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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

50

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Serious Adverse Event (SAE)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：At Week 26 post-dose
The proportion of subjects achieving clinical remission (CDAI score<150) at Week 26
At Week 26 post-dose

二次結果の測定

結果測定
メジャーの説明
時間枠
Clinical remission (CDAI < 150)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2028年12月1日

研究の完了 (推定)

2029年3月1日

試験登録日

最初に提出

2026年6月17日

QC基準を満たした最初の提出物

2026年6月17日

最初の投稿 (実際)

2026年6月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月23日

QC基準を満たした最後の更新が送信されました

2026年6月17日

最終確認日

2026年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • ADM-IV-02

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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