TuBerculosis Incidence in AS, PsA or Pso Patients Treated With Secukinumab: Real World Evidence in Brazilian Environment (ToBeReal)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Number of Active Tuberculosis Cases per 1000 Patient-years in Biologic Naive Patients Treated With Secukinumab
研究概览
简要总结
This was a retrospective observational study that relied on data extracted from patient's chart review at the participating centers. Data was entered into an electronic Case Report Form (eCRF) designed to capture all relevant information to achieve the study objectives.
After the ethical approval for each participating site, the respective Investigator and/or designated qualified study staff were responsible for including all eligible patients in a consecutive manner and entering their information into the eCRF. Patients were primarily identified with ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis (PsO) diagnosis according to the International Classification of Diseases (ICD)-10 code (M45, M07, and L40, respectively). Alternatively, the written diagnosis from applicable departments, such as payment, computing, or data office were also used for patient screening. Potentially eligible patients had their charts reviewed for all selection criteria. Inclusion was performed up to the number of patients determined for each site prior to study initiation or up to completion of sample size. Patient's identification (name, address, and other identifiable data) was not collected and remained confidential.
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
- 未提供
结局指标
主要结局
Number of Active Tuberculosis Cases per 1000 Patient-years in Biologic Naive Patients Treated With Secukinumab
时间窗: Up to approximately 84 months
Biologic naive patients were defined as patients with no previous therapeutic exposure to biologic drugs. Biologic drugs considered were abatacept, adalimumab, certolizumab, etanercept, golimumab, guselkumab, infliximab, ixequizumab, tofacitinibe, and ustekinumab.
次要结局
- Number of Active Tuberculosis Cases per 1000 Patient-years in all Patients Treated With Secukinumab(Up to approximately 84 months)
- Number of Active Tuberculosis Cases per 1000 Patient-years in Secondary Naive Patients Treated With Secukinumab(Up to approximately 84 months)
- Number of Patients per Demographic Category(Baseline)
- Demographic: Age(Baseline)
- Demographic: Time to Follow-up From Secukinumab Initiation(Up to approximately 84 months)
- Number of Patients With Comorbidities up to Secukinumab Initiation(Baseline)
- Number of Patients per Comorbidity(Baseline)
- Number of Concomitant Medications Patients Received Before Secukinumab Initiation(Baseline)
- Number of Concomitant Medications Patients Received After Secukinumab Initiation(Up to approximately 84 months)
- Mean Number of Medications per Patient Before Secukinumab Initiation(Baseline)
- Mean Number of Medications per Patient After Secukinumab Initiation(Up to approximately 84 months)
- Number of Concomitant Medications Prescribed Before Secukinumab Initiation Categorized by Reason for Medication Prescription(Baseline)
- Number of Concomitant Medications Prescribed After Secukinumab Initiation Categorized by Reason for Medication Prescription(Up to approximately 84 months)
- Number of Most Frequent Medications Used for Comorbidities Before Secukinumab Initiation Categorized by Type of Medication(Baseline)
- Number of Most Frequent Medications Used for Comorbidities After Secukinumab Initiation Categorized by Type of Medication(Up to approximately 84 months)
- Number of Medications Prescribed for AS, PsA, or PSO Before Secukinumab Initiation Categorized by Type of Medication(Baseline)
- Number of Medications Prescribed for AS, PsA, or PSO After Secukinumab Initiation Categorized by Type of Medication(Up to approximately 84 months)
- Duration of Primary Diagnosis(Baseline)
- Duration of Secukinumab Treatment(Up to approximately 84 months)
- Number of Patients per Secukinumab Use Category(Up to approximately 84 months)
- Duration of Interruption of Secukinumab Treatment(Up to approximately 84 months)
- Number of Patients who Used an Immunobiologic Before Secukinumab(Baseline)
- Number of Patients who Tested Positive or Negative for Latent Tuberculosis Before Secukinumab Initiation(Approximately 6 months)
- Number of Patients who Received Prophylactic Antibiotic Therapy Among Those who Tested Positive for Latent Tuberculosis Before Secukinumab Initiation(Approximately 6 months)
- Number of Patients who Tested Positive or Negative for Latent Tuberculosis After Secukinumab Initiation(Up to approximately 84 months)
- Number of Patients who Received Prophylactic Antibiotic Therapy Among Those who Tested Positive for Latent Tuberculosis After Secukinumab Initiation(Up to approximately 84 months)
- Number of Patients not Tested for Tuberculosis Before Secukinumab Initiation With Prophylactic Antibiotic Use(Approximately 6 months)
- Number of Patients Without a Tuberculosis Test Before Secukinumab Initiation(Approximately 6 months)