Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND) (LELAND)
Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND): a Multicenter Prospective Observational Study in Southern China
To focus on the real world treat-to-target rate of early rheumatoid arthritis patients who will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA.
To explore the factors which influence the treat-to-target outcome.
研究概览
详细说明
Resent study showed that rapid progression of cartilage and bone damage could happen on the early state of RA patients, so the clinicians should try the best to stop the trend, such as early diagnosis, early treatment and treat-to-target. But only half of the RA patients could reach low disease activity in the whole world and about 10% in China.
The investigators enroll early RA patients who are treated according to the 2015 American College of Rheumatology Guideline. The relevant data are collected and analyzed by the statistician including clinical data, imaging markers, blood samples and patient-reported outcomes every 3 months.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Min Yang, doctor
- 电话号码：+86-13802911770
- 邮箱：minyanggz@163.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- ≥18 years,
- be diagnosed with RA according to the 1987 or 2010 ACR criteria,
- in the course of the disease within 6 months,
- fill out questionnaires by oneself,
- fully understand the survey, agree to take part in the survey with signing the informed consent, and authority the researchers to expose and use his or her personal health information.
Exclusion Criteria:
- woman in pregnancy, lactation or plan to pregnant in the next 2 years,
- before enter this study, the patient joint any other RA clinical study in the past 24 weeks,
- according to the clinicians, one may not report his /or her life quality or the utilization of leading medical resources.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
early RA patients
patients must fulfill the 1987 ACR classification criteria for rheumatoid arthritis or 2010 Rheumatoid arthritis classification criteria of ACR/EULAR, and meet the condition that the course of disease was no more than 6 months.
If enrolled, patients will be treated with disease modified antirheumatic drugs or biological agents.
|
Enrolled patients will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the proportion of patients achieving treat to target
大体时间：2018-4-25 to 2022-7-1
|
calculate the proportion of patients achieving treat to target according to the change of DAS28 score
|
2018-4-25 to 2022-7-1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the change of Health Assessment Questionnaire Disability Index(HAQ-DI)
大体时间：2018-4-25 to 2022-7-1
|
the change of Health Assessment Questionnaire Disability Index(HAQ-DI)
|
2018-4-25 to 2022-7-1
|
|
the change of The Work Productivity and Activity Impairment Questionnaire(WPAI)
大体时间：2018-4-25 to 2022-7-1
|
the change of The Work Productivity and Activity Impairment Questionnaire(WPAI)
|
2018-4-25 to 2022-7-1
|
|
the change of European Quality of Life-5 Dimensions(EQ-5D)
大体时间：2018-4-25 to 2022-7-1
|
the change of European Quality of Life-5 Dimensions(EQ-5D)
|
2018-4-25 to 2022-7-1
|
|
the change of Short Form 36 Health Survey Questionnaire(SF-36)
大体时间：2018-4-25 to 2022-7-1
|
the change of Short Form 36 Health Survey Questionnaire(SF-36)
|
2018-4-25 to 2022-7-1
|
合作者和调查者
调查人员
- 首席研究员：Min Yang, doctor、Nanfang Hospital of Southern Medical University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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