A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn's Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects
Overview
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.
Primary outcome measures
- Percentage of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI) [Time frame: Week 48]
- Percentage of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS) [Time frame: Week 48]
Secondary outcome measures (12)
- Time to Guselkumab Discontinuation [Time frame: Up to Week 96]
- Change in Stool Frequency Within the First 4 Weeks of Guselkumab Administration [Time frame: Up to Week 4]
- Change in Rectal Bleeding Within First 4 Weeks of Guselkumab Administration [Time frame: Up to Week 4]
- Change in Abdominal Pain Within the First 4 Weeks of Guselkumab Administration [Time frame: Up to Week 4]
- Change in Bowel Urgency and Nocturnal Bowel Movement (NBM) Within the First 4 Weeks of Guselkumab Administration [Time frame: Up to Week 4]
- Percentage of Participants Achieving Clinical Response for CD as Measured by HBI [Time frame: Up to Week 96]
- Percentage of Participants Achieving Clinical Response for UC as Measured by PMS [Time frame: Up to Week 96]
- Percentage of Participants Achieving Clinical Remission for CD as Measured by HBI [Time frame: Up to Week 96]
- Percentage of Participants Achieving Clinical Remission for UC as Measured by PMS [Time frame: Up to Week 96]
- Percentage of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI [Time frame: Up to Week 96]
- Percentage of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS [Time frame: Up to Week 96]
- Percentage of Participants Achieving Corticosteroid-free Clinical Remission for CD as Measured by HBI [Time frame: Up to Week 96]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Praxis Fur Gastroenteroligie — Berlin
Identifiers
NCT: NCT07102368 · CNTO1959IBD4002 · CNTO1959IBD4002