Active not recruitingPHASE3INTERVENTIONAL

A Long-term Extension Study of Ustekinumab in Pediatric Participants

This study is designed to gather more information about how safe a medicine called ustekinumab is when used over a longer time by children and young people. It's for those aged 2 to 17 years old who are currently receiving ustekinumab for conditions like Crohn's disease, ulcerative colitis, or psoriatic arthritis as part of an earlier study. The main goal is to check for any long-term side effects. Participants must have already finished the main part of their original ustekinumab study and be benefiting from the treatment. This research helps doctors understand better if this medicine is safe and effective for long-term use in younger patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

159

Start

18 Oct 2021

Estimated completion

15 Mar 2028

Crohn Disease Colitis, Ulcerative Arthritis, Psoriatic

What is this study about?

This research study is about a medicine called ustekinumab. It's designed to check how safe this medicine is over a longer period when given to children and young people. Ustekinumab is used to treat conditions like Crohn's disease (a type of inflammatory bowel disease), ulcerative colitis (another inflammatory bowel disease), and psoriatic arthritis (a type of arthritis linked to psoriasis).

The study is specifically for young people who are already taking ustekinumab as part of an earlier research study. The main aim is to carefully watch for and record any side effects or health changes over time that might be linked to the medicine. This helps doctors understand its full safety profile, which is really important when considering long-term treatments for growing children.

By taking part, these young people will help doctors learn more about providing the best and safest care for others with similar conditions in the future. It’s a continuation of existing treatment, but with extra careful monitoring.

Key takeaways

It's a long-term safety study of ustekinumab for children and young people.
Participants must already be in an earlier ustekinumab study and benefiting from treatment.
It aims to understand long-term side effects and health changes over time.
Parents/guardians and the child (if old enough) must agree to participate.
Regular clinic visits and careful monitoring of health will be involved.

Who may be eligible?

To join this study, you must have already finished taking part in the main study for ustekinumab in children. You also need to be benefiting from the ustekinumab treatment you're currently receiving, meaning your health condition has improved or is stable.

Your parent(s) or legal guardian(s) will need to understand the study and agree for you to take part. If you are aged 7 or older, you will also be asked if you understand and agree to participate. When you get older during the study, you'll have the chance to agree again as an adult.

You cannot join if you are pregnant, breastfeeding, or planning to become pregnant or father a child. Also, if you've recently had COVID-19 or been in close contact with someone who has, you might not be able to join unless specific conditions are met, like having a negative test result after a certain time.

Quick self-check

Have you already completed the main part of an earlier ustekinumab study?
Is your ustekinumab treatment currently helping your condition?
Are you between 2 and 17 years old?
Are you able to follow specific instructions about your lifestyle?
Are you currently not pregnant, breastfeeding, or planning a pregnancy (or fathering a child)?
Have you recently had or been exposed to COVID-19? (This might affect your eligibility temporarily.)

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 will continue to receive your ustekinumab medicine. The study will involve regular check-ups at a clinic where doctors and nurses will monitor your health and take necessary tests. This will help them keep track of how you are doing and look out for any changes, especially any side effects. You will need to follow specific instructions about your lifestyle, such as avoiding certain activities or medicines, to ensure the study results are clear and accurate. The total duration of the study will depend on how long the research team needs to collect enough safety information.

Potential risks and benefits

The potential benefits of continuing in this study include ongoing access to your ustekinumab treatment which is helping your condition, along with very close medical monitoring of your health. However, like all medicines, ustekinumab can have side effects, and the study aims to carefully identify any long-term risks. You will be told about any known or potential risks before you decide to join. Remember, taking part is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (48)

Children's Center For Digestive Healthcare, Llc
Atlanta, United States
Mount Sinai
New York, United States
Levine Childrens at Atrium Health
Charlotte, United States
Pediatric Specialists Of Virginia
Fairfax, United States
STAT Research S A
Buenos Aires, Argentina
Hospital de Ninos de Cordoba
Córdoba, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Argentina
Huderf
Brussels, Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
UZ Gent
Ghent, Belgium
UZ Brussel
Jette, Belgium
Uz Gasthuisberg
Leuven, Belgium

+36 more sites — see the official record for the full list.

Common questions

What is ustekinumab?

Ustekinumab is a medicine that helps reduce inflammation in the body. It’s used to treat certain conditions like Crohn's disease and some types of arthritis.

Why is this study only for children currently in another ustekinumab study?

This study is a continuation of an earlier one. It's designed to follow children who are already taking ustekinumab to see how safe the medicine is over a longer period of time.

What does 'long-term safety' mean?

It means doctors want to understand if there are any side effects or health problems that might appear or become more noticeable when ustekinumab is used for many months or years, not just a short time.

Will I get a different medicine in this study?

No, you will continue to receive ustekinumab, which is the medicine you are already taking as part of the earlier study.

What if I decide I don't want to be in the study anymore?

You are free to leave the study at any time, for any reason. Your decision will not affect the medical care you receive for your condition.