Role of 90K/Mac-2 BP as an Indicator of Early Response to Infliximab Therapy in IBD Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- evaluate the clinical usefulness of this new biomarker in the
研究概览
简要总结
The aim of this study is to analyze the relationship between 90K serum levels measured at baseline and after induction in IBD patient undergoing infliximab therapy, in order to clarify the role of serum 90K as an adjuvant biomarker for IBD patients in the active phase. Furthermore, the study aims to evaluate the clinical usefulness of this new biomarker in the management of IBD patients undergoing infliximab therapy.
详细描述
Type of the Study: The current work will be single cohort study.
Study settings: IBD outpatient clinic at Rajhy gastroenterology and Hepatology Hospital at Assiut University Hospital.
Study Duration: June 2023- June 2024 Study population: Participants will be 50 patients were recently diagnosed with Inflammatory Bowel Disease (IBD), Crohn's disease (CD) and Ulcerative Colitis (UC), undergoing the anti-TNF drug infliximab. Infliximab therapy will be administered intravenously initially at a dose of 5 mg/kg/ dose, and then after two and six weeks after the first dose, and fulfill the following inclusion criteria
Inclusion Criteria:
- Adult male and female patients aged 18-60 years old.
- IBD patients, diagnosis was confirmed by biopsy and histopathology, scheduled for treatment with anti-TNF therapy, Infliximab, and no previous treatment with anti-TNF therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female patients aged 18-60 years old.
- •IBD patients, diagnosis was confirmed by biopsy and histopathology, scheduled for treatment with anti-TNF therapy, Infliximab, and no previous treatment with anti-TNF therapy.
排除标准
- •Comorbidities (assessed with the Charlson Comorbidity Index).
- •Ongoing immunosuppressive or immunomodulatory therapy.
- •A malignant neoplasm in the last 10 years.
- •Pregnancy or breast feeding.
- •The need for artificial nutrition.
结局指标
主要结局
evaluate the clinical usefulness of this new biomarker in the
时间窗: 12 months
次要结局
未报告次要终点
研究者
Ahmed Abdelsattar Mohammed Madani
assistant lecturer of internal medicine
Assiut University