A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Abrocitinib.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis, Eczema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treating Atopic Dermatitis With Abrocitinib and Its Impact in Real Life: An Observational Cohort Study To Describe the Effectiveness of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis.
Overview
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).
Interventions
- Drug Abrocitinib
Study Drug for Observational Data Collection
Primary outcome measures
- 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 weeks]
Secondary outcome measures (12)
- 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 months]
- Change in Eczema Area and Severity Index (EASI) score from baseline [Time frame: 16 weeks and at 12, 18, and 24 months]
- Proportion of patients with an EASI75 and EASI90 [Time frame: at 16 weeks and at 12, 18, and 24 months]
- Time to Peak Pruritis-Numerical Rate Scale (PP-NRS) response (improvement of ≥2 points from baseline) [Time frame: at 2, 16 weeks]
- PP-NRS (response improvement of ≥2 points or ≥4 points from baseline) [Time frame: at 2, 16, 24 weeks and at 12 months]
- Absolute change from baseline in PP-NRS score [Time frame: at 2, 16, and 24 weeks, and at 12 months]
- Absolute change from baseline Atopic Dermatitis Control Test (ADCT) score [Time frame: at 16 and 24 weeks, and at 12, 18, and 24 months]
- Absolute changes from baseline score of Epworth sleepiness scale [Time frame: at 2, 16, and 24 weeks, and at 12 months]
- Proportion of patients with ≤2 days per week of topical therapies applications, on average, in the last 4 weeks [Time frame: at 24 weeks and at 12 months]
- Duration of Drug Therapy [Time frame: Baseline to 24 months]
- Duration of each dosage [Time frame: Baseline to 24 months]
- Proportion of patients with each regimen and changes over the treatment period [Time frame: Baseline to 24 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Patients participating in a clinical study assessing a medicinal treatment (patients can participate in registries and observatories).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 30 centers
- CHU Amiens-Picardie - Site Nord — Amiens
- CHU Besancon - Hopital Jean Minjoz — Besançon
- Polyclinique Reims Bezannes — Bezannes
- Chu Bordeaux Hopital Saint Andre — Bordeaux
- CHU Brest Hopital Morvan — Brest
- CHU de Caen — Caen
- Ch de Calais — Calais
- Ch William Morey — Chalon-sur-Saône
- … and 22 more centers
Identifiers
NCT: NCT05689151 · B7451096 · ADAIR