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

17 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

50

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Serious Adverse Event (SAE)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: At Week 26 post-dose
The proportion of subjects achieving clinical remission (CDAI score<150) at Week 26
At Week 26 post-dose

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Clinical remission (CDAI < 150)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2028

Conclusão do estudo (Estimado)

1 de março de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

17 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de junho de 2026

Primeira postagem (Real)

23 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de junho de 2026

Última verificação

1 de fevereiro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ADM-IV-02

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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