ISRCTN12127581已完成未知
A multicentre randomiSed controlled TRial of Intravenous immunoglobulin (IVIg) versus standard therapy for the treatment of transverse myelitis in adults and children
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 170
研究概览
简要总结
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26009577 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28639937
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients will be eligible for inclusion on the trial if on presentation they:
- •1. Are aged 1 year or over
- •2. Have been diagnosed with:
- •2.1. 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:
- •2.1.1. Sensory, motor, or autonomic dysfunction attributable to the spinal cord
- •2.1.2. Bilateral signs and/or symptoms (not necessarily symmetric)
- •2.1.3. Sensory level (except in young children <5 years where this is difficult to evaluate)
- •2.1.4. Lack of MRI brain criteria consistent with MS (McDonald 2010 space criteria)
- •2.1.5. Progression to nadir between 4 h and 21 days)
- •2.2. 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:
- •2.2.1. Optic neuritis
- •2.2.2. Acute myelitis
- •2.3. Plus two out of three supportive criteria:
- •2.3.1. Brain MRI not meeting criteria for MS at disease onset
- •2.3.2. Spinal cord MRI with contiguous T2weighted signal abnormality extending over three or more vertebral segments, indicating a relatively large lesion in the spinal cord
- •2.3.3. AQP 4 seropositive status)
- •3. Have an ASIA Impairment score of A, B or C
- •4. Have commenced steroid treatment but will be randomised no later than day 5 of steroids, and if definitely known, randomisation will not exceed 21 days from the onset of symptoms
- •5. Give assent (8-16 years)/consent to participate in the trial
排除标准
- •Patients would be excluded if they show evidence of:
- •1. Contraindication to IVIg as stated in the product SmPC, or receiving IVIG for other reasons
- •2. Previously known systemic autoimmune disease (eg systemic lupus erythematosus) or any evidence of systemic inflammation during current presentation.
- •3. Direct infectious aetiology (eg varicella zoster)
- •4. Previous episode of CNS inflammatory demyelination
- •5. Acute disseminated encephalomyelitis (ADEM)
- •6. Other causes of myelopathy not thought to be due to myelitis (eg nutritional, ischaemic, tumour etc.)
- •7. Other disease which would interfere with assessment of outcome measures
- •8. Pregnancy
- •9. Circumstances which would prevent follow-up for 12 months
研究者
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