NCT06600009已完成不适用
Treatment Persistence of Biologics in Patients with PsA in Japan; Retrospective Cohort Study Using a Claims Database (The FLYWAY Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- Number of Patients with Persistence of Secukinumab Treatment at One Year
研究概览
简要总结
This study was a retrospective non-interventional cohort study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The study setting was defined as follows:
- The inclusion period covered 01 February 2015 to 30 September 2020.
- The study period covered 01 August 2014 to 30 September 2021 inclusive.
- The index date was defined as the date of the first prescription of secukinumab or adalimumab within the inclusion period.
- The pre-index period was defined as the 6-month period before the index date (exclusive).
- Patients were followed until death, discontinuation of treatments of interest or end of the study period, whichever occurred first.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Having a biologic agent overdose (over 300 mg for secukinumab and over 80 mg for adalimumab) observed during the study period (off-label),
- •Having at least one record of secukinumab (for secukinumab patients) or adalimumab (for adalimumab patients) retrieved during the pre-index period.
研究组 & 干预措施
Secukinumab
Patients had received secukinumab treatment.
干预措施: Secukinumab (Drug)
Adalimumab
Patients had received adalimumab treatment.
干预措施: Adalimumab (Drug)
结局指标
主要结局
Number of Patients with Persistence of Secukinumab Treatment at One Year
时间窗: 1 year
次要结局
- Sex(Baseline)
- Age(Baseline)
- Number of Patients, Categorized by Medical Facility Department(Baseline)
- Height(Baseline)
- Weight(Baseline)
- Body Mass Index (BMI)(Baseline)
- Time from PsA Diagnosis to Index Date, Categorized by Medical Facility Department(Up approximately 6 months)
- Number of Patients with Comorbidities, by Category(Baseline)
- Number of Patients on Concomitant Treatments(Baseline)
- C-reactive Protein (CRP)(Baseline)
- Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Still Treated with the Drug at the End of Follow-up(Up to approximately 5 years)
- Change in C-reactive Protein (CRP) Since Administration of Secukinumab or Adalimumab in Patients Who Discontinued the Drug(Up to approximately 5 years)
- Time from Index Date to the Start of Methotrexate Add-on(Up to approximately 5 years)
- Time from Index Date to Methotrexate Discontinuation in Methotrexate Naive Patients at Index Date(Up to approximately 5 years)
- Time from Index Date to Methotrexate Discontinuation in Methotrexate Experienced Patients at Index Date(Up to approximately 5 years)
- Secukinumab/adalimumab Dose at the Start of Methotrexate Add-on(Up to approximately 5 years)
- Secukinumab/adalimumab Dose at Methotrexate Discontinuation(Up to approximately 5 years)
- Number of Patients with Methotrexate Add-on During Follow-up(Up to approximately 5 years)
- Average Secukinumab/adalimumab Dose at Index Date(Baseline)
- Number of Patients with Persistence of Secukinumab or Adalimumab Treatment(24 weeks, 1 year, 1.5 years, 2 years, 2.5 years, and 3 years)
- Time from PsA Diagnosis to Index Date for Adalimumab Patients(Up approximately 6 months)
- Number of Adalimumab Patients, Categorized by Medical Facility(Baseline)
- Number of Patients with Presence or Absence of Methotrexate(Baseline)
研究者
研究点 (1)
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