A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 主要终点
- Total number of new digital ulcers per patient up to Week 24
研究概览
简要总结
In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Systemic Sclerosis (SSc), diffuse or limited.
- •SSc patients with at least one digital ulcer at baseline qualifying as a cardinal ulcer.
排除标准
- •Digital ulcers due to conditions other than SSc.
- •Severe pulmonary arterial hypertension (PAH) (Who class III and IV).
- •Malabsorption or any severe organ failure (e.g., lung, kidney, liver) or any life-threatening condition.
- •Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, or prostacyclin analogs) during the past 3 months prior to randomization.
- •Treatment with inhaled or oral prostanoids one month prior to randomization.
- •Previous treatment with bosentan.
研究组 & 干预措施
Bosentan
The patients received bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks and then 125 mg b.i.d. for 20 weeks
干预措施: Bosentan 62.5 mg (Drug)
Bosentan
The patients received bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks and then 125 mg b.i.d. for 20 weeks
干预措施: Bosentan 125 mg (Drug)
Placebo
The patients received the matching placebo for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Total number of new digital ulcers per patient up to Week 24
时间窗: 24 weeks
Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks
时间窗: 24 weeks
次要结局
- Change from baseline to Week 24 in hand disability(Baseline and Week 24)
- Proportion of subjects with liver function abnormalities(Every 4 weeks up to Week 24)
- Proportion of subjects with treatment-emergent adverse events(up to 32 weeks (8 week post-treatment follow-up))
- Change from baseline to Week 24 in hand pain(Baseline and Week 24)