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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Fuyang People's Hospital
Fuyang, Anhui, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGZhoukou Central Hospital
Zhoukou, Henan, China
NOT_YET_RECRUITINGHuai'an First People's Hospital
Huaian, Jiangsu, China
NOT_YET_RECRUITINGYancheng No.1 People's Hospital
Yancheng, Jiangsu, China
NOT_YET_RECRUITINGMeihekou Central Hospital
Meihekou, Jilin, China
NOT_YET_RECRUITINGShanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGSerious Adverse Event (SAE)
Incidence rate of serious adverse events,the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Time frame: Baseline up to 54 weeks
Adverse Event (AE)
Incidence rate of adverse events,the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Time frame: Baseline up to 54 weeks
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.
Time frame: Baseline up to 54 weeks
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.
Time frame: Baseline up to 54 weeks
Clinical remission (CDAI < 150)
The proportion of subjects achieving clinical remission (CDAI score\<150) at Week 26
Time frame: At Week 26 post-dose
Clinical remission (CDAI < 150)
The proportion of subjects achieving clinical remission (CDAI \< 150) at Weeks 4, 12, and 52 post-dose.
Time frame: 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.
Time frame: At Weeks 4, 12, 26 and 52 post-dose
Endoscopic remission
The proportion of subjects achieving endoscopic remission at Week 26 post-dose
Time frame: 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.
Time frame: At Weeks 12, 26, and 52 post-dose
Fecal calprotectin (FC)
Changes in fecal calprotectin (FC) from baseline at Weeks 12, 26, and 52 after administration.
Time frame: At Weeks 12, 26, and 52 post-dose
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