A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.

Официальное название

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.

Обзор

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).

Вмешательства

• Препарат Abrocitinib
  Study Drug for Observational Data Collection

Первичные конечные точки

• 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 [Срок оценки: 16 weeks]

Вторичные конечные точки (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 [Срок оценки: 12, 18 and 24 months]
• Change in Eczema Area and Severity Index (EASI) score from baseline [Срок оценки: 16 weeks and at 12, 18, and 24 months]
• Proportion of patients with an EASI75 and EASI90 [Срок оценки: 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) [Срок оценки: at 2, 16 weeks]
• PP-NRS (response improvement of ≥2 points or ≥4 points from baseline) [Срок оценки: at 2, 16, 24 weeks and at 12 months]
• Absolute change from baseline in PP-NRS score [Срок оценки: at 2, 16, and 24 weeks, and at 12 months]
• Absolute change from baseline Atopic Dermatitis Control Test (ADCT) score [Срок оценки: at 16 and 24 weeks, and at 12, 18, and 24 months]
• Absolute changes from baseline score of Epworth sleepiness scale [Срок оценки: 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 [Срок оценки: at 24 weeks and at 12 months]
• Duration of Drug Therapy [Срок оценки: Baseline to 24 months]
• Duration of each dosage [Срок оценки: Baseline to 24 months]
• Proportion of patients with each regimen and changes over the treatment period [Срок оценки: Baseline to 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 30 центров

• 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
• … и ещё 22 центра

Идентификаторы

NCT: NCT05689151 · B7451096 · ADAIR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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