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A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany

This study in Germany aims to understand how a medicine called guselkumab helps people living with Crohn's disease and ulcerative colitis. Researchers want to see how well it works for different groups of people in their everyday lives, not just in strict trial settings. The study will also ask participants about their experiences, including how the medicine affects their tiredness, their overall health and quality of life, their sex life, how well they can work or do daily activities, and how happy they are with their treatment. This information will help doctors better understand the real-world benefits of guselkumab for these conditions.

At a glance

Status
Recruiting
Sponsor
Janssen-Cilag G.m.b.H
Enrolment target
500
Start
18 Aug 2025
Estimated completion
15 Jan 2029

What is this study about?

This study is looking at a medicine called guselkumab, which is used to treat inflammatory bowel disease (IBD). IBD includes conditions like Crohn's disease and ulcerative colitis, which cause ongoing inflammation in the digestive system. While we know guselkumab can help, this study wants to see how well it works and how it affects people in real-life situations, outside of typical research trials. It’s like watching how a car performs on everyday roads, not just on a test track.

The main goal is to understand who might benefit most from guselkumab. Researchers will look at how effective the medicine is for all participants and for different groups, for example, based on their age or how severe their condition is. They also want to understand the bigger picture of how the treatment impacts people's lives.

This includes asking about things like how tired they feel, their overall quality of life, how their condition affects their relationships and sex life, and their ability to work or do daily activities. They’ll also ask how satisfied people are with their treatment. This kind of information is really important because it helps doctors and patients make better decisions about treatment, focusing on what matters most for daily well-being.

Key takeaways

  • This study looks at guselkumab for Crohn's and ulcerative colitis in Germany.
  • It aims to understand how the medicine works in everyday life.
  • Participants will share their experiences regarding tiredness, quality of life, and daily activities.
  • The study helps doctors understand who benefits most from guselkumab.
  • You must be an adult starting guselkumab to participate.
  • You can leave the study at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. You should have Crohn's disease or ulcerative colitis and your doctor must believe that guselkumab is the right treatment for you at this time. You also need to be willing to fill out health questionnaires during the study.

There are some reasons why you might not be able to join. For example, if you've already tried many different advanced treatments for your inflammatory bowel disease (more than four types) in the past, or if you've previously taken certain other medicines that block IL-23 (except for ustekinumab, which is okay). Also, if you've had surgery to remove part of your bowel or have a 'pouch' (a surgically created internal pouch), you won't be able to join. Lastly, if you're already in another similar clinical study backed by Janssen or Johnson & Johnson, you can't join this one.

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.

  1. Are you 18 years old or older?
  2. Do you have Crohn's disease or ulcerative colitis?
  3. Has your doctor decided guselkumab is the right treatment for you?
  4. Are you willing to answer questions about your health and feelings?
  5. Have you had fewer than 5 different advanced IBD treatments before?
  6. Have you not had a bowel removal surgery (colectomy) or pouch?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive guselkumab as part of your regular treatment, as decided by your doctor. The study will mainly involve filling out questionnaires about your health, how you feel, and how the treatment is affecting your daily life. Your doctor will also collect some information about your health during your usual appointments.

Potential risks and benefits

A potential benefit of joining is that your experience will help doctors understand more about how guselkumab works for real people, which could help future patients. Guselkumab is an approved medicine, and you would receive it as part of your standard care. There are no additional risks from the study beyond the typical risks associated with taking guselkumab. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

  • Praxis Fur Gastroenteroligie
    Verified postcode
    Berlin, Germany· Recruiting

Common questions

What is guselkumab?

Guselkumab is a medicine used to treat inflammatory bowel diseases like Crohn's disease and ulcerative colitis.

Am I taking a new, unproven drug in this study?

No, guselkumab is an approved medicine. This study observes how it works in real-life settings, not to test if it's safe or effective initially.

Will I have extra doctor visits?

The study aims to use your regular doctor's appointments as much as possible for data collection. You will mostly be asked to fill out questionnaires.

What does 'patient-reported outcomes' mean?

It means the study asks you directly about your experiences, such as your tiredness, quality of life, and how you feel, rather than just relying on medical tests.

Can I leave the study at any time?

Yes, you can decide to leave the study at any point. Your decision will not affect your medical care.

How to find out more

Study Contact

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Generate Real-world Evidence of Guselkumab Effect…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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