A Registry of Patients With Moderate to Severe Chronic Plaque Psoriasis in Canada and Latin AmErica (LACan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,376
- 试验地点
- 13
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
The main purpose of the current study will be to provide real - world evidence regarding the safety and effectiveness of secukinumab in the management of patients with moderate to severe chronic plaque psoriasis.
详细描述
PURE is a multi-national, prospective, observational cohort study of patients with moderate to severe chronic plaque psoriasis aimed at assessing the real-world safety and effectiveness of secukinumab and other indicated therapies. The study will enroll patients for whom, prior to and independent of study enrollment, the treating physician has decided to treat with secukinumab, or one of the other indicated therapies regimens approved for the management of moderate to severe chronic plaque psoriasis.
Two study cohorts will be defined by patients treated with secukinumab (Cohort 1), and patients treated with other indicated therapies (systemic, phototherapy, or biologic therapy; Cohort 2). Each investigator will recruit approximately the same number of patients in each treatment arm. 2,500 patients (1,250 patients in each cohort) will be followed over a period of 5 years from the Baseline assessment (Visit 1).
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
- •- Patients able to give written informed consent
- •- Patients at least 18 years of age at time of informed consent signature
- •- Confirmed diagnosis of chronic moderate to severe chronic plaque-type psoriasis diagnosed by a specialist and presence of moderate to severe psoriasis symptoms according to physician's clinical judgment at the time of recruitment.
- •- Patients initiating a treatment for psoriasis as per regional policy. This will include secukinumab, other biologics, systemic treatments, and phototherapy. Decision to treat with any of the above-mentioned treatments must have been reached prior to and independently of recruitment in the study.
- •- Treatments prescribed in accordance to the product monograph and regional regulatory and reimbursement policies
- •- Patients able to understand and communicate with the investigator and comply with the requirements of the study.
排除标准
- •- Unwillingness or inability to comply with the study requirements
- •- Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
研究组 & 干预措施
Secikinumab
Patients treated with secukinumab
干预措施: Secikinumab (Drug)
Approved standard of care
Patients treated with other indicated therapies (systemic, phototherapy, or biologic therapy)
干预措施: Secikinumab (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Change from Baseline through month 60
Incidence of all adverse events in the study cohorts as measured by: 1. The proportion of patients that experience at least one event; and 2. The number of events per participant
次要结局
- Mean change for Work Productivity and Activity Impairment (WPAI) score(Change from Baseline through month 60)
- Mean change for Hospital Anxiety and Depression Scale (HADS) score(Change from Baseline through month 60)
- Mean change for Dermatology Life Quality Index (DLQI) score(Change from Baseline through month 60)
- Mean change for Psoriasis Symptom Diary (PSD) score(Change from Baseline through month 60)
- Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response(Change from Baseline through month 60)
- Mean change for Psoriasis Epidemiology Screening Tool (PEST) score(Change from Baseline through month 60)
- Mean change for direct and indirect cost associated to Psoriasis(Change from Baseline through month 60)
- Mean change for Treatment Satisfaction Scale (TSS) score(Change from Baseline through month 60)