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Treatment of Chinese Adult Subjects With Moderate to Severe Crohn's Disease With Tabellvi®

2026年6月17日 更新者：Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Multicenter, Single-Arm Study to Evaluate the Effectiveness and Safety of Tabellvi® (Adalimumab) in Chinese Adult Subjects With Moderate to Severe Active Crohn's Disease in the Real-World Setting

This is a post-marketing real-world study designed to evaluate the efficacy and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial. A total of 50 subjects are planned to be enrolled. The primary endpoints include the incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs) and serious ADRs, as well as the proportion of subjects achieving clinical remission (CDAI score < 150) at Week 26.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

50

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
    • Anhui
      • Fuyang、Anhui、中国、236000
        • Fuyang People's Hospital
        • 接触：
    • Henan
      • Zhengzhou、Henan、中国、450014
        • The Second Affiliated Hospital of Zhengzhou University
        • 接触：
      • Zhoukou、Henan、中国、466000
    • Jiangsu
      • Huaian、Jiangsu、中国、223001
        • Huai'an first people's hospital
        • 接触：
      • Yancheng、Jiangsu、中国、224500
        • Yancheng No.1 People's Hospital
        • 接触：
    • Jilin
      • Meihekou、Jilin、中国、135022
        • Meihekou Central Hospital
        • 接触：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200001
        • Shanghai Jiao Tong University School of Medicine, Renji Hospital
        • 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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • The subject must sign the informed consent form.
  • Aged 18 to 70 years inclusive, no gender restriction.
  • Subjects with definite diagnosis of Crohn's disease in accordance with Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023), presenting moderate to severe active Crohn's disease with inadequate response, intolerance or contraindication to adequate glucocorticoid and/or immunosuppressant therapy.
  • Adult patients with Crohn's disease who are prescribed Tabellvi® Adalimumab Injection by physicians following thorough risk-benefit assessment.
  • Female subjects of childbearing potential must agree to use one contraceptive method approved by the investigator.

Exclusion Criteria:

  • Subjects who are not suitable for treatment with Tabellvi® Adalimumab Injection based on the prescribing information of Tabellvi® Adalimumab Injection and the judgment of the treating physician.
  • Female subjects who are pregnant or breastfeeding, or who plan to become pregnant during the study period.
  • Subjects with hypersensitivity to any component of Tabellvi® Adalimumab Injection.
  • Subjects with active, chronic or recurrent infections, or a medical history of invasive infections (e.g., listeriosis, histoplasmosis).
  • Subjects with active infections requiring intravenous anti-infective therapy within 30 days prior to the first dose, or those who have received oral anti-infective drugs within 14 days prior to the first dose.
  • Subjects with active tuberculosis infection; or latent tuberculosis infection without adequate treatment; subjects infected with human immunodeficiency virus (HIV); subjects positive for hepatitis C virus antibody (HCV Ab) indicating previous or current infection; subjects positive for hepatitis B surface antigen (HBsAg), or positive for total hepatitis B core antibody (total Hepatitis B core Ab) with positive hepatitis B virus (HBV)-DNA polymerase chain reaction test result.
  • Subjects with syphilis infection requiring treatment.
  • Subjects with moderate to severe heart failure (NYHA Class III/IV), recent cerebrovascular accident, or other medical conditions that may put the subject at risk by participating in this study.
  • Subjects with current evidence of dysplasia or a history of malignant tumors (including lymphoma and leukemia), except cured non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized cervical carcinoma in situ.
  • Subjects with a history of demyelinating diseases (including myelitis), or neurological symptoms suggestive of demyelinating diseases.
  • Subjects who have undergone intestinal resection within the past 6 months, or plan to undergo intestinal resection at any time in the future.
  • Subjects receiving total parenteral nutrition (TPN), or planning to receive TPN at any time during the study period.
  • Subjects with an ostomy or an ileal pouch-anal anastomosis (IPAA) pouch.
  • Subjects with internal or external fistulas, except perianal fistulas without abscess.
  • Subjects with known symptomatic obstructive intestinal strictures.
  • Subjects diagnosed with ulcerative colitis or indeterminate colitis.
  • Subjects with any of the following abnormal laboratory or other examination results during the screening period: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times the upper limit of the reference range; white blood cell count < 3.0×10⁹/L; electrocardiogram (ECG) with clinically significant abnormalities; total bilirubin ≥3 mg/dL (isolated elevated indirect bilirubin caused by Gilbert's syndrome excluded); serum creatinine >1.6 mg/dL.
  • Subjects with other clinically significant abnormal laboratory test results (other than those listed above) identified by the investigator during screening.
  • Subjects who have received other tumor necrosis factor-alpha (TNF-α) inhibitor therapy within 12 weeks before receiving the first dose of Tabellvi® Adalimumab Injection.
  • Subjects currently participating in another clinical study.
  • Subjects deemed unsuitable for participation in this trial by the investigator.

