Active — Not RecruitingNot Applicable

A Study to Assess Disease Activity in Adolescent and Adult Participants With Atopic Dermatitis Who Receive Oral Upadacitinib Tablets in a Real-World Setting

Germany634 participantsStarted 2021-12-13

Plain-language summary

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study will assess the real-world effectiveness of upadacitinib on early and sustained response along adolescent and adult participants with AD. This study also aims to understand upadacitinib utilization patterns in real-world clinical practice. Upadacitinib (RINVOQ) is approved in the EU for the treatment of moderate to severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy. Approximately 772 adolescent and adult participants with AD will be enrolled at up to 200 sites in Germany. Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. The overall duration of the study is approximately 2 years. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Body weight \>=30 kg at baseline for participants between \>=12 and \<18 years of age. * Physician confirmed diagnosis of moderate to severe atopic dermatitis at the time of enrollment. * Upadacitinib initiated as per the local label. The decision to prescribe upadacitinib must have been made prior to and independently of study participation. * Medical and medication history available at least for the last 6 months. Exclusion Criteria: \- Current participation in interventional research (note: this does not include non-interventional, post-marketing observational studies, or registry participation).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Achieving Disease Control Defined by Atopic Dermatitis Control Tool (ADCT) Total Score <7 Points

Timeframe: Month 3

Percentage of Participants Achieving Disease Control Defined by ADCT Total Score <7 Points Among Participants Who Achieved Disease Control at Month 3

Timeframe: Month 24

Trial details

NCT IDNCT05139836

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-09

View on ClinicalTrials.gov More Atopic Dermatitis trials