A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia
- Sponsor
- Janssen Research & Development, LLC
- Study ID
- NCT07541261
- Status
- Recruiting
Conditions
- Colitis
- Crohn Disease
- Ulcerative
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.
Key Dates
- First listed
- Apr 21, 2026
- Start date
- May 12, 2026
- Status verified
- Jun 2026
- Primary completion
- Jan 2, 2029
- Completion
- Jan 29, 2029
Study Design
- Enrollment
- 100 participants (estimated)
Arms
- Arm: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD): GuselkumabParticipants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from clinical practice, through routine therapeutic procedures and evaluation assessments 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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