De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
Recruiting
Phase 4
Interventional Study
Crohn Disease (CD)
Ulcerative Colitis (UC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 115 (estimated)
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre · Other
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About 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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Clinical remission
* 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 Cr…
Contacts