LITFULO® CAPSULES SPECIAL INVESTIGATION
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 664
- 试验地点
- 1
- 主要终点
- Proportion of participants with adverse events (AEs)
研究概览
简要总结
The objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug.
详细描述
This study is an open-label, multi-center, one arm prospective observational cohort study of patients receiving this drug. The investigators complete the CRF based on the information extracted from the medical record created in daily medical practice.
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •Patients with alopecia areata who start receiving this drug for the first time after the contract date of this study
- •Patients who have not participated in a clinical trial (clinical study) of this drug
排除标准
- •Patients meeting any of the following criteria will not be included in the study:
- •Patients previously enrolled in this study
- •Patients with a history of treatment with this drug (including investigational product)
研究组 & 干预措施
Japanese participants with alopecia areata
Japanese participants with alopecia areata
干预措施: LITFULO (Drug)
结局指标
主要结局
Proportion of participants with adverse events (AEs)
时间窗: Baseline through year 3
Percentage of patients achieving SALT≤20 [SALT score (absolute value) 20 or less]
时间窗: Baseline, evaluation at Week 12, Week 24 , Week 48, Week 78 , Week 104 , Week 130 , and Week 156 after the start of administration.
The percentage of patients who achieved SALT ≤ 20 (absolute SALT score of ≤ 20) will be calculated at baseline (including the first day of treatment) and each evaluation time point after the start of treatment with this drug.
次要结局
未报告次要终点