EffeCt Of Long-Term PsoRiasis ON PAtienTs' lifE- CORONATE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 543
- 试验地点
- 15
- 主要终点
- CORONATE Questionnaire Score
研究概览
简要总结
Psoriasis, is an inflammatory chronic skin disease which has a heavy physical and psychosocial impact on participant's life. This is a study to finalize and validate a questionnaire to assess the long-term effect of long-term psoriasis in adult participants.
Approximately 550 adult participants with moderate to severe plaque psoriasis will be enrolled in approximately 15 dermatology centers in Italy.
Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study. The duration of this study is up to 22 months.
There is no additional burden for participants in this study. Participants will attend regular visits during the course of the study at a hospital or clinic.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a diagnosis of moderate-to-severe plaque psoriasis (PASI≥10 or PASI<10 with involvement of sensitive areas) since at least 10 years.
- •Adult partner in relationship with the participant since at least 3 years(Part 2 only).
排除标准
- •Participants with psychiatric conditions.
结局指标
主要结局
CORONATE Questionnaire Score
时间窗: Up to 22 months
The CORONATE Questionnaire is a self-administered 25 item questionnaire used to assess the long term effect of moderate to severe psoriasis. Scores range from 0 (false) to 3 (true).
次要结局
未报告次要终点