Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients diagnosed with alopecia areata treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months in Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tofacitinib
DrugIn the real-world settings, patients with AA treated with tofacitinib.
Baricitinib
DrugIn the real-world settings, patients with AA treated with Baricitinib.
Ruxolitinib
DrugIn the real-world settings, patients with AA treated with Ruxolitinib.
Upadacitinib
DrugIn the real-world settings, patients with AA treated with Upadacitinib.
Abrocitinib
DrugIn the real-world settings, patients with AA treated with Abrocitinib.
Ritlecitinib
DrugIn the real-world settings, patients with AA treated with Ritlecitinib.
Treatment groups
150 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Tofacitinib treated group1 intervention
Group B: Baritinib treated group1 intervention
Group C: Ruxolitinib treated group1 intervention
Group D: Upadacitinib treated group1 intervention
Group E: Abrocitinib treated group1 intervention
Group F: Ritlecitinib treated group1 intervention
Trial outcomes
Primary outcomes
1
Mean SALT
Reduction of Severity of Alopecia Tool (SALT) score compared with baseline
Time frame
at week 242
SALT50
Percentage of patient with more than 50% improvement in SALT score
Time frame
at week 243
SALT75
Percentage of patient with more than 70% improvement in SALT score
Time frame
at week 24Secondary outcomes
1
Mean SALT
Reduction of Severity of Alopecia Tool (SALT) score compared with baseline
Time frame
at week 12, 36, 48, 562
SALT50
Percentage of patient with more than 75% improvement in SALT score
Time frame
at week 12, 36, 48, 563
SALT75
Percentage of patient with more than 50% improvement in SALT score
Time frame
at week 12, 36, 48, 564
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, 56Sponsors and contacts
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Source ClinicalTrials.gov