Impact of Air Pollution on the Course of Inflammatory Rheumatism: a Prospective, Single-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Show that there is a difference in average exposure to regulated pollutants according to the occurrence or non-occurrence of inflammatory rheumatism (RA or APS).
研究概览
简要总结
The objective of this study is to see if there is a link between air pollution and inflammatory rheumatism (rheumatoid arthritis and ankylosing spondylitis)
To do this, the investigators are going to follow a cohort of about 200-400 patients for 6 months by means of a self-questionnaire, which the investigators ask the patient to fill in once a week on a fixed day, and opposite the corresponding week to put the letter corresponding to the question concerning the activity of your disease: 3 possible answers: A: no flare-up, B: short flare-up of 1 to 3 days, C: persistent flare-up of more than 3 days
Then the investigators will collect the questionnaire at the end of these 6 months and at each visit to the consultation or day hospital (on average every 4 to 6 weeks), and they will look to see if any relapses have occurred. At the same time the investigators will calculate the disease activity score (DAS or BASDAI) to have an objective score. Then in parallel they will look at the level of exposure to air pollution according to the place of residence and work of each patient.
The hypothesis is that air pollution has an influence on the activity of inflammatory rheumatism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patients with RA according to ACR/EULAR 2010 criteria, or spondyloarthritis according to ASAS criteria.
- •Patients older than 18 years of age
- •Patients with RA or spondyloarthritis considered stable (no change in background or biological therapy for at least 3 months) and in low activity (SAR 28 CRP < 3.2 for RA and BASDAI < 4 for 3 months).
- •Patient treated with biological therapy
排除标准
- •Patient with no fixed abode
- •Patient planning to move within 6 months.
- •Patient unable to read or understand the non-opposition notice.
研究组 & 干预措施
Main Cohort
Cohort of patients with inflammatory rheumatism (rheumatoid arthritis or spondyloarthritis diagnosed according to ACR/EULAR 2010 or ASAS), over 18 years of age, and with stable chronic inflammatory rheumatism under biological treatment
干预措施: Questionnaires (Other)
结局指标
主要结局
Show that there is a difference in average exposure to regulated pollutants according to the occurrence or non-occurrence of inflammatory rheumatism (RA or APS).
时间窗: Every week for 6 months
Occurrence of a flare-up of less than 3 days and/or more than 3 days
次要结局
- Relationship between average exposure to regulated pollutants and severity of SPA/PR.(Every week for 6 months)
- Correlations between average exposure to regulated pollutants and biological severity of SPA/PR.(Every week for 6 months)