Clinical trial · Interventional
A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis
A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin (IVIg) Versus Standard Therapy for the Treatment of Transverse Myelitis in Adults and Children
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Continued effort did not successfully increase recruitment into the study.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelitis, Transverse | — | UNRESOLVED | — |
| Neuromyelitis Optica | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous Immunoglobulin | Drug | — | UNRESOLVED |
| Intravenous Methylprednisolone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intravenous Methylprednisolone
- description
- 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.
- interventionNames
- Drug: Intravenous Methylprednisolone
- type
- EXPERIMENTAL
- label
- Intravenous Immunoglobulin
- description
- 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.
- interventionNames
- Drug: Intravenous Methylprednisolone
- Drug: Intravenous Immunoglobulin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
Inclusion Criteria: * 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 * 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: * 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.) * Other disease which would interfere with assessment of outcome measures * Known pregnancy * Circumstances which would prevent follow-up for 12 month
References
Publications (2)
- DERIVEDAbsoud 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. PMID 28639937
- DERIVEDAbsoud 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. PMID 26009577