Therapeutic Strategy in Rheumatology When Faced With a Patient Treated With Methotrexate (MTX) for Rheumatoid Arthritis (RA).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 854
- 试验地点
- 1
- 主要终点
- Therapeutic options and Impact on the progression of the disease (EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28)
研究概览
简要总结
This is a longitudinal, observational, prospective, multicentre study conducted in metropolitan France, among a representative sample of office-based or mixed practice rheumatology doctors.
The aim of this study is to describe in real life, the therapy strategy when faced with a patient treated with methotrexate as a monotherapy consulting for rheumatoid arthritis and the impact on the progression of the disease at 6 months.
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
- •Adult patient, ambulatory, seen in a rheumatology consultation.
- •With a confirmed diagnosis of RA (ACR 1987 or ACR/EULAR 2010 criteria) receiving a disease-modifying treatment with methotrexate as a monotherapy.
- •With clinical, functional, structural and/or therapeutic disease progression, for whom the rheumatologist intends to change the therapeutic treatment of the RA .
- •Informed about the computer processing of their medical data and their right of access and correction.
排除标准
- •Patient not treated with methotrexate for their RA.
- •Already treated with a biotherapy or receiving other synthetic DMARDs (disease-modifying antirheumatic drugs) in combination with methotrexate .
- •Participating in a clinical trial in rheumatology.
结局指标
主要结局
Therapeutic options and Impact on the progression of the disease (EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28)
时间窗: Patients are included at the time of the change in the treatment of the RA and followed up to 6 months
The distribution of the various therapeutic options will be described overall. Their impact on the progression of the RA will be assessed at 6 months according to the EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28) score during the study)
次要结局
- Patient's satisfaction using a 4-point verbal scale(6 months after inclusion)
- Medical economic aspect (cost/benefit ratio)(6 months after inclusion)