A Post-Marketing Observational Study to Evaluate Safety and Effectiveness of Upadacitinib in Adolescent Patients Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Data Collection
Collected from today forward - ProspectiveDermatitis+8
+ Dermatitis, Atopic
+ Hypersensitivity
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: September 29, 2021
Actual date on which the first participant was enrolled.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, these studies included a limited number of adolescent patients in Japan. Therefore, the purpose of this observational study is to evaluate safety and effectiveness of upadacitinib in adolescent AD participants age 12 to <18 years old in Japan in the real-world setting. Upadacitinib is an approved drug being developed for the treatment of AD in adolescents in Japan. Around 170 participants age 12 to <18 who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled at multiple sites in Japan. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.167 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Participants who are diagnosed with atopic dermatitis (AD). * History of topical anti-inflammatory agents such as topical steroids and topical tacrolimus for AD. * Participants initiating upadacitinib for the treatment of AD in routine clinical practice. * Body weight \>=30 kg at the start of dosing. Exclusion Criteria: * Prior treatment with upadacitinib * Currently participating in another registrational clinical research study * Participants for whom upadacitinib is contraindicated
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 61 locations
Ichinomiya Municipal Hospital /ID# 245070
Ichinomiya-shi, JapanNHO Nagoya Medical Center /ID# 245069
Nagoya, JapanNagoya City University Hospital /ID# 250809
Nagoya, Japan