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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tabellvi® Adalimumab Injection | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TyboWe® Adalimumab Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Baseline up to 54 weeks |
| Clinical remission (CDAI < 150) | The proportion of subjects achieving clinical remission (CDAI score<150) at Week 26 | At Week 26 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission (CDAI < 150) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Shen, Doctor | Contact | 13651829887 | shenjun@vip.163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuyang People's Hospital | Fuyang | Anhui | 236000 | China |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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 | The proportion of subjects achieving endoscopic remission at Week 26 post-dose | 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. | 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. | At Weeks 12, 26, and 52 post-dose |
| The Second Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450014 | China |
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| Zhoukou Central Hospital | Zhoukou | Henan | 466000 | China |
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| Huai'an First People's Hospital | Huaian | Jiangsu | 223001 | China |
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| Yancheng No.1 People's Hospital | Yancheng | Jiangsu | 224500 | China |
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| Meihekou Central Hospital | Meihekou | Jilin | 135022 | China |
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| Shanghai Jiao Tong University School of Medicine, Renji Hospital | Shanghai | Shanghai Municipality | 200001 | China |
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| D007410 | Intestinal Diseases |