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临床试验 NCT06573593 针对斑秃，Janus Kinase Inhibitors目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study 150 真实世界证据
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临床试验NCT06573593是一项针对斑秃，Janus Kinase Inhibitors的观察研究试验，目前试验状态为招募中。试验始于2024年7月29日，计划招募150名患者。该研究由Second Affiliated Hospital, School of Medicine, Zhejiang University主导，预计于2026年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年8月27日。
简要概括
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 disea...显示更多
官方标题
Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study
疾病
斑秃Janus Kinase Inhibitors其他研究标识符
- 20240699
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Tofacitinib treated group In the real-world settings, patients with AA treated with tofacitinib. | Tofacitinib In the real-world settings, patients with AA treated with tofacitinib. |
Baritinib treated group In the real-world settings, patients with AA treated with baritinib. | Baricitinib In the real-world settings, patients with AA treated with Baricitinib. |
Ruxolitinib treated group In the real-world settings, patients with AA treated with ruxolitinib | 鲁索利替尼 In the real-world settings, patients with AA treated with Ruxolitinib. |
Upadacitinib treated group In the real-world settings, patients with AA treated with upadacitinib. | 乌帕替尼 In the real-world settings, patients with AA treated with Upadacitinib. |
Abrocitinib treated group In the real-world settings, patients with AA treated with abhicitinib. | Abrocitinib In the real-world settings, patients with AA treated with Abrocitinib. |
Ritlecitinib treated group In the real-world settings, patients with AA treated with ritlecitinib. | Ritlecitinib In the real-world settings, patients with AA treated with Ritlecitinib. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Mean SALT | Reduction of Severity of Alopecia Tool (SALT) score compared with baseline | at week 24 |
SALT50 | Percentage of patient with more than 50% improvement in SALT score | at week 24 |
SALT75 | Percentage of patient with more than 70% improvement in SALT score | at week 24 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Mean SALT | Reduction of Severity of Alopecia Tool (SALT) score compared with baseline | at week 12, 36, 48, 56 |
SALT50 | Percentage of patient with more than 75% improvement in SALT score | at week 12, 36, 48, 56 |
SALT75 | Percentage of patient with more than 50% improvement in SALT score | at week 12, 36, 48, 56 |
Safety profile | Any adverse events including infection, hypohepatia, thrombus, gastrointestinal reaction and any other system events. | at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
最低年龄要求
2 Years
适龄性别
全部
- 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
- 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
Second Affiliated Hospital, School of Medicine, Zhejiang University研究中心联系人
联系人: Ru Dai, MD, 15982215914, [email protected]
联系人: Wu, [email protected]
1 位于 1 个国家/地区的研究中心
Zhejiang
Second Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, 310009, China
Ru Dai, Ph.D, 联系人, 86 15982215914, [email protected]
招募中