A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,002
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving a 90% reduction in the Psoriasis Area and Severity Index (PASI) score
研究概览
简要总结
This non-interventional, prospective, multi-center study aims to provide short- and long- term treatment patterns, effectiveness, and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis (with and without PsA) initiating treatment of secukinumab.
详细描述
All patients will be followed up for 52 weeks no matter they adhere to secukinumab or they have shifted to other treatment plans. Data will be collected in conjunction with routine care visits, most likely happen at week 0, 4, 12, 16, 24, 36, 52. No extra study visits, examinations, laboratory tests or procedures will be mandated. If visits happen at other time points (not within the window period), then they will be counted as unscheduled visits.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years;
- •Diagnosis of clinically moderate to severe plaque-psoriasis;
- •Initiating treatment with secukinumab during the identification period or within 30 days prior to the index date;
- •Patient agrees to sign the informed consent
排除标准
- •Participation in any dermatology or rheumatology clinical trial, concurrent or within the last 30 days of the secukinumab initiating date
研究组 & 干预措施
secukinumab
Patients administered secukinumab by prescription
干预措施: secukinumab (Drug)
结局指标
主要结局
Percentage of patients achieving a 90% reduction in the Psoriasis Area and Severity Index (PASI) score
时间窗: week 24
The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.
次要结局
- Percentage of patients achieving DLQI 0 or 1 response(week 4, week12, week 16, week 24, week 36, week 52)
- Incidence of unexpected treatment related AEs/SAEs on-treatment and post-discontinuation follow up(52 weeks)
- Mean change of Investigator Global Assessment Mod 2011(IGA mod 2011)(week 4, week12, week 16, week 24, week 36, week 52)
- Frequency distribution of patients by dosing pattern(52 weeks)
- Frequency distribution of patients by secukinumab retention(Week 4, week 12, week 16, week 24, week 36 and week 52)
- Mean (SD) time to secukinumab discontinuation(Up to 52 weeks)
- Median (interquartile range) time to secukinumab discontinuation(52 weeks)
- Percentage of patients experiencing a 75% reduction of PASI (PASI75)(week 4, week12, week 16, week 24, week 36, week 52)
- Percentage of patients experiencing a 90% reduction of PASI (PASI90)(week 4, week12, week 16, week 36, week 52)
- Percentage of patients experiencing a 100% reduction of PASI (PASI100)(week 4, week12, week 16, week 24, week 36, week 52)
- Percentage of patients with absolute PASI change ≤1, ≤2, ≤3,and ≤5(week 4, week12, week 16, week 24, week 36, week 52)
- Percentage of patients with Investigator Global Assessment Mod 2011 (IGA mod 2011) 0 or 1(week 4, week12, week 16, week 24, week 36, week 52)
- Proportion of patients experiencing at least one AE(52 weeks)
- Percentage of patients achieved (Body Surface Area) BSA≤1%(week 4, week12, week 16, week 24, week 36, week 52)
- Mean change in Dermatology life quality index (DLQI)(Baseline,week 4, week12, week 16, week 24, week 36, week 52)
- Incidence of AEs/SAEs(52 weeks)
- Incidence of treatment-related AEs on-treatment and post-discontinuation follow up(52 weeks)
- Incidence of AEs of special interest on-treatment and post discontinuation follow up(52 weeks)
- Average number of AEs per patient(52 weeks)
- Percentage of secukinumab discontinuation caused by AE(52 weeks)
- Incidence of treatment-related SAEs on-treatment and post-discontinuation follow up(52 weeks)