EUCTR2005-003382-16-GB进行中（未招募）1 期
Pilot randomised controlled trial of methotrexate for chronic inflammatory demyelinating polyradiculoneuropathy (RMC trial). - RMC Trial
Guy's & St Thomas's NHS Foundation Trust0 个研究点目标入组 62 人开始时间: 2005年8月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men or women aged >18 years
- •2. Diagnosis of CIDP by a consultant neurologist with a special interest in peripheral neuropathy
- •3. Chronically progressive, stepwise, or recurrent weakness, with or without sensory dysfunction, of all extremities, developing over at least 2 months
- •4. Absent or reduced tendon reflexes
- •5. 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 15 mg daily). The dose must have been stable (within 25%) for at least 12 weeks and not changed for the past 4 weeks. Patients who are going to withdraw from IVIg in the trial must be receiving it at least every 8 weeks.
- •6. Duration not less than 6 months
- •7. At least moderate disability in arms or legs (overall neuropathy disability scale (ONLS) which has been very slightly modified from the INCAT overall disability status scale grade 2) and MRC grade 4 or less weakness in at least one muscle at baseline OR following reduction of steroid or IVIg dose at some time during the past 12 months.
- •8. Fulfillment of definite or neurophysiological criteria10 proposed by INCAT or EFNS/PNS (Appendix 1) within the past 3 years. In some centres, nerve conduction data as specified in the EFNS/PNS criteria will be collected at the screening or baseline visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnancy, planned pregnancy, breast feeding or unwillingness to practice contraception.
- •2. Severe concurrent medical conditions which would prevent treatment or assessment, including significant haematological, renal, liver function (including liver enzymes >twice the upper limit of normal) or chest radiograph abnormalities.
- •3. Alternative cause of peripheral neuropathy such as drug or toxin, hereditary neuropathy or concomitant diseases such as 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. IgG, IgA and IgM paraproteins without anti-MAG antibodies will not be exclusion criteria.
- •4. Presence of neurogenic sphincter disturbance.
- •5. Multifocal motor neuropathy (fulfilling proposed EFNS/PNS criteria Appendix 2).
- •6. Atypical CIDP with pure sensory or persistent unifocal impairment or significant CNS involvement.
- •7. Immunomodulatory treatment other than IVIg or corticosteroids during the previous 12 weeks. Treatment with methotrexate at any time.
- •8. Participation in a controlled trial of an investigational medicinal product within the past 12 weeks.
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