Crohn Disease (CD), Ulcerative Colitis (UC)
Conditions
Keywords
CD, UC, ustekinumab, UST
Brief summary
The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohns 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.
Detailed description
Participation in this research study will last 12 months and will include 4-6 visits.
Interventions
BIOLOGICALUstekinumab 90 mg SC q8w
Sub-group switching from Q4w to Q8w
BIOLOGICALUstekinumab 90 mg SC q12w
Sub-group switching from Q8w to Q12w
Sponsors
Janssen Inc.
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loss of clinical remission | From treatment switch to end of participation (12 months) | Proportion of patients experiencing loss of remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-loss of Remission | From treatment switch to end of participation (12 months) | — |
| Change from Baseline in the C-reactive protein (CRP) level at loss of remission. | 12 months | To define if CRP level is a predictor of loss of remission. |
| Change from Baseline in the calprotectin level at loss of remission. | 12 months | To define if calprotectin level is a predictor of loss of remission. |
| Disease duration before loss of remission. | Up to 50 years. | Define if disease duration is a predictor of loss of remission. |
| Change in drug concentration before loss of remission. | 12 months | Define if drug concentration in blood is a predictor of loss of remission. |
Countries
Canada
Contacts
Primary ContactWaqqas Afif, MD
Outcome results
None listed