JPRN-jRCTs031190015已完成未知
Prospective multi-center study on pathophysiological features of generalized myasthenia gravis(MG)patients treated with eculizumab: Chronological changes of blood complement proteins and MG-related antibody titers in Japanese patients - PREDICT-MG
Murai Hiroyuki0 个研究点目标入组 41 人开始时间: 2019年4月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 41
研究概览
简要总结
The results of a study of the relationship between the efficacy of anti-AChR antibody-positive gMG patients with various complement proteins, MG-related antibody titers, and inflammatory markers before and after treatment with eculizumab suggested that anti-Kv1.4 antibody and severity of disease (MGFA classification) may be candidate predictors of response, but further research is needed to accumulate the results. However, we believe that further accumulation of research is needed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Not administration history of Eculizumab
- •2.Anti acetylcholie receptor antibody positive (the technique does not matter)
- •3.Age at registration 18 years old or older in both Sexes
- •4.Patients with systemic myasthenia gravis ( MGFA Clinical Classification Class II-V)
- •5.Symptom management by IVIg or the PP is insufficient ( QMG score of 12 points or more as the standard )
- •6.Start Eculizumab treatment
- •7.Received meningococcal vaccines
- •8.Written informed consent
排除标准
- •1.Meningococcal infectious disease
- •2.Hypersensitivity for an ingredient of Eculizumab
- •3.Ocular myasthenia gravis ( MGFA Clinical Classification Class I)
- •4.Participate in the trial using a unapproved drug, medical equipment or the therapy
- •5.Judged not eligible in participate
研究者
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