A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab
- Sponsor
- Janssen-Cilag A.G., Switzerland
- Study ID
- NCT07532213
- Status
- Recruiting
Conditions
- Colitis, Ulcerative
- Crohn Disease
- Inflammatory Bowel Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
The purpose of this study is to evaluate how long guselkumab remains 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 15, 2026
- Start date
- Apr 13, 2026
- Status verified
- Jun 2026
- Primary completion
- Apr 10, 2029
- Completion
- Apr 10, 2029
Study Design
- Enrollment
- 50 participants (estimated)
Arms
- Arm: 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. No drug will be provided as part of this study. Only data available from standard clinical practice and medical records will be collected.
Primary Outcome Measure
Time to Guselkumab Persistence [ Time Frame: Up to Week 96 ]
Central Contacts
- Study Contact844-434-4210
Find similar trials
Related Studies
- Immune Regulation in Ulcerative Colitis or Crohn s DiseaseRecruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland
- A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel DiseaseRecruiting · University of California, San Francisco · San Francisco, California
- Gene Expression in Inflammatory Bowel DiseaseEnrolling By Invitation · Johns Hopkins University · Baltimore, Maryland
- Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy ProjectRecruiting · University of California, San Diego · La Jolla, California