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    Clinical Trial Results:
    A multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin (IVIg) versus standard therapy for the treatment of transverse myelitis in adults and children

    Summary
    EudraCT number
    		 2014-002335-34
    Trial protocol
    		 GB  
    Global end of trial date
    11 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Oct 2018
    First version publication date
    06 Oct 2018
    Other versions
    Summary report(s)
    		 FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    STRiVE
    Additional study identifiers
    ISRCTN number
    		 ISRCTN12127581
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Dr Ming Lim, Guy's and St Thomas NHS Foundation Trust, 0044 0207188 4002, Ming.Lim@gstt.nhs.uk
    Scientific contact
    Dr Ming Lim, Guy's and St Thomas NHS Foundation Trust, 0044 0207188 4002, Ming.Lim@gstt.nhs.uk
    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
    11 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    11 May 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this randomized controlled trial is to evaluate if additional, and early, treatment with IVIg is of extra benefit in TM when compared to the current standard therapy of intravenous steroids.
    Protection of trial subjects
    Patients will be eligible for inclusion in the trial if on presentation they:  Are aged 1 year or over  Have been diagnosed with: EITHER acute first onset transverse myelitis (The TM CONSORTIUM WORKING GROUP 2002 criteria for probable TM will be used. Hence, following clinical and radiological exclusion of a compressive myelopathy
    Background therapy
    		 none
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jul 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
    United Kingdom: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    1
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Only 2 participants were recruited into this multi center trial located within the UK

    Pre-assignment
    Screening details
    		 Patients will be eligible for inclusion in the trial if on presentation they:  Are aged 1 year or over  Have been diagnosed with: EITHER acute first onset transverse myelitis (The TM CONSORTIUM WORKING GROUP 2002 criteria for probable TM will be used. Hence, following clinical and radiological exclusion of a compressive myelopathy

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    Due to the technical challenges of masking IVIg from saline, the need for rapid recruitment and the fact that follow-up will be many months after the event using objective well-defined clinical endpoints; treatment will not be blinded (no placebo). The trial manager, pharmacy, and those administering treatment are not blinded; whilst staff carrying out primary outcome assessments at follow-up and statistical analyses will be blinded to intervention.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 Only1 participants were recruited into this arm before early termination. Therefore no statistical analysis has been performed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IViG
    Investigational medicinal product code
    Other name
    Intratect
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Participants were randomised 1:1 to treatme.nt with IV methylprednisolone alone (control arm) or IV methylprednisolone plus 2kg/kg IVIG in divided doses (treatment arm).

    Arm title
    		 No intervention
    Arm description
    		 Participants were randomised 1:1 to treatment with IV methylprednisolone alone (control arm) as standard of care.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Due to the technical challenges of masking IVIg from saline, the need for rapid recruitment and the fact that follow-up will be many months after the event using objective well-defined clinical endpoints; treatment will not be blinded (no placebo). The trial manager, pharmacy, and those administering treatment are not blinded; whilst staff carrying out primary outcome assessments at follow-up and statistical analyses will be blinded to intervention.
    Number of subjects in period 1
    		Intervention No intervention
    Started
    1
    1
    Completed
    0
    0
    Not completed
    1
    1
         Physician decision
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Only1 participants were recruited into this arm before early termination. Therefore no statistical analysis has been performed.

    Reporting group title
    No intervention
    Reporting group description
    		 Participants were randomised 1:1 to treatment with IV methylprednisolone alone (control arm) as standard of care.

    Reporting group values
    		 Intervention No intervention Total
    Number of subjects
    		 1 1 2
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 1 1
        Adults (18-64 years)
    		 1 0 1
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 62.5 (60 to 65) 12.5 (10 to 15) -
    Gender categorical
    Units: Subjects
        Female
    		 0 1 1
        Male
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Only1 participants were recruited into this arm before early termination. Therefore no statistical analysis has been performed.

    Reporting group title
    No intervention
    Reporting group description
    		 Participants were randomised 1:1 to treatment with IV methylprednisolone alone (control arm) as standard of care.

    Primary: Clinical Endpoint

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    End point title
    		 Clinical Endpoint [1]
    End point description
    The primary objective of the study was to evaluate if additional and early treatment with IVIG is of extra benefit in transverse myelitis compared to standard therapy of intravenous steroids. An improvement of 2 points or greater on the ASIA Impairment scale (classified A-E) at 6 months after randomisation, compared to the value measured at baseline just prior to randomisation.
    End point type
    Primary
    End point timeframe
    baseline to 6 months post randomisation
    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: Trial was terminated early, with only 1 participant randomised to intervional arm and 1 participant to non interventional arm. No analysis performed.
    End point values
    		 Intervention No intervention
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Points on ASIA scale
        number (not applicable)
    Notes
    [2] - Trial was discontinued due to inability to recruit. Only 2 participants randomised and 0 completed.
    [3] - Trial was discontinued due to inability to recruit. Only 2 participants randomised and 0 completed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    randomisation to 6 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Group 1 - Intervention
    Reporting group description
    		 -

    Reporting group title
    Group 2 - No Intervention
    Reporting group description
    		 -

    Serious adverse events
    		 Group 1 - Intervention Group 2 - No Intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group 1 - Intervention Group 2 - No Intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    Respiratory, thoracic and mediastinal disorders
    Chest Infection
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    Skin and subcutaneous tissue disorders
    Pressure Sore
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0

    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.
    Study was ended prematurely, after12months of recruitment. 2 Participants randomised into the study were withdrawn from the study following their 6-month visit post randomisation visit. As n=2 no statistical analysis will be carried out on the data

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28639937
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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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