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

17 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Serious Adverse Event (SAE)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: At Week 26 post-dose
The proportion of subjects achieving clinical remission (CDAI score<150) at Week 26
At Week 26 post-dose

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinical remission (CDAI < 150)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 december 2028

Avslutad studie (Beräknad)

1 mars 2029

Studieregistreringsdatum

Först inskickad

17 juni 2026

Först inskickad som uppfyllde QC-kriterierna

17 juni 2026

Första postat (Faktisk)

23 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 juni 2026

Senast verifierad

1 februari 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ADM-IV-02

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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