NCT02354105已完成不适用
A Noninterventional Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Practice
UCB Biopharma S.P.R.L.100 个研究点 分布在 3 个国家目标入组 680 人开始时间: 2015年1月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 680
- 试验地点
- 100
- 主要终点
- Change from Baseline to Week 52 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in the overall axial spondyloarthritis (axSpA) population, and the ankylosing spondylitis (AS) and nonradiographic axSpA (nr-axSpA) subpopulations
研究概览
简要总结
The primary purpose is to assess the effectiveness of certolizumab pegol in patients with axial spondyloarthritis under 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
- •The patient personally signed and dated a Patient Data Consent Form (PDCF) prior to Visit
- •No data can be entered into the electronic Documentation form (eDF) prior to signature of the PDCF.
- •The patient must have a clinical diagnosis of active axial spondyloarthritis (axSpA), [ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (nr-axSpA)] according to the diagnostic criteria used by the physician in routine clinical practice.
- •The decision to prescribe Certolizumab Pegol (CZP) is made by the physician independent of the patient's participation in the NIS.
- •The patient must be newly prescribed CZP according to local regulations or guidelines (eg, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4).
- •Treatment is according to instructions in the Summary of Product Characteristics (SmPC) for patients considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires).
- •If a patient is participating in an ongoing investigational study, then he/she will not be able to take part in this study.
排除标准
- 未提供
结局指标
主要结局
Change from Baseline to Week 52 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in the overall axial spondyloarthritis (axSpA) population, and the ankylosing spondylitis (AS) and nonradiographic axSpA (nr-axSpA) subpopulations
时间窗: From Baseline to Week 52
The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.
次要结局
- Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 24(At Week 24)
- Change from Baseline to Week 12 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in the overall axSpA population, and the AS and nr-axSpA subpopulations(From Baseline to Week 12)
- Change from Baseline to Week 24 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in the overall axSpA population, and the AS and nr-axSpA subpopulations(From Baseline to Week 24)
- Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 12(At Week 12)
- Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 12(At Week 12)
- Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 52(At Week 52)
- Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 52(At Week 52)
- Change from Baseline to Week 12 in Patient's Global Assessment of Disease Activity (PtGADA) in the overall axSpA population, and the AS and nr-axSpA subpopulations(From Baseline to Week 12)
- Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 24(At Week 24)
- Change from Baseline to Week 12 in Bath Ankylosing Spondylitis Functional Index (BASFI) in the overall axSpA population, and the AS and nr-axSpA subpopulations(From Baseline to Week 12)
- Change from Baseline to Week 52 in Bath Ankylosing Spondylitis Functional Index (BASFI) in the overall axSpA population, and the AS and nr-axSpA subpopulations(From Baseline to Week 52)
- Change from Baseline to Week 24 in Bath Ankylosing Spondylitis Functional Index (BASFI) in the overall axSpA population, and the AS and nr-axSpA subpopulations(From Baseline to Week 24)
- Change from Baseline to Week 24 in Patient's Global Assessment of Disease Activity (PtGADA) in the overall axSpA population, and the AS and nr-axSpA subpopulations(From Baseline to Week 24)
- Change from Baseline to Week 52 in Patient's Global Assessment of Disease Activity (PtGADA) in the overall axSpA population, and the AS and nr-axSpA subpopulations(From Baseline to Week 52)
研究者
研究点 (100)
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