A Phase 4 interventional study of Ustekinumab 90 mg SC q8w and Ustekinumab 90 mg SC q12w in Crohn Disease (CD) and Ulcerative Colitis (UC), sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 4, Interventional, and Treatment
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.
Participation in this research study will last 12 months and will include 4-6 visits.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 115 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Ustekinumab 90 mg SC q8w
Biological: Ustekinumab 90 mg SC q12w
Sub-group switching from Q4w to Q8w
Sub-group switching from Q8w to Q12w
Loss of clinical remission
Proportion of patients experiencing loss of remission
Time frame: From treatment switch to end of participation (12 months)
Time-to-loss of Remission
Time frame: From treatment switch to end of participation (12 months)
Change from Baseline in the C-reactive protein (CRP) level at loss of remission.
To define if CRP level is a predictor of loss of remission.
Time frame: 12 months
Change from Baseline in the calprotectin level at loss of remission.
To define if calprotectin level is a predictor of loss of remission.
Time frame: 12 months
Disease duration before loss of remission.
Define if disease duration is a predictor of loss of remission.
Time frame: Up to 50 years.
Change in drug concentration before loss of remission.
Define if drug concentration in blood is a predictor of loss of remission.
Time frame: 12 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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McGill University Health Centre/Research Institute of the McGill University Health Centre