Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study

Second Affiliated Hospital, School of Medicine, Zhejiang University150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Alopecia Areata Janus Kinase Inhibitors

Interventions

TofacitinibDRUG

In the real-world settings, patients with AA treated with tofacitinib.

BaricitinibDRUG

In the real-world settings, patients with AA treated with Baricitinib.

RuxolitinibDRUG

In the real-world settings, patients with AA treated with Ruxolitinib.

UpadacitinibDRUG

In the real-world settings, patients with AA treated with Upadacitinib.

AbrocitinibDRUG

In the real-world settings, patients with AA treated with Abrocitinib.

RitlecitinibDRUG

In the real-world settings, patients with AA treated with Ritlecitinib.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Mean SALT

Reduction of Severity of Alopecia Tool (SALT) score compared with baseline

Time frame: at week 24

SALT50

Percentage of patient with more than 50% improvement in SALT score

Time frame: at week 24

SALT75

Percentage of patient with more than 70% improvement in SALT score

Time frame: at week 24

Secondary Outcomes

Mean SALT

Reduction of Severity of Alopecia Tool (SALT) score compared with baseline

Time frame: at week 12, 36, 48, 56

SALT50

Percentage of patient with more than 75% improvement in SALT score

Time frame: at week 12, 36, 48, 56

SALT75

Percentage of patient with more than 50% improvement in SALT score

Time frame: at week 12, 36, 48, 56

Safety profile

Any adverse events including infection, hypohepatia, thrombus, gastrointestinal reaction and any other system events.

Time frame: at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56

Central Contacts

Ru Dai, MD

CONTACT

15982215914 dairu@zju.edu.cn

CONTACT

wuxianjie@zju.edu.cn

Data from ClinicalTrials.gov

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