A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis

Study Identifier
P20-441
CT.gov Identifier
NCT05081557
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Dermatology - Atopic Dermatitis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    12+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Physician confirmed diagnosis of atopic dermatitis (AD) or atopic eczema at baseline. * Symptom onset \>=1-year prior to baseline. * Initiation of upadacitinib treatment for AD is indicated and prescribed per local label. * The decision to prescribe UPA is made prior to and independently of study participation. * Medical and medication history available for previous 6 months. * Participants who can understand the questionnaires, with parental support as required for adolescents. * Participants who are able to understand and communicate with the investigator and comply with the requirements of the study. * Participants who are willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., tablet). * Participants who are willing and able to complete the patient-reported questionnaires.
    Exclusion Criteria:
    \- Participants who are currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).

    Protocol Summary

    Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, important information is missing on the use patterns and outcomes with upadacitinib in a real-world setting. Therefore, the purpose of this observational study is to help inform real-world usage patterns regarding the safety and effectiveness and duration of response of upadacitinib in adolescent and adult AD participants \>=12 years old in the real-world setting.

    Upadacitinib is an approved drug being developed for the treatment of AD. Around 975 adolescent and adult participants who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled worldwide.

    Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years.

    There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

    Study Locations

    Location
    Status
    Location
    Hospital Universitario Austral /ID# 241607
    Pilar, Buenos Aires, Argentina, 1629
    Status
    Not applicable
    Location
    Buenos Aires Skin /ID# 241606
    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1055
    Status
    Not applicable
    Location
    CEDIC Centro de Investigaciones Clinicas /ID# 241605
    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1425
    Status
    Not applicable
    Location
    Instituto de Neumonologia y Dermatologia /ID# 241604
    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1425
    Status
    Not applicable
    Location
    Centro Respiratorio Infantil /ID# 241609
    Rosario, Santa Fe Province, Argentina, 2000
    Status
    Not applicable
    Location
    Hospital Italiano /ID# 241608
    CABA, Argentina, C1199ABB
    Status
    Not applicable
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