A Study to Evaluate Ustekinumab in Clinical Practice in Patients With Plaque Psoriasis in Asia-Pacific Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 主要终点
- Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval
研究概览
简要总结
The purpose of this study is to determine how patients use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries.
详细描述
This is an open-label (all people know the identity of the medication), multicenter, Phase 4, observational study (no study medication was administered during the study) designed to assess how patients will use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries. The study will consist of 4 study visits which will take place over the duration of 1 year. At the first visit (ie, Week 0), eligibility for the study will be determined (it will be screening and baseline visit). At each subsequent visit (Weeks 16, 28, and 52), exposure to ustekinumab will be recorded, questionnaires for efficacy will be completed, and information about adverse events and concomitant medications will be collected. As many patient reported outcome questionnaires as possible will be administered, depending on the availability of validated translations. Safety will be assessed by monitoring of adverse events, vital signs and physical examination.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of plaque psoriasis, according to the dermatologists' clinical judgment
- •Agree to initiate treatment with ustekinumab on the same day as enrollment into the study
- •Have not received anti-IL12/23 therapies within 6 months prior to enrollment into the study
排除标准
- •Has difficulty understanding questions posed by any of the questionnaires
- •Are currently participating in an investigational drug clinical study
研究组 & 干预措施
Patients with plaque psoriasis
Patients with plaque psoriasis using ustekinumab in Asia-Pacific countries.
干预措施: No intervention (Drug)
结局指标
主要结局
Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval
时间窗: up to 52 weeks
Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval will be assessed at Weeks 0, 16, 28, 52.
次要结局
- Change from baseline (Week 0) in Dermatology Life Quality Index (DLQI) score(Baseline, Weeks 16, 28 and 52)
- Change from baseline (Week 0) in Nail Psoriasis Severity Index (NAPSI) score at Weeks 16, 28, and 52(Baseline, Weeks 16, 28 and 52)
- Change from baseline in productivity VAS at Weeks 16, 28, and 52(Baseline, Weeks 16, 28 and 52)
- Epidemiologic characteristics of the psoriasis population(Week 0)
- Number of patients achieving a DLQI improvement (reduction) of greater than or equal to 5 points(up to 52 weeks)
- Change from baseline (Week 0) in Patient Benefit Index (PBI) score at Weeks 16, 28, and 52(Baseline, Weeks 16, 28 and 52)
- Number of patients achieving PASI 50, 75, and 90 response (ie, at least 50%, 75% and 90% improvement in PASI)(up to 52 weeks)
- Number of patients with comorbidities (obesity, hypertension, diabetes, dyslipidemia, and heart disease)(up to 52 weeks)
- Health Economics/Medical Resource Utilization Questionnaire (HE/MRU)(up to 52 weeks)
- Change from baseline (Week 0) in Psoriasis Area and Severity Index (PASI) score at Weeks 16, 28 and 52(Baseline (Week 0), Weeks 16, 28 and 52)
- Change from baseline in EuroQol 5 Dimensional Questionnaire (EQ-5D) index score and EQ visual analog scale (VAS) at Weeks 16, 28, and 52(Baseline, Weeks 16, 28 and 52)
- Number of patients achieving a score of 0 or 1 in DLQI(up to 52 weeks)
- Number of patients achieving an improvement in PBI(up to 52 weeks)