Active not recruitingOBSERVATIONAL

Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)

This research is looking closely at a medicine called filgotinib, which is used to treat ulcerative colitis (UC). It's an "observational study," meaning doctors will watch how people who are already prescribed filgotinib for their moderate to severe UC are doing. They want to understand how well the medicine works in a real-world setting, not just in a controlled trial. Researchers will record details about how the treatment is given, if it helps improve patients' quality of life, and whether there are any side effects. This information will help doctors understand more about using filgotinib for UC patients outside of strict clinical trial conditions.

At a glance

Status

Active not recruiting

Sponsor

Alfasigma S.p.A.

Enrolment target

509

Start

12 Jun 2023

Estimated completion

01 Dec 2027

Ulcerative Colitis

What is this study about?

This research is about a medicine called filgotinib, which is used to treat a condition called ulcerative colitis (UC). UC is a long-term illness where the lining of your large intestine (bowel) becomes inflamed and can develop small sores, called ulcers. This can cause symptoms like tummy pain, diarrhoea, and needing to go to the toilet a lot.

This isn't a study where doctors are testing a new, unapproved medicine. Instead, it's an "observational study." This means they're going to watch and collect information from people who are already being treated with filgotinib for their moderate to severe UC, as part of their normal care. They want to see how well the medicine helps control symptoms, if it improves patients' daily lives, and if there are any side effects. This kind of study helps us understand how a medicine works for a wide range of people in real-life situations, which can be different from very controlled clinical trials.

The information gathered will help doctors and researchers understand more about using filgotinib for ulcerative colitis in everyday practice. This knowledge can then inform future treatment decisions and help more people with UC manage their condition better.

Key takeaways

This study looks at how filgotinib works for ulcerative colitis in everyday life.
It's for people starting filgotinib for moderate to severe UC.
Researchers will observe how well it works, its safety, and impact on quality of life.
This is an observational study, collecting information from normal treatment.
You must be 18 or older and not have Crohn's disease.

Who may be eligible?

To be part of this study, you must be at least 18 years old and have moderate to severe ulcerative colitis. You also need to be starting treatment with filgotinib for the first time, and your doctor should feel this medicine is right for you according to standard medical guidelines.

There are a couple of reasons why you might not be able to join. You can't be taking part in another medical study (unless it's a national registry, which is usually okay). Also, if you have Crohn's disease, rather than ulcerative colitis, this study wouldn't be suitable for you.

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 18 years old or older?
Do you have moderate or severe ulcerative colitis?
Are you about to start taking filgotinib for the first time for your UC?
Do you currently have Crohn's disease?
Are you taking part in another medical study right now (not including national registries)?

Answer every question to see your result.

What does participation involve?

This is an observational study, which means it’s a bit different from a traditional clinical trial. You won't be given a new medicine just for the study; instead, information will be gathered about your treatment with filgotinib as part of your normal care for ulcerative colitis. The details of how often you visit your doctor, what assessments are done, and your medication schedule will be decided by your doctor based on standard practice for your condition. The study will simply collect this information over time to see how filgotinib works for you. The total duration of your participation will depend on your treatment plan and the study's observation period, which your doctor can explain.

Potential risks and benefits

Participating in this study means your doctors will be carefully tracking your treatment and progress, which could lead to a deeper understanding of how filgotinib works for you. This could, in turn, help medical professionals improve care for others with ulcerative colitis in the future. As an observational study, you are taking a medication already approved for your condition, so there are no new medical risks beyond the known potential side effects of filgotinib, which your doctor will discuss with you. You have the right to withdraw from the data collection part of the study at any time without affecting your medical treatment or care.

Locations (81)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

LKH - Universitätsklinikum Graz
Verified postcode
Graz, Austria
Klinikum Klagenfurt am Wörthersee
Verified postcode
Klagenfurt, Austria
KH der Barmherzigen Brüder St.Veit an der Glan
Verified postcode
Sankt Veit an der Glan, Austria
AKH - Medizinische Universität Wien
Verified postcode
Vienna, Austria
Imeldaziekenhuis
Verified postcode
Bonheiden, Belgium
CHU Saint-Pierre
Verified postcode
Brussels, Belgium
Cliniques Universitaires de Bruxelles Hopital Erasme
Verified postcode
Brussels, Belgium
UZA
Verified postcode
Edegem, Belgium
AZ Maria Middelares
Verified postcode
Ghent, Belgium
AZ Sint-Lucas
Verified postcode
Ghent, Belgium
Universitair Ziekenhuis Gent
Verified postcode
Ghent, Belgium
Sint-Franciscus ziekenhuis
Verified postcode
Heusden-Zolder, Belgium

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of your large intestine (colon) becomes inflamed and develops small ulcers (sores), causing symptoms like tummy pain and diarrhoea.

What is filgotinib?

Filgotinib is a medicine used to treat ulcerative colitis. It helps to reduce the inflammation in your bowel.

Is this a new experimental drug?

No, filgotinib is an approved medicine that your doctor can already prescribe for ulcerative colitis. This study is observing how it works in real-world patients.

Will I have extra doctor visits if I join?

It's unlikely this study will add extra visits. The researchers will gather information during your regular appointments for your ulcerative colitis treatment.

What does 'observational study' mean?

It means doctors will simply watch and record information about your existing treatment with filgotinib, rather than telling you what treatment to take. It's about seeing how treatment works in daily life.