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Taking people in GermanyNo phase

Studies guselkumab in adults with Crohn's disease and ulcerative colitis

Observes how guselkumab works in routine care for adults with Crohn's or colitis.

Key facts

Who runs it
Janssen-Cilag G.m.b.H
Where
Berlin, GermanySee the site
Trial code
Registry title
A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
Status
Recruiting
People taking part
500 people, planned
Started
18 Aug 2025
Expected to end
15 Jan 2029
Type of study
Observational
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Crohn's disease or ulcerative colitis who are starting guselkumab as part of their usual care in Germany.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Crohn's disease or ulcerative colitis; the person must be able to receive a biologic treatment.
Earlier treatment
Cannot have had more than 4 lines of advanced IBD therapy. Cannot have had an interleukin (IL)-23 inhibitor before. Past ustekinumab use is allowed.

Main reasons for not taking part

  • More than 4 lines of advanced IBD therapy in the past
  • Earlier treatment with an interleukin (IL)-23 inhibitor (past ustekinumab is allowed)
  • Colectomy and/or a pouch
  • Currently in an interventional study or another non-interventional study from Janssen or Johnson & Johnson (J&J)

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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
  • Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements
  • By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study

Who cannot take part

  • Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included
  • Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy
  • Has had a colectomy and/or a pouch
  • Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson \& Johnson (J\&J)

Where in Germany

  • Praxis Fur GastroenteroligieBerlin, GermanyTaking people

About the trial

What the trial wants to find out

The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.

The group in the trial

  • Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)

    Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. Only data available from clinical routine will be collected in this study. During the observational period, data will be collected at weeks 0 (baseline), 4, 8, 12, 24, 48, 72, and 96, where available as per clinical routine. The respective collection times relate to the first study dose of guselkumab.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects
Plain-language title
Studies guselkumab in adults with Crohn's disease and ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026