Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

An Open-Label Extension and long-term efficacy and safety monitoring study of patients with Crohn's disease previously included in the loss of RESponse to Ustekinumab treated by dose Escalation study (REScUE-OLE)

This study, called REScUE-OLE, is an ongoing project designed for people with Crohn's disease who previously took part in a study testing a medicine named Stelara. It aims to understand the long-term effects of Stelara, specifically a 90 mg injection, on managing Crohn's. Researchers want to see if patients can stay in remission (meaning their symptoms are well-controlled) without needing steroids. The study will also carefully monitor any side effects to make sure the treatment is safe over an extended period. This helps doctors learn more about how to best use Stelara to keep people with Crohn's disease feeling better for longer.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Belgian IBD Research and Development

Enrolment target

108

Start

01 Jul 2024

Crohn's disease

What is this study about?

This study is called REScUE-OLE, which stands for `loss of RESponse to Ustekinumab treated by dose Escalation study - Open Label Extension`. It builds on a previous study where people with Crohn's disease used a medicine called Stelara. The main goal of this new study is to see how well Stelara works over a long time (up to 112 weeks, which is about two years) and if it can help people with Crohn's disease stay symptom-free without needing other medicines called steroids.

Crohn's disease is a condition where parts of your digestive system become inflamed. This can cause tummy pain, severe diarrhoea, tiredness, and weight loss. Steroids are often used to calm down flare-ups, but they can have side effects, so doctors try to reduce their use if possible. Stelara is a treatment that aims to reduce inflammation, helping to control Crohn's symptoms.

The researchers in this study will be looking closely at a few things. Firstly, they want to see what number of people can achieve 'steroid-free clinical remission'. This means their Crohn's symptoms (like belly pain and how often they go to the toilet) are very low, and they haven't used steroids for nearly a month. They'll also be tracking any side effects to make sure Stelara is still safe when used for a long time. This information is really important to help doctors understand the best ways to manage Crohn's disease and improve the quality of life for patients.

Key takeaways

This study is for people who were already in the REScUE study for Crohn's disease.
It examines the long-term effectiveness and safety of Stelara (90mg injection).
A key goal is to see if patients can stay well without needing steroids.
The study lasts for about two years and involves regular health check-ups.
It aims to provide more information about managing Crohn's disease over time.

Who may be eligible?

To be able to take part in this study, you must have been part of the previous REScUE study for Crohn's disease.

You need to be at least 18 years old to join. There are no restrictions based on your gender, so both men and women can participate.

Essentially, this study is a continuation for people who have already started treatment with Stelara in the earlier REScUE study.

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.

Were you previously in the REScUE study for Crohn's disease?
Are you 18 years old or older?
Are you comfortable continuing with Stelara treatment?
Do you understand the commitment of around two years for the study duration?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive Stelara injections, either every 4 or every 8 weeks, as directed by the study doctors. You will have regular visits to the clinic so the doctors can check how you are doing, measure your symptoms, and see if the medicine is working. These visits will also involve checking for any side effects.

The study will last for a total of 112 weeks, which is about two years. During this time, the medical team will carefully monitor your health and how your Crohn's disease is responding to the treatment.

Potential risks and benefits

Participating in this study might offer the benefit of continued treatment with Stelara, which could help manage your Crohn's disease symptoms and potentially allow you to reduce or stop steroid use. However, like all medicines, Stelara can have side effects, which will be carefully monitored throughout the study. There's also the chance that the treatment might not work as well as hoped, or your dose might need adjusting. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Belgium

Common questions

What is Crohn's disease?

Crohn's disease is a long-term condition that causes inflammation in parts of your digestive system, leading to symptoms like tummy pain and diarrhoea.

What is Stelara?

Stelara is a medicine used to treat conditions like Crohn's disease by reducing inflammation in the body.

What does 'steroid-free remission' mean?

It means your Crohn's symptoms are well controlled, and you haven't needed to use steroid medicines for a certain period, usually a month or more.

How long will the study last?

The study is planned to last for about 112 weeks, which is roughly two years.

Can I stop participating in the study if I change my mind?

Yes, you are free to withdraw from the study at any time, without it affecting your medical care.