Guselkumab use in Crohn's disease and ulcerative colitis

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 observational study follows patients with moderate-to-severe Crohn's disease or ulcerative colitis who start guselkumab to see how long they continue the treatment in typical clinical settings. It uses real-world data to assess treatment persistence and adherence to the prescribed plan. Enrolment occurs at or before the first gab of dosing, with physicians deciding eligibility according to current labeling. The analysis will focus on patients seen at the Medical University of Vienna and may inform persistence patterns in everyday practice. No interventional procedures are described beyond routine guselkumab administration.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration
* Confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records
* Must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements

Exclusion criteria:

* Contraindicated to guselkumab per the label
* Is currently enrolled in an interventional clinical study
* Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya (guselkumab), Skyrizi (risankizumab) and Omvoh (mirikizumab). As an exception, participants with history of Ustekinumab exposure may be included
* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
* Is unable to provide informed consent

Where it's running

• Medical University Vienna
  Vienna, Austria Recruiting

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.

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• Guselkumab in Ulcerative Colitis and Crohn’s Disease in Saudi Arabia: Real-World Use

  This study looks at how long people with moderate-to-severe Crohn’s disease or ulcerative colitis continue taking guselkumab in everyday clinical practice in Saudi Arabia.

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• Guselkumab versus risankizumab for moderate-to-severe Crohn's disease

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  Recruiting at 162 sites Phase 3 Janssen Research & Development, LLC · Dothan, Alabama and 163 other locations · NCT07499232

• New treatments for adults with ulcerative colitis or Crohn's disease

  This study tests new treatments for adults with moderately to severely active ulcerative colitis or Crohn's disease to see if they work and are safe.

  Recruiting at 55 sites Phase 2 Eli Lilly and Company · Scottsdale, Arizona and 70 other locations · NCT07483073

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.