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临床试验/NCT06786507
NCT06786507进行中(未招募)不适用

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

Helwan University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月15日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
(CRP) and Improvement degree of ulcerative colitis

研究概览

简要总结

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.

详细描述

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic inflammatory relapsing disorder affecting the gastrointestinal tract and is characterized by a progressive and unpredictable disease course.. The major subtypes are :

  1. Crohn's Disease which affects any part of GIT.
  2. Ulcerative Colitis which affects mainly the colon . And a subtype of IBD is called intermediate colitis (IC) when its unable to diffrentiate between UC and Crohns disease . There has been a global rise in the incidence of IBD over the last few decades, in 2017; there were 6.8 million cases of IBD globally. The age-standardized prevalence rate increased from 79.5 per 100, 000 population in 1990 to 84.3 per 100, 000 population in 2017. The annual incidence of Crohn's disease is 5.0 per 100,000 person-years in Asia and the Middle East, whereas incidence rates of ulcerative colitis are 6.3 per 100,000 person-years in Asia and the Middle East . some studies suggest the relative incidence ratio of UC and CD is 6:1 .Regarding UC the highest incidence of the disease is in Northern Europe and Canada at 24.3 and 19.2/100,000, respectively. Prevalence rates are also the highest in these two regions, at 505/100,000 in Northern Europe and 248/100,000 in Canada with incidence rate of 2.33 per 100,000 persons per year for UC in the Arab world Ulcerative colitis (UC) is a chronic, idiopathic inflammatory condition that affects the mucosa of the colon and rectum. Ulcerative colitis is also considered a progressive disease as it is associated with increased risk of disease extension, dysplasia/neoplasia, fibrosis and rectal dysfunction. Observational studies suggest that one-third of patients with left-sided colitis or disease limited to the rectum will develop pancolitis over a period of 10 years .

The changing epidemiology and the progressive nature of the disease require a clear understanding of the available and soon to become available therapeutic agents to treat UC and the different aspects of their pharmacology .

Treatments for inducing remission include 5-aminosalicylic acid drugs and corticosteroids. Maintenance treatments include 5-aminosalicylic acid drugs, thiopurines, biologics (eg,anti TNF , anti-cytokines and anti-integrins), and small molecules (Janus kinase inhibitors and sphingosine-1-phosphate receptor modulators) .

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 .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • - 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

研究组 & 干预措施

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

干预措施: Ustekinumab 90 mg (Drug)

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

干预措施: Infliximab (Drug)

结局指标

主要结局

(CRP) and Improvement degree of ulcerative colitis

时间窗: 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

时间窗: baseline and after 6 months

Any adverse event will be reported by the patient for safety evaluation of both drugs will be analyzed.

次要结局

  • improvement in quality of life(baseline and after 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Myrna Mamdouh Sedki

Teaching assistant at Pharmacy Practice Department Faculty of Pharmacy - Helwan University

Helwan University

研究点 (1)

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