Active not recruitingOBSERVATIONAL

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

This study is for people aged 12 and older who have a skin condition called atopic dermatitis (also known as eczema) and are taking a medicine called upadacitinib. While previous research has shown this medicine to be helpful, this study aims to understand how it works in everyday situations, not just in strict clinical trials. Researchers want to see how patients actually use upadacitinib, how safe it is, how well it works, and for how long its benefits last when used in regular doctor's care. About 975 patients around the world will take part. Participants will receive their medication as their doctor prescribes, and information will be collected for about two years. The study will not add extra burden beyond their usual medical care.

At a glance

Status

Active not recruiting

Sponsor

AbbVie

Enrolment target

873

Start

17 Nov 2021

Estimated completion

01 Oct 2026

Atopic Dermatitis

What is this study about?

Atopic dermatitis, often called eczema, is a common skin condition that causes itchy, red, and swollen skin. While we know medicines like upadacitinib can help, most of what we know comes from carefully controlled studies. This study is different because it wants to understand how upadacitinib works in the 'real world' – that is, when people are using it as part of their everyday medical care, rather than under strict trial conditions.

The main goal is to see how upadacitinib is used in practice, how safe it is for people aged 12 and older with eczema, how effective it is in reducing symptoms, and how long those improvements last. Around 975 people from different parts of the world will join this study. They will all be people who have been prescribed upadacitinib by their doctor for their eczema.

This is an 'observational study', which means doctors will simply watch and record what happens as patients go about their usual treatment. You won't be given specific experimental treatments or asked to do anything extra beyond what your doctor would normally recommend for your condition. This real-world information is really important for doctors and patients to understand the full picture of using upadacitinib.

Key takeaways

This study looks at how a medicine for eczema (upadacitinib) is used in everyday life.
It helps us understand the safety, effectiveness, and lasting benefits of upadacitinib outside of strict trials.
Participants must be 12 years or older and already prescribed upadacitinib by their doctor.
Your involvement won't add extra steps beyond your usual doctor's appointments and treatments.
You'll need to fill out questionnaires, possibly using a mobile app, during your regular visits.
The study gathers important information to help other eczema patients and their doctors in the future.

Who may be eligible?

To be able to join this study, you must have been diagnosed with atopic dermatitis (eczema) by a doctor, and you should have had symptoms for at least a year. Importantly, your doctor must have already decided to prescribe upadacitinib for you as part of your normal care, before you even consider joining the study. This means the decision to start this medicine is completely separate from whether you join the study or not.

You also need to be at least 12 years old. You should be able to understand questionnaires (with a parent's help if you're a teenager) and be able to talk with your doctor and the study staff. You'll also need to be willing to use a mobile app on a smart device (like a tablet) to record some information about your health.

There are not many reasons you can't join, but one main one is if you're already taking part in another study where you're being given an experimental treatment or medicine. However, you can still join this study if you're in other studies that are just about observing health, like a registry or another non-interventional study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you been diagnosed with atopic dermatitis (eczema) by a doctor?
Are you at least 12 years old?
Has your doctor already prescribed upadacitinib for your eczema?
Are you able to fill out questionnaires (with parental help if you are an adolescent)?
Are you willing to use a mobile app on a smart device to provide information?
Are you not currently in another clinical study where you are trying an experimental treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't have any extra treatments or visits beyond what your doctor would normally recommend for your eczema. You'll receive upadacitinib exactly as your own doctor has prescribed it for you. During your regular appointments at the hospital or clinic, the study team will collect information about your health and how you're responding to the medicine.

You'll also be asked to fill out questionnaires at each of these regular visits. These questionnaires will ask about your symptoms and how you're feeling. You'll use a mobile app on a smart device to provide this information. The study team will collect data from participants for about two years. There's no additional burden on you compared to your standard medical care.

Potential risks and benefits

This study is designed to observe how upadacitinib works in real life, so you won't be asked to do anything extra or different from your usual medical care. This means there are no additional risks specific to being in the study beyond those already associated with taking upadacitinib as prescribed by your doctor. The potential benefit is that the information you provide will help doctors and other patients better understand how upadacitinib works for people with eczema in everyday situations. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (140)

Hospital Universitario Austral /ID# 241607
Verified postcode
Pilar, Argentina
Buenos Aires Skin /ID# 241606
City only
Ciudad Autonoma de Buenos Aire, Argentina
CEDIC Centro de Investigaciones Clinicas /ID# 241605
City only
Ciudad Autonoma de Buenos Aire, Argentina
Instituto de Neumonologia y Dermatologia /ID# 241604
City only
Ciudad Autonoma de Buenos Aire, Argentina
Centro Respiratorio Infantil /ID# 241609
Verified postcode
Rosario, Argentina
Hospital Italiano /ID# 241608
City only
CABA, Argentina
Kingsway Dermatology & Aesthetics /ID# 242276
Verified postcode
Miranda, Australia
Veracity Clinical Research /ID# 242275
Verified postcode
Woolloongabba, Australia
Flinders Medical Centre /ID# 242162
Verified postcode
Bedford Park, Australia
Sinclair Dermatology - Melbourne /ID# 242163
Verified postcode
East Melbourne, Australia
Burswood Dermatology /ID# 243767
Verified postcode
Victoria Park, Australia
Sydney Skin /ID# 242277
Verified postcode
Newtown, Australia

Common questions

What is atopic dermatitis?

Atopic dermatitis is another name for atopic eczema, which is a common skin condition causing itchy, red, and inflamed patches on the skin.

What is upadacitinib?

Upadacitinib is a medicine that has been approved for treating atopic dermatitis. Your doctor prescribes it if they think it's right for you.

Will I get a new medicine in this study?

No, you will only take the medicine (upadacitinib) that your own doctor has already prescribed for your eczema as part of your usual care.

What does 'real-world setting' mean?

It means the study is looking at how a medicine works in everyday life, with patients and doctors making decisions as they normally would, rather than in a highly controlled research environment.

How long will I be in the study?

Information will be collected from participants for about two years as part of their regular medical visits.