Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis
Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis (COMBO-UC)
Medical University of Lodz
172 participants
Feb 17, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if combined therapy with infliximab and ustekinumab works better than using these drugs alone in adult patients with ulcerative colitis. It will also learn about the safety of this combination. The main questions it aims to answer are: Does the combination therapy improve the symptoms and heal the intestine quicker and better than these drugs administered alone? Does the combination therapy improve the quality of life better than these drugs administered alone? What medical problems do participants have when taking the combination therapy? Participants: Patients diagnosed with UC will be qualified to biologic therapy (infliximab/ustekinumab/infliximab + ustekinumab). Visit the clinic in stated periods for assessment and to apply medication. Take drugs based on the schedule.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Infliximab 5 mg/kg i.v at Weeks 0, 2, 6 and then every 8 weeks for 52 weeks.
Ustekinumab: first dose i.v. at Week 0 (Patients with body weight ≤55 kg - 260 mg, patients with body weight \>55-≤85 kg 390 mg, patients with body weight \>85 kg - 520 mg) then 90 mg s.c. every 8/12 weeks for 52 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06453317