Clinical trial NCT05250115: A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
Official title: This is a Prospective, Single-arm, Multicenter, Observational Non-interventional Study (NIS) in Germany of Patient Characteristics, Usage, and Effectiveness of Abrocitinib in Patients With Moderate to Severe Atopic Dermatitis (AD)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dermatitis, Atopic
Keywords: Atopic Dermatitis
Abrocitinib
JAK inhibitors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-02-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective, single-arm, multi-center, observational non-interventional study looking at adult patients with moderate-severe atopic dermatitis, who have been chosen to start treatment with Abrocitinib in Germany according to the current routine practice of the treating physician.

Brief summary: The purpose of this non-interventional observational study is to learn about the safety and effects of the medicinal product (called Abrocitinib) for the potential treatment of moderate to severe atopic dermatitis (AD). AD is a long-lasting disease that causes redness and irritation of the skin. This non-interventional study is seeking participants who is eligible for Abrocitinib treatment according to the summary of product characteristics (SmPC):

* Are aged at least 18 years old
* Have a confirmed diagnosis of AD by a skin doctor
* Decide to start treatment with Abrocitinib as part of routine clinical practice
* Have a personally signed and dated informed consent document. This is used to indicate that the patient has been informed of all pertinent aspects of the study and data privacy aspects

Participants will take the medicinal product as prescribed in the real-world setting. We will examine the experiences of people receiving Abrocitinib. This will help us determine if the medicinal product is effective and safe. Participants will take part in this study for 3 months. During this time, participants will be followed up from the date of their first Abrocitinib prescription for 12 months. During this non-interventional study, some participants may switch to other therapies after their initial Abrocitinib therapy. We will follow these participants further when they switch therapy to monitor their experiences. Participant documentation is expected quarterly as per standard clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years
* Confirmed diagnosis of AD by dermatologist prior to study inclusion
* Patient for whom the decision to initiate treatment with abrocitinib was made as part of routine clinical practice irrespective of the patients being

  1. abrocitinib naive or,
  2. patients who reinitialize treatment with abrocitinib after being off treatment for ≥28 days prior to study inclusion
* Patient is eligible for abrocitinib treatment according to Summary of Product Characteristics (SmPC)
* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the non-interventional study

Exclusion Criteria:

* Contraindications according to SmPC
* Receipt of any investigational drug within 3 months or longer if required according to wash-out period prior to inclusion or participation in a clinical trial during observation period
* Patients being treated with abrocitinib within a time period of \<28 days prior to the timepoint of study inclusion
* Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the non-interventional study
* Patients who are unable to consent

