Effectiveness of Upadacitinib in Patients With Axial Spondyloarthritis Suffering From Typical Disease Activity and Pain in a Real-World Setting
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 338
- 试验地点
- 140
- 主要终点
- Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1])
研究概览
简要总结
Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain that might be difficult to distinguish from other causes of chronic back pain. Many participants report persistent pain, including back pain, which impacts disease activity and and impairs quality of life while evoking typical disease burden such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained disease control, and the association between pain and clinical/patient-reported outcomes in axSpA participants.
Upadacitinib is being developed for the treatment of axSpA. Approximately 352 adult participants with active axSpA will be enrolled in Germany.
Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. The overall duration of the study is approximately 52 weeks.
There may be a higher burden for participants in this study compared to usual standard of care due to study procedures. 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 questionnaires.
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
- •Clinical diagnosis of axSpA upon physician's judgement.
- •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 local label.
排除标准
- •Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib).
- •Participants with primary fibromyalgia (upon physician´s judgement)
- •Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days or five half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study.
- •Participants who cannot be treated with upadacitinib according to the applicable local label.
研究组 & 干预措施
Participants Receiving Upadacitinib.
干预措施: Upadacitinib (Drug)
结局指标
主要结局
Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1])
时间窗: Week 24
The ASDAS combines the following 5 disease activity variables: back pain (BASDAI Question 2 NRS score 0 - 10), peripheral pain/swelling (BASDAI Question 3 NRS score 0 - 10), duration of morning stiffness (BASDAI Question 6 NRS score 0 - 10), PtGA, and high-sensitivity c reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). Low disease is defined as an ASDAS \< 2.1.
Percentage of Participants Achieving ASDAS LDA (< 2.1) (i.e., Maintenance of Response)
时间窗: Up to Week 52
The ASDAS combines the following 5 disease activity variables: back pain (BASDAI Question 2 NRS score 0 - 10), peripheral pain/swelling (BASDAI Question 3 NRS score 0 - 10), duration of morning stiffness (BASDAI Question 6 NRS score 0 - 10), PtGA, and high-sensitivity c reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). Low disease is defined as an ASDAS \< 2.1. Maintenance of response is defined as those achieving LDA at Week 24 and Week 52.
次要结局
- Percentage of Participants Achieving ASDAS LDA (< 2.1)(Up to Week 52)
- Mean Change from Baseline in Total Back Pain in Past 24 Hours(Up to Week 52)
- Percentage of Participants Achieving Assessment of Spondyloarthritis International Society Health Index (ASAS-HI) Score of 40(Up to Week 52)
- Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score < 4(Up to Week 52)
- Percentage of Participants Achieving ASDAS Inactive Disease (ID [< 1.3])(Up to Week 52)
- Change from Baseline in BASDAI(Up to Week 52)
- Change from Baseline in BASDAI at Week 1-4(Week 4)
- Percentage of Participants with Resolution of Enthesitis (Leeds Enthesitis Index [LEI] = 0) for Participants with Baseline Enthesitis(Up to Week 52)
- Percentage of Participants with Resolution of Dactylitis for Participants with Baseline Dactylitis(Up to Week 52)
- Mean Change from Baseline in ASAS-HI(Up to Week 52)
- Percentage of Participants with ASAS-HI <= 4(Up to Week 52)
- Mean Change from Baseline in Nocturnal Back Pain in Past 24 Hours(Up to Week 52)
- Mean Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)(Up to Week 52)
- Percentage of Participants with new onset of typical EMMs(Up to Week 52)
- Percentage of Participants with Recurrence of Typical Extra-Musculoskeletal Manifestations (EMMs)(Up to Week 52)
- Mean Change from Baseline in Patient Health Questionnaire-4 (PHQ-4)(Up to Week 52)