Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Mean SALT
研究概览
简要总结
The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.
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
- 2 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with alopecia areata between 2 to 18 years old
- •Patients diagnosed with alopecia areata according to AA guideline
- •AA Patients treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months
排除标准
- •Patients had previously received hair implants
- •Other alopecia
- •Other diseases may induce alopecia including psoriasis, lichen planus, et al.
- •Unable to estimate SALT score at baseline or at follow-up
- •Patients are participating in other clinical trials
研究组 & 干预措施
Tofacitinib treated group
In the real-world settings, patients with AA treated with tofacitinib.
干预措施: Tofacitinib (Drug)
Baritinib treated group
In the real-world settings, patients with AA treated with baritinib.
干预措施: Baricitinib (Drug)
Ruxolitinib treated group
In the real-world settings, patients with AA treated with ruxolitinib
干预措施: Ruxolitinib (Drug)
Upadacitinib treated group
In the real-world settings, patients with AA treated with upadacitinib.
干预措施: Upadacitinib (Drug)
Abrocitinib treated group
In the real-world settings, patients with AA treated with abhicitinib.
干预措施: Abrocitinib (Drug)
Ritlecitinib treated group
In the real-world settings, patients with AA treated with ritlecitinib.
干预措施: Ritlecitinib (Drug)
结局指标
主要结局
Mean SALT
时间窗: at week 24
Reduction of Severity of Alopecia Tool (SALT) score compared with baseline
SALT50
时间窗: at week 24
Percentage of patient with more than 50% improvement in SALT score
SALT75
时间窗: at week 24
Percentage of patient with more than 70% improvement in SALT score
次要结局
- Mean SALT(at week 12, 36, 48, 56)
- Safety profile(at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56)
- SALT50(at week 12, 36, 48, 56)
- SALT75(at week 12, 36, 48, 56)