AuthorisedTherapeutic use (Phase IV)Interventional

Impact of early proactive therapeutic drug monitoring on the durability and efficacy of infliximab therapy in pediatric inflammatory bowel disease: a multicenter open-label randomized-control trial

This study is for children and teenagers with Inflammatory Bowel Disease who are beginning treatment with a medicine called infliximab. The researchers want to find out if regularly checking the amount of infliximab in a patient's blood early on helps the treatment work more effectively and keeps them feeling well for longer. They will compare this approach to the standard way infliximab is given. The main goal is to see if early monitoring helps prevent the need to stop the medicine, or increase the dose, during the first year of treatment. This is an open-label study, meaning both patients and their doctors will know which treatment plan they are on. It's a 'Phase IV' study, which means it's looking at how a medicine already approved for use works in real-world settings.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo

Enrolment target

Start

14 Oct 2024

Inflammatory Bowel Disease

What is this study about?

This study focuses on children and teenagers who have Inflammatory Bowel Disease (IBD). IBD is a long-term condition where the gut becomes inflamed. One of the treatments for IBD is a medicine called infliximab. This medicine helps reduce inflammation and can make a big difference for many patients.

The researchers in this study want to understand if regularly checking the levels of infliximab in a patient's blood, right from when they start treatment, can make the medicine work better and for a longer time. Sometimes, the body can get used to infliximab, or not enough medicine gets to where it’s needed, which can mean the treatment isn't as effective. By checking levels early, doctors might be able to adjust the dose sooner if needed, potentially preventing problems later on.

The aim is to see if this early checking helps patients stay on infliximab without needing to stop it due to side effects or it not working well enough, or without needing to take more of the medicine, during the first year of treatment. This is important because staying on a treatment that works well for longer means better health and quality of life for young people with IBD. The study will also look at how often patients have reactions to the medicine, how well their gut heals, and how they feel generally.

Key takeaways

Study looks at infliximab treatment for young people with IBD.
Compares early medicine level checks with standard care.
Aims to make treatment work better and last longer.
Will last for one year.
Participants will know which treatment group they are in.

Who may be eligible?

This study is looking for children and young people with Inflammatory Bowel Disease.

To be considered for the study, you would need to be starting treatment with a medicine called infliximab for your IBD. The study is open to both boys and girls, and there are no specific age limits mentioned, meaning a wide range of young people are welcome to take part.

Your doctor will be able to tell you if this study might be a good fit for you based on your specific health situation.

Quick self-check

Are you a child or young person?
Do you have Inflammatory Bowel Disease (IBD)?
Are you about to start treatment with infliximab for your IBD?
Are you willing to have regular hospital visits and blood tests for one year?

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

What does participation involve?

If you join this study, you would be assigned to one of two groups. One group will have regular checks of their infliximab medicine levels in their blood early in their treatment. The other group will receive infliximab as usual, without these extra early blood level checks. Both you and your doctor will know which group you are in.

Your involvement will last for one year. During this time, you will have regular hospital visits for check-ups, assessments, and to receive your infliximab treatment. These visits will also involve giving blood samples to check medicine levels and other health markers. The study will monitor how well the treatment is working, for example, by looking at how you feel and sometimes using scans or scopes to see how your gut is healing.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A possible benefit of this study is that if early monitoring helps infliximab work better, you might experience more stable treatment and fewer flare-ups of your IBD. However, there's no guarantee this will happen, and some people may not respond to the treatment as hoped. The main risks involve the extra blood tests, which can be uncomfortable, and the potential for side effects from infliximab, which would be explained fully by your doctor. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Italy

Common questions

What is Inflammatory Bowel Disease (IBD)?

IBD is a condition where the gut becomes inflamed. It includes conditions like Crohn's disease and ulcerative colitis.

What is infliximab?

Infliximab is a medicine given by drip that helps reduce inflammation in the gut for people with IBD.

What does 'early proactive therapeutic drug monitoring' mean?

It means regularly checking the amount of infliximab in your blood right from the start of your treatment to make sure you have the right levels for it to work best.

Will I know if my medicine levels are being checked early?

Yes, this is an 'open-label' study, meaning you and your doctor will know if you are in the group having early medicine level checks.

How long will I be in the study?

Your involvement in the study will last for one year from when you start your infliximab treatment.