Psoriatic Disease and Related Manifestations; Real World Evidence in Brazilian Secukinumab Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before and 6 Months After Secukinumab Initiation
研究概览
简要总结
This was a retrospective observational study that relied on data extracted from patient chart review at the participating sites. At least 12 months of patient data was verified, comprising at least 6 months (pre-period) and 6 months (post-period) after secukinumab initiation (index date). All data extracted from patient charts was entered into an electronic case report form (eCRF), specifically designed to capture all variables needed for the study data analysis.
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
- •Adult patients aged ≥18 years at index date.
- •Patients with PsO diagnosed with PsA (concomitant or sequentially), either by a rheumatologist or dermatologist, at least 6 months prior to initiation of secukinumab treatment.
- •Continuously treated with secukinumab for at least 24 weeks (6 months) after index date.
- •Medical history available from at least the one-year study period (at least 6 months previous to the start of secukinumab treatment and at least 6 months after).
排除标准
- •Patients who interrupted secukinumab treatment for 3 or more months during the 6-month period (post-period) for any cause.
- •Patients known to be participating in an interventional study at any point of the one-year study period.
结局指标
主要结局
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before and 6 Months After Secukinumab Initiation
时间窗: Up to 1 year
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before Secukinumab Introduction Who Experienced Reduced or Eliminated Manifestations During 6 Months of Secukinumab Treatment
时间窗: Up to 1 year
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before Secukinumab Introduction Who Experienced Increased Clinical Manifestations During 6 Months of Secukinumab Treatment
时间窗: Up to 1 year
Proportion of Patients With Disease-related Clinical Manifestations at the Time of Secukinumab Introduction Who Experienced Reduced or Eliminated Manifestations During 6 Months of Secukinumab Treatment
时间窗: Up to 6 months
Proportion of Patients With Disease-related Clinical Manifestations at the Time of Secukinumab Introduction Who Experienced Increased Manifestations During 6 Months of Secukinumab Treatment
时间窗: Up to 6 months
次要结局
- Age(Baseline)
- Gender(Baseline)
- Ethnicity(Baseline)
- Time Since First PsA Symptoms(Baseline)
- Time Since First PsO Symptoms(Baseline)
- Proportion of Patients With Disease-related Clinical Manifestations at Diagnosis(Baseline)
- Proportion of Patients per Screening Tool Used for PsA and PsO Diagnosis(Up to 1 year)
- Psoriasis Area and Severity Index (PASI)(Up to 1 year)
- Body Surface Area (BSA)(Up to 1 year)
- Dermatology Life Quality Index (DLQI)(Up to 1 year)
- Disease activity in PsA (DAPSA)(Up to 1 year)
- Health Assessment Questionnaire Disability Index (HAQ-DI)(Up to 1 year)
- Proportion of Patients per Treatment History Prior to Secukinumab Initiation(Up to 6 months)
- Proportion of Patients per Line of treatment (LOT) of PsA/PsO-target Treatment Before Secukinumab Initiation(Up to 6 months)
- Proportion of Patients With Disease-related Clinical Manifestations per Biologic Naïve and Non-biologic Naïve Patients, Categorized by Disease Severity(Up to 6 months)
- Proportion of Patients With Concomitant Medications, per Category(Up to 1 year)