STRIVE
What it found
The trial ended early for another reason (see below).
Reason given: Continued effort did not successfully increase recruitment into the study.
What was tested
Treatment tested
- Methylprednisolone
Glucocorticoid receptor agonist
- Intravenous Immunoglobulin
- Intratect
What it measured
Main measures
2 points or greater improvement on the American Spinal Injury Association (ASIA) Impairment scale (classified A-E)
6 months
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
Improvement of 2 points or greater on the ASIA Impairment scale (classfiied A-E); Timepoint(s): 6 months
Other measures (8)
Change in ASIA motor scale (0-100) and ASIA sensory scale (0-112)
6 months
Change in Kurtzke's expanded disability status scale (EDSS) measured with Neurostatus scoring
6 months
Disability progressionEQ-5D-Y (for patients aged 8-12 years at presentation)
6 months
Quality of life (reported by participants)EQ-5D-5L (for patients aged 13 years or over at presentation)
6 months
Quality of life (reported by participants)International Spinal Cord Injury (SCI) Quality of Life Basic Data Set (for patients aged 13 years or over at presentation)
6 months
Quality of life (reported by participants)Client Service Receipt Inventory (CSRI)
6 months
SECONDARY
1. Change in ASIA motor scale (0-100) and ASIA sensory scale (0-112) at 3, 6, and 12 months post randomisation 2. Change in Kurtzke expanded disability status scale (EDSS) measured by Neurostatus scoring at 3, 6, and 12 months 3. EQ-5D-Y for patients aged 8-12 years (at presentation) at 3,6 and 12 months post randomisation 4. EQ-5D-5L for patients aged ≥ 13 years (at presentation) at 3, 6 and 12
Disability progressionQuality of life (reported by participants)
Who could take part
NMOSD · 1 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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
Results
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
Loading reviews and guidelines…
Related trials
- ELITE
Phase 3 · Recruiting
Still running
- EASE-NMO
Phase 2 · Running, not recruiting
Still running
- EASE-NMO
Phase 2 · Withdrawn
Stopped early
- PANDA
Not a drug-phase study · Recruiting
Still running
- FACT
Phase 2 · Status unknown
No result found
- Efgartigimod in Acute Neuromyelitis Optica Spectrum Disor…
Status unknown
No result found
History
Started
Mar 2015
Main results due
Mar 2016
Finished
Mar 2016
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error