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

Sponsor
Helwan University
Study ID
NCT06786507
Status
Active Not Recruiting

Conditions

  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab 90 mg — DRUG
    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 — DRUG
    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 Details

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 Dates

First listed
Jan 22, 2025
Start date
May 15, 2025
Status verified
Sep 2026
Primary completion
Dec 12, 2027
Completion
Dec 12, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: arm A is infliximab
    for induction patients in this group will receive infliximab in week 0,2,6 for maintenance they will receive the drug every 8 weeks dose for both induction and maintenance is 5mg/kg IV
  • Arm: arm B is ustekinomab
    for induction patients in this group will receive an IV infusion with a weight based dose for maintenance they will receive a SC injection with a fixed dose 90mg every 8 weeks

Primary Outcome Measure

(CRP) and Improvement degree of ulcerative colitis [ Time Frame: baseline and after 6 months ]

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