A Direct Head-to-head Comparison of Ustekinumab with Infliximab for the Treatment of Ulcerative Colitis

Launched by HELWAN UNIVERSITY · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to compare two medications, ustekinumab and infliximab, for treating a condition called ulcerative colitis (UC), which is a type of inflammatory bowel disease. The study aims to find out which of these two treatments is more effective in helping patients achieve remission, which means reducing or eliminating their symptoms. It will also look at how safe each medication is and how they affect the overall quality of life for people living with UC.

To participate in this trial, individuals must be between 18 and 80 years old and have been diagnosed with moderate to severe UC. They should not have previously used either of these medications. Participants will be closely monitored throughout the study, and they will have the opportunity to contribute to important research that could improve treatment options for UC in the future. If you're interested in joining the trial or learning more about it, please speak with your healthcare provider.

Gender

ALL

Eligibility criteria

• 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