NCT07080125进行中（未招募）不适用
Non-interventional Post-authorization Effectiveness Study to Assess Long-term Outcomes of Nintedanib Treatment in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Time to absolute Forced Vital Capacity (FVC) decline (% predicted) ≥5%, lung transplantation (indicating end stage ILD), or death
研究概览
简要总结
This post-approval registry study is planned to generate data to address remaining questions on long-term effectiveness and to better characterize longer term beneficial effects of Nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) in terms of survival, quality of life, pattern of disease progression as well as effectiveness and safety in the subgroup of patients with pulmonary hypertension.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Enrolled in the EUSTAR registry
- •Provided consent at their site to have their data included in the EUSTAR registry for a broad range of research studies, and agree to visit the site every 12 months
- •Have a diagnosis of ILD defined by radiological findings on High Resolution Computed Tomography (HRCT) and/or X-ray that is documented in the electronic Case Report Form (eCRF) by the treating physician
排除标准
- •Women with Systemic Sclerosis Interstitial Lung Disease (SSc-ILD) who are pregnant, or breastfeeding will be excluded since Ofev® is contraindicated for women who are pregnant due to safety concerns
- •SSc-ILD patients aged <18 years: only adults will be included in the study since Ofev® is approved for treatment of SSc-ILD in adults
- •Patients with a previous Hematopoietic Stem Cell Transplantation (HSCT)
研究组 & 干预措施
Exposed group
Individuals that initiate Ofev® including either:
- with an ongoing or new immunosuppressive therapy (IST) regimen (i.e., Ofev® combination therapy) or
- after discontinuing an IST regimen or individuals that have never been on IST (i.e. Ofev® monotherapy)
干预措施: Ofev® (Drug)
结局指标
主要结局
Time to absolute Forced Vital Capacity (FVC) decline (% predicted) ≥5%, lung transplantation (indicating end stage ILD), or death
时间窗: up to 10 years
Time to absolute FVC decline (% predicted) ≥10%, lung transplantation (indicating end-stage ILD), or deat
时间窗: up to 10 years
次要结局
- Time to absolute (% predicted) FVC decline ≥5%(up to 10 years)
- Time to absolute (% predicted) FVC decline ≥10%(up to 10 years)
- Time to relative (ml) FVC decline ≥5%(up to 10 years)
- Time to relative (ml) FVC decline ≥10%(up to 10 years)
- Time to lung transplantation (indicating end-stage ILD)(up to 10 years)
- Time to death(up to 10 years)
- Change from baseline in FVC (% predicted)(at baseline, up to 10 years)
- Change from baseline in FVC (ml)(at baseline, up to 10 years)
- Lung specific Quality of Life (QoL) measured as change from baseline of total, impact, and symptom scores using the Living with Pulmonary Fibrosis (L-PF) questionnaire, measured as change of baseline at years 1, 2, 3,….10(at baseline, up to 10 years)
- Time to worsening of Pulmonary Hypertension (PH) in the sub-population of patients with PH at baseline(up to 10 years)
- Incidence rate of major bleeding (defined as those requiring intervention or hospitalization) in exposed vs unexposed treatment groups(up to 10 years)
- Final outcome for the major bleeding events (i.e., recovered or fatal) overall(up to 10 years)
- Proportion of patients with major bleeding that had a pre-existing risk for bleeding(up to 10 years)
- Incidence rate of gastrointestinal perforations in exposed vs unexposed treatment groups(up to 10 years)
- Final outcome (i.e., recovered or fatal) for gastrointestinal perforation events overall(up to 10 years)
- Proportion of patients with gastrointestinal perforations that had a pre-existing risk for gastrointestinal perforations(up to 10 years)
- Incidence rate of thromboembolism (arterial or venous) in exposed vs unexposed treatment groups(up to 10 years)
- Final outcome (i.e., recovered or fatal) for thromboembolic events overall(up to 10 years)
- Proportion of patients with thromboembolism that had a pre-existing risk for thromboembolism(up to 10 years)
研究者
研究点 (1)
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