A Special Drug Use-results Survey to Evaluate the Safety and Efficacy of Subcutaneous Administration of Cosentyx in Pediatric Patients With Psoriasis Vulgaris, Psoriatic Arthritis, or Pustular Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse events
研究概览
简要总结
This was a multicenter, centrally registered observational study without a control group. This observational study was a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during the observation period (52 weeks after the start of treatment with this drug) in pediatric patients with psoriasis vulgaris, psoriatic arthritis, or pustular psoriasis who received this drug.
详细描述
For patients who discontinued or completed this drug before the end of the observation period, the investigator recorded adverse events that occurred within 30 days after the day following the last administration of this drug, or the day of discontinuation of the survey (the day when discontinuation of the survey was judged), whichever is later, in the CRF.
If a patient withdraw consent, information was collected during the observation period up to the date of consent withdrawal.
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
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have obtained written consent from their legally acceptable representative to cooperate in this survey before the start of treatment with this drug
- •Patients aged less than 18 years at the start of treatment with this drug
- •Patients newly treated with this drug for any of the following diseases: Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis
排除标准
- •Prior treatment with this drug
- •Participation in an interventional study (e.g., a clinical trial) at the time of starting this drug.
结局指标
主要结局
Incidence of serious adverse events
时间窗: 52 weeks
Incidence of SAEs was collected
次要结局
- Subjects with psoriasis vulgaris and psoriatic arthritis: IGA mod 2011 with 0 or 1 response(Baseline, week 4, week 12, week 24 and week 52)
- Subjects with psoriasis vulgaris and psoriatic arthritis: PASI 75/90/100 response(Baseline, week 4, week 12, week 24 and week 52)
- All patients: Change from baseline in CDLQI(Baseline, week 4, week 12, week 24 and week 52)
- Subjects with psoriatic arthritis: Change from baseline in C-HAQ(Baseline, week 4, week 12, week 24 and week 52)
- Subjects with psoriatic arthritis: Change from baseline in JADAS -27(Baseline, week 4, week 12, week 24 and week 52)
- Subjects with pustular psoriasis: Change from Baseline in the Japanese Dermatological Association (JDA) Severity Index(Baseline, week 4, week 12, week 24 and week 52)
- Subjects with pustular psoriasis: General improvement in GPP(Baseline, week 4, week 12, week 24 and week 52)
- Incidence of adverse events and adverse drug reactions(52 weeks)
- Incidence of adverse events and adverse reactions included in the safety specifications(52 weeks)