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This study is a real - world clinical research of adalimumab. The project plans to enroll 30 subjects, aiming to evaluate the incidence of serious adverse events (SAEs) within 12, 26, and 52 weeks after treatment; as well as the incidence of adverse events (AEs), adverse drug reactions (ADRs), adverse events of special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab Solution for Injection 20mg/40mg | Experimental | For children with a body weight of ≥ 40 kg, the recommended loading dose is 160 mg. Then, 80 mg is given 2 weeks later, and subsequently, 40 mg is administered every 2 weeks for maintenance treatment. For children with a body weight of 17 - 40 kg, the loading dose is 80 mg. 40 mg is given 2 weeks later, and then 20 mg is administered every 2 weeks for maintenance treatment. If necessary, the dosing frequency can be increased to once a week according to the results of therapeutic drug monitoring and/or clinical response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab Solution for Injection | Drug | Adalimumab is a fully human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking Tumor Necrosis Factor-α (TNF-α), a core inflammatory factor in psoriasis. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (AE), adverse drug reactions (ADR), adverse events of special interest (AESI) and serious ADR at 12, 26 and 52 weeks after treatment | The incidences of adverse events (AEs), adverse drug reactions (ADRs), adverse events of special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment | Weeks 12, 26, 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with clinical remission patients with moderate - to - severe active Crohn's disease in the real - world setting. | The proportion of patients achieving clinical remission (PCDAI ≤ 10 points) at 12, 26 and 52 weeks after treatment. | Weeks 12, 26, 52 |
| Proportion of patients with clinical response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lanlan Geng, Doctor | Contact | 18902268612 | 13622237569@163.com |
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The proportion of patients with clinical response (PCDAI score decreased by ≥ 15 points compared to the baseline) at 12, 26, and 52 weeks after treatment |
| Weeks 12, 26, 52 |
| Changes in C-reactive protein (CRP) levels | The changes in C - reactive protein (CRP) compared to the baseline level at 12, 26 and 52 weeks after treatment. | Weeks 12, 26, 52 |
| Changes in fecal calprotectin (FC) levels | The changes in fecal calprotectin (FC) compared to the baseline level at 12, 26 and 52 weeks after treatment. | Weeks 12, 26, 52 |
| Effective trough concentration of adalimumab | The effective trough concentration of adalimumab before the third injection of adalimumab (at 4 weeks). | week 4 |
| Growth and development of pediatric patients-Weight | Weight status of children's growth and development at Week 12, 26 and 52 after treatment . | Weeks 12, 26, 52 |
| Growth and development of pediatric patients-Height | Height status of children's growth and development at Weeks 12, 26 and 52 after treatment. | Weeks 12, 26, 52 |
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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