NCT04053881已完成不适用
A Multicenter, Noninterventional, Prospective Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Moderate to Severe Plaque Psoriasis in Daily Practice
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 412
- 试验地点
- 79
- 主要终点
- Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 2
研究概览
简要总结
The purpose of the study is to assess the effectiveness of certolizumab pegol in patients with moderate to severe plaque psoriasis as part of 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 is ≥18 years of age at observational point 1
- •The patient must have a clinical diagnosis of moderate to severe Plaque psoriasis according to the diagnostic criteria used by the physician in routine clinical practice
- •The patient has an available PASI assessment prior to the first certolizumab pegol dose according to the standard of care
- •The patient must be newly prescribed with certolizumab pegol
- •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
- •Not applicable
研究组 & 干预措施
Certolizumab pegol
Plaque psoriasis patients who have been newly prescribed certolizumab pegol (CZP).
干预措施: Certolizumab pegol (Drug)
结局指标
主要结局
Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 2
时间窗: From Baseline up to Week 21
The Psoriasis Area Severity Index (PASI75) response assessments are based on at least 75 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions with a score of 0 (clear) to 4 (very marked).
次要结局
- Change from Baseline in Dermatology Life Quality Index score at observational point 2(From Baseline up to Week 21)
- Change from Baseline in Dermatology Life Quality Index score at observational point 4(From Baseline up to Week 56)
- Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 4(From Baseline up to Week 56)
- Percentage of patients achieving Psoriasis Area Severity Index 90% response at observational point 2(From Baseline up to Week 21)
- Percentage of patients achieving Psoriasis Area Severity Index 90% response at observational point 4(From Baseline up to Week 56)
研究者
研究点 (79)
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