NCT05082805Unknown不适用
Therapeutic Strategy Concerning the Drug Management Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The Primary Outcome Measure is not provided for now to the investigators (and public) in order not to bias the therapeutic strategies.
研究概览
简要总结
This is a longitudinal, observational, prospective, multicentre study conducted in France, among a representative sample of rheumatology doctors.
The aim of this study is to describe in real life the therapeutic strategy when faced with a patient with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) who requires initiation of treatment with biotherapy or targeted therapy. The evolution of the disease and the possible therapeutic adaptations will then be followed for 2 years.
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
- •Major patient (age ≥ 18 years)
- •Patient with RA according to American College of Rheumatology (ACR) / European Congress of Rheumatology (EULAR) 2010 or ACR 1987 or patient with PsA according to ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria
- •Patient undergoing treatment with methotrexate (MTX) (oral or injectable) initiated for at least 3 months.
- •Naïve patient of biotherapy or tsDMARD and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease.
- •Patient informed and accepting the computer processing of his/her medical data and informed of his/her rights of access and rectification.
排除标准
- •Patient participating in an interventional study in rheumatology
- •Patient with axial spondyloarthritis (for patients with PsA)
结局指标
主要结局
The Primary Outcome Measure is not provided for now to the investigators (and public) in order not to bias the therapeutic strategies.
时间窗: 12 months after inclusion
Not provided as Outcome 1 is blinded
次要结局
- Functional capacity (Health Assessment Questionnaire (HAQ))(12 and 24 months after inclusion)
- Care path at the end of the visit(12 and 24 months after inclusion)
- Disease outcome(12 and 24 months after inclusion)
- Fatigue and pain(12 and 24 months after inclusion)
- Cross-perception (doctor / patient) about participation in the "shared medical decision"(12 and 24 months after inclusion)
- Patient adherence to treatment(12 and 24 months after inclusion)
- Main criteria analysis(24 months after inclusion)
- Therapeutic adaptations of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), targeted synthetic DMARDs (tsDMARDs), Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids(12 and 24 months after inclusion)
研究者
研究点 (1)
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