Intravenous immunoglobulin vs standard therapy for treatment of transverse myelitis

• Register: EUCTR
• Last refreshed on: 22 May 2017
• Main ID: EUCTR2014-002335-34-GB
• Date of registration: 23/10/2014
• Prospective Registration: Yes
• Primary sponsor: Guy's and St Thomas NHS Foundation Trust
• Public title: Intravenous immunoglobulin vs standard therapy for treatment of transverse myelitis
• Scientific title: A multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin (IVIg) versus standard therapy for the treatment of transverse myelitis in adults and children - STRiVE
• Date of first enrolment: 30/10/2014
• Target sample size: 0
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002335-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Standard therapy with intravenous methylprednisalone only Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Contacts

• Name: Dr Ming Lim
• Affiliation: Guy's and St Thomas NHS Foundation Trust

• Name: Dr Ming Lim
• Affiliation: Guy's and St Thomas NHS Foundation Trust

Key inclusion & exclusion 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 <5 years where this is difficult to
evaluate)
? Lack of MRI brain criteria consistent with MS (McDonald 2010 space criteria)
? Progression to nadir between 4 h and 21 days)
OR Have been diagnosed with first presentation of neuromyelitis optica.
(Patients with definite modified NMO will meet the following criteria (Wingerchuck et al, 2006).
Absolute criteria, both:
1. Optic neuritis
2. Acute myelitis
Plus two out of three supportive criteria:
i. Brain MRI not meeting criteria for MS at disease onset
ii. 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
iii. NMO-IgG seropositive status)
• Have an ASIA Impairment score of A, B or C
• Give assent/consent to participate in the trial

Are the trial subjects under 18? yes
Number of subjects for this age range: 170
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Immune system processes [G12]

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

Intervention(s)

Trade Name: Intratect
Product Name: Intratect
Pharmaceutical Form: Solution for infusion

Primary Outcome(s)

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

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.

Timepoint(s) of evaluation of this end point: The primary outcome is measured at timepoint T2, 6 months post randomisation.

Secondary Outcome(s)

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.

Secondary ID(s)

STRiVE

Source(s) of Monetary Support

National Institute for Health Research Health Technology Assessment Programme