Guselkumab for Juvenile Arthritis and Inflammatory Bowel Disease

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

Recruiting Phase 3 Interventional Study
Crohns Disease Colitis, Ulcerative Arthritis, Psoriatic Arthritis, Juvenile
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
3 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Other
Participants needed
196 (estimated)
Sponsor
Janssen Research & Development, LLC · Industry
Who this trial is looking for

This trial is looking for children and adolescents with certain types of arthritis or inflammatory bowel disease who have benefited from an earlier treatment with guselkumab. Participants will continue receiving this medication to evaluate its long-term safety.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have completed the main study with guselkumab.
  • I have benefited from guselkumab in the opinion of my doctor.
  • I am not pregnant or nursing.
  • I agree to use effective contraception if I can get pregnant.

You may not be able to join if

  • I am 18 years or older and live in a country where the medicine is available for adults.
  • I am under 18 years old and live in a country where the medicine is available for children.
  • I am pregnant, nursing, or planning to become pregnant.
  • I have taken any medications that are not allowed before this study.
  • I have a medical condition that my doctor thinks would not be in my best interest to participate.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

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About This Trial

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).

Trial Locations
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Eligibility Criteria
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 ch…
Contacts

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

CONTACT