Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD) (NCT07245394)
SHIFT-IBD: Switching to High-efficacy Anti-IL-23 Guselkumab in Ustekinumab-exposed Persons With Active IBD
🩺 Plain-English Summary (8th-Grade Level)
The SHIFT-IBD Study is being conducted at multiple medical centers across Canada to evaluate how well guselkumab (Tremfya) works for people with inflammatory bowel disease (IBD) who haven't responded well enough to ustekinumab. Patients will begin guselkumab based on their doctor's decision. If eligible, they may be invited to participate in the study, which involves monitoring symptoms, test results, and overall health over the course of one year. Guselkumab will be given according to local medical guidelines. Doctors can adjust the treatment as needed, just like in routine care. Researchers believe that switching to guselkumab may be as effective as other advanced treatments. For those who saw some improvement on ustekinumab but not enough, guselkumab may offer better symptom control-without worsening results on medical tests like endoscopy. The goal is to explore better treatment options for people whose IBD has not been well controlled with current therapies.
Who can join: Review the eligibility criteria below.
Location: University of Calgary — Calgary, Alberta
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- University of Calgary — Calgary, Alberta
- MA MacMillan — Fredericton, New Brunswick
- Hamilton Health Sciences Corporation — Hamilton, Ontaio
- Barrie GI Associates — Barrie, Ontario
- Brampton Gastroenterology Research Group Inc — Brampton, Ontario
- GNRR Digestive Clinics and Research Center Inc. — Brampton, Ontario
- LDDI Clinical Trials Inc. dba London Digestive Disease Institute — London, Ontario
- West Gta Research Inc. — Mississauga, Ontario
- Abp Research Services Corporation — Oakville, Ontario
- Taunton Surgical Center — Oshawa, Ontario
- Toronto Immune and Digestive Health Institute — Toronto, Ontario
- The Research Institute of the McGill University Health Centre — Montreal, Quebec
📞 Contact the Study Coordinator
Phone: (647) 812-2113
Email: ajeyakumar@tidhi.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.