Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorMedical University of Lodz
About this trial
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 criteria
Qualifiers
Obtaining informed, written consent for the patient's participation in the in the study and for all planned procedures.
Age ≥ 18 years and ≤65 at the time of screening.
In the case of women of reproductive potential, agreement to not donate oocytes for the entire period of participation in the in the study and 6 months after receiving the last dose of the drug.
For women of reproductive potential, agreement to use effective contraception (Table 4) during the entire period, during which the patient participates in the study and for a period counted from the last dose of 15 weeks if using UST (patients in arms B and C) or 6 months if using IFX (patients in arm A).
Disqualifiers
Previous use of the study drug IFX or UST.
Hypersensitivity to the active substance or excipients.
Moderate or severe myocardial insufficiency (NYHA III or IV).
Unstable coronary artery disease.
Trial design
Treatments tested in this trial
- Infliximab
- Ustekinumab
Treatment groups
172 Participants
are divided into 3 treatment groupsSponsors and collaborators
Medical University of Lodz
Lead sponsor
Poznan University of Medical Sciences
Collaborator
Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań
Collaborator
Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz
Collaborator
Medical Research Agency, Poland
Collaborator
Source ClinicalTrials.gov