Factors of ILD in Newly Diagnosed Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Presence of an interstitial lung disease
研究概览
简要总结
To determine factors associated with early RA-ILD (which may be asymptomatic). It is planned to recruit all patients with a newly diagnosed RA (symptoms since less than 3 years). In this study, all relevant demographic and clinical data will be collected. All patients will undergo lung function tests and high-resolution CT-scan of the lungs. Blood sample will be collected for measurement of (1) anti-CCP and rheumatoid factor measurement (good clinical practice) and a specific sample for the detection of the MUC5 promoter variant rs35705950.
Our aim is thus to identify determinants of RA-ILD in the following population:
- Adults aged 18 to 90 years-old
- Diagnosis of rheumatoid arthritis (RA) based on ACR-EULAR 2010 criteria
- Onset of disease duration at least 1 year and at most 10 years prior to inclusion
详细描述
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OBJECTIVES The objectives are to (1) detect ILD within a population of early RA and (2) identify potential predictive factors of the development of ILD.
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METHODS
The study is held in the Rheumatology, Pneumology and Radiology departments of the Cliniques universitaires Saint-Luc and other Belgian hospitals. Patients will be recruited in the rheumatology department (RA consultations). Recruitment will also be possible while patients are hospitalized for a work-up of their RA. At the time of the consultation, the following tests will be performed:
Data collection Clinical data (Standard of Care, SOC)
- Demographic data
- Environmental inquiry (smoking status, occupation, domestic exposure)
- Past medical history
- Assessment of RA:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
All statistical analysis, including power calculation, will be performed in collaboration with the "Plate-forme en méthodologie statistique" of the UCLouvain. Pre-study estimations revealed that a sample size of 289 patients produces a two-sided 95% confidence interval with a precision (half-width) of 0,04 when the actual proportion is near 0,14.
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
- •Adults aged 18 to 90 years-old
- •Diagnosis of rheumatoid arthritis (RA) based on ACR-EULAR 2010 criteria
- •Onset of disease duration at least 1 year and at most 10 years prior to inclusion
排除标准
- •Pregnancy
- •Inability to provide informed consent
- •Inability to perform lung function tests or to comply with the protocol
- •Active pulmonary infection
结局指标
主要结局
Presence of an interstitial lung disease
时间窗: from enrollment of patient to 3 months post enrollment
Detection of an interstitial lung disease associated with RA. We define RA-ILD by the presence of reticulations, ground-glass opacity and/or honeycombing at HRCT not explained by another cause (i.e. cardiac disease, infection or neoplasia).
次要结局
- Proportion of different ILD subtypes(from enrollment of patient to 3 months post enrollment)
- relevant exposure(from enrollment of patient to 3 months post enrollment)
- anti-CCP antibodies(from enrollment of patient to 3 months post enrollment)
- Proportion of patients presenting with a non-ILD lung involvement of RA(from enrollment of patient to 3 months post enrollment)
- rs35705950 variant of the MUC5B promoter(from enrollment of patient to 3 months post enrollment)