RecruitingNCT05689151

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

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.


Sponsor

Pfizer

Enrollment

183 participants

Start Date

Mar 9, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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).

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Interventions

DRUGAbrocitinib

Study Drug for Observational Data Collection


Locations(30)

CHU Amiens-Picardie - Site Nord

Amiens, Somme, France

CHU Besancon - Hopital Jean Minjoz

Besançon, France

Polyclinique Reims Bezannes

Bezannes, France

Chu Bordeaux Hopital Saint Andre

Bordeaux, France

CHU Brest Hopital Morvan

Brest, France

CHU de Caen

Caen, France

Ch de Calais

Calais, France

Ch William Morey

Chalon-sur-Saône, France

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, France

Chu Estaing

Clermont-Ferrand, France

Hopital Henri Mondor

Créteil, France

Chu Dijon

Dijon, France

Hopital Franco Britannique

Levallois-Perret, France

Hopital Claude Huriez

Lille, France

CH de Martigues

Martigues, France

CHU Montpellier

Montpellier, France

Hopital Emile Muller

Mulhouse, France

Hopital Hotel Dieu

Nantes, France

Hopital Cochin

Paris, France

Hopital Tenon

Paris, France

Hopital Saint Louis (APHP) - Service Hematologic Senior

Paris, France

CHU Lyon Sud

Pierre-Bénite, France

Hopital Pontchaillou

Rennes, France

Ch de Romans Sur Isere

Romans-sur-Isère, France

Hopital Charles Nicolle

Rouen, France

Chi Poissy Saint Germain En Laye

Saint-Germain-en-Laye, France

Hopital Bégin

Saint-Mandé, France

Hopital Larrey

Toulouse, France

Ch de Valenciennes

Valenciennes, France

CHU Nancy

Vandœuvre-lès-Nancy, France

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NCT05689151


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