Transverse myelitis (TM) (acute, first onset cases), including first presentation of neuromyelitis optica (NMO) MedDRA version: 17.1 Level: PT Classification code 10028527 Term: Myelitis transverse System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1 Level: PT Classification code 10029322 Term: Neuromyelitis optica System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Intratect
Product Name: Intratect
Pharmaceutical Form: Solution for infusion
Sponsors
Guy's and St Thomas NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible for inclusion on the trial if on presentation they: • Are aged 1 year or over • Have been diagnosed with: EITHER acute first onset transverse myelitis (The TM CONSORTIUM WORKING GROUP 2002 criteria for probable TM will be used. Hence, following clinical and radiological exclusion of a compressive myelopathy, patient will be diagnosed to have TM if they meet all the following criteria: ? Sensory, motor, or autonomic dysfunction attributable to the spinal cord ? Bilateral signs and/or symptoms (not necessarily symmetric) ? Sensory level (except in young children =65 years) yes F.1.3.1 Number of subjects for this age range 170
Exclusion criteria
Exclusion criteria: Patients would be excluded if they show evidence of: • Contraindication to IVIg as stated in the product SmPC, or receiving IVIG for other reasons • Previously known systemic autoimmune disease (eg systemic lupus erythematosus) or any evidence of systemic inflammation during current presentation. • Direct infectious aetiology (eg varicella zoster) • Previous episode of CNS inflammatory demyelination • Acute disseminated encephalomyelitis (ADEM) • Other causes of myelopathy not thought to be due to myelitis (eg nutritional, ischaemic, tumour etc.) • Pregnancy •Circumstances which would prevent follow-up for 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this randomized controlled trial is to evaluate if additional, and early, treatment with IVIg is of extra benefit in TM when compared to the current standard therapy of intravenous steroids. ;Secondary Objective: Secondary objectives are to provide benefits whereby: 1. The clinical and para-clinical data collected from patients will provide a robust resource and platform for other clinical studies, including identification of early predictors of poor outcome. 2. Bio banked samples from patients recruited to the study will be collected and used for carefully designed biological studies by a consortium of established basic science researchers in the field. ;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: The primary outcome is measured at timepoint T2, 6 months post randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): SECONDARY 1. Change in ASIA motor and sensory scales (0-100) at 3, 6, and 12 months 2. Change in Kurtzke expanded disability status scale (EDSS) at 3, 6, and 12 months 3. Individuals >7 years: EQ-5D-Y for patients age 7-12 and EQ-5D > 12; short standardised instrument for measurement of health outcomes to be used in health economics assessment at 3, 6, and 12 months 4. Individuals = 12 years: International SCI Quality of Life Basic Data Set at 6 and 12 months ;Timepoint(s) of evaluation of this end point: Secondary end points 1, 2 and 3 are evaluated at timepoints T1 (3 months post randomisation)6 , T2 (6 months post randomisation) and T3 (12 months post randomisation). Secondary end point 4 is evaluated at timepoints T2 ad T3. Tertiary end points are measured ate timepoints T2 and T3. | — |
Countries
United Kingdom
Contacts
Public ContactDr Ming Lim
Guy's and St Thomas NHS Foundation Trust
Outcome results
None listed