Actively Recruiting
Real-World Study of Guselkumab Treatment in Adults with Moderate to Severe Ulcerative Colitis or Crohns Disease in Saudi Arabia
Led by Janssen Research & Development, LLC · Updated on 2026-07-02
100
Participants Needed
1
Research Sites
3 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating how long participants with moderate to severe Crohns disease CD or ulcerative colitis UC continue their treatment with guselkumab without stopping in a real-world setting. CD and UC are inflammatory bowel diseases affecting the colon and small intestine. The study is observational and aims to understand treatment persistence and effectiveness in routine clinical practice. Participants with confirmed moderate-to-severe UC or CD who are prescribed guselkumab by their doctors will be enrolled. No study drug is provided by the trial instead, data will be collected from the participants routine clinical care and therapeutic procedures. The study will observe treatment use and outcomes over up to 96 weeks, including responses measured at various time points and clinical assessments. During the study, participants medical records and clinical data will be reviewed to track treatment persistence and outcomes such as clinical responses, remission status, quality of life, inflammatory markers, and safety events. Data will be collected at baseline and multiple follow-up visits up to week 96. This includes monitoring disease activity, medication use, adverse events, and hospital visits to provide a comprehensive understanding of guselkumab use in real-world practice.
CONDITIONS
Brief Title
A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia
Research Team
S
Study Contact
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