ISRCTN73774524已完成不适用

A Pilot Randomised controlled trial of Methotrexate for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

King's College London and Guy's and St Thomas' NHS Foundation Trust (Co-Sponsors) (UK)0 个研究点目标入组 62 人开始时间: 2005年9月1日最近更新: 2015年1月13日

试验速览

暂无简介。

•1. Diagnosis of CIDP by a consultant neurologist with a special interest in peripheral neuropathy
•2. Chronically progressive, stepwise, or recurrent symmetric proximal and distal weakness with or without sensory dysfunction of all extremities, developing over at least 2 months
•3. Absent or reduced tendon reflexes in all extremities
•4. Ongoing treatment with at least one of IVIg (equivalent to at least 0.4 g/kg every 4 weeks) or corticosteroid (equivalent to at least prednisolone 5 mg daily). The dose must have been stable (within 25%) for at least 12 weeks.
•5. Duration not less than 6 months
•6. At least moderate disability and weakness in arms or legs according to defined criteria at baseline OR following reduction of steroid or IVIg dose at some time during the past year
•7. Fulfillment of one of two sets of defined neurophysiological criteria at baseline or within the past 3 years

•1. Age <18 years
•2. Breast-feeding, pregnancy, planned pregnancy or unwillingness to practice contraception
•3. Severe concurrent medical conditions which would prevent treatment or assessment, including significant haematological, renal, liver function or chest radiograph abnormalities
•4. Alternative cause of peripheral neuropathy, such as drug or toxin, hereditary neuropathy or concomitant diseases such as human immunodeficiency virus (HIV) infection, Lyme disease, chronic active hepatitis, systemic lupus erythematosus, IgM paraprotein with anti-MAG antibodies, vasculitis, hematological and non-hematological malignancies. Diabetes mellitus will not be an exclusion criterion.
•5. Presence of sphincter disturbance
•6. Multifocal motor neuropathy (fulfilling defined criteria)
•7. Atypical CIDP with pure sensory, persistent unifocal impairment or significant central nervous system (CNS) involvement
•8. Immunomodulatory treatment other than IVIg or corticosteroids during the previous 12 weeks

发起方

King's College London and Guy's and St Thomas' NHS Foundation Trust (Co-Sponsors) (UK)