A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPfizer
About this trial
The purpose of this study is to learn about the safety and effects of Abrocitinib in the real-life clinical setting given for the treatment of moderate to severe atopic dermatitis. Atopic dermatitis, or AD, is a long-lasting disease that causes inflammation, redness, and irritation of the skin.
This study is seeking participant who are older than 18 years with moderate-to-severe chronic AD. Participants must have no underlying medical conditions that prevent them from taking Abrocitinib.
All participants in this study will receive Abrocitinib as a tablet once daily. They can take Abrocitinib and use medicated topical treatment for AD at the same time.
We will examine the experiences of patients receiving the study medicine. This will help us determine if the study medicine is safe and helps in treating AD.
Participants will take part in this study for 24 months. During this time, they will visit the study clinic about 5 times (about 1 time every 4 to 6 months).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients older than 18 years of age at inclusion.
Patients with clinical diagnosis of moderate-to-severe chronic atopic dermatitis (also referred to as atopic eczema) at inclusion according to the investigator and eligible for abrocitinib according to its marketing approval.
Patients that have been informed of the study procedures and have signed the consent.
Disqualifiers
Patients for whom abrocitinib is contraindicated.
Patients unable to follow and respect the study procedures and judged inapt to respond to the questions required for the study due to linguistical, psychological, social, or geographical reasons.
Patients not affiliated to the French social security system.
Patients deprived of liberty, under guardianship, or unable to provide oral consent.
Trial population
Patients with a diagnosis of moderate to severe atopic dermatitis for whom the dermatologist has decided to initiate a treatment with Abrocitinib
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Abrocitinib
DrugStudy Drug for Observational Data Collection
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Proportion of patients with an Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5- point scale) and a reduction from baseline of ≥2 points
Time frame
16 weeksSecondary outcomes
1
Proportion of patients with an Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5- point scale) and a reduction from baseline of ≥2 points
Time frame
12, 18 and 24 months2
Change in Eczema Area and Severity Index (EASI) score from baseline
Time frame
16 weeks and at 12, 18, and 24 months3
Proportion of patients with an EASI75 and EASI90
Time frame
at 16 weeks and at 12, 18, and 24 months4
Time to Peak Pruritis-Numerical Rate Scale (PP-NRS) response (improvement of ≥2 points from baseline)
Time frame
at 2, 16 weeks Source ClinicalTrials.gov