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：Tabellvi® Adalimumab Injection

The induction dosage is 160 mg at Week 0, followed by 80 mg at Week 2. After induction therapy, the recommended maintenance dosage is 40 mg administered subcutaneously once every 2 weeks.

Administer subcutaneously once every two weeks. For induction therapy, the dosage is 160 mg at Week 0, followed by 80 mg at Week 2. After induction therapy, the recommended maintenance dose is 40 mg administered subcutaneously once every two weeks.
药品：TyboWe® Adalimumab Injection
Adalimumab is a human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking 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
Serious Adverse Event (SAE)
大体时间：Baseline up to 54 weeks
Incidence rate of serious adverse events，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Baseline up to 54 weeks
Adverse Event (AE)
大体时间：Baseline up to 54 weeks
Incidence rate of adverse events，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Baseline up to 54 weeks
Adverse Drug Reaction (ADR)
大体时间：Baseline up to 54 weeks
Incidence rate of adverse drug reaction，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Baseline up to 54 weeks
Serious Adverse Drug Reaction
大体时间：Baseline up to 54 weeks
Incidence rate of serious adverse drug reaction，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Baseline up to 54 weeks
Clinical remission (CDAI < 150)
大体时间：At Week 26 post-dose
The proportion of subjects achieving clinical remission (CDAI score<150) at Week 26
At Week 26 post-dose

次要结果测量

结果测量
措施说明
大体时间
Clinical remission (CDAI < 150)
大体时间：At Weeks 4, 12, and 52 post-dose
The proportion of subjects achieving clinical remission (CDAI < 150) at Weeks 4, 12, and 52 post-dose.
At Weeks 4, 12, and 52 post-dose
Clinical response (reduction in CDAI ≥70 points from baseline)
大体时间：At Weeks 4, 12, 26 and 52 post-dose
The proportion of subjects achieving clinical response (CDAI reduction ≥70 points from baseline) at Weeks 4, 12, 26, and 52 post-dose.
At Weeks 4, 12, 26 and 52 post-dose
Endoscopic remission
大体时间：At Week 26 post-dose
The proportion of subjects achieving endoscopic remission at Week 26 post-dose
At Week 26 post-dose
C-reactive protein (CRP)
大体时间：At Weeks 12, 26, and 52 post-dose
Changes in C-reactive protein (CRP) from baseline at Weeks 12, 26, and 52 post-dose.
At Weeks 12, 26, and 52 post-dose
Fecal calprotectin (FC)
大体时间：At Weeks 12, 26, and 52 post-dose
Changes in fecal calprotectin (FC) from baseline at Weeks 12, 26, and 52 after administration.
At Weeks 12, 26, and 52 post-dose

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 (估计的)

2026年8月1日

初级完成 (估计的)

2028年12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6月17日

首先提交符合 QC 标准的

2026年6月17日

首次发布 (实际的)

2026年6月23日

研究记录更新

最后更新发布 (实际的)

2026年6月23日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年2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-02

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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