Post-marketing Case Registration Study on the Safety and Efficacy of Taibowei® Adalimumab Injection for Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease
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
- The incidence of adverse events (AE), adverse drug reactions (ADR), adverse events of special interest (AESI) and serious ADR at 12, 26 and 52 weeks after treatment
研究概览
简要总结
This study is a real - world clinical research of adalimumab. The project plans to enroll 30 subjects, aiming to evaluate the incidence of serious adverse events (SAEs) within 12, 26, and 52 weeks after treatment; as well as the incidence of adverse events (AEs), adverse drug reactions (ADRs), adverse events of special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment.
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 is between 6 years old (inclusive) and 17 years old (inclusive), regardless of gender.
- •Diagnosed as having moderate - to - severe active pediatric Crohn's disease according to the "Expert Consensus on the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease 2019".
- •(3) Pediatric Crohn's disease patients who have been prescribed Adalimumab Solution for Injection by doctors after a full assessment of risks/benefits.Both the patient and their guardian must sign the informed consent form. The research protocol/informed consent form used for data collection and data verification should comply with local laws and regulatory requirements.
排除标准
- •(1) According to the instruction manual of Adalimumab Solution for Injection and the judgment of the treating physician, the patient is not suitable for treatment with Adalimumab Solution for Injection.
- •(2) Pediatric Crohn's disease patients who have received any live vaccines within 3 months prior to the first dose of Adalimumab Solution for Injection or who plan to receive any live vaccines during the study period.
- •Patients who are participating in other clinical studies. (4) Patients whom the investigator deems unsuitable for participation in this trial.
研究组 & 干预措施
Adalimumab Solution for Injection 20mg/40mg
For children with a body weight of ≥ 40 kg, the recommended loading dose is 160 mg. Then, 80 mg is given 2 weeks later, and subsequently, 40 mg is administered every 2 weeks for maintenance treatment.
For children with a body weight of 17 - 40 kg, the loading dose is 80 mg. 40 mg is given 2 weeks later, and then 20 mg is administered every 2 weeks for maintenance treatment.
If necessary, the dosing frequency can be increased to once a week according to the results of therapeutic drug monitoring and/or clinical response.
干预措施: Adalimumab Solution for Injection (Drug)
结局指标
主要结局
The incidence of adverse events (AE), adverse drug reactions (ADR), adverse events of special interest (AESI) and serious ADR at 12, 26 and 52 weeks after treatment
时间窗: Weeks 12, 26, 52
The incidences of adverse events (AEs), adverse drug reactions (ADRs), adverse events of special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment
次要结局
- Changes in C-reactive protein (CRP) levels(Weeks 12, 26, 52)
- Proportion of patients with clinical remission patients with moderate - to - severe active Crohn's disease in the real - world setting.(Weeks 12, 26, 52)
- Proportion of patients with clinical response(Weeks 12, 26, 52)
- Changes in fecal calprotectin (FC) levels(Weeks 12, 26, 52)
- Effective trough concentration of adalimumab(week 4)
- Growth and development of pediatric patients-Weight(Weeks 12, 26, 52)
- Growth and development of pediatric patients-Height(Weeks 12, 26, 52)