STRIVE - Intravenous immunoglobulin vs standard therapy for TM
Research type
Research Study
Full title
A multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin (IVIg) versus standard therapy for the treatment of transverse myelitis in adults and children
IRAS ID
157664
Contact name
Ming Lim
Contact email
Eudract number
2014-002335-34
Clinicaltrials.gov Identifier
11/129/148, HTA Project
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Transverse myelitis (TM) is a rare immune-mediated disorder of the spinal cord affecting children and adults, characterised by a rapid onset of paraplegia or tetraplegia, loss of sensation and sphincter disturbance; in severe cases, it is potentially a devastating and sometimes life threatening condition. Patients can recover fully from TM but a large number are left with significant disability. Neuromyelitis-optica (NMO) is an uncommon relapsing condition where transverse myelitis can be the first presenting symptom, with damage also to the optic nerve; neurodisability accrues with progressive relapses.
There are various treatments for these conditions and evidence suggests that the sooner they are administered, the less damage that is done to the nerves and the better the long term prognosis. At present the standard therapy that is offered is intravenous steroids for 3-5 days, although treatment with intravenous immunoglobulins (IVIg) has also proven to be very successful, as has plasma exchange (PLEX), although the latter is very costly. Strategies to reduce disability in these patients are urgently required, yet there are no robust controlled trials to inform on optimal treatment.
This will be a multicentre, randomised controlled trial involving children and adults, to evaluate if the early addition of IVIg treatment to standard therapy with intravenous steroids is of extra benefit in TM, when compared to the current standard therapy alone.There will be two treatment arms:
A control arm which will receive an intravenous steroid, methylprednisolone (IV-MP) for up to 5 days
An intervention arm which will receive IV-MP plus IVIg for up to 5 days.The primary outcome will be an improvement of 2 points or greater on the ASIA Impairment scale, 6 months post randomisation. Further outcome measures will capture the extent and impact of resulting disability and the economic implications on the health service.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/1329
Date of REC Opinion
30 Oct 2014
REC opinion
Further Information Favourable Opinion