Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Safety and adverse events
研究概览
简要总结
There is likely a role for using anti-fibrotic medications in patients with myositis-associated interstitial lung disease (MA-ILD) to slow down disease progression, especially in patients who have fibrotic and progressive disease. These patients however are currently being excluded from clinical trials of anti-fibrotic agents in progressive ILD because of the concomitant use of immunosuppression. The benefit of anti-fibrotic agents is being assessed in other rheumatic diseases and should be assessed in MA-ILD as well. They are a unique group of patients with a heterogeneous disease, and are much more frequently on concomitant immune-modulating therapy. As such, they should be studied on their own in separate clinical trials, and the use of nintedanib should be studied as an addition to standard of care immunosuppression.
The objective of this study is to assess safety and tolerability of nintedanib in patients with MA-ILD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •1. 18 years and older
- •Diagnosis of autoimmune myopathy (dermatomyositis, polymyositis, overlap myositis or anti-synthetase syndrome) as diagnosed by a rheumatologist.
- •3. Interstitial lung disease confirmed by high resolution CT scan (Extent of disease 10% or more on CT done within 12 months of enrolment) with evidence of fibrosis, defined as reticular abnormality with traction bronchiectasis with or without honeycombing.
- •4. Evidence of progressive disease within 24 months of screening visit:
- •Clinically significant decline in Forced Vital Capacity (FVC) % pred based on a relative decline of >=10%
- •Marginal decline in FVC % pred based on a relative decline of .>=5-<10% combined with worsening of respiratory symptoms
- •Marginal decline in FVC % pred based on a relative decline of >=5-<10% combined with increasing extent of fibrotic changes on chest imaging
- •Worsening of respiratory symptoms such as cough or shortness of breath as well as increasing extent of fibrotic changes on chest imaging as per radiologist or pulmonologist who read the scan
- •Current and ongoing treatment with immunosuppressive medications, on a stable medication regimen and dosage for at least 6 weeks (considered standard of care medical therapy) Concomitant medications allowed are:
- •mycophenolate,
- •azathioprine,
- •tacrolimus,
- •cyclosporine,
- •rituximab (injection within the last year),
- •prednisone low dose =<20 mg daily,
- •Intravenous immunoglobulins
排除标准
- •Contraindication to treatment with nintedanib (based on Canadian labeling)
- •The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
- •The male patient plans to father a child during the course of the study
- •Hypersensitivity to nintedanib, peanut or soy
- •Elevated liver enzymes greater than 1.5 times the upper limit of normal
- •Creatinine clearance <30 mL/min
- •Patient with risks factors of aneurysm or artery dissection, such as known history of aneurysm or uncontrolled hypertension
研究组 & 干预措施
Nintedanib treatment
Single arm treatment with nintedanib
干预措施: Nintedanib 150 milligrams [Ofev] (Drug)
结局指标
主要结局
Safety and adverse events
时间窗: 24 weeks
numbers of patients with adverse events during course of the study
Tolerability - completed doses
时间窗: 24 weeks
Percentage of subjects who complete 24 weeks on nintedanib. Subjects will be considered to have completed the 24 weeks of the study if they took 90% of the study drug doses.
次要结局
- Change in forced vital capacity(24 weeks)
- Change in diffusion capacity of the lung for carbon monoxide(24 weeks)
- Change in 6 minute walking distance(24 weeks)
研究者
Deborah Assayag
Scientist
McGill University Health Centre/Research Institute of the McGill University Health Centre