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This study is a real-world clinical research on adalimumab. The project plans to enroll 30 subjects. The safety and efficacy of adalimumab injection for adult non-infectious uveitis are being investigated. The time of treatment failure for subjects at 6 weeks of treatment or between 6 and 24 weeks of treatment is the primary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TyboWe® Adalimumab Injection 40mg | Experimental | The initial subcutaneous dose is 80mg, followed by 40mg subcutaneous injections every 2 weeks starting 1 week after the first administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TyboWe® Adalimumab 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 (TNF) α, a core inflammatory factor in psoriasis. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of treatment failure in subjects | Time to treatment failure at week 6 or between weeks 6 and 24. | Week 6, week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects meeting treatment failure criteria | Proportion of subjects meeting the treatment failure criteria at week 6 and week 24 | Week 6, week 24 |
| The proportion of subjects with inactive inflammatory choroidoretinitis and/or inflammatory retinal vasculopathy in both eyes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manli Li, Doctor | Contact | 15093292527 | 343507699@qq.com |
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The proportion of subjects with inactive inflammatory choroidoretinitis and/or inflammatory retinal vasculopathy in both eyes at week 24 compared to the proportion of subjects with inactive inflammatory choroidoretinitis and/or inflammatory retinal vasculopathy in both eyes at baseline. |
| Week 24 |
| The proportion of subjects with anterior chamber (AC) cell grading of ≤0.5+ in both eyes | The proportion of subjects whose anterior chamber (AC) cell grading reached ≤0.5+ in both eyes at week 24. | Week 24 |
| The proportion of subjects with bilateral vitreous opacity (VH) grading of ≤0.5+ | The proportion of subjects with a vitreous opacity (VH) grading of ≤0.5+ in both eyes at week 24 | Week 24 |
| The proportion of subjects whose best corrected visual acuity (BCVA) in both eyes has not deteriorated to ≥15 letters | In the Early Treatment Diabetic Retinopathy Study (ETDRS), the proportion of subjects whose best corrected visual acuity (BCVA) in both eyes did not deteriorate to ≥15 letters at week 24. | Week 24 |
| The proportion of subjects whose systemic corticosteroid dose is reduced to ≤7.5mg | The proportion of subjects whose systemic corticosteroid dose was reduced to ≤7.5mg at week 24. | Week 24 |
| Changes in Visual Function Questionnaire-25 (VFQ-25) | Changes in visual function questionnaire VFQ-25 at week 6 and week 24 | Week 6, week 24 |
| Incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and serious ADRs | Incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and serious ADRs. | Week 24 |