Effectiveness and Safety of Tildrakizumab in the Treatment of Genital Psoriasis in Austria, Switzerland, and the Czech Republic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of "Clear" (0) or "Almost Clear" (1)
研究概览
简要总结
The main aim of this study is to check the safety and effectiveness of tildrakizumab regarding the alleviation of symptoms in the genital area after administration according to the summary of product characteristics (SmPC) and to access overall treatment safety and quality of life assessed on multiple scales.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of psoriasis, with significant involvement of genital regions, i.e., sPGA-G greater than or equal to (>=)
- •Need for systemic biologic therapy based on the local country specific regulations. Tildrakizumab, in accordance with the SmPC, must be the anti-IL23p19 selected therapy before including the patient in the study.
- •Age 18 - 99 years.
- •Informed consent in writing in accordance with applicable country regulations
- •Patient must have plaque psoriasis affecting a body surface area (BSA) >= 1% in a non-genital area at baseline.
- •Patient willing and able to fill out study questionnaires.
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.
- •Patient exposed to any experimental treatment in the past 3 months prior to baseline.
- •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, including but not restricted to employees of the study site.
- •Previous treatment with Tildrakizumab.
研究组 & 干预措施
Tildrakizumab
Participants who have been prescribed tildrakizumab in the treatment of plaque psoriasis with a manifestation in the genital area according to SmPC in routine clinical practice settings will be observed prospectively for up to 52 weeks.
干预措施: Tildrakizumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of "Clear" (0) or "Almost Clear" (1)
时间窗: Baseline up to Week 52
The sPGA-G is a 5-point score ranging from 0 to 4, with a larger score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of psoriatic genital lesions.
Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score
时间窗: Baseline up to Week 52
mGPASI determines participants psoriasis severity in the genital region at a given time point yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Scoring index incorporates the degree of erythema (or redness), induration (or thickness), and scaling) of the genital plaques as well as erosion, fissure, and/or ulcer as a product of the genital area involved.
次要结局
- Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Score(Baseline, Week 4, 16, 28 and 52)
- Change From Baseline in the Dermatological Life Quality Index (DLQI) Score(Baseline, Week 4, 16, 28 and 52)
- Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score(At Week 28 and 52)
- Change from Baseline in Physician's Global Assessment (PGA) Score(Baseline, Week 4, 16, 28 and 52)
- Change From Baseline in World Health Organisation - 5 Well-Being Index (WHO-5) Score(Baseline, Week 28 and 52)
- Change From Baseline in Pain, Itch, and Discomfort on Numerical Rating Scales (NRS) for the Genital Region(Baseline, Week 4, 16, 28 and 52)
- Change From Baseline in Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Score(Baseline, Week 28 and 52)