Primary outcomes:
measure: Response based on achieving the IGA of clear (0) or almost clear (1)
timeFrame: Month 3
measure: Response based on achieving the EASI-75
timeFrame: Month 3
Secondary outcomes:
measure: Response based on achieving the IGA of clear (0) or almost clear (1)
timeFrame: Baseline, month 1, month 6, month 9, month 12
measure: Response based on achieving the EASI-75
timeFrame: Baseline, month 1, month 6, month 9, month 12
measure: Response based on achieving the EASI-90
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Response based on achieving the IGA of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Percentage change of IGA compared to baseline
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Percentage change of SCORAD compared to baseline
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Percentage of patients with EASI-75 response compared to baseline
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Absolute EASI values over time
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Percentage change of EASI compared to baseline
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Absolute change of IGA compared to baseline
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Physician´s satisfaction with treatment
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Response based on achieving at least 4 points improvement of Pruritus NRS from baseline
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Change of Peak-Pruritus NRS over time
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Change of POEM from baseline
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Change of MOS from baseline
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Change of DLQI from baseline
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Change of HADS from baseline
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Change of EuroQol five-dimensional-five level (EQ-5D-5L) from baseline
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Change of PBI from baseline
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Patients satisfaction with treatment
timeFrame: At all scheduled time points (Baseline, month 1, month 3, month 6, month 9, month 12)
measure: Number of days with topical-treatment use (TCS, TCI)
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Number of days with emollients use
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
Other outcomes:
Locations:
city: Buxtehude
country: Germany
facility: Elbe Kliniken Stade - Buxtehude GmbH
state: Niedersachsen
city: Gelsenkirchen
country: Germany
facility: ÜUeberoertliche Gemeinschaftspraxis Jost Kai Rietkoetter Robert Jablonka
state: Nordrhein-westfalen
city: Mainz
country: Germany
facility: Dermatologische Gemeinschaftspraxis Dres. Quist PartG
state: Rheinland-pfalz
city: Magdeburg
country: Germany
facility: "Magdeburger company for Medical studies & Services"
state: Sachsen-anhalt
city: Ahaus
country: Germany
facility: Hautärztliche Gemeinschaftspraxis
city: Augsburg
country: Germany
facility: Hautarztpraxis Dr. Virgil Mihaescu
city: Bad Kreuznach
country: Germany
facility: Dermatologie Bad Kreuznach - Dr. med. Georg Mauer
city: Bensheim
country: Germany
facility: Praxis Dr. A. Magerl
city: Bergen
country: Germany
facility: Hautzentrum
city: Berlin
country: Germany
facility: Dr. Christiane Handrick Hautarztpraxis
city: Berlin
country: Germany
facility: Dres. Ziethen-Stavermann GbR
city: Berlin
country: Germany
facility: Hautarztpraxis Dr. med. Thomas Schirmer
city: Berlin
country: Germany
facility: Hautzentrum Weißensee
city: Bingen
country: Germany
facility: Hautarztpraxis Weid
city: Bramsche
country: Germany
facility: Hautarztpraxis an der Hase Studienzentrum
city: Braunschweig
country: Germany
facility: Hautärzte Braunschweig
city: Buxtehude
country: Germany
facility: Hautarztpraxis Dr. med. Daniela Kasche
city: Falkensee
country: Germany
facility: BAG Freitag und Knöll
city: Freising
country: Germany
facility: Haut- und Laserzentrum Freisung Prof. Kurzen
city: Gernsbach
country: Germany
facility: Hautarztpraxis Dr. med Michael Loth
city: Gladbeck
country: Germany
facility: Hautarztpraxis Dr. Brinkmann, Schult & Samimi-Fard
city: Hamburg
country: Germany
facility: Cutaneum Praxis Dr. Buck
city: Hamburg
country: Germany
facility: Hautarztpraxis Dr. med. Matthias Lütten
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Karlsruhe
country: Germany
facility: dermaSANA
city: Kulmbach
country: Germany
facility: Kosmedikulm
city: Köln
country: Germany
facility: Praxis Dr. Voth
city: Langenau
country: Germany
facility: Dr. Beate Schwarz
city: Mutterstadt
country: Germany
facility: Hautarztpraxis Dr. Susanne Gißler-Walter
city: Mölln
country: Germany
facility: Dermatologie Mölln, Praxis Dr Segert
city: Mönchengladbach
country: Germany
facility: ZENTderma, Dr. Rolf Ostendorf
city: Mönchengladbach
country: Germany
facility: Hautarztpraxis Dorittke / Kardorff
city: München
country: Germany
facility: Praxis Dr. Quack
city: Nürnberg
country: Germany
facility: Dermatologische Praxis im Hautzentrum Johannis Dr. med. Esther Völkel
city: Remscheid
country: Germany
facility: Hautarztpraxis Mortazawi
city: Selters
country: Germany
facility: Dermatologische Spezialpraxis Dr. med. Ralph von Kiedrowski
city: Simmern/Hunsrück
country: Germany
facility: Dermatologisches Studienzentrum Hunsrück - DSH
city: Witten
country: Germany
facility: Hautarztpraxis Dr. Hoffmann
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: