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

Last updated: October 30, 2024
Sponsor: Pfizer
Overall Status: Terminated

Phase

N/A

Condition

Allergies & Asthma

Rash

Atopic Dermatitis

Treatment

N/A

Clinical Study ID

NCT05250115
B7451089
ABROAD
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 aspart of routine clinical practice irrespective of the patients being

  1. abrocitinib naive or,

  2. patients who reinitialize treatment with abrocitinib after being off treatmentfor ≥28 days prior to study inclusion

  • Patient is eligible for abrocitinib treatment according to Summary of ProductCharacteristics (SmPC)

  • Evidence of a personally signed and dated informed consent document indicating thatthe patient has been informed of all pertinent aspects of the non-interventionalstudy

Exclusion

Exclusion Criteria:

  • Contraindications according to SmPC

  • Receipt of any investigational drug within 3 months or longer if required accordingto wash-out period prior to inclusion or participation in a clinical trial duringobservation period

  • Patients being treated with abrocitinib within a time period of <28 days prior tothe timepoint of study inclusion

  • Patients who are investigational site staff members or patients who are Pfizeremployees directly involved in the conduct of the non-interventional study

  • Patients who are unable to consent

Study Design

Total Participants: 112
Study Start date:
May 10, 2022
Estimated Completion Date:
July 25, 2024

Connect with a study center

  • Elbe Kliniken Stade - Buxtehude GmbH

    Buxtehude, Niedersachsen 21614
    Germany

    Site Not Available

  • ÜUeberoertliche Gemeinschaftspraxis Jost Kai Rietkoetter Robert Jablonka

    Gelsenkirchen, Nordrhein-westfalen 32423
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis Dres. Quist PartG

    Mainz, Rheinland-pfalz 55128
    Germany

    Site Not Available

  • "Magdeburger company for Medical studies & Services"

    Magdeburg, Sachsen-anhalt 39104
    Germany

    Site Not Available

  • Hautärztliche Gemeinschaftspraxis

    Ahaus, 48688
    Germany

    Site Not Available

  • Hautarztpraxis Dr. Virgil Mihaescu

    Augsburg, 86150
    Germany

    Site Not Available

  • Dermatologie Bad Kreuznach - Dr. med. Georg Mauer

    Bad Kreuznach, 55543
    Germany

    Site Not Available

  • Praxis Dr. A. Magerl

    Bensheim, 64625
    Germany

    Site Not Available

  • Hautzentrum

    Bergen, 18528
    Germany

    Site Not Available

  • Dr. Christiane Handrick Hautarztpraxis

    Berlin, 10117
    Germany

    Site Not Available

  • Dres. Ziethen-Stavermann GbR

    Berlin, 12353
    Germany

    Site Not Available

  • Hautarztpraxis Dr. med. Thomas Schirmer

    Berlin, 12489
    Germany

    Site Not Available

  • Hautzentrum Weißensee

    Berlin, 13086
    Germany

    Site Not Available

  • Hautarztpraxis Weid

    Bingen, 55411
    Germany

    Site Not Available

  • Hautarztpraxis an der Hase Studienzentrum

    Bramsche, 49565
    Germany

    Site Not Available

  • Hautärzte Braunschweig

    Braunschweig, 38114
    Germany

    Site Not Available

  • Hautarztpraxis Dr. med. Daniela Kasche

    Buxtehude, 21614
    Germany

    Site Not Available

  • BAG Freitag und Knöll

    Falkensee, 14612
    Germany

    Site Not Available

  • Haut- und Laserzentrum Freisung Prof. Kurzen

    Freising, 85354
    Germany

    Site Not Available

  • Hautarztpraxis Dr. med Michael Loth

    Gernsbach, 76593
    Germany

    Site Not Available

  • Hautarztpraxis Dr. Brinkmann, Schult & Samimi-Fard

    Gladbeck, 45964
    Germany

    Site Not Available

  • Cutaneum Praxis Dr. Buck

    Hamburg, 20095
    Germany

    Site Not Available

  • Hautarztpraxis Dr. med. Matthias Lütten

    Hamburg, 20095
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • dermaSANA

    Karlsruhe, 76131
    Germany

    Site Not Available

  • Kosmedikulm

    Kulmbach, 95326
    Germany

    Site Not Available

  • Praxis Dr. Voth

    Köln, 50677
    Germany

    Site Not Available

  • Dr. Beate Schwarz

    Langenau, 89129
    Germany

    Site Not Available

  • Hautarztpraxis Dr. Susanne Gißler-Walter

    Mutterstadt, 67112
    Germany

    Site Not Available

  • Dermatologie Mölln, Praxis Dr Segert

    Mölln, 23879
    Germany

    Site Not Available

  • Hautarztpraxis Dorittke / Kardorff

    Mönchengladbach, 41236
    Germany

    Site Not Available

  • ZENTderma, Dr. Rolf Ostendorf

    Mönchengladbach, 41061
    Germany

    Site Not Available

  • Praxis Dr. Quack

    München, 81539
    Germany

    Site Not Available

  • Dermatologische Praxis im Hautzentrum Johannis Dr. med. Esther Völkel

    Nürnberg, 90419
    Germany

    Site Not Available

  • Hautarztpraxis Mortazawi

    Remscheid, 42897
    Germany

    Site Not Available

  • Dermatologische Spezialpraxis Dr. med. Ralph von Kiedrowski

    Selters, 56242
    Germany

    Site Not Available

  • Dermatologisches Studienzentrum Hunsrück - DSH

    Simmern/Hunsrück, 55469
    Germany

    Site Not Available

  • Hautarztpraxis Dr. Hoffmann

    Witten, 58453
    Germany

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.