CTRI/2024/09/073987尚未招募不适用
A multicenter evaluation of the treatment persistence of advanced therapies (Biological disease-modifying agents and Targeted synthetic Disease Modifying Anti-Rheumatic Drugs) in the treatment of rheumatoid arthritis (RA): A Real World Evidence (RWE) study from India.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 225
- 试验地点
- 10
- 主要终点
- Evaluate the treatment persistence/drug survival in patients on the advanced therapies
研究概览
简要总结
The aim of this study is to define treatment persistence, the parameters to change the therapy, the prescribing patterns of advanced therapies and to evaluate the effectiveness and safety of persistence of these therapies in the management of rheumatoid arthritis in a real world setting.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 years and over diagnosed with RA eligible for treatment with advanced therapies (bDMARDs as well as tsDMARDs)
- •Agree to a minimum of 3 follow up visits with the rheumatologist.
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •Patients not willing to sign the informed consent document
- •Participation in a clinical trial during the past 6 months before enrolment into the study
- •Patients on therapy with bDMARDs/tsDMARDs for over 3 months.
结局指标
主要结局
Evaluate the treatment persistence/drug survival in patients on the advanced therapies
时间窗: 1 year
for rheumatoid arthritis.
时间窗: 1 year
次要结局
- To study the effectiveness parameters as per the routine clinical practice and understand the real-world practice towards management of rheumatological disorders (DAS 28 scores, HAQ-DI scores or any other routine parameters evaluated).(Record the adverse events including serious adverse events, non-serious adverse events while on treatment during the study inclusion.)
研究者
Amod Tilak
Pfizer Limited
研究点 (10)
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