RecruitingOBSERVATIONAL

Study of Oral Upadacitinib to Assess Change in Disease Activity in Adult Participants With Ulcerative Colitis

This study is for adults with ulcerative colitis, a condition that causes inflammation and bleeding in the large intestine. It aims to understand how effective the approved medication upadacitinib (RINVOQ) is when used in everyday medical care. Around 400 adults in Germany, Austria, and Switzerland who have already been prescribed upadacitinib by their doctor will be included. Participants will receive their medication as usual, and their treatment will be decided by their doctor, not the study. The study involves regular clinic visits where routine health information is collected over up to two years. There are no extra tests or appointments beyond what participants would normally have for their condition.

At a glance

Status

Recruiting

Sponsor

AbbVie

Enrolment target

400

Start

20 Oct 2022

Estimated completion

01 Aug 2027

Ulcerative Colitis

What is this study about?

This study is looking into an approved medication called upadacitinib (also known as RINVOQ) for adults who have ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and sometimes bleeding in the lining of your large intestine (colon) and rectum.

Upadacitinib is already used to treat ulcerative colitis. This study wants to understand how well it works and how people get on with it when it's prescribed by doctors in the usual way. It's collecting information from people in Germany, Austria, and Switzerland who are already taking this medication because their doctor decided it was right for them.

Researchers will follow these individuals for up to two years, gathering information during their regular check-ups. The idea is to learn more about the drug's effectiveness in a real-world setting without changing how patients are treated by their doctors.

Key takeaways

It's about an approved drug for ulcerative colitis.
No changes to your current or planned treatment.
No extra appointments or tests are needed.
Information is collected from your routine check-ups.
Helps doctors learn more about the drug in real life.
Participation lasts up to two years.

Who may be eligible?

To be part of this study, you need to be an adult with ulcerative colitis that's been confirmed by a doctor using a scope (a camera test). Your doctor must have already decided to prescribe you upadacitinib as part of your normal care, before you even consider joining the study. This decision must be made based on the approved guidelines for the drug in your country.

It's also important that you can understand what the study involves, talk with the doctors, and follow the study's instructions. Even if you stop taking upadacitinib, you should be willing to allow the study to continue collecting your routine health information.

You cannot join the study if you have any medical reasons that mean you shouldn't take upadacitinib. Also, if you have ever taken a type of medicine called a 'JAK inhibitor' before, you wouldn't be able to participate.

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.

Are you an adult with ulcerative colitis confirmed by a doctor?
Has your doctor decided to prescribe you upadacitinib (RINVOQ)?
Have you never taken a 'JAK inhibitor' medication before?
Do you understand what the study involves and can you talk with the study team?
Are you happy for your routine health information to be used for research?

Answer every question to see your result.

What does participation involve?

If you join this study, your treatment with upadacitinib will continue exactly as your doctor has prescribed, based on your normal medical care. The study won't change your medication or how your doctor manages your condition.

You will attend your usual regular appointments at the hospital or clinic, just as you would normally for your ulcerative colitis. During these visits, the medical team will collect information that they routinely record about your health anyway. This information will then be used for the study.

The study will follow you for up to two years. Crucially, there are no extra appointments, tests, or procedures required beyond your standard care. The aim is to simply observe how your treatment progresses in a real-world setting.

Potential risks and benefits

Because the study involves receiving upadacitinib as part of your standard medical care, any potential benefits or risks associated with the medication itself would be part of your doctor's discussion with you before you start treatment. The study itself does not add extra procedures or change your treatment, so it doesn't introduce new risks beyond what's already involved in your regular care. A potential benefit of participating is knowing that your routine health information is contributing to a better understanding of how upadacitinib works for people with ulcerative colitis. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (94)

Krankenhaus der Barmherzigen Brueder Wien /ID# 251867
Verified postcode
Vienna, Austria· Active not recruiting
Kepler Universitaetsklinikum GmbH /ID# 251868
Verified postcode
Linz, Austria· Active not recruiting
Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869
Verified postcode
Salzburg, Austria· Active not recruiting
Universitaetsklinik Heidelberg /ID# 249922
Verified postcode
Heidelberg, Germany· Active not recruiting
Praxis fuer Gastroenterologie - Heidelberg /ID# 249917
Verified postcode
Heidelberg, Germany· Active not recruiting
Rems-Murr-Klinikum Winnenden /ID# 278791
Verified postcode
Winnenden, Germany· Completed
Klinikum Augsburg /ID# 249979
Verified postcode
Augsburg, Germany· Completed
Medizinisches Versorgunszentrum Dachau /ID# 249945
Verified postcode
Dachau, Germany· Active not recruiting
TUM Klinikum rechts der Isar /ID# 262176
Verified postcode
Munich, Germany· Active not recruiting
Dr.med. Johannes Behrendt Facharzt für Innere Medizin und Gastroenterologie /ID# 260516
Verified postcode
Brandenburg an der Havel, Germany· Completed
Praxis Dr. Grümmer /ID# 249925
Verified postcode
Potsdam, Germany· Completed
Private Practice - Dr. Kempelmann /ID# 249935
City only
Tostedt, Germany· Active not recruiting

Common questions

What is ulcerative colitis?

Ulcerative colitis is a condition that causes swelling and sores in the lining of your large bowel (colon) and rectum.

What is upadacitinib (RINVOQ)?

Upadacitinib is a prescribed medication used to treat chronic conditions like ulcerative colitis by reducing inflammation.

Will my treatment change if I join this study?

No, your doctor will continue to manage your treatment exactly as they would normally. The study just collects information during your regular visits.

Do I need extra hospital visits for this study?

No, you will only attend your usual, routine appointments. There are no additional visits or tests specifically for the study.

How long will I be part of this study?

You will be followed for up to two years, but only by collecting information from your routine medical appointments.

How to find out more

Medical Information Germany

medinfo.germany@abbvie.com 49 611 1720 1520 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.