Psoriatic Arthritis In Skin Clinics (PARIS) Study. A Multicentre, Observational, Descriptive Cross-Cultural Validation Study and Estimate of the Proportion of Patients With Psoriatic Arthritis Among Psoriasis Patients Attending Dermatology Clinics Selected for This Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Percentage of Participants With Psoriatic Arthritis
研究概览
简要总结
The purpose of this study is to conduct full psychometric testing of the Early Arthritis for Psoriatic Patients (EARP) questionnaire in Australian, Korean and Chinese populations
详细描述
This is a multicentre, observational, descriptive estimate of the proportion of participants with psoriatic arthritis among psoriasis participants attending dermatology clinics selected for this study. In addition, this study will involve full psychometric assessment of the Early psoriatic screening questionnaire (EARP) questionnaire with the aim of identifying and appropriately referring participants to a rheumatologist for review if their EARP score is 3 or greater at Screening (i.e. >= 3 at Visit 1).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be a man or woman aged 18 to 65 years of age, inclusive
- •The patient must have an established diagnosis of psoriasis (based upon clinical evidence, and documented medical history [19])
- •The patient must be able to read and write in the target language (English, Mandarin or Korean; or other relevant target languages)
- •Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
排除标准
- •An established diagnosis of psoriatic arthritis
- •Ever have received systemic treatment with a disease modifying antirheumatic drug (DMARD) for arthritis or spondylitis (inflammatory back pain)
- •Ever have received systemic treatment with a biologic therapy for psoriasis (including infliximab, golimumab, ustekinumab, adalimumab or etanercept)
- •A history of employment in or are currently employed in the healthcare industry; or
- •Participated in the translation and linguistic validation of the EARP questionnaire
结局指标
主要结局
Percentage of Participants With Psoriatic Arthritis
时间窗: Baseline up to Day 28
Percentage of participants with psoriatic arthritis will be assessed using formula: Number of participants diagnosed with psoriatic arthritis divided by total number of participants with psoriasis attending the dermatology clinic.
次要结局
未报告次要终点