NCT03982394已完成不适用
Multi-Country Prospective ObserVAtionaL, Cohort Study of Patients With Moderate to Severe Chronic PlaqUE Psoriasis (VALUE)
AbbVie302 个研究点 分布在 4 个国家目标入组 2,759 人开始时间: 2019年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,759
- 试验地点
- 302
- 主要终点
- Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 90
研究概览
简要总结
This study will assess the use of risankizumab in adult patients with moderate to severe chronic plaque psoriasis and compare risankizumab to other commonly used 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
- •Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a specialist and presence of moderate to severe psoriasis symptoms according to physician's judgement at time of recruitment.
- •Participant starting any approved treatment for psoriasis and physician's decision must be reached prior to recruitment in the study.
- •Participant willing to continue with study documentation after cessation of therapy.
排除标准
- •Unwillingness or inability to comply with study requirements.
- •Participation in an interventional clinical trial, concurrently or within the last 30 days. Participation in a post-market observational study (PMOS) or Registry is acceptable.
结局指标
主要结局
Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 90
时间窗: From Month 4 to 3 years
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
Time to first treatment change
时间窗: From Week 0 (Baseline) to first treatment change
Identify time to first treatment change including discontinuation, dose escalation and dosing interval shortening
次要结局
- Change in Dermatology Quality of Life Index (DLQI) Score(From Week 0 to up to 3 years)
- Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score(From Week 0 to up to 3 years)
- Time to first treatment change rate(At 1 year, 2 year, and 3 year)
- Time to achieve sPGA 0/1 or sPGA 0(Up to 3 years)
- Percentage of participants who achieved PASI 90 or PASI 100 at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval(At 4 months and 1 year, 2 years, and 3 years)
- Change in PASI(From Week 0 to up to 3 years)
- Percentage of participants who achieve sPGA 0/1 or sPGA 0 at 4 Months and maintained the response status at 1 Year, 2 Years and 3 Years without increasing the dose or shortening the dose interval(At 4 months to 1 year, 2 years, and 3 years)
- Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75, 90, or 100(Monthly for up to 3 years)
- Percentage of participants who achieve DLQI 0/1(Monthly for up to 3 years)
- Percentage of participants who achieved Static Physicians Global Assessment (sPGA) 0/1 or sPGA 0(Monthly for up to 3 years)
- Percentage of participants who achieved Absolute PASI<=5, <=3 or <=1(Monthly for up to 3 years)
- Time to achieve PASI 75, 90,or 100(Up to 3 years)
- Change in Body Surface Area (BSA)(From Week 0 to up to 3 years)
研究者
研究点 (302)
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