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

NCT07102368 | Recruiting

• 1 other identifier: CNTO1959IBD4002
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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; Crohn's Disease; Colitis, Ulcerative

Keywords

IBD; Ulcerative Colitis; Crohn's Disease; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases; Colitis, Ulcerative; Ulcer; Guselkumab; Tremfya; Inflammatory

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)

  Clinical remission for CD is defined as the HBI score less than or equal to (\<=) 4. HBI score is used to assess disease severity and treatment effectiveness.

  Week 48

• Percentage of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)

  Clinical remission for UC is defined as the PMS score \<=2 and a rectal bleeding subscore of 0. Mayo scoring system is used to assess disease severity and treatment effectiveness.

  Week 48

Secondary Outcomes (28)

• Time to Guselkumab Discontinuation

  Up to Week 96

• Change in Stool Frequency Within the First 4 Weeks of Guselkumab Administration

  Up to Week 4

• Change in Rectal Bleeding Within First 4 Weeks of Guselkumab Administration

  Up to Week 4

• Change in Abdominal Pain Within the First 4 Weeks of Guselkumab Administration

  Up to Week 4

• Change in Bowel Urgency and Nocturnal Bowel Movement (NBM) Within the First 4 Weeks of Guselkumab Administration

  Up to Week 4

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative colitis (UC) disease.

You may qualify if:

• 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

You may not qualify if:

• Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy
• Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included
• 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)

Sponsors & Collaborators

• Janssen-Cilag G.m.b.H: lead

Study Sites (1)

Praxis Fur Gastroenteroligie

Berlin, 10825, Germany

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Ulcer

Condition Hierarchy (Ancestors)

Colitis; Pathological Conditions, Signs and Symptoms

Study Officials

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

  Janssen-Cilag G.m.b.H

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): January 15, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)