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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGTime of treatment failure in subjects
Time to treatment failure at week 6 or between weeks 6 and 24.
Time frame: Week 6, week 24
Proportion of subjects meeting treatment failure criteria
Proportion of subjects meeting the treatment failure criteria at week 6 and week 24
Time frame: Week 6, week 24
The proportion of subjects with inactive inflammatory choroidoretinitis and/or inflammatory retinal vasculopathy in both eyes
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Week 24
Changes in Visual Function Questionnaire-25 (VFQ-25)
Changes in visual function questionnaire VFQ-25 at week 6 and week 24
Time frame: 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.
Time frame: Week 24
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