Hemorrhagic Proctocolitis Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
MUHC - Montreal General Hospital
RECRUITING
Montreal
Contact Information
Primary
Waqqas Afif, MD
waqqas.afif@mcgill.ca
514-934-1943
Time Frame
Start Date: 2025-10-08
Estimated Completion Date: 2027-10-15
Participants
Target number of participants: 115
Treatments
Other: Ustekinumab Q4w
Other: Ustekinumab Q8w
Sponsors
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: Janssen Inc.

This content was sourced from clinicaltrials.gov

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