Active not recruitingOBSERVATIONAL

An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice

This study is for adults with moderate to severe Ulcerative Colitis, a long-term condition affecting the bowel. It aims to understand how well a medicine called upadacitinib works in real-world settings, rather than a highly controlled clinical trial. The study will track about 1000 participants worldwide, who are already prescribed upadacitinib by their doctors. Researchers will closely monitor how effective the treatment is at managing their symptoms and also keep an eye on any side effects. Participants will attend their usual doctor's appointments, with no extra burden from the study. The study will follow participants for up to three years to see the longer-term effects of the medicine.

At a glance

Status

Active not recruiting

Sponsor

AbbVie

Enrolment target

785

Start

15 Aug 2022

Estimated completion

01 Mar 2028

Ulcerative Colitis

What is this study about?

This study focuses on people living with Ulcerative Colitis (UC), a chronic condition that causes inflammation in the large bowel. When someone has UC, the lining of their bowel becomes inflamed, leading to symptoms like pain, diarrhoea, and urgency. This particular study is interested in adults who have moderate to severe UC.

The main goal is to observe how a medicine called upadacitinib works for these patients in their daily lives, as prescribed by their own doctors. This isn't a study where participants are given a new or experimental drug; upadacitinib is already approved and used for treating Ulcerative Colitis. Instead, researchers want to gather information on its safety and how well it helps control the condition under typical healthcare conditions.

By following around 1000 people receiving upadacitinib, the study aims to build a clearer picture of its effectiveness and any side effects over time. This kind of 'real-world' study helps doctors and patients understand how treatments perform outside of very controlled trial environments, offering valuable insights into managing UC.

Key takeaways

This study observes upadacitinib for Ulcerative Colitis in real-world settings.
It aims to understand safety and effectiveness in daily use.
Participants are already taking upadacitinib as prescribed by their doctor.
No extra appointments; data collected during routine clinic visits.
Participation helps future patients by improving understanding of the disease and treatment.
You can withdraw from the study at any time without impacting your care.

Who may be eligible?

This study is looking for adults aged 18 to 75 who have been diagnosed with moderate to severe Ulcerative Colitis. To join, you must already be starting upadacitinib treatment because your doctor has decided it's the right choice for you, and this decision must happen before you consider joining the study.

You also need to be receiving upadacitinib according to how it's approved for use in the UK. You should be able to understand the study requirements and be willing to keep track of information about your health, potentially using a provided smartphone app.

However, you cannot join if you've ever taken upadacitinib in a previous medical study or if you have any medical reason that makes taking upadacitinib unsuitable for you. You also shouldn't be currently involved in another clinical study that involves a specific treatment.

Quick self-check

Are you between 18 and 75 years old?
Have you been diagnosed with moderate to severe Ulcerative Colitis?
Has your doctor already decided to prescribe upadacitinib for you?
Are you willing to potentially use a smartphone app to share some health information?
Have you *not* participated in a previous study using upadacitinib?
Are you *not* currently involved in another clinical trial that provides a specific treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive upadacitinib as prescribed by your own doctor, just as you would normally. You won't be given specific instructions on how to take the medication by the study team, beyond what your doctor advises. The study will mainly involve collecting information during your regular hospital or clinic visits related to your Ulcerative Colitis, so there are no extra appointments specifically for the study.

Researchers will collect information on your disease activity and any side effects you experience. You might also be asked to provide some information about your health using a mobile app on a provided smartphone. The study will follow your progress for up to three years in total.

Potential risks and benefits

Participating in this study might offer the benefit of contributing to a better understanding of how upadacitinib works for people with Ulcerative Colitis in real-life situations, which can help other patients in the future. As you are already taking upadacitinib, the study itself doesn't introduce new medical risks beyond those associated with your prescribed treatment. You will continue to have regular medical care from your doctor. You are free to withdraw from the study at any time without affecting your medical care.

Locations (153)

Gedyt /ID# 249611
Ciudad Autonoma de Buenos Aire, Argentina
Hospital Britanico de Buenos Aires /ID# 249605
Ciudad Autonoma de Buenos Aire, Argentina
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 249612
Córdoba, Argentina
Blacktown Hospital /ID# 248354
Blacktown, Australia
Nepean Hospital /ID# 248351
Kingswood, Australia
Coral Sea Clinical Research institute /ID# 248352
North Mackay, Australia
Austin Health /ID# 249133
Heidelberg, Australia
The Royal Melbourne Hospital /ID# 248353
Parkville, Australia
University of Calgary /ID# 259183
Calgary, Canada
Gastroenterology and Internal Medicine Research Institution /ID# 251463
Edmonton, Canada
Dr. J Siffledeen Profess Pract /ID# 256903
Edmonton, Canada
Six08 Gastroenterology /ID# 259452
Lethbridge, Canada

+141 more sites — see the official record for the full list.

Common questions

What is Ulcerative Colitis?

Ulcerative Colitis is a long-term condition where the lining of your large bowel (colon) becomes inflamed and develops small sores, which can cause symptoms like tummy pain and diarrhoea.

What is upadacitinib?

Upadacitinib is a medicine that helps reduce the inflammation caused by Ulcerative Colitis.

Will I get extra medicine or different treatment in this study?

No, you will receive upadacitinib exactly as your own doctor has prescribed it for your usual care. The study doesn't change your treatment plan.

Will there be extra doctor's appointments?

No, you will attend your regular doctor's appointments for your Ulcerative Colitis. The study will collect information during these routine visits, so there shouldn’t be extra burden for you.

How long will I be followed in the study?

The study will follow participants for up to three years to see how the medicine works over time.