A Study to Evaluate Safety and Effectiveness of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan (SELECT AXIS RW)
概览
- 阶段
- 不适用
- 干预措施
- Rinvoq
- 疾病 / 适应症
- Ankylosing Spondylitis
- 发起方
- AbbVie
- 入组人数
- 69
- 试验地点
- 70
- 主要终点
- Incidence Percentage of Serious Infection as Adverse Drug Reactions ( ADR)
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
Axial spondyloarthritis (axSpA), which encompasses radiographic axSpA (r-axSpA, also known as ankylosing spondylitis [AS]) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. This study will assess how effective Rinvoq is in treating axSpA.
Rinvoq is an approved drug for treating axSpA. Approximately 100 adult participants who are prescribed Rinvoq by their physician in accordance with local label will be enrolled in Japan.
Participants will receive Rinvoq as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
研究者
入排标准
入选标准
- •Participant with clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York Criteria for AS.
- •Participant who is administered the first dose of Rinvoq for AS.
排除标准
- •Participant with prior treatment by JAK inhibitors.
- •Participant currently participating in another clinical study except non-interventional study.
- •Participant for whom upadacitinib is contraindicated.
- •Participants who are not registered within 14 days after initiation of Rinvoq treatment for AS.
研究组 & 干预措施
Rinvoq
Participants will receive Rinvoq as prescribed by their physician according to local label.
结局指标
主要结局
Incidence Percentage of Serious Infection as Adverse Drug Reactions ( ADR)
时间窗: Up to 52 Weeks
Incidence of serious drug related adverse reactions will be assessed.