De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
NCT ID: NCT07303686
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
115 participants
INTERVENTIONAL
2025-10-08
2027-10-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ustekinumab Q4w
Ustekinumab 90 mg SC q8w
Sub-group switching from Q4w to Q8w
Ustekinumab Q8w
Ustekinumab 90 mg SC q12w
Sub-group switching from Q8w to Q12w
Interventions
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Ustekinumab 90 mg SC q8w
Sub-group switching from Q4w to Q8w
Ustekinumab 90 mg SC q12w
Sub-group switching from Q8w to Q12w
Eligibility Criteria
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Inclusion Criteria
* Biochemical remission
* Endoscopy remission
* Not on corticosteroid
* A woman must be ;
* not of childbearing potential
* of childbearing potential and practicing a medically accepted method of contraception.
* Able t provide informed consent
Exclusion Criteria
* Use of oral or topical steroids within 6months of study entry
* pregnancy
* Any issue that could lead to non-compliance, as alcohol, drug use
* Unable to provide consent or t comply with follw-up visit
18 Years
ALL
No
Sponsors
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Janssen Inc.
INDUSTRY
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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waqqas.afif
Principal Investigator
Locations
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MUHC - Montreal General Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-5567
Identifier Type: -
Identifier Source: org_study_id
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