A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis
NCT ID: NCT02398994
Last Updated: 2016-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
2 participants
INTERVENTIONAL
2015-03-31
2016-03-31
Brief Summary
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Detailed Description
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Intravenous immunoglobulin (IVIG) is often used as second-line treatment in steroid-unresponsive central nervous system demyelination, although evidence for its efficacy is limited to small case series and case reports. Randomized controlled trials have demonstrated that IVIG reduces inflammation and enhances remyelination in a number of neurological conditions, although there have been no randomized controlled trials testing its use in adults and children with TM.
This study will evaluate if additional and early treatment with IVIG is of extra benefit in TM when compared to the current standard therapy of intravenous steroids alone.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intravenous Methylprednisolone
Paediatric patients - 30mg/kg or 500mg/m2 up to a maximum daily dose of 1g/day for 5 days.
Adult patients - 1g/day for 5 days.
Intravenous Methylprednisolone
Intravenous Immunoglobulin
Paediatric patients \<41.2kg - total dose of 2g/kg in divided doses over 2 days.
All other patients - total dose of 2g/kg in divided doses over 5 days.
PLUS Intravenous Methylprednisolone
Pediatric patients - 30mg/kg or 500mg/m2 up to a maximum daily dose of 1g/day for 5 days.
Adult patients - 1g/day for 5 days.
Intravenous Methylprednisolone
Intravenous Immunoglobulin
Interventions
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Intravenous Methylprednisolone
Intravenous Immunoglobulin
Eligibility Criteria
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Inclusion Criteria
EITHER acute first onset transverse myelitis (using the TM Consortium Working Group 2002 criteria) - patients must fulfill all of the following criteria:
* Sensory, motor, or autonomic dysfunction attributable to spinal cord disease
* 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 multiple sclerosis
* Progression to nadir between 4 h and 21 days
OR first presentation of neuromyelitis optica (using standardised criteria) - patients must fulfil both absolute criteria:
* Optic neuritis
* Acute myelitis, plus two out of three supportive criteria (as Aquaporin 4 antibody (AQP4) is often not available acutely, only the first two supportive criteria would be applied),
* Brain MRI not meeting criteria for Multiple Sclerosis (MS) at disease onset
* 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
* AQP4 seropositive status
* ASIA Impairment Score of A-C
* Randomisation to occur no later than day 5 of steroids, and, if definitely known, within 21 days from symptom onset.
* Give assent (8-16 years)/consent to participate in the trial
Exclusion Criteria
* Previously known systemic autoimmune disease (e.g. systemic lupus erythematosus) or any evidence of systemic inflammation during current presentation.
* Direct infectious aetiology (e.g. varicella zoster)
* Previous episode of central nervous system (CNS) inflammatory demyelination
* Acute disseminated encephalomyelitis (ADEM)
* Other causes of myelopathy not thought to be due to myelitis (e.g. nutritional, ischaemic, tumour etc.)
* Other disease which would interfere with assessment of outcome measures
* Known pregnancy
* Circumstances which would prevent follow-up for 12 month
1 Year
ALL
No
Sponsors
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King's College London
OTHER
Barts and the London School of Medicine and Dentistry
OTHER
Cardiff University
OTHER
University College, London
OTHER
King's College Hospital NHS Trust
OTHER
Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
Barts & The London NHS Trust
OTHER
Alder Hey Children's NHS Foundation Trust
OTHER
Walton Centre NHS Foundation Trust
OTHER
Oxford University Hospitals NHS Trust
OTHER
Birmingham Women's and Children's NHS Foundation Trust
OTHER
University Hospital Birmingham NHS Foundation Trust
OTHER
Cardiff and Vale University Health Board
OTHER_GOV
North Bristol NHS Trust
OTHER
University Hospitals Bristol and Weston NHS Foundation Trust
OTHER
Manchester University NHS Foundation Trust
OTHER_GOV
Northern Care Alliance NHS Foundation Trust
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Nottingham University Hospitals NHS Trust
OTHER
NHS Lothian
OTHER_GOV
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Ming Lim, MB, PhD
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust
Locations
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Birmingham Children's Hospital NHS Foundation Trust
Birmingham, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
North Bristol NHS Trust
Bristol, , United Kingdom
University Hospital Bristol NHS Foundation Trust
Bristol, , United Kingdom
Cardiff and Vale University Health Board
Cardiff, , United Kingdom
NHS Lothian
Edinburgh, , United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, , United Kingdom
Walton Centre NHS Foundation Trust
Liverpool, , United Kingdom
Great Ormond Street Children's Hospital
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
University of London and Bart's Health NHS Trust
London, , United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, , United Kingdom
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Oxford University Hospitals NHS Trust
Oxford, , United Kingdom
Salford Royal NHS Foundation Trust
Salford, , United Kingdom
University Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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References
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Absoud M, Brex P, Ciccarelli O, Diribe O, Giovannoni G, Hellier J, Howe R, Holland R, Kelly J, McCrone P, Murphy C, Palace J, Pickles A, Pike M, Robertson N, Jacob A, Lim M. A multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin compared with standard therapy for the treatment of transverse myelitis in adults and children (STRIVE). Health Technol Assess. 2017 May;21(31):1-50. doi: 10.3310/hta21310.
Absoud M, Gadian J, Hellier J, Brex PA, Ciccarelli O, Giovannoni G, Kelly J, McCrone P, Murphy C, Palace J, Pickles A, Pike M, Robertson N, Jacob A, Lim M. Protocol for a multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin versus standard therapy for the treatment of transverse myelitis in adults and children (STRIVE). BMJ Open. 2015 May 25;5(5):e008312. doi: 10.1136/bmjopen-2015-008312.
Other Identifiers
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2014-002335-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11/129/148
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
12127581
Identifier Type: OTHER
Identifier Source: secondary_id
RJ115/N065
Identifier Type: -
Identifier Source: org_study_id
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