Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting - Light Version
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 7
- 主要终点
- Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
研究概览
简要总结
The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC).
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
- 是
入选标准
- •Participant with diagnosis of moderate or severe chronic plaque PSO documented in the medical chart.
- •Participant who needs systemic biologic therapy and qualifies for treatment with an IL-23p19 inhibitor. Tildrakizumab must be the anti-Il-23p19 selected therapy before including the patient in the study.
- •Participant aged greater than or equal to (>=) 18 years at Inclusion.
- •Written informed consent.
排除标准
- •Participant unable or unwilling to comply with the requirements of the study.
- •Participant who should not participate in the study for any reason at the discretion of the treating physician.
- •Participants participating in a simultaneous clinical trial.
- •Any contraindication against the use of Tildrakizumab according to the SmPC.
- •Exposure to >= 3 biologics prior to inclusion.
- •Participant dependent on the investigator, e.g. as employee
研究组 & 干预措施
Tildrakizumab
Participants who received Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the SmPC will be observed for Week 28.
干预措施: Tildrakizumab (Drug)
结局指标
主要结局
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
时间窗: Baseline to Week 28
The WHO-5 is a widely used self-reported questionnaire designed to measure subjective well-being. It assesses the individual's overall psychological well-being and quality of life. The WHO-5 consists of five simple questions that ask respondents to rate their well-being over the past two weeks. The questions cover aspects such as positive mood, vitality, and general interest in life. The questionnaire is scored on a scale from 0 to 100, with higher scores indicating better well-being.
次要结局
- Number of Participants with Psoriasis Treatment on Physician's Satisfaction(Baseline, Week 28)
- Change from Baseline in Relative PASI Score(Baseline, Week 16 and 28)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score(Baseline, Week 16 and 28)
- Number of Participants Achieving Scalp Specific Physician's Global Assessment (PGA) Score(Baseline, Week 16 and 28)
- Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score(Baseline, Week 16 and 28)
- Number of Participants Achieving Nail Specific PGA Score(Baseline, Week 16 and 28)
- Change from Baseline in Patient´s Assessment of Itch, Pain and Joint Pain as Measured by Numerical Rating Scale (NRS)(Baseline, Week 16 and 28)
- Number of Participants Achieving Palmoplantar PGA Score(Baseline, Week 16 and 28)
- Number of Participants with Psoriasis (PSO) on Family and Partners by Family PSO Questionnaire(Baseline, Week 16 and 28)
- Hospital Anxiety and Depression Scales (HADS) Questionnaire(Baseline, Week 16 and 28)
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(Baseline, Week 16 and 28)
- Correlations Between the Aforementioned Parameters, in Particular WHO-5 and HADS(Baseline, Week 16 and 28)
- Correlations Between the Aforementioned Parameters, in Particular WHO-5 and FACIT-F(Baseline, Week 16 and 28)