Myelitis, TransversePhase 3STRIVENCT02398994
A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis
A Phase 3 study testing Intravenous Methylprednisolone and Intravenous Immunoglobulin in people with Myelitis, Transverse and Neuromyelitis Optica, run by Guy's and St Thomas' NHS Foundation Trust at 18 sites in United Kingdom.
Trial summary
This multi-center randomized controlled trial evaluates if the addition of intravenous immunoglobulin to standard treatment of corticosteroids improves outcome in children and adults with first episode of Transverse Myelitis of Neuro-myelitis optica. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Myelitis, Transverse, Neuromyelitis Optica
- What is being tested?
- Intravenous Methylprednisolone and Intravenous Immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 18 sitesUnited Kingdom
- Study dates
- Mar 2015to Mar 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of
- 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
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- 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
Who cannot join
- Contraindication to IVIG as stated in the summary of product characteristics (SmPC), or receiving IVIG for other reasons
- 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.)
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- Other disease which would interfere with assessment of outcome measures
- Known pregnancy
- Circumstances which would prevent follow-up for 12 month
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United Kingdom18 sites
Birmingham Children's Hospital NHS Foundation Trust
Birmingham
University Hospitals Birmingham NHS Foundation Trust
Birmingham
North Bristol NHS Trust
Bristol
University Hospital Bristol NHS Foundation Trust
Bristol
Cardiff and Vale University Health Board
Cardiff
NHS Lothian
Edinburgh
Alder Hey Children's NHS Foundation Trust
Liverpool
Walton Centre NHS Foundation Trust
Liverpool
Great Ormond Street Children's Hospital
London
Guy's and St Thomas' NHS Foundation Trust
London
King's College Hospital NHS Foundation Trust
London
University of London and Bart's Health NHS Trust
London
Central Manchester University Hospitals NHS Foundation Trust
Manchester
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle
Nottingham University Hospitals NHS Trust
Nottingham
Oxford University Hospitals NHS Trust
Oxford
Salford Royal NHS Foundation Trust
Salford
University Southampton NHS Foundation Trust
Southampton
About this study
Official title: A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin (IVIg) Versus Standard Therapy for the Treatment of Transverse Myelitis in Adults and Children
This multi-center randomized controlled trial evaluates if the addition of intravenous immunoglobulin to standard treatment of corticosteroids improves outcome in children and adults with first episode of Transverse Myelitis of Neuro-myelitis optica. Half of participants will receive corticosteroids alone, whilst the other half will receive corticosteroids plus intravenous immunoglobulin.
Read the detailed description
Transverse myelitis (TM) is a severe demyelinating condition predominantly affecting young people, which causes significant long-term disability in approximately one third. Current initial treatment is with corticosteroids, although evidence for their use is based on extrapolation from trials in adult multiple sclerosis relapses. In view of the severity of the condition, additional treatments have been trialed.
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
- Myelitis, Transverse, Neuromyelitis Optica
- Being tested
- Intravenous Methylprednisolone, Intravenous Immunoglobulin
- Keywords
- Clinical Trials Unit, Pediatric
- Medical subject headings
- Myelitis, Transverse, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous MethylprednisoloneDrug
Intravenous ImmunoglobulinDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Methylprednisolone | Active comparator | 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. Receives: Drug: Intravenous Methylprednisolone |
| Intravenous Immunoglobulin | Experimental | 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. Receives: Drug: Intravenous Methylprednisolone; Drug: Intravenous Immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 points or greater improvement on the American Spinal Injury Association (ASIA) Impairment scale (classified A-E)
Measured: 6 months
Secondary outcomes (6)
Change in ASIA motor scale (0-100) and ASIA sensory scale (0-112)
Measured: 6 months
Change in Kurtzke's expanded disability status scale (EDSS) measured with Neurostatus scoring
Measured: 6 months
EQ-5D-Y (for patients aged 8-12 years at presentation)
Measured: 6 months
EQ-5D-5L (for patients aged 13 years or over at presentation)
Measured: 6 months
International Spinal Cord Injury (SCI) Quality of Life Basic Data Set (for patients aged 13 years or over at presentation)
Measured: 6 months
Client Service Receipt Inventory (CSRI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Continued effort did not successfully increase recruitment into the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myelitis, TransverseStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Barts and the London School of Medicine and Dentistry, Cardiff University, University College, London, King's College Hospital NHS Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, Barts & The London NHS Trust, Alder Hey Children's NHS Foundation Trust, Walton Centre NHS Foundation Trust, Oxford University Hospitals NHS Trust, Birmingham Women's and Children's NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, Cardiff and Vale University Health Board, North Bristol NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Manchester University NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Nottingham University Hospitals NHS Trust, NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Ming Lim, MB, PhD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398994
- Sponsor's protocol ID
- RJ115/N065
- Other IDs
- 2014-002335-34, 11/129/148, 12127581, 2014
- Acronym
- STRIVE
- Status last verified
- Jul 2016
- First submitted
- 23 Mar 2015
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28639937Absoud 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.
