NL-OMON30649已完成3 期
A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone - TxMG trial
ational Institute of Health0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Male and female MG patients aged 18 to 60 years inclusive (thymectomy is not regularly performed in non-thymomatous MG patients > 60 years of age).
- •Onset of generalized MG within the last 3 years.
- •Positive serum anti-acetylcholine receptor binding antibodies (AChR Ab <=/> 1.0 nmol/L).
- •MGFA class II-IV at entry, using the MG Foundation of America (MGFA) classification, while receiving optimal anti-cholinesterase treatment with or without oral prednisone.
排除标准
- •Ocular MG without generalized weakness (MGFA Class I) or minimal weakness that would not require the use of corticosteroids.
- •Myasthenic weakness requiring intubation (MGFA class V) in the prior month.
- •Immunosuppressive therapy other than corticosteroids in the preceding year.
- •Medically unfit for thymectomy.
- •Chest computertomogreaphy evidence for thymoma.
- •Pregnancy or lactation; contraindications to the use of corticosteroids; unwillingness to practice effective contraception.
- •A serious concurrent medical, neurological or psychiatric condition.
- •Current daily dose of prednisone of more than 50 mg.
- •Participation in another experimental clinical trial.
- •History of alcohol or drug abuse.
- •Unwillingness or inability to comply with the requirements of the protocol.
研究者
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