JPRN-jRCTs031180370已完成2 期
Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis - Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis
Yoshizaki Ayumi0 个研究点目标入组 5 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
This study suggested that tocilizumab may improve skin sclerosis in systemic sclerosis safely.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old(—)
- 性别
- All
入选标准
- •1)Patients with systemic sclerosis with sever skin sclerosis
- •2)Over 6 modified Rodnan total skin score with skin sclerosis on fingers, dorsal hands, forearms, and upper arms; change of total skin score is within 20% during the screening period (two months)
- •3)no malignancy
- •4)from 20 years old to 80 years old
- •5)Agreement to contraception during the study period
- •6)Patients who are able to give consent in writing after reading the explanatory text
排除标准
- •1)during treatment with equal drug
- •2)previous history of anaphylactic reactions to this drug
- •3)significant infection
- •4)significant liver damage
- •5)significant renal damage
- •6)pregnancy
- •7)breast-feeding
- •8)participating in other clinical trial within three months before the beginning of this trial
- •9)judged inappropriate for this study by the physicians
研究者
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