JPRN-jRCTs031180346已完成未知
The efficacy and safety of an anti-interluekin-6 receptor antibody in multiple sclerosis
Yamamura Takashi0 个研究点目标入组 6 人开始时间: 2019年3月18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
- 6
研究概览
简要总结
This is an exploratory clinical study investigating the safety profiles and efficacy of tocilizumab for plasmablast-high reflactory multiple sclerosis patients. Among six patients enrolled, 3 patients showed clinical benefit by the treatment. The safety profiles revealed there were no severe or unexpected adverse events.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •A)Diagnosis as relapsing-remitting multiple sclerosis (RRMS) according to 2010 revised McDonald criteria (Ann Neurol 2011; 69: 292-302).
- •B)Intractable patients with RRMS resistant to standard therapies other than tocilizumab with more than two relapses or disability progression during the 1 year prior to initiation to this study.
- •C)With a higher plasmablast frequency in peripheral blood than the mean frequency + 2SD in healthy donors by flow cytometry.
- •Since a relapsing-remitting phase could turn out to be a secondary-progressive phase after the entry, the patients with secondary-progressive MS (SPMS) could be included in this study.
排除标准
- •1) Patients with severe infection such as tuberculosis, pneumocystis carinii pneumonia, nontuberculous mycobacterial infection, hepatitis B, hepatitis C, or chronic active EB virus infection.
- •2) Patients with a history of tuberculosis infection or patients with pleural thickness or old tuberculin in chest X-ray.
- •3) Patients with a history of hypersensitivity to this drug.
- •4) Patients with a history of intestinal diverticulum.
- •5) Patients with interstitial pneumonitis.
- •6) Patients with leukopenia (white blood cell number < 3500/mm3), lymphopenia (lymphocyte number < 500/mm3) or seropositivity for beta-D-glucan in peripheral blood.
- •7) Patients with positivity for anti- aquaporin 4 antibody.
- •8) Pregnant women or patients with possible pregnancy.
- •9) Patients with a history of allergy to this drug
- •10) Patients who can not provide consent to participate in this study by themselves.
研究者
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