A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany

NCT ID: NCT07102368

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2029-01-15

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.

Conditions

Inflammatory Bowel Disease; Colitis, Ulcerative; Crohn's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag G.m.b.H

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag G.m.b.H, Germany Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag G.m.b.H

Locations

Praxis Fur Gastroenteroligie

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Study Contact

Role: CONTACT

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

844-434-4210

Other Identifiers

CNTO1959IBD4002

Identifier Type: OTHER

Identifier Source: secondary_id

CNTO1959IBD4002

Identifier Type: -

Identifier Source: org_study_id