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

Pfizer

Status: Enrolling

Conditions: Dermatitis, Atopic

Study type: Observational

Funder types: Industry

Identifiers

NCT05250115

B7451089

ABROAD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

750 participants in 1 patient group

Evaluate the effectiveness, usage and patient characteristics of real-world use of Abrocitinib

Description:

This is a 60-month, prospective, non-interventional, multicenter study to evaluate the effectiveness, usage and patient characteristics of abrocitinib in patients with moderate to severe AD in a real-world setting. Eligible patients will be followed up from the date of first Abrocitinib prescription for 12 months. from the date of enrollment. Patients who are switched from the initial abrocitinib therapy to other therapies continue to be observed. Patient documentation is expected quarterly as per standard clinical practice.