Long-term Treatment Strategies and Effectiveness of Secukinumab in Juvenile Idiopathic Arthritis Patients of Psoriatic and Enthesitis-related Arthritis Categories: Secondary Use of Data and Primary Data Collection From the German BIKER Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Number of patients who had the following long-term treatment strategy after achieving inactive disease on secukinumab
研究概览
简要总结
The goal of this study is to understand the long-term treatment strategies in children and adolescents diagnosed with ERA or JPsA who received secukinumab and achieved inactive disease and to evaluate the long-term treatment effectiveness of secukinumab in the ERA or JPsA patients in the postauthorization setting.
详细描述
This is a multicenter, non-interventional cohort study with a combined data collection principle based on secondary use of data and primary data collection from the existing BIKER registry among pediatric patients with a recorded diagnosis of ERA or JPsA who have been treated with secukinumab.
The primary objective of this study is to characterize potentially less demanding long-term treatment strategies (e.g., dose tapering, treatment withdrawal followed by treatment re-initiation as needed) and to characterize their effectiveness (evaluated by occurrence of disease flares) in children and adolescents with Enthesitis-Related Arthritis (ERA) or Juvenile Psoriatic Arthritis (JPsA) categories documented in the German Biologics in pediatric rheumatology (BIKER) registry who received secukinumab and achieved inactive disease.
The date of first treatment/prescription of secukinumab will be considered as the index date. The baseline period to evaluate the demographic and clinical characteristics includes the index date and up to 1 year prior to the index date; if no record is available at the index date whichever record is closest to the index date will be used. For JIA-related variables, such as JIA-related manifestations, the evaluation will not have a specific time limit prior to the index date."
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In the BIKER registry, males and females ≥ 6 years old and ≤ 17 years old diagnosed with ERA according to the ILAR-criteria or JPsA according to the ILAR or the Vancouver criteria, who initiated at least one dose of secukinumab after it was approved in Germany and according to the label.
- •Written informed consent from parent/legal guardian and assent from minor patient (11-17 years of age) for participating in the BIKER registry and for this study enrolment.
排除标准
- •Patients taking other biologic immunomodulating agent(s) or Janus kinase (JAK) inhibitors concomitantly with secukinumab at index date.
- •Patients participating in any interventional trials at index date.
结局指标
主要结局
Number of patients who had the following long-term treatment strategy after achieving inactive disease on secukinumab
时间窗: Up to 5 years
Number of patients who had the following long-term treatment strategy after achieving inactive disease on secukinumab * Secukinumab treatment remained unchanged or dose was increased. * Dose tapering of secukinumab (by dose reduction or prolongation of treatment interval). * Increase of secukinumab dose after a tapering period. * Initiation of other biologics after a tapering period. * Entering a secukinumab-free period due to achieving inactive disease or clinical remission (stratified by those who discontinue secukinumab due to achieving inactive disease without achieving clinical remission and those who achieve clinical remission) * Re-initiation of secukinumab after a secukinumab-free period * Initiation of other biologics after a secukinumab-free period
Number of patients experiencing at least one episode of flare
时间窗: Up to 5 years
Number of patients experiencing at least one episode of flare: * Following inactive disease for patients whose secukinumab treatment remained unchanged or increased dose. * Following the start of tapering or discontinuation of secukinumab treatment after achieving inactive disease
次要结局
- Number of patients with following secukinumab treatment patterns(every 3 months after index date until end of follow-up, up to 5 years)
- Number of participants by reason for changes to treatment strategy(every 3 months after index date until end of follow-up, up to 5 years)
- Number of patients achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 criteria at follow-up(Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Number of patients achieving at least minimal disease activity(Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Number of patients achieving inactive disease(Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Number of patients achieving clinical remission(Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Number of patients achieving complete resolution of dactylitis and enthesitis.(Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Change from baseline in pain score(Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Change from baseline in JIA ACR criteria individual components(Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Change from baseline in JADAS-10 individual criteria:(Baseline, up to 5 years)
- Total dactylitis count(At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- JADAS-10 score(At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Change from baseline in swollen joint count(Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Change from baseline in tender joint count(Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Total enthesitis count(At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Enthesitis score(At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Number of participants by JIA-related manifestations(At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Modified Schoeber's test to assess axial mobility (ERA only).(At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Overall and nocturnal back pain NRS (ERA only).(At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Skin involvement using the Investigator Global Assessment Modified (IGA Mod) 2011 score (JPsA only).(At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Psoriasis Area Severity Index (PASI) (JPsA only).(At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years)
- Number of participants with relevant JIA-related manifestations(Baseline)
- Time from symptom onset to diagnosis of ERA or JPsA(Baseline)
- Disease duration at the time of secukinumab initiation(Baseline)
- Therapy duration prior to start of secukinumab(Baseline)
- Number of treatment lines prior to start of secukinumab(Baseline)
- Prior medication(Baseline)