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    Summary
    EudraCT Number:2014-002335-34
    Sponsor's Protocol Code Number:STRiVE
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-002335-34
    A.3Full title of the trial
    A multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin (IVIg) versus standard therapy for the treatment of transverse myelitis in adults and children
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intravenous immunoglobulin vs standard therapy for treatment of transverse myelitis
    A.3.2Name or abbreviated title of the trial where available
    STRiVE
    A.4.1Sponsor's protocol code numberSTRiVE
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGuy's and St Thomas NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute for Health Research Health Technology Assessment Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy's and St Thomas NHS Foundation Trust
    B.5.2Functional name of contact pointDr Ming Lim
    B.5.3 Address:
    B.5.3.1Street AddressChildren’s Neurosciences, 1st Floor, D Block South Wing, St Thomas’ Hospital
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440207188 4002
    B.5.5Fax number00440207188 4269
    B.5.6E-mailMing.Lim@gstt.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Intratect
    D.2.1.1.2Name of the Marketing Authorisation holderBiotest Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIntratect
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Transverse myelitis (TM) (acute, first onset cases), including first presentation of neuromyelitis optica (NMO)
    E.1.1.1Medical condition in easily understood language
    TM is a rare disease that affects the coating (myelin) of nerve cells in the spinal cord, causing inflammation which damages the cells: in NMO vision is also effected.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10028527
    E.1.2Term Myelitis transverse
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10029322
    E.1.2Term Neuromyelitis optica
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to provide benefits whereby:
    1. The clinical and para-clinical data collected from patients will provide a robust resource and platform for other clinical studies, including identification of early predictors of poor outcome.
    2. Bio banked samples from patients recruited to the study will be collected and used for carefully designed biological studies by a consortium of established basic science researchers in the field.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be eligible for inclusion on 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, patient will be diagnosed to have TM if they meet all the following criteria:
     Sensory, motor, or autonomic dysfunction attributable to the spinal cord
     Bilateral signs and/or symptoms (not necessarily symmetric)
     Sensory level (except in young children <5 years where this is difficult to
    evaluate)
     Lack of MRI brain criteria consistent with MS (McDonald 2010 space criteria)
     Progression to nadir between 4 h and 21 days)
    OR Have been diagnosed with first presentation of neuromyelitis optica.
    (Patients with definite modified NMO will meet the following criteria (Wingerchuck et al, 2006).
    Absolute criteria, both:
    1. Optic neuritis
    2. Acute myelitis
    Plus two out of three supportive criteria:
    i. Brain MRI not meeting criteria for MS at disease onset
    ii. Spinal cord MRI with contiguous T2-weighted signal abnormality extending over
    three or more vertebral segments, indicating a relatively large lesion in the
    spinal cord
    iii. NMO-IgG seropositive status)
    • Have an ASIA Impairment score of A, B or C
    • Give assent/consent to participate in the trial
    E.4Principal exclusion criteria
    Patients would be excluded if they show evidence of:
    • Contraindication to IVIg as stated in the product SmPC, or receiving IVIG for
    other reasons
    • Previously known systemic autoimmune disease (eg systemic lupus erythematosus) or
    any evidence of systemic inflammation during current presentation.
    • Direct infectious aetiology (eg varicella zoster)
    • Previous episode of CNS inflammatory demyelination
    • Acute disseminated encephalomyelitis (ADEM)
    • Other causes of myelopathy not thought to be due to myelitis (eg nutritional,
    ischaemic, tumour etc.)
    • Pregnancy
    •Circumstances which would prevent follow-up for 12 months
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome measure is defined as the binary responder, being an improvement of 2 points or greater on the ASIA scale (classified A-E) at 6 months post randomisation
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome is measured at timepoint T2, 6 months post randomisation.
    E.5.2Secondary end point(s)
    SECONDARY
    1. Change in ASIA motor and sensory scales (0-100) at 3, 6, and 12 months
    2. Change in Kurtzke expanded disability status scale (EDSS) at 3, 6, and 12 months
    3. Individuals >7 years: EQ-5D-Y for patients age 7-12 and EQ-5D > 12; short standardised instrument for measurement of health outcomes to be used in health economics assessment at 3, 6, and 12 months
    4. Individuals ≥ 12 years: International SCI Quality of Life Basic Data Set at 6 and 12 months

    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points 1, 2 and 3 are evaluated at timepoints T1 (3 months post randomisation)6 , T2 (6 months post randomisation) and T3 (12 months post randomisation).

    Secondary end point 4 is evaluated at timepoints T2 ad T3.

    Tertiary end points are measured ate timepoints T2 and T3.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard therapy with intravenous methylprednisalone only
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned23
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 170
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 170
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 170
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 170
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 170
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-10-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state170
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients are returned to normal clinical care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-11
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