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NOT YET RECRUITING
NCT06786507

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

Sponsor: Helwan University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-05-15

Completion Date

2026-10-01

Last Updated

2025-01-22

Healthy Volunteers

No

Interventions

DRUG

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

DRUG

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

Locations (1)

El-Demerdash hospital

Cairo, Egypt