Actively Recruiting
Pilot Study to Assess 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
26 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
Researchers are evaluating whether patients with Crohn's Disease (CD) and Ulcerative Colitis (UC) who are taking ustekinumab (UST) can maintain disease remission when the dose of their biologic therapy is reduced. The main goal is to find out if reducing UST dosing from every 4 weeks (Q4) to every 8 weeks (Q8), or from every 8 weeks (Q8) to every 12 weeks (Q12), can keep patients in deep remission without losing their response. The study is a phase 4 clinical trial sponsored by McGill University Health Centre. Participants will switch their UST dose according to their current schedule: some will change from every 4 weeks to every 8 weeks, and others from every 8 weeks to every 12 weeks. The treatment involves subcutaneous injections of UST at these intervals. The study lasts for 12 months, during which participants will have 4 to 6 clinic visits for checkups and testing. During the study, researchers will monitor blood levels of UST, inflammation markers such as C-reactive protein and calprotectin, and the integrity of the intestinal lining to assess if remission is maintained. The main outcome measured is the loss of clinical remission from the time of treatment switch until the end of participation. Secondary outcomes include time to loss of remission, changes in inflammation markers, drug concentrations, and disease duration before loss of remission. Participants will visit the clinic every 12 weeks for follow-up and assessments.
CONDITIONS
Brief 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 of Crohn's Disease or Ulcerative Colitis
- Biochemical remission
- Endoscopic remission
- Not currently using corticosteroids
- Women not of childbearing potential, or women of childbearing potential practicing medically accepted contraception
- Able to provide informed consent
You will not qualify if you...
- Using more than one biologic drug
- Used oral or topical steroids within 6 months before study entry
- Pregnant
- Issues that may cause non-compliance, such as alcohol or drug use
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive Ustekinumab therapy with dosing intervals of either every 8 weeks or every 12 weeks as part of the de-escalation strategy.
4 to 6 visits over 12 months
Trial Site Locations
Total: 1 location
1
MUHC - Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
Actively Recruiting
Research Team
W
Waqqas Afif, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here