跳至主要内容
临床试验/NCT04821206
NCT04821206Unknown不适用

PANLAR's Latin American Registry of Rheumatic Patients Treated With Jak Inhibitors

Liga Panamericana de Asociaciones de Reumatologia (PANLAR)2 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物

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

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

发起方
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas Marin Zucaro

MD

Liga Panamericana de Asociaciones de Reumatologia (PANLAR)

研究点 (2)

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