Ustekinumab for Crohn's Disease and Ulcerative Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for individuals with Crohn's Disease or Ulcerative Colitis who are in clinical and endoscopic remission, not using corticosteroids. Women must either be unable to have children or use reliable birth control. Participants must also give informed consent and be in biochemical remission.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo de-escalation of ustekinumab therapy, changing dosing from every 4 weeks to every 8 weeks or from every 8 weeks to every 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ustekinumab
Trial Overview
The study tests if patients can maintain remission when the dose of Ustekinumab (UST) is reduced from every 4 weeks to every 8 weeks, or from every 8 weeks to every 12 weeks. It monitors UST blood levels, inflammation markers, and intestinal health during less frequent dosing.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
Janssen Inc.
Industry Sponsor
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