Real-world Effectiveness and Treatment Patterns of Upadacitinib in Monotherapy or Used in Combination With Methotrexate in Active Psoriatic Arthritis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 464
- 试验地点
- 177
- 主要终点
- Percentage of Participants Achieving Disease Activity in Psoriatic Arthritis (DAPSA): score <=14
研究概览
简要总结
Psoriatic arthritis (PsA) is a chronic, immune-mediated, systemic disease affecting less than 1% of people with variations by parts of the world, and around 20%-30% of participants with psoriasis.
Upadacitinib (RINVOQ) is approved drug for the treatment of adult participants with active PsA in Europe. Approximately 450 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 4 countries in Europe: France, Germany, Greece and Italy.
Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 24 months.
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
- •Confirmed diagnosis of active psoriatic arthritis (PsA) whose peripheral involvement justifies the prescription of upadacitinib upon judgement of the treating physician.
- •Physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.
- •Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.
- •Participants able to understand and communicate with the investigator and comply with the requirements of the study.
排除标准
- •Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
- •Prior treatment with upadacitinib.
结局指标
主要结局
Percentage of Participants Achieving Disease Activity in Psoriatic Arthritis (DAPSA): score <=14
时间窗: Month 6
Disease Activity in Psoriatic Arthritis (DAPSA) score is calculated by the sum of values of rheumatic parameters \[tender joint count (TJC/ 68) + swollen joint count (SJC/ 66) + visual analog scale VAS Patient Global Disease Activity (PtGA) in cm + VAS Patient Pain in cm + C Reactive Protein (CRP) in mg/dL\].
次要结局
未报告次要终点