hypotonia
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Immune system disorders
    Relapse
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Flu-like symptoms
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences all number
    2

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25878009
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