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This study is a real-world clinical study of adalimumab. The project plans to enrol 30 participants and aims to evaluate the efficacy and safety of adalimumab in Chinese children with plaque psoriasis, with the primary endpoint being the proportion of participants achieving PASI 75 (PASI score reduction ≥75% from baseline) at week 16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab Solution for Injection 20mg/40mg | Experimental | For a body weight of 15 kg~30 kg, the initial dose is 20 mg, with 20mg administered every 2 weeks starting 1 week after the first dose. For a body weight ≥30 kg, the initial dose is 40 mg, with 40mg administered every 2 weeks starting 1 week after the first dose. |
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| 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. In March 2020, adalimumab was approved in China for the treatment of severe plaque psoriasis in children and adolescents aged four years and older who have not responded well to topical therapies and phototherapy or are unsuitable for such treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index 75 at week 16 | The proportion of subjects achieving PASI 75 at week 16 (PASI score decreased by ≥75% from baseline). | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index 75 at weeks 8, 32, and 52 | Proportion of subjects achieving PASI 75 at weeks 8, 32, and 52 | Week 8, Week 32, Week 52 |
| Psoriasis Area and Severity Index 90 | Proportion of subjects achieving PASI 90 (PASI score decreased by ≥90% from baseline) at weeks 8, 16, 32, and 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Yang, Doctor | Contact | 13922207231 | yangbin101@hotmail.com |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Week 8, Week 16, Week 32, Week 52 |
| Psoriasis Area and Severity Index 100 | Proportion of subjects achieving PASI 100 (100% reduction in PASI score from baseline) at Weeks 8, 16, 32 and 52 | Week 8, Week 16, Week 32, Week 52 |
| Achieve a Physician's Global Assessment (PGA) score of clear (0) or very mild (1) | Proportion of subjects who achieved a PGA score of clear (0) or almost clear (1) at weeks 8, 16, 32, and 52 | Week 8, Week 16, Week 32, Week 52 |
| Children's Dermatology Life Quality Index (CDLQI) score | The changes from baseline in the Children's Dermatology Life Quality Index (CDLQI) score at Weeks 8, 16, 32 and 52 were used to assess efficacy. | Week 8, Week 16, Week 32, Week 52 |
| Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs | Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs | Up to 54 weeks |