JPRN-jRCTs031230077招募中2 期
Single-arm phaseII trial to Efficacy and Safety of Delgocitinib Ointment for Skin Symptoms of Dermatomyositis
Watanabe Tomoya0 个研究点目标入组 21 人开始时间: 2023年5月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Men and women 18 years of age or older at the time of enrollment
- •(2) Patients diagnosed with dermatomyositis
- •(3) Patients with stable interstitial pneumonia or myositis after systemic therapy with oral steroids or immunosuppressive drugs
- •(4) Patients with residual skin rash after systemic therapy with oral steroids or immunosuppressive agents, patients with flare-ups of skin rash after tapering off of oral steroids or immunosuppressive agents, or patients with skin rash alone without myositis or interstitial pneumonia and not eligible for systemic therapy
- •(5) Patients in (4) who have a skin rash refractory to treatment despite standard therapy*.
- •(6) Patients who are able to walk independently and answer questionnaires
- •(7) Patients who give written consent to participate in this study.
排除标准
- •(1) Patients with a history of hypersensitivity to delgocitinib
- •(2) Women who are pregnant, lactating, may be pregnant, or wish to become pregnant during the treatment period
- •(3) Patients with severe skin infections
- •(4) Patients with dermatomyositis who have anti-ARS antibody
- •(5) Patients who are judged by doctor to be inappropriate as subjects
研究者
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