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Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study 150 Real-World Evidence
Clinical Trial NCT06573593 is an observational study for Alopecia Areata, Janus Kinase Inhibitors that is recruiting. It started on 29 July 2024 with plans to enroll 150 participants. Led by Second Affiliated Hospital, School of Medicine, Zhejiang University, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 27 August 2024.
Brief Summary
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...Show More
Official Title
Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study
Conditions
Alopecia AreataJanus Kinase InhibitorsOther Study IDs
- 20240699
NCT ID Number
Start Date (Actual)
2024-07-29
Last Update Posted
2024-08-27
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
150
Study Type
Observational
Status
Recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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 | Ruxolitinib 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. | Upadacitinib 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
2 Years
Eligible Sexes
All
- 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 UniversityStudy Central Contact
Contact: Ru Dai, MD, 15982215914, [email protected]
Contact: Wu, [email protected]
1 Study Locations in 1 Countries
Zhejiang
Second Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, 310009, China
Ru Dai, Ph.D, Contact, 86 15982215914, [email protected]
Recruiting