Clinical Research Directory
Browse clinical research sites, groups, and studies.
De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Summary
The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST). The main question it aims to answer is: Can we de-escalate UST subcutaneous dose either from every 4 weeks (Q4) to every 8 weeks (Q8) or every 8 weeks (Q8) to every 12 weeks (Q12) in CD or UC patients in deep remission without loosing their response? Researchers will follow UST blood levels, inflammation markers and intestinal mucosa integrity and to see if UST dose can be reduced while maintaining clinical remission. Participants will: Change UST dosing from Q4 to Q8 or from Q8 to Q12. Visit the clinic once every 12 weeks for checkups and tests.
Official title: Pilot Study to Assess De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
115
Start Date
2025-10-08
Completion Date
2027-10-15
Last Updated
2025-12-26
Healthy Volunteers
No
Interventions
Ustekinumab 90 mg SC q8w
Sub-group switching from Q4w to Q8w
Ustekinumab 90 mg SC q12w
Sub-group switching from Q8w to Q12w
Locations (1)
MUHC - Montreal General Hospital
Montreal, Quebec, Canada