Ustekinumab 90 mg: Ustekinumab is a human monoclonal IgG1 antibody that blocks the p40 subunit of both IL-12 and IL-23 this antagonistic action inhibits the interaction of these cytokines with the IL-12Rβ1 receptor. The IL-12Rβ1 receptor is found on the surface of NK cells and T cells which reduces inflammation and alters the body's immune response
Infliximab: Infliximab is a biological therapy/immunotherapy medication designed to stimulate the body's immune system and treat certain diseases. Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor necrosis factor-alpha (TNF-α). TNF-α is a signaling protein involved in acute phase reactions and systemic inflammation. Macrophages, CD4+ lymphocytes, NK cells, neutrophils, mast cells, eosinophils, and neurons produce TNF-α. This TNF-α inhibition inhibits the inflammatory reaction's cascade, leading to improved disease condition inflammatory bowel disease
Study summary
the goal of this study is to compare the efficacy of ustekinumab with infliximab for the treatment of ulcerative colitis aim of the study :
1. Compare effectiveness of ustekinumab versus infliximab therapy in remission achievement in UC patients.
2. Compare safety of ustekinumab therapy versus infliximab therapy in UC
3. To asses quality of life of ustekinumab therapy versus infliximab therapy in UC patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Subjects who are voluntarily able to give informed consent
* Subjects who can participate in all aspects of this clinical study
* Males and females aged from ≥ 18 to ≤ 80 years, at screening visit
* Diagnosis of moderate to severe UC established by clinical and endoscopic evidence.
* Biological therapy naïve patients.
Exclusion Criteria:
* \- Previous exposure to IFX or UST or any other in IFX or UST-containing product
* Has a history of hypersensitivity or allergies to the ingredients of IFX or UST formulations
* Unstable angina
* Moderate or severe heart failure (defined as New York Heart Association Class III or IV)
* Chronic respiratory failure
* History of any major neurological disorders including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease
* Chronic hepatitis B or C infection. Patients with positive viral serology at screening for infection with hepatitis B (HBV) or hepatitis C virus (HCV) may be eligible if the polymerase chain reaction test is negative, and the patients receive standard of-care antiviral prophylaxis (if applicable)
* Known severe chronic kidney failure
* Known severe chronic liver failure
* Known active or latent tuberculosis
* Ongoing HIV infection
Primary outcome measure(s)
(CRP) and Improvement degree of ulcerative colitis — baseline and after 6 months Efficacy that will be evaluated by:
Degree of reduction in the level of inflammatory markers (CRP), Improvement degree of ulcerative colitis ( ≤5 mg/l)
safety evaluation — baseline and after 6 months Any adverse event will be reported by the patient for safety evaluation of both drugs will be analyzed.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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