EUCTR2019-004718-32-NL进行中（未招募）1 期
pfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized controlled trial
MC Utrecht0 个研究点目标入组 120 人开始时间: 2020年10月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age between 18 and 65 years.
- •2. Fulfilling the 2013 ACR-EULAR classification criteria
- •3. Disease duration = 2 years (from onset of first non-Raynaud’s symptoms) and
- •- progressive skin involvement with a mRSS = 15 (diffuse skin pattern) and/or
- •- major organ involvement as defined by either:
- •a) clinically significant respiratory involvement
- •b) clinically significant renal involvement
- •c) clinically significant cardiac involvement
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •1. Pregnancy or unwillingness to use adequate contraception during study
- •2. Concomitant severe disease (respiratory,renal, cardiac, liver failure, psychiatric disorders including active drug or alcohol abuse,concurrent neoplasms or myelodysplasis, bone marrow insufficiency, uncontrolled hypertension, uncontrolled acute or chronic infection, including HIV, HTLV-1,2 positivity,ZUBROD-ECOG-WHO Performance Status Scale > 2, known hypersensitivity to any of the study drug constituents)
- •3. Previous treatments with immunosuppressants > 6 months including mycophenolate mofetil, methotrexate, azathioprine, rituximab, tocilizumab, glucocorticosteroids.
- •4. Previous treatments with TLI, TBI or alkylating agents including cyclophosphamide.
- •5. Significant exposure to bleomycin, tainted rapeseed oil, vinyl chloride, trichlorethylene or silica;
- •6. eosinophilic myalgia syndrome; eosinophilic fasciitis.
- •7. Poor compliance of the patient as assessed by the referring physicians.
研究者
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