NCT07102368 A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
| NCT ID | NCT07102368 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Janssen-Cilag G.m.b.H |
| Condition | Inflammatory Bowel Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-08-18 |
| Primary Completion | 2029-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-08-18 with a primary completion date of 2029-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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)
Contact & Investigator
Janssen-Cilag G.m.b.H, Germany Clinical Trial
STUDY DIRECTOR
Janssen-Cilag G.m.b.H
Frequently Asked Questions
Who can join the NCT07102368 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07102368 currently recruiting?
Yes, NCT07102368 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07102368 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07102368 clinical trial?
NCT07102368 is sponsored by Janssen-Cilag G.m.b.H. The principal investigator is Janssen-Cilag G.m.b.H, Germany Clinical Trial at Janssen-Cilag G.m.b.H. The trial plans to enroll 500 participants.