Special Drug Use - Results Survey Of Evaluating Safety And Effectiveness Of RINVOQ In Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,211
- 试验地点
- 2,033
- 主要终点
- Number (Percentage) Of Participants Who Reported Of Serious Infection
研究概览
简要总结
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. The purpose of this study is to observe the incidence of serious infections, regardless of their relationship to RINVOQ, in Japanese daily practice.
RINVOQ is an approved drug for the treatment of adults with moderately to severely active RA. This study evaluates medical records from institutions participating in the study to identify any adverse events (untoward medical occurrence), and reasons for discontinuation of RINVOQ in participants taking the study drug. A target of 1000 Japanese participants' data will be observed for 3 years.
Participants will receive RINVOQ per their physicians' usual prescription. Individual data will be collected for three years.
No additional study-related tests will be conducted during routine clinic visits. Only data which are routinely collected during clinic visits will be utilized for this study.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All participants treated with RINVOQ.
排除标准
- •- Participants not taking RINVOQ.
结局指标
主要结局
Number (Percentage) Of Participants Who Reported Of Serious Infection
时间窗: 24 Weeks
Number (Percentage) of participants with incidence of serious infections are reported.
次要结局
- Number (Percentage) Of Participants Who Reported Adverse Drug Reactions (ADRs)(24 Weeks)
- Number (Percentage) Of Participants Who Reported Malignancies(3 Years)
- Number (Percentage) Of Participants Who Reported Major Adverse Cardiovascular Events (MACE)(3 Years)
- Number (Percentage) Of Participants Who Reported Venous Thrombosis And Pulmonary Embolus (VTEs)(3 Years)
- Number (Percentage) Of Participants Who Reported Of Serious Infection(3 Years)
- Percentage Of Participants Achieving Clinical Remission (CR) on Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)(24 Weeks)
- Percentage Of Participants Achieving Low Disease Activity (LDA) on Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)(24 Weeks)