Tabellvi for moderate to severe Crohn's disease in Chinese adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a post-marketing, real-world, single-arm study enrolling 50 Chinese adults with moderate to severe Crohn's disease who have not adequately responded to or tolerated prior therapies. Participants receive TyboWe® Adalimumab Injection as part of routine clinical practice, with safety and efficacy tracked through adverse events and remission rates at Week 26. Primary endpoints include incidence of AEs, SAEs, ADRs, and serious ADRs, along with the proportion achieving CDAI < 150. The study aims to characterize real-world use and safety in a Chinese population under ongoing pharmacovigilance. Leading sponsor is Chia Tai Tianqing Pharmaceutical Group Co., Ltd., with participating sites in Fuyang, Zhengzhou, and Zhoukou.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Jiao Tong University School of Medicine, Renji Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Fuyang People's Hospital
  Fuyang, Anhui, China Not yet recruiting
• The Second Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Not yet recruiting
• Zhoukou Central Hospital
  Zhoukou, Henan, China Not yet recruiting
• Huai'an First People's Hospital
  Huaian, Jiangsu, China Not yet recruiting
• Yancheng No.1 People's Hospital
  Yancheng, Jiangsu, China Not yet recruiting

Study contacts

• Study coordinator: Jun Shen, Doctor
• Email: shenjun@vip.163.com
• Phone: 13651829887

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.