PubMed 26009577
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin (IVIg) Versus Standard Therapy for the Treatment of Transverse Myelitis in Adults and Children
- ClinicalTrials.gov ID
- NCT02398994
- Acronym / sponsor ID
- STRIVE / RJ115/N065
- Conditions
- Myelitis, Transverse, Neuromyelitis Optica
- Keywords
- Clinical Trials Unit, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Continued effort did not successfully increase recruitment into the study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London, Barts and the London School of Medicine and Dentistry, Cardiff University, University College, London, King's College Hospital NHS Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, Barts & The London NHS Trust, Alder Hey Children's NHS Foundation Trust, Walton Centre NHS Foundation Trust, Oxford University Hospitals NHS Trust, Birmingham Women's and Children's NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, Cardiff and Vale University Health Board, North Bristol NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Manchester University NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Nottingham University Hospitals NHS Trust, NHS Lothian
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center randomized controlled trial evaluates if the addition of intravenous immunoglobulin to standard treatment of corticosteroids improves outcome in children and adults with first episode of Transverse Myelitis of Neuro-myelitis optica. Half of participants will receive corticosteroids alone, whilst the other half will receive corticosteroids plus intravenous immunoglobulin.
Detailed description
Transverse myelitis (TM) is a severe demyelinating condition predominantly affecting young people, which causes significant long-term disability in approximately one third. Current initial treatment is with corticosteroids, although evidence for their use is based on extrapolation from trials in adult multiple sclerosis relapses. In view of the severity of the condition, additional treatments have been trialed.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Methylprednisolone | Active comparator | Drug: Intravenous MethylprednisolonePaediatric 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 Immunoglobulin | Experimental | Drug: Intravenous Methylprednisolone, Drug: Intravenous ImmunoglobulinPaediatric 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of
- 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)
Key exclusion criteria (9 listed)
- Contraindication to IVIG as stated in the summary of product characteristics (SmPC), or receiving IVIG for other reasons
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Methylprednisolone | Drug | Intravenous Immunoglobulin, Intravenous Methylprednisolone |
| Intravenous Immunoglobulin | Drug | Intravenous Immunoglobulin |
Primary outcome
2 points or greater improvement on the American Spinal Injury Association (ASIA) Impairment scale (classified A-E)
Time frame: 6 months
6 secondary outcomes
Change in ASIA motor scale (0-100) and ASIA sensory scale (0-112)
Time frame: 6 months
Change in Kurtzke's expanded disability status scale (EDSS) measured with Neurostatus scoring
Time frame: 6 months
EQ-5D-Y (for patients aged 8-12 years at presentation)
Time frame: 6 months
EQ-5D-5L (for patients aged 13 years or over at presentation)
Time frame: 6 months
International Spinal Cord Injury (SCI) Quality of Life Basic Data Set (for patients aged 13 years or over at presentation)
Time frame: 6 months
Client Service Receipt Inventory (CSRI)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Continued effort did not successfully increase recruitment into the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Derived from this study: PubMed 28639937Absoud 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.
- Derived from this study: PubMed 26009577Absoud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Lim, MB, PhD principal investigator
Guy's and St Thomas' NHS Foundation Trust
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous Methylprednisolone and Intravenous Immunoglobulin in people with Myelitis, Transverse and Neuromyelitis Optica, run by Guy's and St Thomas' NHS Foundation Trust at 18 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Continued effort did not successfully increase recruitment into the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 points or greater improvement on the American Spinal Injury Association (ASIA) Impairment scale (classified A-E) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02398994, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.