Long-term evaluation of guselkumab for children with inflammatory bowel disease and juvenile arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the long-term safety of guselkumab, a medication administered subcutaneously, in pediatric patients suffering from moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis. Participants must have previously completed a primary study involving guselkumab and demonstrated benefit from the therapy. The study aims to gather data on the ongoing effects and safety profile of the treatment over an extended period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Must have completed the dosing planned in the primary pediatric guselkumab study
* Must have received benefit from continued guselkumab therapy in the opinion of the investigator
* Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure
* Parent(s) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. An adolescent who provides assent will have the opportunity to sign an adult ICF upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate.

Exclusion Criteria:

* Participant is greater than or equal to (\>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication
* Participant is \<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication
* Are pregnant, nursing, or planning pregnancy or fathering a child
* Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention
* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

Where it's running

• Emory University
  Atlanta, Georgia, United States Recruiting
• Children's Center for Digestive Healthcare
  Atlanta, Georgia, United States Recruiting
• Riley Hospital for Children
  Indianapolis, Indiana, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Cook Childrens Medical Center
  Fort Worth, Texas, United States Recruiting
• University of Utah
  Salt Lake City, Utah, United States Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Real-world use of guselkumab for adults with moderate-to-severe ulcerative colitis and Crohn's disease in the UK

  This project will see how well guselkumab works for adults with moderate-to-severe ulcerative colitis or Crohn's disease who are starting the treatment in routine UK care.

  Recruiting Janssen-Cilag Ltd. · Harrow · NCT07242248

• Guselkumab treatment for Crohn's disease and ulcerative colitis in Germany

  This project will try to see how well guselkumab works and how it affects symptoms, quality of life, and daily activities for adults with Crohn's disease or ulcerative colitis receiving routine care in Germany.

  Recruiting Janssen-Cilag G.m.b.H · Berlin · NCT07102368

• Guselkumab in Breast Milk for Lactating Women on Guselkumab

  This study tests how much guselkumab is present in the breast milk of lactating women who are already receiving guselkumab for their approved conditions.

  Recruiting Phase 4 Janssen Research & Development, LLC · Chapel Hill, North Carolina · NCT07654751

• Guselkumab use in Crohn's disease and ulcerative colitis

  This study looks at how long people with moderate-to-severe Crohn's disease or ulcerative colitis stay on guselkumab in real-world care.

  Recruiting Janssen-Cilag Pharma GmbH · Vienna · NCT07606339

• One-year guselkumab use in adults with psoriatic arthritis

  This project will see how long adults with psoriatic arthritis stay on guselkumab over one year when prescribed as part of routine care.

  Recruiting Janssen-Cilag Ltd. · Lille · NCT07532226

• Real-world use of guselkumab in Crohn’s disease and ulcerative colitis

  This study tests how long guselkumab stays in the bodies of adults with moderate-to-severe Crohn’s disease or ulcerative colitis treated in real-world clinical settings.

  Recruiting Janssen-Cilag A.G., Switzerland · Bern · NCT07532213

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.