A Non-interventional, Prospective Cohort, Multicentre, Real-world Evidence Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis in Austria and Switzerland
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score
研究概览
简要总结
The main aim of this study is to assess the effects of switching from another biologic to tildrakizumab on patient-reported outcomes and to assess psoriasis intensity, patient's quality of life prior and after switching and the individual rationales for switching biologics.
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
- •Written informed consent.
- •>=18 years of age.
- •Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFα antagonist, IL12/23 antagonist, IL17 antagonist).
- •Switch to tildrakizumab due to:
- •primary or secondary treatment failure (PASI >= 3 or ΔPASI < 75 and/or DLQI > 5)
- •adverse events, contraindication, intolerance
- •patient wish (dosing regimen), lack of adherence, or other, including nonmedical reason
- •Treatment with tildrakizumab planned in the frame of clinical practice.
排除标准
- •Patient appears to be unwilling or unable to comply with the requirements of the study or who, in the opinion of the Investigator, should not participate in the study.
- •>=3 previous biologic treatments in the last 3 years.
- •Participation in a clinical trial simultaneous to participation in SW-ATCH.
- •Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance.
- •Patient dependent on the Investigator.
- •Previous treatment with Tildrakizumab.
研究组 & 干预措施
Tildrakizumab
Participants who have been prescribed tildrakizumab to manage moderate-to-severe plaque psoriasis according to summary of product characteristic (SmPC) in routine clinical practice settings will be observed prospectively for up to 28 weeks.
干预措施: Tildrakizumab (Drug)
结局指标
主要结局
Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score
时间窗: Baseline, Week 28
TSQM 11-item scale is derived from the TSQM version 1.4, which comprises four domains: global satisfaction, medication effectiveness, convenience, and side effects with scores at each domain ranging from 0 to 100. Higher scores indicating greater satisfaction and lower scores reflecting room for improvement.
World Health Organisation Well-Being Index (WHO-5) Score
时间窗: Baseline up to Week 28
The WHO-5 consists of 5-items that measure current mental well-being. Each item is rated on 6-point Likert scale, ranging from 0 (at no the time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
次要结局
- Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab(At Baseline)
- Change from Baseline in Physician's Global Assessment (PGA) Score(Baseline, Week 4, 16 and 28)
- Change from Baseline in absolute Psoriasis Area and Severity Index (PASI) Score(Baseline, Week 4, 16 and 28)
- Change from Baseline in Dermatology Life Quality Index (DLQI) Score(Baseline, Week 4, 16 and 28)