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

Phase 4RecruitingNCT07303686

McGill University Health Centre/Research Institute of the McGill University Health Centre115 enrolled

Overview

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.

Participation in this research study will last 12 months and will include 4-6 visits.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Crohn Disease (CD)Ulcerative Colitis (UC)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Loss of clinical remission

Proportion of patients experiencing loss of remission

Time frame: From treatment switch to end of participation (12 months)

Secondary Outcomes

Time-to-loss of Remission

Time frame: From treatment switch to end of participation (12 months)

Change from Baseline in the C-reactive protein (CRP) level at loss of remission.

To define if CRP level is a predictor of loss of remission.

Time frame: 12 months

Change from Baseline in the calprotectin level at loss of remission.

To define if calprotectin level is a predictor of loss of remission.

Time frame: 12 months

Disease duration before loss of remission.

Define if disease duration is a predictor of loss of remission.

Time frame: Up to 50 years.

Change in drug concentration before loss of remission.

Define if drug concentration in blood is a predictor of loss of remission.

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts