A European, Multicenter, Prospective Observational Phase IV Clinical Study to Assess the Impact of Lebrikizumab on Health-Related Well-Being and Control of Skin Manifestations in Patients with Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Absolute Measures in the Overall Health-related Well-being Index Evaluated Through World Health Organization (WHO-5) Score Throughout the Study Observation Period
研究概览
简要总结
The main purpose of this study is to evaluate the impact of lebrikizumab treatment on the overall well-being of adult participants with moderate-to-severe AD in real-world clinical practice settings across Europe, as measured using validated 5-item World Health Organization Well-being Index (WHO-5) and to investigate effectiveness and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on participants in terms of disease symptomatology/control, fatigue, work impairment, patient's relationship with their skin, and overall QOL among adult participants.
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
- •Adult (greater than or equal to [>=] 18 years) male or female participants with diagnosis of moderate-to-severe Atopic dermatitis.
- •Adult participants prescribed lebrikizumab as part of routine/usual care to manage their moderate-to severe Atopic dermatitis.
- •Willingness and ability to participate in the study; participants must give their written consent to participate.
排除标准
- •Hypersensitivity to the active substances or to any of the excipients of lebrikizumab (Ebglyss®).
- •Participants with pre-existing helminth infections. These participants should be treated for helminth infection before starting lebrikizumab therapy.
- •Concomitant use of live and live attenuated vaccines.
- •Pregnant women, except when the potential benefit justifies the potential risk.
- •Participants included in a clinical trial at baseline or at any time during the planned study period.
- •Participants unable to comply with the requirements of the study or who, in the opinion of the study physician, should not participate in the study.
- •Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.
结局指标
主要结局
Absolute Measures in the Overall Health-related Well-being Index Evaluated Through World Health Organization (WHO-5) Score Throughout the Study Observation Period
时间窗: Baseline up to Week 104
The WHO-5 item well-being index is a generic global rating scale measuring subjective well-being and contains positively phrased items. The respondent is asked to rate how well each of the 5 items applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score therefore theoretically ranges from 0 (absence of well-being) to 25 (maximal well-being). To standardize the score on a scale from 0 (absent) to 100 (maximal), it is recommended to multiply the raw score by 4.
Change From Baseline in the Overall Health-related Well-being Index Evaluated Through WHO-5 Score Throughout the Study Observation Period
时间窗: Baseline up to Week 104
The WHO-5 item well-being index is a generic global rating scale measuring subjective well-being and contains positively phrased items. The respondent is asked to rate how well each of the 5 items applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score therefore theoretically ranges from 0 (absence of well-being) to 25 (maximal well-being). To standardize the score on a scale from 0 (absent) to 100 (maximal), it is recommended to multiply the raw score by 4.
次要结局
- Percentage of Participants with 50 Percent (%) or Greater Reduction From Baseline in Overall Eczema Area and Severity Index (EASI) Score (EASI50) Throughout the Study Observation Period(Baseline up to Week 104)
- Percentage of Participants with 75% or Greater Reduction From Baseline in Overall EASI Score (EASI75) Throughout the Study Observation Period(Baseline up to Week 104)
- Percentage of Participants with 90% or Greater Reduction From Baseline in Overall EASI Score (EASI90) Throughout the Study Observation Period(Baseline up to Week 104)
- Percentage of Participants with 100% Reduction From Baseline in Overall EASI Score (EASI100) Throughout the Study Observation Period(Baseline up to Week 104)
- Percentage of Participants With Absolute EASI Score Less than or Equal (<=) to 7 Throughout the Study Observation Period(Baseline up to Week 104)
- Percentage of Participants with Overall Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) Throughout the Study Observation Period(Baseline up to Week 104)
- Absolute Measures in Overall IGA Score Throughout the Study Observation Period(Baseline up to Week 104)
- Change from Baseline in Overall IGA Score Throughout the Study Observation Period(Baseline up to Week 104)
- Absolute Measures in Patient-Oriented Eczema Measure (POEM) Score Throughout the Study Observation Period(Baseline up to Week 104)
- Change From Baseline in POEM Score Throughout the Study Observation Period(Baseline up to Week 104)
- Absolute Measures in Pruritus Numerical Rating Scale (NRS) Score Throughout the Study Observation Period(Baseline up to Week 104)
- Change From Baseline in Pruritus NRS Score Throughout the Study Observation Period(Baseline up to Week 104)
- Absolute Measures in Skin Pain NRS Score Throughout the Study Observation Period(Baseline up to Week 104)
- Change From Baseline in Skin Pain NRS Score Throughout the Study Observation Period(Baseline up to Week 104)
- Absolute Measures in Fatigue NRS Score Throughout the Study Observation Period(Baseline up to Week 104)
- Change From Baseline in Fatigue NRS Score Throughout the Study Observation Period(Baseline up to Week 104)
- Absolute Measures in Sleep Quality Scale Throughout the Study Observation Period(Baseline up to Week 104)
- Change From Baseline in Sleep Quality Scale Throughout the Study Observation Period(Baseline up to Week 104)
- Number of Participants With Adverse Events (AEs), Serious AEs, Adverse Drug Reactions (ADRs) and Serious ADRs Throughout the Study Observation Period(Baseline up to Week 104)