NCT01377090已完成不适用
A Multicenter, Prospective Cohort Study Using Nailfold VideoCAPillaroscopy(NVC) and Other Factors to Determine the Risk of Developing Digital Ulceration in Patients With Systemic Sclerosis (SSc)
Actelion50 个研究点 分布在 15 个国家目标入组 630 人开始时间: 2011年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 630
- 试验地点
- 50
- 主要终点
- Occurence of first new digital ulcer (DU)
研究概览
简要总结
The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.
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
- •For all patients:
- •Signed informed consent prior to enrollment
- •Male or female, ≥ 18 years of age
- •Diagnosis of systemic sclerosis (SSc) according to the American College of Rheumatology and/or limited cutaneous SSc or diffuse cutaneous SSc according to LeRoy criteria
- •For patients with no history of digital ulcers (DU) and no DU at enrollment only:
- •Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature
排除标准
- •SSc sine scleroderma (without any skin involvement)
- •Patients who underwent stem cell transplantation
- •Participation in interventional clinical trials within 3 months prior to enrollment and/or during the study
- •Inability to undergo Nailfold Videocapillaroscopy (NVC) assessment (e.g., inability to extend fingers sufficiently)
结局指标
主要结局
Occurence of first new digital ulcer (DU)
时间窗: 6 months
Occurrence of the first new digital ulcer (DU) within 6 months
次要结局
未报告次要终点
研究者
研究点 (50)
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