PANLAR's Latin American Registry of Rheumatic Patients Treated With Jak Inhibitors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Incidence rate of severe adverse events per each one of the drugs included.
研究概览
简要总结
This prospective, non-interventional, research registry is designed to study the comparative safety and comparative effectiveness of approved Jak Inhibitors treatment for RA-PsA-SpA in a cohort of patients and theirs controls cared for by rheumatologists across Latin América (LA).
详细描述
There is scarce data on the real-world safety and effectiveness of Jak in Latin America. This registry will provide reliable data on the use of JAKi in LA, as will be a prospective study involving carefully selected rheumatologists and centers. Soon, a good number of copies of original JAKi will be available in LA, and it is important to keep track of the safety and effectiveness of this drugs in the real world.
The primary objective of the registry is to prospectively study the comparative safety and comparative effectiveness of approved Jak Inhibitors treatment for RA-PsA-SpA in a cohort of patients and theirs controls cared for by rheumatologists across Latin América (LA).
The registry will be a cohort study where cases will be patients with RA, PsA and SpA initiating any approved JAK inhibitor. To have an active control group, patients with RA, PsA o SpA initiating any other disease modifying antirheumatic drug (DMARD) (biologic or not biologic) will also be included in the registry.
It will be a Web based registry, where the investigators will include data related to the cases and controls. Data collected will include, demographics, disease characteristics, disease activity, past and current medications, comorbidities. At each visit adherence with the medications, adverse events, changes in medications, disease activity and disability will be assessed.Patients will be followed up at three months intervals, after inclusion in the registry and thereafter every 6 months during the next three years. Adverse events could be included at any time between visits if the investigator is notified.
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
- 未提供
排除标准
- •Patients who do not wish to participate or are unable to give informed consent
研究组 & 干预措施
Cases
Patients with diagnosis of RA, PsA and SpA
干预措施: JAK Inhibitor (Drug)
Controls
Patients with diagnosis of RA, PsA and SpA
干预措施: DMARDs (Drug)
Controls
Patients with diagnosis of RA, PsA and SpA
干预措施: biologic DMARDs (Drug)
结局指标
主要结局
Incidence rate of severe adverse events per each one of the drugs included.
时间窗: 36 months
次要结局
- Proportion of patients on remission (according to definition) for each one of the drugs included and for each one of the diseases included.(36 months)
- Incidence rate of all adverse events for each one of the drugs included.(36 months)
- Incidence rate of severe infections for each one of the drugs included. years.(36 months)
- Proportion of patients still on each one of the drugs included.(36 months)
- Proportion of patients receiving each one of the drugs included and for each one of the diseases included as first, second, third- and fourth-line therapy.(Baseline)
研究者
Nicolas Marin Zucaro
MD
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
