A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 580
- 试验地点
- 194
- 主要终点
- Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
研究概览
简要总结
Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nintedanib
patient receives capsules containing nintedanib twice a day
干预措施: Nintedanib (Drug)
Placebo
patient receives capsules identical to those containing active drug
干预措施: Placebo (Drug)
结局指标
主要结局
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
时间窗: up to week (wk) 52 after the start of administration
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.
次要结局
- Absolute Change From Baseline in the Modified Rodnan Skin Score (mRSS) at Week 52(Baseline and up to 52 weeks after the start of administration)
- Absolute Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 52.(Baseline and up to 52 weeks after the start of administration)
- Absolute Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Dyspnoea Score at Week 52(Baseline and up to 52 weeks after the start of administration)
- Annual Rate of Decline in FVC in Percentage (%) Predicted Over 52 Weeks(up to 52 weeks after the start of administration)
- Absolute Change From Baseline in FVC in mL at Week 52(Baseline and up to 52 weeks after the start of administration)
- Relative Change From Baseline [%] of mRSS at Week 52(Baseline and up to 52 weeks after the start of administration)
- Time to Death(From date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks))
- The Percentage (%) of Responder Based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52(Week 52)
- Absolute Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) in % Predicted at Week 52(Baseline and up to 52 weeks after the start of administration)
- Absolute Change From Baseline in Digital Ulcer Net Burden at Week 52(Baseline and up to 52 weeks after the start of administration)
- Absolute Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52(Baseline and up to 52 weeks after the start of administration)