Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 13
- 主要终点
- physical activities and sleep quality
研究概览
简要总结
European recommendations indicate to start a conventional synthetic disease modifying antirheumatic drug (csDMARD) as soon as possible to reach the remission in early RA or low disease activity in established RA. If the target is not achieved with the first csDMARD and in presence of poor prognostic, addition of a biologic (b)DMARD or a targeted synthetic (ts)DMARD should be considered . Nevertheless, as many as one-third of patients have persistent disease activity and insufficient (inadequate) response to a first b/tsDMARD according to international recommendations. This relatively long time (3 to 6 months) between treatment initiation and determination of individual clinical response represents:
- a risk for the patient who could be usually exposed to potential side effects,
- a loss of chance for the patient who will not receive an adequate treatment during the most favorable period and thus may develop irreversible lesions
- a cost for the healthcare system, especially in terms of expensive drug reimbursements, notwithstanding the increasing use of biosimilars.
Despite 20 years of research, no biomarker or no way are available in the daily practice to predict disease activity and the non-response to a b/tDMARD [11]. Thus exploration of a new approach is totally in purpose.
The aim of this project is to benefit from the declarative PRO (Patient Reported Outcomes), the physical activity and sleep quality to predict the individual clinical response to the b/tsDMARDs
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Social security affiliation
- •Signed informed consent
- •Adult patient (over 18 years old)
- •RA according to ACR/EULAR 2010 criteria since less than 6 months
- •DAS28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bDMARD or a tsDMARD
- •Having an internet access at home and using an email address
排除标准
- •Other arthritis than RA
- •To participate to a blind-randomized study to assess RA treatment
- •Pregnancy or breastfeeding
- •Patient unable to understand the study, unable to give consent
- •Patient deprived of liberty or patient under guardianship
- •Patient refusing to participate in the study
- •Patients having difficulty using connected objects
结局指标
主要结局
physical activities and sleep quality
时间窗: 3 months
sleep quality data including time of sleeping (number of hours). sleep quality is measured with a smart watch (with accelerometer without location data)
Rapid-3 score
时间窗: 3 months
Routine Assessment of Patient Index Data (Rapid-3) score is a self-administered score demonstrated capacity to capture Rheumatoid arthritis activity (score : 0,0 to 30,0). Remission : score 0- 3,0 Low Disease Activity : score 3,1- 6,0 Moderate Disease Activity : score 6,1 - 12,0 High Disease Activity : score 12,1 - 30
physical activities
时间窗: 3 months
Physical activities including number of steps per day and per hour. Physical activities are measured with a smart watch (with accelerometer without location data)
次要结局
未报告次要终点