Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 主要终点
- Skin score as measured by modified rodnan skin score
研究概览
简要总结
The aim of the study is to compare the effectiveness of commonly used immunosuppressant treatments for early diffuse cutaneous systemic sclerosis (SSc).
详细描述
Diffuse cutaneous systemic sclerosis (SSc) is a rare autoimmune disease characterised by excessive connective tissue in the skin (causing skin thickening called 'scleroderma'), muscle, joints and internal organs. A number of different drugs with effects on the immune system (known as 'immunosuppressants') are currently being used by clinicians in the treatment of early diffuse cutaneous SSc, but all can have significant side effects. We want to know whether any one is definitely effective and, if so, which is the most effective.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 Skin thickening < 3 years Immunosuppressant use < 4 months Proximal skin involvement to face/neck, elbow or knee
排除标准
- •Previous use of more than 4 months of methotrexate, mycophenolate mofetil, cyclophosphamide or other immunosuppressive treatments
- •Previous use of immunosuppressant therapy other than methotrexate, mycophenolate mofetil or cyclophosphamide within previous months
- •Previous stem cell transplantation therapy
研究组 & 干预措施
Methotrexate
Patients treated with Methotrexate at the entry of the study.
干预措施: Methotrexate (Drug)
Mycophenolate Mofetil
Patients treated with Mycophenolate Mofetil at the entry of the study.
干预措施: Mycophenolate mofetil (Drug)
Cyclophosphamide
Patients treated with Cyclophosphamide at the entry of the study
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Skin score as measured by modified rodnan skin score
时间窗: 24 months
次要结局
- Haemoglobin(24 months)
- Estimated glomerular filtration rate (eGFR)(24 months)
- Pulmonary function as measured by right ventricular systolic pressure (RVSP) or pulmonary artery pressure (PAP)(24 months)
- Echocardiographic findings(24 months)
- Cochin hand function(24 months)
- Fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) scale(24 months)
- Short form 36 questionnaire (SF-36)(24 months)
- Scleroderma Health Assessment Questionnaire(24 months)
- Erythrocyte sedimentation rate(24 months)
研究者
Prof. Ariane herrick
Professor
University of Manchester