Regulatory Post-Marketing Surveillance to Assess Safety and Effectiveness in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cosentyx®(Secukinumab) in Korea : a rPMS Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Number of participants having Adverse Events (AEs) and Serious Adverse Events (SAEs) within each indication
研究概览
简要总结
Regulatory Post-Marketing Surveillance in hidradenitis suppurativa, pediatric plaque psoriasis and JIA treated with Cosentyx®(secukinumab) in Korea
详细描述
This post-marketing study is a multicenter, single-arm, prospective, observational study.
Cosentyx is prescribed within the scope of the approved indications for hidradenitis suppurativa, pediatric plaque psoriasis, enthesitis-related arthritis and juvenile psoriatic arthritis in the juvenile idiopathic arthritis category. The decision to treat patients with the drug will be made within current clinical practice and will be clearly distinguished from the decision to include patients in this investigation. No additional diagnostics or monitoring will be performed for this study beyond what is typically performed in clinical practice.
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 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hidradenitis suppurativa:
- •Adults 18 years of age and older with moderate to severe hidradenitis suppurativa who are or will be receiving Cosentyx within the scope of approved indication.
- •Patients who have agreed to participate in study (written informed consent)
- •Pediatric plaque psoriasis:
- •Patients with moderate to severe plaque psoriasis between the ages of 6 and 18 years who are receiving or will receive Cosentyx within the scope of approved indication.
- •Patients with patient or guardian consent to participate in study (written informed consent)
- •Juvenile idiopathic arthritis:
- •Enthesitis related arthritis and juvenile psoriatic arthritis in juvenile idiopathic arthritis category patients with enthesitis related arthritis and juvenile psoriatic arthritis in juvenile idiopathic arthritis category between the ages of 6 and 18 years and are receiving or will receive Cosentyx within the scope of approved indication.
- •Patients with patient or guardian consent to participate in study (written informed consent)
排除标准
- •Patients who are contraindicated according to national prescribing information
- •Patients participating in other interventional clinical trials
研究组 & 干预措施
Secukinumab - HS
Participants with Hidradenitis Supurativa who are receiving or will receive Cosentyx after the start of this study in routine clinical practice.
干预措施: Secukinumab (Drug)
Secukinumab - Pediatric plaque psoriasis
Participants with pediatric plaque psoriasis who are receiving or will receive Cosentyx after the start of this study in routine clinical practice.
干预措施: Secukinumab (Drug)
Secukinumab - JIA
Participants with juvenile idiopathic arthritis who are receiving or will receive Cosentyx after the start of this study in routine clinical practice.
干预措施: Secukinumab (Drug)
结局指标
主要结局
Number of participants having Adverse Events (AEs) and Serious Adverse Events (SAEs) within each indication
时间窗: Up to 24 weeks
All AEs, regardless of severity or causality, will be collected from all participants enrolled in the study.
次要结局
- Proportion of participants by Hurley stage - HS participants(12 and 24 weeks)
- Change from baseline in active joints by Tender Joint Count (TJC) - JIA participants(12 and 24 weeks)
- Physician evaluation of participant symptoms(12 and 24 weeks)
- Proportion of paticipants achieving 50% reduction in hidradenitis suppurativa clinical response (HiSCR50) - HS participants(12 and 24 weeks)
- Proportion of participants achieving a severity of 0 or 1 on the hidradenitis supurativa-physician's global assessment (HS-PGA) - HS participants(12 and 24 weeks)
- Proportion of participants with a 55% or greater reduction in international hidradenitis suppurativa severity scoring system (IHS4-55) - HS participants(12 and 24 weeks)
- Proportion of participants with a ≥30% reduction in Hidradenitis suppurativa-related skin pain numerical rating scale (NRS) - HS participants(12 and 24 weeks)
- Proportion of participants with an Hidradenitis supurativa flare - HS participants(12 and 24 weeks)
- Change from baseline in Psoriasis Area and Severity Index (PASI) - Pediatric plaque psoriasis participants(12 and 24 weeks)
- Proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 - Pediatric plaque psoriasis participants(12 and 24 weeks)
- Change from baseline in active joints by swollen joint count (SJC)- JIA participants(12 and 24 weeks)
- Change from baseline in clinical juvenile arthritis disease activity score (cJADAS) - JIA participants(12 and 24 weeks)