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RECRUITINGPhase 4INTERVENTIONAL

De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis

Pilot Study to Assess De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - On more than one biologics drug - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 Criteria: * On more than one biologics drug * 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

Treatments Being Tested

BIOLOGICAL

Ustekinumab 90 mg SC q8w

Sub-group switching from Q4w to Q8w

BIOLOGICAL

Ustekinumab 90 mg SC q12w

Sub-group switching from Q8w to Q12w

Locations (1)

MUHC - Montreal General Hospital
Montreal, Quebec, Canada