RecruitingOBSERVATIONAL

A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)

This study, taking place in the UK, is investigating how effective a medicine called guselkumab is for adults living with moderate to severe Ulcerative Colitis or Crohn's Disease. These are both types of Inflammatory Bowel Disease (IBD). The main goal is to understand how well guselkumab works in everyday medical care, rather than a highly controlled research setting. Researchers will look at how different patients respond to this treatment and what their overall health outcomes are. This will help doctors and patients understand the real-world benefits of guselkumab and identify which patients might benefit most.

At a glance

Status

Recruiting

Sponsor

Janssen-Cilag Ltd.

Enrolment target

220

Start

17 Nov 2025

Estimated completion

17 Mar 2029

Inflammatory Bowel Disease Colitis, Ulcerative Crohn's Disease

What is this study about?

This study, called "A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)", aims to understand how a medication called guselkumab works for people with Ulcerative Colitis (UC) or Crohn's Disease (CD) in a real-life setting. UC and CD are chronic conditions that cause inflammation in your digestive system, often referred to as Inflammatory Bowel Disease (IBD).

Unlike traditional clinical trials that often have very strict conditions, this study focuses on how guselkumab performs under normal healthcare circumstances in the UK. The researchers want to see how effective the treatment is for different people, depending on their previous treatments and other factors. They will look at things like how much the medication helps with symptoms and improves overall health.

By gathering this 'real-world' information, doctors and patients can get a clearer picture of how guselkumab helps people manage their UC or CD outside of a research lab. This kind of study is very helpful for understanding the benefits and how the treatment fits into standard medical care for IBD.

Key takeaways

This UK study is about an existing IBD medication called guselkumab.
It aims to see how well guselkumab works in everyday patient care for Ulcerative Colitis and Crohn's Disease.
Participation involves sharing your routine medical data, not extra treatments.
You must be an adult with moderate to severe IBD and your doctor must have decided guselkumab is right for you.
The findings will help doctors better understand guselkumab's benefits for different patients.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or over with a confirmed diagnosis of moderate to severe Crohn's Disease or Ulcerative Colitis. Your doctor must have decided that guselkumab is the right treatment for you, following standard NHS guidelines for biologic treatments, and this decision must happen before or on the day you receive your first dose.

You cannot join the study if you are already taking part in another medicinal research study. Also, if you have previously used certain types of similar drugs (called IL-23 inhibitors like Tremfya®, Skyrizi®, or Omvoh®), you won't be able to participate. However, if you've only used a drug called ustekinumab in the past, you might still be considered. Lastly, if you've had more than four different advanced IBD treatments (like biologics or small molecules) before, you wouldn't be able to join this particular study.

Quick self-check

Are you 18 years old or older?
Do you have a confirmed diagnosis of moderate to severe Crohn's Disease or Ulcerative Colitis?
Has your doctor decided to prescribe guselkumab for you, following standard NHS guidelines?
Are you *not* currently taking part in another medical research study?
Have you *not* previously used similar specific drugs called IL-23 inhibitors (like Tremfya®, Skyrizi®, Omvoh®), excluding ustekinumab?
Have you had fewer than 5 different advanced IBD treatments (like biologics or small molecules) before?

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

What does participation involve?

This is an observational study, which means it involves collecting information from your routine medical care rather than you receiving a new or experimental treatment just for research. You will receive guselkumab as prescribed by your doctor, just as you normally would. There are no extra visits or procedures specifically for the study. Researchers will simply collect information from your existing medical records to see how you respond to the treatment over time. The total duration of your participation will depend on how long your doctor continues your treatment and records are collected.

Potential risks and benefits

The main benefit of participating in this study is that it helps doctors understand how guselkumab truly works for people with IBD in a real-world setting, which can improve care for future patients. Since you're receiving treatment as part of your standard care, there are no additional medical risks from taking part in the study itself. Any risks related to guselkumab are those already known and discussed with your doctor when you are prescribed the medication. You are free to withdraw your consent and stop participation in the study at any time without affecting your medical care.

Locations (1)

London North West University Healthcare NHS Trust
Harrow, United Kingdom· Recruiting

Common questions

What is guselkumab?

Guselkumab is a type of medication used to treat certain inflammatory conditions, including Ulcerative Colitis and Crohn's Disease, by targeting specific parts of your immune system.

Is this a new treatment?

No, guselkumab is an approved medication for these conditions. This study is looking at how it works in everyday clinical practice, not testing a new drug.

What is 'real-world evidence'?

It means the study collects information from real patients receiving the treatment as part of their regular care, rather than in a highly controlled research setting. This gives a more accurate picture of how a medication works for typical patients.

Do I need to do anything extra if I join?

No, you don't need additional appointments or tests. The study simply collects information from your existing medical records once your doctor has decided to prescribe guselkumab for you.

Will my information be kept private?

Yes, all your personal information will be handled confidentially and used in a way that protects your privacy, as required by patient data protection laws.

How to find out more

Study Contact

Participate-In-This-Study1@its.jnj.com 844-434-4210 Official trial record

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