Effectiveness, Safety, and Adverse Events of Conventional and Biologic Therapy in Pediatric Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Clinical remission rate
研究概览
简要总结
This combined retrospective-prospective cohort study aims to evaluate the effectiveness, safety, and adverse events of conventional versus biologic therapy in children and adolescents with inflammatory bowel disease at Assiut University Children Hospital.
详细描述
Pediatric-onset inflammatory bowel disease differs from adult-onset disease in phenotype, disease extent, and long-term prognosis. Conventional therapy (5-aminosalicylates, corticosteroids, and immunomodulators) and biologic therapy (mainly anti-TNFα agents) are used for induction and maintenance of remission.
This observational cohort study will include pediatric patients with confirmed Crohn's disease, ulcerative colitis, or IBD-unclassified. Patients will be classified into conventional therapy and biologic therapy groups. Clinical remission, response rates, steroid-free remission, adverse events, and growth parameters will be assessed over a 12-month period.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Confirmed diagnosis of Crohn's disease, ulcerative colitis, or IBD-unclassified according to revised Porto criteria
- •Age at diagnosis less than 18 years
- •Receipt of conventional therapy and/or biologic therapy for a minimum evaluable treatment duration
- •Availability of adequate medical records
- •Written informed consent (for prospective component)
排除标准
- •- Incomplete medical records precluding assessment of primary endpoints
- •Age more than 18 years
- •Discontinuation of follow-up before a minimum evaluable treatment period
研究组 & 干预措施
Conventional Therapy
Patients managed with 5-aminosalicylates, corticosteroids, and/or immunomodulators without biologic exposure during the observation period.
Biologic Therapy
Patients who received biologic therapy (with or without concomitant conventional agents) during the observation period.
结局指标
主要结局
Clinical remission rate
时间窗: At week 8-12, 6 months, and 12 months
Proportion of patients achieving clinical remission at week 8-12, 6 months, and 12 months, defined as PCDAI ≤ 10 for Crohn's disease or PUCAI \< 10 for ulcerative colitis.
次要结局
- Clinical response rate(At week 8-12, 6 months, and 12 months)
- Steroid-free remission rate(At 12 months)
- Incidence of adverse events(Through 12 months)
- Change in growth parameters(From baseline to 12 months)
- Treatment escalation or switch rate(Through 12 months)
研究者
Elizabeth Makar Ishak
Resident Physician
Assiut University