An Observational Study to Assess Change in Disease Activity and Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in Real World

Study Identifier
P23-628
CT.gov Identifier
NCT05669794
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 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 upadacitinib is made prior to and independently of study participation. * Participants who can understand and who are willing and able to complete the questionnaires, with parental support as required for adolescents. * Participants (or legal representatives for adolescents) with a smartphone/tablet with internet access and willing to download the dedicated application to complete the questionnaires via this application. * Participants (and legal representatives for adolescents) who have been informed verbally and in writing about this study before inclusion, and who do not object to their data being processed. * Participants (and legal representatives for adolescents) able to understand and communicate with the investigator.
    Exclusion Criteria:
    * Participation in a clinical trial assessing an investigational drug, concurrently or within the last 30 days. * Prior treatment with upadacitinib.

    Protocol Summary

    Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. This study will assess how effective upadacitinib is in treating AD.

    Upadacitinib is an approved drug for treating AD. Approximately 300 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in France.

    Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection.

    There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

    Study Locations

    Location
    Status
    Location
    Ch Saint Quentin /Id# 249270
    Saint-Quentin, Aisne, France, 02321
    Status
    Not applicable
    Location
    CHU Clermont-Ferrand /ID# 248611
    Clermont, Auvergne-Rhône-Alpes, France, 63100
    Status
    Not applicable
    Location
    Hôpital Européen Marseille /ID# 257643
    Marseille, Bouches-du-Rhone, France, 13003
    Status
    Not applicable
    Location
    Hopital Saint Joseph /ID# 255537
    Marseille, Bouches-du-Rhone, France, 13008
    Status
    Not applicable
    Location
    Hopital Ponchaillou /ID# 251225
    Rennes, Brittany Region, France, 35000
    Status
    Not applicable
    Location
    CHU Dijon /ID# 248984
    Dijon, Cote-d Or, France, 21000
    Status
    Not applicable
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