A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting
- Sponsor
- Janssen Sciences Ireland UC
- Study ID
- NCT07746765
- Status
- Not Yet Recruiting
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Conditions
- Colitis, Ulcerative
- Crohn Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.
Key Dates
- First listed
- Aug 5, 2026
- Start date
- Sep 30, 2026
- Status verified
- Aug 2026
- Primary completion
- Aug 3, 2029
- Completion
- Sep 30, 2029
Study Design
- Enrollment
- 35 participants (estimated)
Arms
- Arm: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)Participants with confirmed diagnosis of moderate to severe crohn's disease (CD) or ulcerative colitis (UC) treated with guselkumab in accordance with routine clinical practice as per the approved prescribing label will be enrolled. No drug will be provided as a part of this study. Only data available from clinical practice and medical records will be collected within this study.
Primary Outcome Measure
Time to Guselkumab Discontinuation [ Time Frame: Up to Week 96 ]
Central Contacts
- Study Contact844-434-4210
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