RecruitingPHASE3INTERVENTIONAL

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

This research study, called a Long-term Extension (LTE) study, is investigating the safety of a drug named guselkumab over a longer period. It's for children and young people who have moderately to severely active Crohn's disease, ulcerative colitis, or juvenile psoriatic arthritis (a type of arthritis affecting young people). Participants will be those who have already been taking guselkumab in a previous study and have found it helpful. The main goal is to understand if guselkumab continues to be safe for them when used for an extended time. This study is an important step in learning more about how this medication works in the long run for these conditions.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

196

Start

29 Oct 2024

Estimated completion

12 Dec 2031

Crohns Disease Colitis, Ulcerative Arthritis, Psoriatic Arthritis, Juvenile

What is this study about?

This study is called a 'Long-term Extension' study, which means it builds on previous research where participants were already taking a medicine called guselkumab. The main goal here is to see how safe this medicine is when used for a longer time in children and young people. The conditions it's looking at are Crohn's disease and ulcerative colitis, which are types of inflammatory bowel disease, and juvenile psoriatic arthritis, a form of arthritis that can affect young people.

Guselkumab is given as an injection under the skin. By continuing to study participants over a longer period, doctors can gather important information about any long-term side effects or changes in how the medicine works. This helps them understand the overall safety profile of guselkumab for these specific groups of young patients.

Understanding the long-term safety of medicines is crucial. It helps healthcare professionals make informed decisions about prescribing treatments and ensures that patients can receive care with the best possible outcomes. This study is a key part of developing a complete picture of how guselkumab can help young people manage their conditions safely over time.

Key takeaways

This study evaluates the long-term safety of guselkumab in young people.
It's for those with Crohn's, ulcerative colitis, or juvenile psoriatic arthritis who've benefited from guselkumab.
Participants continue to receive the medicine and will have regular check-ups.
The main aim is to understand long-term effects and safety.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to join this study, participants must have already completed a previous study involving guselkumab for children. Importantly, a doctor must believe that they have been helped by guselkumab and have seen benefits from taking it.

Female participants who are able to have children must either not be sexually active or be using highly effective contraception and agree to continue using it during the study and for 12 weeks after their last dose. For participants under 18, a parent or legal guardian must give their permission by signing a consent form. Also, if the child is old enough to understand, usually from about 7 years old, they will also need to agree to take part.

You cannot join the study if you are pregnant, breastfeeding, or planning to become pregnant or father a child. Also, if you’re an adult (18 or over) or a child/young person under 18, and it's been a long time (more than 2 years) since guselkumab became available in your country for your specific condition, you also won't be able to join.

Quick self-check

Have you already taken part in a previous guselkumab study for children?
Does your doctor think guselkumab has helped you?
If you are female and can have children, are you not sexually active or using effective contraception?
Are you able to attend regular appointments and follow study instructions?
Are you under 18 years old and guselkumab has not been commonly available for your condition for more than 2 years in your country?

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

What does participation involve?

This study is an extension, so you would continue to receive guselkumab as an injection under the skin. The specific schedule for your visits and assessments will be explained by the study team, but they will involve regular check-ups to monitor your health and how you're responding to the medication. This will include physical examinations, blood tests, and discussions about any side effects you might be experiencing. The total duration of your participation will vary depending on how long you were in the original study and how long the medical team believes it's beneficial for you to continue. You will be closely supported by the study team throughout.

Potential risks and benefits

Participating in this study might offer potential benefits such as continuing to receive a medication that has already shown help for your condition, with careful monitoring from medical professionals. Like all medicines and studies, there are also potential risks, which could include side effects from the guselkumab or discomfort from tests like blood draws. The study team will explain all known potential risks in detail before you decide to join. It's very important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (42)

Emory University
Atlanta, United States· Recruiting
Children's Center for Digestive Healthcare
Atlanta, United States· Recruiting
Riley Hospital for Children
Indianapolis, United States· Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, United States· Recruiting
University of Utah
Salt Lake City, United States· Recruiting
Instituto Caici
Rosario, Argentina· Recruiting
The Kids Research Institute Australia on behalf of the Centre for Child Health Research
Nedlands, Australia· Recruiting
Mater Hospital Brisbane Inflammatory Bowel Diseases
South Brisbane, Australia· Recruiting
Capital Center For Children's health Capital Medical University
Beijing, China· Recruiting
Changzhou No 2 Peoples Hospital
Changzhou, China· Recruiting
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, China· Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China· Recruiting

+30 more sites — see the official record for the full list.

Common questions

What is guselkumab?

Guselkumab is a medicine given by injection under the skin, used to treat certain inflammatory conditions like Crohn’s disease, ulcerative colitis, and psoriatic arthritis.

Who is this study for?

It's for children and young people who have Crohn's disease, ulcerative colitis, or juvenile psoriatic arthritis, and who have already taken guselkumab in a previous study and found it helpful.

Why is this study happening?

The study aims to see how safe guselkumab is when used for a long time in children and young people with these conditions, monitoring for any long-term effects.

What does 'Long-term Extension' mean?

It means this study continues from a previous study. Participants will keep taking the study medicine longer to see its effects over an extended period.

Can I stop participating if I want to?

Yes, joining is voluntary, and you can decide to leave the study at any time without it affecting your regular medical care.

How to find out more

Study Contact

Participate-In-This-Study1@its.jnj.com 844-434-4210 Official trial record

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