NCT05020873终止不适用
Prospective, Observational Study in Sickle Cell Disease Patients on Crizanlizumab Treatment in Middle East Countries and India (SPOTLIGHT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Annualized rate of healthcare visit and home-managed (VOCs) requiring a medical facility visit
研究概览
简要总结
This is a multicenter, prospective, single-arm observational non-interventional study (NIS), which will be conducted in various countries in the Middle East and India.
详细描述
The study is designed to collect information on the utilization and effectiveness of crizanlizumab treatment in SCD patients under routine clinical practice conditions, to which the physician has made an independent decision to prescribe crizanlizumab.
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
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with clinical diagnosis of SCD (based on laboratory parameters) of any genotype.
- •Patients newly initiated on treatment with locally approved crizanlizumab.
- •Patients aged 16 years or older at crizanlizumab initiation.
排除标准
- •Patients who did not provide informed consent.
- •Patients who received a stem cell transplant at time of enrollment.
- •Patients who participated in or are participating in a clinical trial at time of enrollment or in the 12 months prior to starting commercial crizanlizumab.
- •According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reasons such as unavailability or severe concomitant illnesses.
结局指标
主要结局
Annualized rate of healthcare visit and home-managed (VOCs) requiring a medical facility visit
时间窗: 12 months
The annualized rate of VOCs is defined as the total number of pain crises for a patient occurring from the date of initial infusion with crizanlizumab (commercially available) to the last contact date of the study end date × 365 divided by the number of days during that same time period. This calculation accounts for early dropouts or lost to follow-up by extrapolating the VOC rate of every patient to 1 year.
次要结局
- Type of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home.(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Dose of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home.(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Duration of healthcare visit and home-managed (VOCs) leading to hospitalization(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Frequency of patients on blood transfusions(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Type of healthcare visit and home-managed (VOCs) leading to hospitalization(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Annualized rate home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S.(month 12 and month 24)
- Outcome of healthcare visit and home-managed (VOCs) leading to hospitalization(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Number of home managed healthcare visit and home-managed (VOCs) as captured in the medical records and as per data from the SCPD-S.(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Percentage of patients free from healthcare visit and home-managed (VOCs) leading to a healthcare visit(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Duration of use of opioids for pain management of healthcare visit and home-managed (VOCs) within the medical facility and at home.(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Percentage of patients with acute and chronic complications/ end organ damage related to SCD(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Frequency of patients with SCD-related Healthcare Resource Utilization (HRU)(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Number of healthcare visit and home-managed (VOCs) leading to hospitalization(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
- Number of patients with clinical laboratory parameters abnormalities(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
研究者
研究点 (1)
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