RecruitingOBSERVATIONAL

A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis

This study is a real-world look at how a medicine called etrasimod helps people in the UK with moderate to severe ulcerative colitis, a long-term condition affecting the bowel. It's not a typical trial with strict rules; instead, it observes patients who are prescribed etrasimod by their doctor as their best treatment choice. Patients will receive their usual care, and the study will collect additional health information through online questionnaires they fill out on their own devices. The aim is to understand how etrasimod works in daily life by comparing patients' symptoms before and after starting the medication, over the course of about a year.

At a glance

Status

Recruiting

Sponsor

Pfizer

Enrolment target

360

Start

08 May 2024

Estimated completion

30 Jun 2026

Colitis, Ulcerative

What is this study about?

This study is designed to understand how a medicine called etrasimod works for people living with ulcerative colitis. Ulcerative colitis is a condition where the lining of your large intestine (colon) and rectum becomes swollen and develops sores, causing symptoms like tummy pain and diarrhoea. Etrasimod is a treatment that helps manage these symptoms.

Unlike some clinical trials, this isn't a study where you are given a new or experimental treatment. Instead, it focuses on patients who are already going to be prescribed etrasimod by their doctor because it's considered the best option for their moderate to severe ulcerative colitis. The study simply observes what happens when patients use the medicine in their everyday lives. By doing this, researchers can get a clearer picture of how well etrasimod works and if it improves things like quality of life for people in the UK.

The main goal is to see how your condition changes once you start taking etrasimod. Researchers will compare your health and symptoms before you started the medication to how you feel after taking it for a period. This information will help doctors and patients understand more about the real-world benefits of etrasimod for ulcerative colitis.

Key takeaways

This study observes how etrasimod works for ulcerative colitis in real life.
You'll be prescribed etrasimod by your doctor as part of your usual care.
Participation involves filling out health questionnaires online.
The study lasts about a year.
It helps researchers understand etrasimod's effects for UK patients.
Your medical care won't change due to the study.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 64 years old with a confirmed diagnosis of ulcerative colitis. Your doctor must also have decided that etrasimod is the right treatment for your moderately or severely active ulcerative colitis, according to the official guidance for the medicine. You also need to agree to take part and provide your signed consent.

However, you can't join the study if you have certain other conditions, like Crohn's disease, or if your doctor thinks you might need urgent hospital care or surgery for your ulcerative colitis soon. You also can't have been treated with etrasimod before or be taking certain other specific medications for your ulcerative colitis. Finally, you'll need access to a smartphone, tablet, or computer with internet to fill out health questionnaires, and be comfortable using it.

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 between 18 and 64 years old?
Do you have a confirmed diagnosis of moderate to severe ulcerative colitis?
Has your doctor decided etrasimod is the right treatment for you?
Do you have access to a smartphone, tablet, or computer with internet to complete online questionnaires?
Have you never taken etrasimod before?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be treated with etrasimod as prescribed by your doctor, just as you would if you weren't in the study. Your appointments and medical care will continue as normal. The main extra activity for you will be completing health questionnaires online using your own mobile phone, tablet, or computer. You'll be asked to fill these out regularly during the study.

The study will last for about 52 weeks (roughly one year), with an additional 28 days of follow-up for safety reasons. You'll continue seeing your doctor for your ulcerative colitis, and the study will gather information from your routine visits and the questionnaires you complete.

Potential risks and benefits

Participating in this study might help researchers understand more about how etrasimod works for people with ulcerative colitis in real-world situations, which could benefit others with the condition in the future. You will be receiving your prescribed medication and usual care, so there are no additional medical procedures or risks imposed by the study itself beyond what your doctor would normally recommend. As with any medication, etrasimod has potential side effects, and your doctor will discuss these with you. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (34)

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

Vancouver Coastal Health
Verified postcode
Vancouver, Canada· Not yet recruiting
Providence Health Care (PHC)
Verified postcode
Vancouver, Canada· Recruiting
London Health Sciences Centre
Verified postcode
London, Canada· Not yet recruiting
CHUM
Verified postcode
Montreal, Canada· Recruiting
Montreal General Hospital
Verified postcode
Montreal, Canada· Not yet recruiting
Gastroenterologie OpernstraBe
Verified postcode
Kassel, Germany· Recruiting
MVZ Gastroenterologie Aachen
Verified postcode
Aachen, Germany· Recruiting
Praxis Heil und Müller
Verified postcode
Andernach, Germany· Recruiting
MVZ für Gastroenterologie am Bayerischen Platz
Verified postcode
Berlin, Germany· Recruiting
Evangelisches Krankenhaus Kalk
Verified postcode
Cologne, Germany· Recruiting
MVZ Dachau
Verified postcode
Dachau, Germany· Recruiting
Interdisziplinares Crohn Colitis Centrum
Verified postcode
Frankfurt am Main, Germany· Recruiting

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of your large bowel becomes inflamed and develops small sores, leading to symptoms like tummy pain and frequent diarrhoea.

What is etrasimod?

Etrasimod is a medicine used to treat ulcerative colitis. It helps to reduce the inflammation and symptoms of the condition.

Do I have to take part in the study?

No, taking part in any study is completely voluntary. Your decision will not affect the medical care you receive.

Will my doctor know I'm in the study?

Yes, your treating doctor will be aware of your participation as they are involved in the study.

How long will the study last for me?

The study will last for about one year (52 weeks), plus an extra month (28 days) for safety checks.

How to find out more

Pfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com 1-800-718-1021 Official trial record

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