Crohn'sUCRecruiting
A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
Observational · No treatment assigned · 1 site · Janssen-Cilag G.m.b.H
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease, Colitis, Ulcerative and Crohn's Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 500 participants are expected to take part.
- The study has 1 group.
- Start date: 2025-08-18.
- Main results expected around 2029-01-15 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Germany.
Groups in this study
- Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)
Main thing being measured
- Percentage of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI) (Week 48)
- Percentage of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS) (Week 48)
In the researchers’ words
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…
Words you might see
- Mayo score: a score used to measure how active ulcerative colitis is.
- Remission: a period when the disease is quiet or under control.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease; Colitis, Ulcerative; Crohn's Disease |
| Lead sponsor | Janssen-Cilag G.m.b.H |
| Enrollment | 500 (estimated) |
| Start date | 2025-08-18 |
| Primary completion (est.) | 2029-01-15 |
| First posted | 2025-08-03 |
| Last updated | 2026-09-25 |
| Official title | Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects |
| ClinicalTrials.gov ID | NCT07102368 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: 1. 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 2. Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements 3. 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 Exclusion Criteria: 1. Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy 2. Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included 3. Has had a colectomy and/or a pouch 4. Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson \& Johnson (J\&J)
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Praxis Fur Gastroenteroligie | Berlin | Germany | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.