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A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease

2026年9月6日 更新者：Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

30

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国、510600
        • 招聘中
        • Women and Children's Medical Center, Guangzhou Medical University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • (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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：Adalimumab Solution for Injection
Adalimumab is a fully human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking Tumor Necrosis Factor-α (TNF-α), a core inflammatory factor in psoriasis.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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
Weeks 12, 26, 52

次要结果测量

结果测量
措施说明
大体时间
Proportion of patients with clinical remission patients with moderate - to - severe active Crohn's disease in the real - world setting.
大体时间：Weeks 12, 26, 52
The proportion of patients achieving clinical remission (PCDAI ≤ 10 points) at 12, 26 and 52 weeks after treatment.
Weeks 12, 26, 52
Proportion of patients with clinical response
大体时间：Weeks 12, 26, 52
The proportion of patients with clinical response (PCDAI score decreased by ≥ 15 points compared to the baseline) at 12, 26, and 52 weeks after treatment
Weeks 12, 26, 52
Changes in C-reactive protein (CRP) levels
大体时间：Weeks 12, 26, 52
The changes in C - reactive protein (CRP) compared to the baseline level at 12, 26 and 52 weeks after treatment.
Weeks 12, 26, 52
Changes in fecal calprotectin (FC) levels
大体时间：Weeks 12, 26, 52
The changes in fecal calprotectin (FC) compared to the baseline level at 12, 26 and 52 weeks after treatment.
Weeks 12, 26, 52
Effective trough concentration of adalimumab
大体时间：week 4
The effective trough concentration of adalimumab before the third injection of adalimumab (at 4 weeks).
week 4
Growth and development of pediatric patients-Weight
大体时间：Weeks 12, 26, 52
Weight status of children's growth and development at Week 12, 26 and 52 after treatment .
Weeks 12, 26, 52
Growth and development of pediatric patients-Height
大体时间：Weeks 12, 26, 52
Height status of children's growth and development at Weeks 12, 26 and 52 after treatment.
Weeks 12, 26, 52

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月13日

初级完成 (估计的)

2029年3月1日

研究完成 (估计的)

2029年3月1日

研究注册日期

首次提交

2026年4月24日

首先提交符合 QC 标准的

2026年4月29日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月6日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ADM-IV-01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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