NCT05906576招募中4 期
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical response rate at 14 weeks
研究概览
简要总结
Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
详细描述
This is a prospective, multicenter registry study in Chinese pediatric Crohn's disease patients. A total of 30 subjects were planned to be enrolled and treated with Infliximab. Subjects were observed for 102 weeks after administration to evaluate the clinical efficacy and safety of infliximab in the treatment of children with Crohn's disease in a real diagnostic setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranged 6 to 17 years (both inclusive), no gender limitation.
- •A clear diagnosis was made in children with moderate to severe active stage (PCDAI≥30) Crohn's disease refer to the expert consensus on the diagnosis and treatment of inflammatory bowel disease in children (2019 edition).
- •Patients and/or their guardians must sign ICF, and the research agreement/ICF for data collection and data verification shall comply with local laws and regulations.
- •The patient received infliximab for the first time.
排除标准
- •Patients with contraindications to infliximab use (such as severe infection, active tuberculosis, lymphoma or other malignancies), moderate to severe heart failure, and allergies to other murine proteins, infliximab or any component of this product.
- •Those who accept other anti-TNF-α any biological drugs or any other biologicals.
- •Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period
- •Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF
- •The investigator judges the subject inappropriate to be included in this study.
研究组 & 干预措施
Infliximab
Experimental
Infliximab for the treatment of Crohn's disease in children
干预措施: Infliximab (Drug)
结局指标
主要结局
Clinical response rate at 14 weeks
时间窗: up to 14 weeks
Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points
次要结局
- Changes from baseline in height-for-age z-score (HAZ), weight-for-age z-score (WAZ) and BMI-for-age z-score at week 14 and 54(up to 54 weeks)
- Clinical remission rate at week 14 and 54(up to 54 weeks)
- Endoscopic response rate at week 14 and 54(up to 54 weeks)
- Changes from baseline in serum C-reactive protein at week 14 and 54(up to 54 weeks)
- Changes from baseline in erythrocyte sedimentation rate at week 14 and 54(up to 54 weeks)
- ADA positive rate(up to 54 weeks)
- Percentage of participants with Adverse Events(up to 102 weeks)
- Mucosal healing rate at week 14 and 54(up to 54 weeks)
- Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks(up to 54 weeks)
研究者
研究点 (1)
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