Comparison of Morning Versus Evening Oral Administration of a JAK Inhibitor in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- EULAR response criteria between the two groups
研究概览
简要总结
The aim of this study is to offer patients two treatment options: morning or evening administration of a JAK inhibitor prescribed within the framework of its marketing authorization, according to the EULAR response.
The objective is to determine whether evening administration in our patients with rheumatoid arthritis provides greater efficacy than morning administration in our patients taking JAK inhibitors once daily.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 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
- •Patient aged over 18 years
- •Patient with Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria
- •Patient meeting the criteria for initiation of a JAK inhibitor according to the marketing authorization and international recommendations
- •Patient capable of providing informed, written, dated, and signed consent before the start of any trial-related procedure.
排除标准
- •No contraindication to a bDMARD
- •Not stable dose of corticosteroids in the 4 weeks preceding enrollment
- •Not stable dose of maintenance therapy (methotrexate, leflunomide, hydroxychloroquine, cyclosporine, gold salts) in the 4 weeks preceding enrollment
- •Prior treatment with a JAK inhibitor
- •Patient unable to be followed-up in the study during 6 months
- •Minors or adults under guardianship or curatorship, or deprived of their liberty
- •Pregnant or breastfeeding patient
- •Patient refusing to use an effective method of contraception for the duration of the study
- •Person not affiliated with a social security scheme.
研究组 & 干预措施
JAK inhibitor morning then evening
JAK inhibitor intake every morning during 3 months then every evening during 3 months
JAK inhibitor evening then morning
JAK inhibitor intake every evening during 3 months then every morning during 3 months
结局指标
主要结局
EULAR response criteria between the two groups
时间窗: From first intake to six months
Comparison of the evolution of the response rate (according to EULAR response criteria) between the two treatment modalities between the two groups (morning + evening vs evening + morning)
次要结局
- Percentage of remission (DAS<2.6) or low disease activity(3 months and 6 months)
- Adverse events related to study treatment(From Baseline through study completion)
- Continuation of treatments(From baseline to 3 months and from 3 months to 6 months)
- EULAR response at Month 3(from baseline to third month)
- EULAR response at Month 6(from baseline to six month)