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.
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.
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).
Single group
TyboWe® Adalimumab Injection
DrugAdalimumab 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.
Serious Adverse Event (SAE)
Incidence rate of serious adverse events，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Adverse Event (AE)
Incidence rate of adverse events，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Adverse Drug Reaction (ADR)
Incidence rate of adverse drug reaction，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Serious Adverse Drug Reaction
Incidence rate of serious adverse drug reaction，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Clinical remission (CDAI < 150)
The proportion of subjects achieving clinical remission (CDAI \< 150) at Weeks 4, 12, and 52 post-dose.
Clinical response (reduction in CDAI ≥70 points from baseline)
The proportion of subjects achieving clinical response (CDAI reduction ≥70 points from baseline) at Weeks 4, 12, 26, and 52 post-dose.
Endoscopic remission
The proportion of subjects achieving endoscopic remission at Week 26 post-dose
C-reactive protein (CRP)
Changes in C-reactive protein (CRP) from baseline at Weeks 12, 26, and 52 post-dose.
Click on the lead sponsor to view all of their trials.
