Prospective Observational Study With Retrospective Part to Evaluate Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Moderate-to-severe Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Drug survival rate of secukinumab
研究概览
简要总结
Multicenter, non-interventional, cohort study in pediatric patients with moderate to severe plaque-type psoriasis. Retrospective data collection is planned at patients' inclusion.
详细描述
This observational study will be performed at healthcare facilities treating pediatric psoriasis patients. The study population will consist of a representative group of pediatric patients with moderate-to-severe plaque psoriasis for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 16 weeks Retrospective data collection is planned at patients' inclusion. Prospective data collection will continue during follow-up routine visits until secukinumab discontinuation or maximum duration of follow-up for 104 weeks after index date.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study.
- •Age ≥6 to <18 years old.
- •Established diagnosis of active moderate-to-severe plaque psoriasis defined as a PASI score ≥ 10, body surface area (BSA) involvement of ≥10% and PGA score ≥ 3 only or with concomitant psoriatic arthritis.
- •Failure or intolerance of prior psoriasis treatment.
- •Patient was prescribed with secukinumab within 4-16 weeks before inclusion.
- •Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of this non-interventional study conduct.
排除标准
- •Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
- •History of chronic recurrent infection.
- •Clinically significant infection exacerbation, including active tuberculosis.
- •Age <6 years or ≥18 years.
- •Pregnancy and breastfeeding.
- •Patients participating in parallel in an interventional clinical trial.
- •Patients participating in parallel in other Novartis-sponsored non-interventional study generating primary data for secukinumab.
- •Patients within the safety follow-up phase of interventional study.
- •Active inflammatory bowel disease at inclusion.
- •Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
- •Any medical or psychological condition in the investigator's opinion which may prevent the study participation.
结局指标
主要结局
Drug survival rate of secukinumab
时间窗: 52 weeks
Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab (defined as ≥2 missed consecutive doses with drug discontinuation proved by investigator in eCRF).
次要结局
- Proportion of patients achieving PASI 75 responses(Baseline (study inclusion), week 24, week 52, and week 104 after the index date)
- Proportion of patients achieving PASI 90 responses(Baseline (study inclusion), week 24, week 52, and week 104 after the index date)
- Time to treatment discontinuation due to ineffectiveness(Week 12, week 24, week 52, week 104)
- Proportion of patients discontinued secukinumab by reason(Week 12, week 24, week 52 and week 104)
- Proportion of patients achieving a physicians' global assessment (PGA) 0/1 response(Baseline (study inclusion), week 24, week 52, and week 104 after the index date)
- Secukinumab survival rates(Week 24, week 52, and week 104 after the index date)
- Proportion of patients achieving PASI 100 responses(Baseline (study inclusion), week 24, week 52, and week 104 after the index date)
- Adverse events (AEs) of special interest(Week 12, week 24, week 52, week 104 after the index date)
- Drug survival rate(104 weeks)