Real-World Effectiveness of Upadacitinib in Patients Joining Subgroups Either With Oligo- or Poly-ArtIcular Psoriatic Arthritis on Minimal Disease Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 394
- 试验地点
- 93
- 主要终点
- Percentage of Participants Receiving Upadacitinib who Attain Minimal Disease Activity (MDA)
研究概览
简要总结
Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by the body's immune system mistakenly attacking healthy joint tissue causing inflammation, joint damage, disability, and a reduced life expectancy. The main objective of this study is to characterize attainment of minimal disease activity (MDA) at week 24 under continuous treatment with upadacitinib in participants with oligo- or polyarticular PsA as part of real-world practice.
Upadacitinib is a drug approved for the treatment of Psoriatic arthritis (PsA) in Germany and Canada. Approximately 380 adult participants with PsA at multiple sites in Germany and Canada.
Participants will receive oral Upadacitinib tablets per current local label, according to local standard of care and international guidelines.
There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by questionnaire.
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
- •Diagnosis of active Psoriatic Arthritis (PsA) upon judgment of the treating physician.
- •Swollen joint count (SJC) >= 1 out of 66 joints.
- •Decision on the treatment with Upadacitinib was made prior to any decision to approach the participant to participate in this study.
排除标准
- •Cannot be treated with Upadacitinib according to the local Upadacitinib Summary of Product Characteristics (SmPC).
- •Prior treatment with Upadacitinib.
- •Currently participating in interventional research or within the last 30 days.
结局指标
主要结局
Percentage of Participants Receiving Upadacitinib who Attain Minimal Disease Activity (MDA)
时间窗: At Week 24
MDA will be determined based on participants fulfilling 5 of 7 outcome measures: tender joint count 68 (TJC68) \<= 1, swollen joint count (SJC66) ≤ 1, body surface area (BSA) \<= 3%; Patient's Assessment of Pain numeric rating scale (NRS) \<= 1.5, Patient's Global Assessment of Disease Activity (PtGA) NRS \<= 2.0, Health Assessment Questionnaire Disability Index (HAQ-DI) \<= 0.5, tender entheseal points \<= 1.
次要结局
- Percentage of Participants Maintaining MDA Under Upadacitinib Treatment, in Participants who had Achieved MDA at Week 24(At Week 48)
- Mean Change in Disease Activity in PSoriatic Arthritis score (DAPSA)(Baseline to Week 48)
- Mean Change in Dermatology Life Quality Index (DLQI) [in Participants with Skin Involvement](Baseline to Week 48)
- Mean Change in 12-Item Short Form Health Survey (SF-12)(Baseline to Week 48)
- Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 (Pain in Neck, Back or Hip)(Baseline to Week 48)
- Mean Change in Percentage of Participants with Dactylitis(Baseline to Week 48)
- Mean Change in Number of Fingernails Affected with Psoriasis(Baseline to Week 48)