Active not recruitingOBSERVATIONAL

Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting

This study aims to understand how well people with Inflammatory Bowel Disease (IBD) continue using a medicine called Hyrimoz® for up to six months after they start it. It’s an observational study, meaning researchers will simply watch and collect information from patients' regular medical records and a few questionnaires, without changing any treatment plans. This helps doctors see how Hyrimoz® is used and tolerated in actual everyday practice in clinics, rather than in a highly controlled trial. The study will last for three years in total, with each patient followed for up to one year.

At a glance

Status

Active not recruiting

Sponsor

Sandoz

Enrolment target

562

Start

16 Feb 2023

Estimated completion

01 Dec 2026

Inflammatory Bowel Disease

What is this study about?

This study focuses on a medicine called Hyrimoz®, which is a type of 'biosimilar' adalimumab, used to treat Inflammatory Bowel Disease (IBD). IBD includes conditions like Crohn's disease and ulcerative colitis. Doctors are interested in how long people stay on this treatment once they start it, as this can tell us a lot about how effective and tolerable it is in the real world.

Unlike traditional clinical trials, this is an 'observational study'. This means the researchers won't ask you to try a new treatment or change anything about your current care. Instead, they will simply collect information from your existing medical records during your normal doctor's appointments. They want to see how patients with IBD use Hyrimoz® and how they respond to it over time.

The main goal is to find out how many IBD patients continue taking Hyrimoz® for at least six months. This kind of information is very valuable because it shows how the medicine performs for a wide range of patients in everyday clinical practice. It helps healthcare professionals better understand the long-term use of Hyrimoz®.

Key takeaways

Looks at how long IBD patients stay on Hyrimoz®.
It's an 'observational study', so no changes to your treatment.
Information is collected from your regular medical records.
No extra tests or clinic visits required.
You'll be followed for up to one year.
Helps doctors understand real-world use of Hyrimoz® for IBD.

Who may be eligible?

You might be able to join this study if you are 18 years old or older and have been diagnosed with Crohn's disease or ulcerative colitis. You must be either just starting Hyrimoz® as a new treatment, or you're switching to Hyrimoz® from another similar medicine you've been taking for at least six months and your disease has been stable.

Crucially, the decision for you to start or switch to Hyrimoz® must have already been made by you and your doctor before you're asked to join the study. You should also be able to fill out simple questionnaires. You won't be able to join if you are already taking part in another clinical study, have any reasons not to take Hyrimoz® according to its instructions, are about to have bowel surgery, or have used other experimental drugs recently.

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 Crohn's disease or ulcerative colitis?
Has your doctor already decided that you will start or switch to Hyrimoz®?
Are you able to fill out simple questionnaires?
Are you NOT currently in another clinical study?
Are you NOT about to have bowel surgery soon?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your doctor will continue to manage your care and treatment with Hyrimoz® as they normally would. The study will not change your medication, dose, or clinic visits. Researchers will collect information from your medical notes during your regular appointments over a maximum of one year. There will be four main times when information is collected: when you join, after about 3 months, again at 6 months, and finally at 12 months.

You might be asked to complete a few simple questionnaires, but there won't be any extra tests or examinations just for the study. The entire study will run for three years, but each individual patient will only be involved for up to one year.

Potential risks and benefits

Since this is an observational study and doesn't involve any new treatments or changes to your routine care, there are virtually no additional medical risks for you. Your treatment decisions will remain entirely with you and your doctor. You won't directly benefit from taking part, but the information collected will help doctors and researchers understand how Hyrimoz® works in real life for many patients with IBD, which could help others in the future. You are free to withdraw from the study at any time without affecting your medical care.

Locations (51)

Sandoz Investigational Site Belgium
Verified postcode
Aalst, Belgium
Sandoz Investigational Site Belgium
Verified postcode
Antwerp, Belgium
Sandoz Investigational Site Belgium
Verified postcode
Bonheiden, Belgium
Sandoz Investigational Site Belgium
Verified postcode
Brussels, Belgium
Sandoz Investigational Site Belgium
Verified postcode
Eeklo, Belgium
Sandoz Investigational Site Belgium
Verified postcode
Ghent, Belgium
Sandoz Investigational Site Belgium
Verified postcode
Herentals, Belgium
Sandoz Investigational Site Belgium
Verified postcode
Kortrijk, Belgium
Sandoz Investigational Site Belgium
Verified postcode
Liège, Belgium
Sandoz Investigational Site Belgium
Verified postcode
Namur, Belgium
Sandoz Investigational Site Belgium
Verified postcode
Seraing, Belgium
Sandoz Investigational Site Belgium
Verified postcode
Sint-Niklaas, Belgium

Common questions

What is Hyrimoz®?

Hyrimoz® is a medicine used to treat Inflammatory Bowel Disease (IBD). It's a 'biosimilar' version of another medicine called adalimumab.

Will my treatment change if I join this study?

No, your treatment with Hyrimoz® and your regular doctor's appointments will not change because of this study. It simply looks at how you use the medicine as part of your normal care.

How long will I be involved in the study?

You will be followed for up to one year, but your information will only be collected during your usual clinic visits.

Do I have to do extra tests or visits?

No, you don't need extra visits or medical tests. Information will be taken from your existing medical records, and you might complete some simple questionnaires.

What's the main goal of this study?

The main goal is to see how long people with IBD continue to take Hyrimoz® in real-world settings, helping doctors understand its long-term use.