De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
Participation in this research study will last 12 months and will include 4-6 visits.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
115 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Waqqas Afif, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal