A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: Alder Hey Children's NHS Foundation Trust; Barts & The London NHS Trust; Barts and the London School of Medicine and Dentistry; Birmingham Children's Hospital NHS Foundation Trust; Birmingham Women's and Children's NHS Foundation Trust; Cardiff and Vale University Health Board; Cardiff University; Central Manchester University Hospitals NHS Foundation Trust; Great Ormond Street Hospital for Children NHS Foundation Trust; King's College Hospital NHS Trust; King's College London; Manchester University NHS Foundation Trust; Newcastle-upon-Tyne Hospitals NHS Trust; NHS Lothian; North Bristol NHS Trust; Nottingham University Hospitals NHS Trust; Oxford University Hospitals NHS Trust; Salford Royal NHS Foundation Trust; University College, London; University Hospital Birmingham NHS Foundation Trust; University Hospital Southampton NHS Foundation Trust; University Hospitals Bristol and Weston NHS Foundation Trust; University Hospitals Bristol NHS Foundation Trust; Walton Centre NHS Foundation Trust
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rho(D) Immune Globulin

Criteria

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