Actively Recruiting
De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2025-12-26
115
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
J
Janssen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical remission
- Biochemical remission
- Endoscopy remission
- Not currently using corticosteroids
- Women not of childbearing potential or using medically accepted contraception
- Able to provide informed consent
You will not qualify if you...
- Taking more than one biologic drug
- Use of oral or topical steroids within 6 months before study entry
- Pregnant
- Issues such as alcohol or drug use that may cause non-compliance
- Unable to provide consent or comply with follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MUHC - Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
Actively Recruiting
Research Team
W
Waqqas Afif, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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