De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ustekinumab 90 mg SC q8w, Ustekinumab 90 mg SC q12w.
- Who it may be relevant to
- Registry conditions: Crohn Disease (CD), Ulcerative Colitis (UC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study to Assess De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
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.
Detailed description
Participation in this research study will last 12 months and will include 4-6 visits.
Interventions
- 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
Primary outcome measures
- Loss of clinical remission [Time frame: From treatment switch to end of participation (12 months)]
Secondary outcome measures (5)
- 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. [Time frame: 12 months]
- Change from Baseline in the calprotectin level at loss of remission. [Time frame: 12 months]
- Disease duration before loss of remission. [Time frame: Up to 50 years.]
- Change in drug concentration before loss of remission. [Time frame: 12 months]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- MUHC - Montreal General Hospital — Montreal
Identifiers
NCT: NCT07303686 · 2020-5567