A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.
ADAIR
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.
2 other identifiers
observational
183
1 country
30
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2023
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2023
CompletedFirst Posted
Study publicly available on registry
January 19, 2023
CompletedStudy Start
First participant enrolled
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
December 8, 2025
December 1, 2025
3.2 years
January 9, 2023
December 5, 2025
Conditions
Keywords
Outcome Measures
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
16 weeks
Secondary Outcomes (39)
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
12, 18 and 24 months
Change in Eczema Area and Severity Index (EASI) score from baseline
16 weeks and at 12, 18, and 24 months
Proportion of patients with an EASI75 and EASI90
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)
at 2, 16 weeks
PP-NRS (response improvement of ≥2 points or ≥4 points from baseline)
at 2, 16, 24 weeks and at 12 months
- +34 more secondary outcomes
Interventions
Study Drug for Observational Data Collection
Eligibility Criteria
Patients with a diagnosis of moderate to severe atopic dermatitis for whom the dermatologist has decided to initiate a treatment with Abrocitinib
You may qualify if:
- Patients that have been informed of the study procedures and have signed the consent.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (30)
CHU Amiens-Picardie - Site Nord
Amiens, Somme, 80080, France
CHU Besancon - Hopital Jean Minjoz
Besançon, 25000, France
Polyclinique Reims Bezannes
Bezannes, 51430, France
Chu Bordeaux Hopital Saint Andre
Bordeaux, 33075, France
CHU Brest Hopital Morvan
Brest, 29609, France
CHU de Caen
Caen, 14033, France
Ch de Calais
Calais, 62107, France
Ch William Morey
Chalon-sur-Saône, 71100, France
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, 63000, France
Chu Estaing
Clermont-Ferrand, 63003, France
Hopital Henri Mondor
Créteil, 94010, France
Chu Dijon
Dijon, 21000, France
Hopital Franco Britannique
Levallois-Perret, 92300, France
Hopital Claude Huriez
Lille, 59000, France
CH de Martigues
Martigues, 13698, France
CHU Montpellier
Montpellier, 34295, France
Hopital Emile Muller
Mulhouse, 68070, France
Hopital Hotel Dieu
Nantes, 44000, France
Hopital Cochin
Paris, 75014, France
Hopital Tenon
Paris, 75020, France
Hopital Saint Louis (APHP) - Service Hematologic Senior
Paris, 75475, France
CHU Lyon Sud
Pierre-Bénite, 69495, France
Hopital Pontchaillou
Rennes, 35033, France
Ch de Romans Sur Isere
Romans-sur-Isère, 26102, France
Hopital Charles Nicolle
Rouen, 76031, France
Chi Poissy Saint Germain En Laye
Saint-Germain-en-Laye, 78105, France
Hopital Bégin
Saint-Mandé, 94160, France
Hopital Larrey
Toulouse, 31000, France
Ch de Valenciennes
Valenciennes, 59322, France
CHU Nancy
Vandœuvre-lès-Nancy, 54511, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2023
First Posted
January 19, 2023
Study Start
March 9, 2023
Primary Completion (Estimated)
June 5, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
December 8, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.